TY - JOUR AU - Keefe, M. Janice AU - McCloskey, Rose AU - Hodgins, J. Marilyn AU - McArthur, Caitlin AU - MacKenzie, Adrian AU - Weeks, E. Lori AU - Estabrooks, A. Carole PY - 2025/3/31 TI - Examining Quality of Work Life in Atlantic Canadian Long-Term Care Homes: Protocol for a Cross-Sectional Survey Study JO - JMIR Res Protoc SP - e66338 VL - 14 KW - residential long-term care KW - care staff KW - Atlantic Canada KW - quality of work life KW - work environment KW - health and well-being N2 - Background: The Canadian long-term care (LTC) workforce cares for increasingly complex residents. With greater care needs come greater demands. Despite this, LTC staffing and resources are largely unchanged and underresearched over the last decade. The Atlantic provinces are home to the oldest population in Canada, indicating a high need for LTC. The health and well-being of the LTC workforce are critical components of care quality, yet only in Western Canada are such data routinely and systematically collected. Translating Research in Elder Care is a 2-decade research program studying the LTC work environment and has found strong links between the working conditions of LTC staff and resident outcomes. We draw upon their success to generate the evidence needed to understand, support, and manage the LTC workforce in Canada?s four Atlantic provinces. Objective: This study aims (1) to assess the quality of work life among staff in LTC homes in Atlantic Canada; (2) to examine the effects of the work environment on the quality of work life; and (3) to build capacity for research in the LTC sector in Atlantic Canada among knowledge users, researchers, and trainees. The objective of this paper is to describe the approach needed to examine the quality of work life and health of care staff in LTC homes. Methods: Stratified random sampling will be used to recruit homes in Atlantic Canada. The sampling frame was designed to recruit 25% of the LTC homes in each of the 4 provinces with proportional representation by size; ownership model; and, if applicable, region or language. Key outcome variables include measures of mental health and well-being, quality of work life, intention to leave, workplace context, and missed or rushed care. Primary data will be obtained through structured interviews with care aides and web-based surveys from registered nurses, licensed practical nurses, managers, and allied health providers. Eligible participants were from an LTC home with at least 25 residents, 90% of whom were aged 65 years or older, and had worked in the home for at least 3 months. Multivariate analyses include regression analysis for explaining predictors of quality of work-life outcomes and multilevel modeling for more complex relationships of staff outcomes by provinces and LTC home characteristics. Results: Data collection and cleaning are complete as of October 2024 (N=2305). Care aides (n=1338), nurses (n=724), allied health providers (n=154), and managers (n=89) from 53 homes make up the sample. Data analysis is ongoing. Initially, individual reports will present descriptive data for each participating LTC home. Concurrent analysis is planned for publication in peer-reviewed journals. Conclusions: This peer-reviewed research protocol lays the foundation for a comprehensive analysis of the effects of the work environment on the quality of work life of LTC staff in Atlantic Canada. International Registered Report Identifier (IRRID): DERR1-10.2196/66338 UR - https://www.researchprotocols.org/2025/1/e66338 UR - http://dx.doi.org/10.2196/66338 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/66338 ER - TY - JOUR AU - Munce, P. Sarah E. AU - Jarrett, Clementine AU - Senthilnathan, Vjura AU - Luong, Dorothy AU - Allemang, Brooke AU - Bailey, Katherine AU - Biddiss, Elaine AU - Britto, T. Maria AU - Buchanan, Francine AU - Cassidy, Christine AU - Cross, Andrea AU - Cunningham, Jessie AU - Dimitropoulos, Gina AU - Hadland, E. Scott AU - Kastner, Monika AU - Killackey, Tieghan AU - Kokorelias, Kristina AU - Macarthur, Colin AU - Micsinszki, Samantha AU - Niles, Chavon AU - Wright, Virginia F. AU - Toulany, Alene PY - 2025/3/28 TI - Development of a Framework for Youth- and Family-Specific Engagement in Research: Proposal for a Scoping Review and Qualitative Descriptive Study JO - JMIR Res Protoc SP - e65733 VL - 14 KW - youth and family engagement KW - frameworks KW - implementation science KW - scoping review KW - qualitative N2 - Background: Youth and families play an indispensable role in health research, given their unique lived experiences and expertise. Aligning research with patients? needs, values, and preferences can significantly enhance its relevance and impact; however, recent research has highlighted various challenges and risks associated with youth and family engagement in health research. These challenges encompass the perils of tokenism, power imbalances and dynamics, questioning the motives behind engagement, and limited accessibility to patient-friendly training for patient partners, as well as inadequate training on patient engagement for researchers and the absence of equitable engagement tools. To address these risks and challenges, different patient engagement models, theories, frameworks, and guiding principles have been developed and adopted; to date, however, their transferability to youth- and family-specific engagement in research has been limited. Objective: The objectives of this project are (1) to determine the extent of the literature on the application of patient engagement models, theories, frameworks, and guiding principles in the context of youth-specific research; and (2) to determine how meaningful the key components and constructs of these models, theories, frameworks, and guiding principles are to youth and their family members. Methods: This project will use an integrated knowledge translation approach and consists of 2 phases: (1) a scoping review to identify patient engagement models, theories, frameworks and guiding principles in youth research; and (2) a qualitative descriptive study using one-on-one semistructured interviews with youth and family members to understand their conceptualization of meaningful engagement in health research. For phase 1, the following databases were searched: Medline, CINAHL, EMBASE, PsycINFO, and the Cochrane Central Register of Controlled Trials. Literature from 2013 to August 28, 2024, was captured. Primary studies using a patient engagement in research model, theory, or framework, or guiding principles, in youth will be included. The risk of bias of included studies will not be assessed. Extracted data will be quantitatively summarized using numerical counts and qualitatively using content analysis. For phase 2, we will recruit 9 to 17 youth and 9 to 17 family members. Transcripts will be analyzed using an inductive approach outlined by Braun and Clarke. Results: The project has received funding from the Canadian Institutes of Health Research. A 9-member integrated knowledge translation panel consisting of 6 youth and 3 family members has been established. Conclusions: The findings from this study will identify what is currently known about the application of patient engagement models, theories, frameworks, and guiding principles in youth-specific research and the important components of these models, theories, frameworks, and guiding principles from the perspective of youth and their families. These findings will be instrumental to developing a youth- and family-specific engagement in research framework called the UNITE framework and subsequently, a validated measure. International Registered Report Identifier (IRRID): PRR1-10.2196/65733 UR - https://www.researchprotocols.org/2025/1/e65733 UR - http://dx.doi.org/10.2196/65733 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/65733 ER - TY - JOUR AU - Gélinas, Céline AU - Shahiri T, Shiva AU - Wang, Ting Han AU - Gallani, Cecilia Maria AU - Oulehri, Walid AU - Laporta, Denny AU - Richebé, Philippe PY - 2025/2/28 TI - Validation of the Nociception Level Index for the Detection of Nociception and Pain in Critically Ill Adults: Protocol for an Observational Study JO - JMIR Res Protoc SP - e60672 VL - 14 KW - validation KW - NOL KW - Nociception Level KW - nociception KW - pain KW - intensive care unit KW - ICU KW - critical care KW - protocol N2 - Background: In the intensive care unit (ICU), many patients are unable to communicate their pain through self-reporting or behaviors due to their critical care condition, mechanical ventilation, and medication (eg, heavily sedated or chemically paralyzed). Therefore, alternative pain assessment methods are urgently needed for this vulnerable patient population. The Nociception Level (NOL) index is a multiparameter technology initially developed for the monitoring of nociception and related pain in anesthetized patients, and its use in the ICU is new. Objective: This study aims to validate the NOL for the assessment of nociception and related pain in critically ill adults in the ICU. Specific objectives are to examine the ability of the NOL to: (1) detect pain using standard criteria (ie, self-report and behavioral measures), (2) discriminate between nociceptive and nonnociceptive procedures, and (3) generate consistent values when patients are at rest. Methods: The NOL will be monitored in three ICU patient groups: (1) Group A, participants able to self-report their pain (the reference standard criterion using the 0-10 Faces Pain Thermometer) and express behaviors; (2) Group B, participants unable to self-report but able to express behaviors (the alternative standard criterion using the Critical-Care Pain Observation Tool); and (3) Group C, participants unable to self-report and express behaviors. The NOL will be tested before, during, and after two types of standard care procedures: (1) nonnociceptive (eg, cuff inflation to measure blood pressure, soft touch) and (2) nociceptive (eg, tube or drain removal, endotracheal or tracheal suctioning). Receiver operating characteristic curve analysis of the NOL will be performed for Groups A and B using pain standard measures as reference criteria. Mixed linear models for repeated measures will be used to compare time points, procedures, and their interaction in each group (A, B, and C). Based on power analyses and considering an attrition rate of 25%, a total sample size of 146 patients (68 in Group A, 62 in Group B, and 16 in Group C) is targeted. Results: This study was funded in April 2020 but could not be launched until 2022 due to the COVID-19 pandemic. Recruitment and data collection began at the primary site in July 2022 and has been implemented at the secondary sites in 2023 and 2024 and is planned to continue until 2026. Conclusions: The primary strength of this study protocol is that it is based on rigorous validation strategies with the use of pain standard criteria (ie, self-report and behavioral measures). If found to be valid, the NOL could be used as an alternative physiologic measure of pain in critically ill adults for whom no other pain assessment methods are available. Trial Registration: ClinicalTrials.gov NCT05339737; https://clinicaltrials.gov/study/NCT05339737 International Registered Report Identifier (IRRID): DERR1-10.2196/60672 UR - https://www.researchprotocols.org/2025/1/e60672 UR - http://dx.doi.org/10.2196/60672 UR - http://www.ncbi.nlm.nih.gov/pubmed/40053798 ID - info:doi/10.2196/60672 ER - TY - JOUR AU - Heels-Ansdell, Diane AU - Kelly, Laurel AU - O'Grady, K. Heather AU - Farley, Christopher AU - Reid, C. Julie AU - Berney, Sue AU - Pastva, M. Amy AU - Burns, EA Karen AU - D'Aragon, Frédérick AU - Herridge, S. Margaret AU - Seely, Andrew AU - Rudkowski, Jill AU - Rochwerg, Bram AU - Fox-Robichaud, Alison AU - Ball, Ian AU - Lamontagne, Francois AU - Duan, H. Erick AU - Tsang, Jennifer AU - Archambault, M. Patrick AU - Verceles, C. Avelino AU - Muscedere, John AU - Mehta, Sangeeta AU - English, W. Shane AU - Karachi, Tim AU - Serri, Karim AU - Reeve, Brenda AU - Thabane, Lehana AU - Cook, Deborah AU - Kho, E. Michelle PY - 2024/10/28 TI - Early In-Bed Cycle Ergometry With Critically Ill, Mechanically Ventilated Patients: Statistical Analysis Plan for CYCLE (Critical Care Cycling to Improve Lower Extremity Strength), an International, Multicenter, Randomized Clinical Trial JO - JMIR Res Protoc SP - e54451 VL - 13 KW - rehabilitation KW - mechanical ventilation KW - cycle ergometry KW - critical illness KW - exercise therapy KW - recovery of function N2 - Background: Survivors of critical illness are at risk of developing physical dysfunction following intensive care unit (ICU) discharge. ICU-based rehabilitation interventions, such as early in-bed cycle ergometry, may improve patients? short-term physical function. Objective: Before unblinding and trial database lock, we describe a prespecified statistical analysis plan (SAP) for the CYCLE (Critical Care Cycling to Improve Lower Extremity Strength) randomized controlled trial (RCT). Methods: CYCLE is a 360-patient, international, multicenter, open-label, parallel-group RCT (1:1 ratio) with blinded primary outcome assessment at 3 days post-ICU discharge. The principal investigator and statisticians of CYCLE prepared this SAP with approval from the steering committee and coinvestigators. The SAP defines the primary and secondary outcomes (including adverse events) and describes the planned primary, secondary, and subgroup analyses. The primary outcome of the CYCLE trial is the Physical Function Intensive Care Unit Test-scored (PFIT-s) at 3 days post-ICU discharge. The PFIT-s is a reliable and valid performance-based measure. We plan to use a frequentist statistical framework for all analyses. We will conduct a linear regression to evaluate the primary outcome, incorporating randomization as an independent variable and adjusting for age (?65 years versus <65 years) and center. The regression results will be reported as mean differences in PFIT-s scores with corresponding 95% CIs and P values. We consider a 1-point difference in PFIT-s score to be clinically important. Additionally, we plan to conduct 3 subgroup analyses: age (?65 years versus <65 years), frailty (Baseline Clinical Frailty Scale ?5 versus <5), and sex (male versus female). Results: CYCLE was funded in 2017, and enrollment was completed in May 2023. Data analyses are complete, and the first results were submitted for publication in 2024. Conclusions: We developed and present an SAP for the CYCLE RCT and will adhere to it for all analyses. This study will add to the growing body of evidence evaluating the efficacy and safety of ICU-based rehabilitation interventions. Trial Registration: ClinicalTrials.gov NCT03471247; https://clinicaltrials.gov/ct2/show/NCT03471247 and NCT02377830; https://clinicaltrials.gov/ct2/show/NCT02377830 International Registered Report Identifier (IRRID): RR1-10.2196/54451 UR - https://www.researchprotocols.org/2024/1/e54451 UR - http://dx.doi.org/10.2196/54451 UR - http://www.ncbi.nlm.nih.gov/pubmed/ ID - info:doi/10.2196/54451 ER - TY - JOUR AU - Taylor, Marin AU - Bondi, Christina Bianca AU - Andrade, F. Brendan AU - Au-Young, H. Stephanie AU - Chau, Vann AU - Danguecan, Ashley AU - Désiré, Naddley AU - Guo, Ting AU - Ostojic-Aitkens, Dragana AU - Wade, Shari AU - Miller, Steven AU - Williams, Samantha Tricia PY - 2024/10/4 TI - Stepped-Care Web-Based Parent Support Following Congenital Heart Disease: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e64216 VL - 13 KW - congenital heart disease KW - neurodevelopmental outcomes KW - web-based mental health care KW - stepped care KW - positive parenting KW - family well-being KW - mental health KW - I-InTERACT-North N2 - Background: Early neurodevelopmental risks, compounded with traumatic medical experiences, contribute to emotional and behavioral challenges in as many as 1 in 2 children with congenital heart disease (CHD). Parents report a strong need for supports; yet, there remains a lack of accessible, evidence-based behavioral interventions available for children with CHD and their families. I-InTERACT-North is a web-based stepped-care mental health program designed to support family well-being and reduce behavioral concerns through positive parenting for children with early medical complexity. In previous pilot studies, the program was effective in increasing positive parenting skills and decreasing child behavior problems, with high parent-reported acceptability. This paper presents the protocol for the first randomized study of stepped-care parent support for families of children with CHD. Objective: This study will involve a single-site, 2-arm, single-blind randomized controlled trial to evaluate (1) the feasibility and acceptability of a web-based stepped-care parent support program (I-InTERACT-North) and (2) the effectiveness of the program in enhancing positive parenting skills and reducing behavioral concerns among families of children with CHD. Methods: Families will be randomized (1:1) to either receive treatment or continue with care as usual for 12 months. Randomization will be stratified by child?s sex assigned at birth and baseline parent-reported child behavior intensity. Primary outcomes include positive parenting skills and child behavior at baseline, 3 months, 6 months, and 12 months. Secondary outcomes include parental mental health, quality of life, service usage, and feasibility including program reach and adherence. A sample size of 244 families will provide >95% power to detect an effect size of d=0.64. Based on attrition data from pilot studies, a target of 382 families will be enrolled. Parent reports of acceptability, adoption, and suggested adaptability of the program will be examined using cross-case thematic analyses. Primary efficacy analysis will be conducted using an intent-to-treat approach. Generalized estimating equations will be used to examine changes in positive parenting. Child behavior, quality of life, and parent mental health will be tested with repeated-measures analyses. Additional sensitivity and replication analyses will also be carried out. Results: Recruitment began in February 2024, and recruitment and follow-up will continue until January 2029. We anticipate results in late 2029. Conclusions: This study aims to test the effectiveness of I-InTERACT-North web-based stepped-care parent support in improving positive parenting skills and reducing child behavior problems in families of children with CHD compared with a care as usual control group. Results will inform future clinical implementation and expansion of this program among families of children with early medical conditions. Trial Registration: ClinicalTrials.gov NCT06075251; https://clinicaltrials.gov/study/NCT06075251 International Registered Report Identifier (IRRID): DERR1-10.2196/64216 UR - https://www.researchprotocols.org/2024/1/e64216 UR - http://dx.doi.org/10.2196/64216 UR - http://www.ncbi.nlm.nih.gov/pubmed/39365658 ID - info:doi/10.2196/64216 ER - TY - JOUR AU - Toulany, Alene AU - Khodyakov, Dmitry AU - Mooney, Sarah AU - Stromquist, Lisa AU - Bailey, Katherine AU - Barber, EH Claire AU - Batthish, Michelle AU - Cleverley, Kristin AU - Dimitropoulos, Gina AU - Gorter, Willem Jan AU - Grahovac, Danijela AU - Grimes, Ruth AU - Guttman, Beverly AU - Hébert, L. Michèle AU - John, Tomisin AU - Lo, Lisha AU - Luong, Dorothy AU - MacGregor, Laura AU - Mukerji, Geetha AU - Pidduck, Jacklynn AU - Senthilnathan, Vjura AU - Shulman, Rayzel AU - Trbovich, Patricia AU - Munce, EP Sarah PY - 2024/9/10 TI - Quality Indicators for Transition from Pediatric to Adult Care for Youth With Chronic Conditions: Proposal for an Online Modified Delphi Study JO - JMIR Res Protoc SP - e60860 VL - 13 KW - transition to adult care KW - adolescent health KW - chronic conditions KW - quality indicators KW - consensus KW - caregivers KW - adolescent KW - stakeholder engagement KW - patient engagement KW - Delphi N2 - Background: The transition from pediatric to adult care poses a significant health system?level challenge impeding the delivery of quality health services for youth with chronic health conditions. In Canada and globally, the transition to adult care is regarded as a top priority in adolescent health in need of readily applicable, adaptable, and relevant national metrics to evaluate and benchmark transition success across disease populations and clinical care settings. Unfortunately, existing literature fails to account for the lack of engagement from youth and caregivers in developing indicators, and its applicability across chronic conditions, primary care involvement, and health equity considerations. Objective: Our proposed study aims to establish a consensus-driven set of quality indicators for the transition to adult care that are universally applicable across physical, developmental, and mental health conditions, clinical care settings, and health jurisdictions. Methods: Using an integrated knowledge translation (iKT) approach, a panel comprising youth, caregivers, interdisciplinary health care providers, and health system leaders will be established to collaborate with our research team to ensure that the study methodology, materials, and knowledge dissemination are suitable and reflect the perspectives of youth and their families. We will then conduct an iterative 3-round Online Modified Delphi (OMD) study (n=160) to (1) compare and contrast the perspectives of youth, caregivers, health care providers, and health system leaders on quality indicators for transition; and (2) prioritize a key set of quality indicators for transition applicable across disease populations that are the most important, useful, and feasible in the Canadian context. Using the RAND/UCLA Appropriateness Method (RAM) multistage analytic approach, data from each panel and stakeholder group will be examined separately and compared to establish a key set of indicators endorsed by both panels. Results: The study is funded by the Canadian Institutes of Health Research and Physicians Services Incorporated. Conclusions: This study will produce quality indicators to evaluate and inform action equitably to improve transition from pediatric to adult care for youth and their families in Canada. International Registered Report Identifier (IRRID): PRR1-10.2196/60860 UR - https://www.researchprotocols.org/2024/1/e60860 UR - http://dx.doi.org/10.2196/60860 UR - http://www.ncbi.nlm.nih.gov/pubmed/38889353 ID - info:doi/10.2196/60860 ER - TY - JOUR AU - Berthelot, Simon AU - Longtin, Yves AU - Margni, Manuele AU - Guertin, Robert Jason AU - LeBlanc, Annie AU - Marx, Tania AU - Mangou, Khadidiatou AU - Bluteau, Ariane AU - Mantovani, Diego AU - Mikhaylin, Sergey AU - Bergeron, Frédéric AU - Dancause, Valérie AU - Desjardins, Anne AU - Lahrichi, Nadia AU - Martin, Danielle AU - Sossa, Jérôme Charles AU - Lachapelle, Philippe AU - Genest, Isabelle AU - Schaal, Stéphane AU - Gignac, Anne AU - Tremblay, Stéphane AU - Hufty, Éric AU - Bélanger, Lynda AU - Beatty, Erica PY - 2023/12/7 TI - Postpandemic Evaluation of the Eco-Efficiency of Personal Protective Equipment Against COVID-19 in Emergency Departments: Proposal for a Mixed Methods Study JO - JMIR Res Protoc SP - e50682 VL - 12 KW - COVID-19 KW - SARS-CoV-2 KW - personal protective equipment KW - emergency department KW - health care workers KW - systematic review KW - cost-consequence analysis KW - time-driven activity-based costing KW - life cycle assessment KW - ecological footprint N2 - Background: The COVID-19 pandemic has had a profound impact on emergency department (ED) care in Canada and around the world. To prevent transmission of COVID-19, personal protective equipment (PPE) was required for all ED care providers in contact with suspected cases. With mass vaccination and improvements in several infection prevention components, our hypothesis is that the risks of transmission of COVID-19 will be significantly reduced and that current PPE use will have economic and ecological consequences that exceed its anticipated benefits. Evidence is needed to evaluate PPE use so that recommendations can ensure the clinical, economic, and environmental efficiency (ie, eco-efficiency) of its use. Objective: To support the development of recommendations for the eco-efficient use of PPE, our research objectives are to (1) estimate the clinical effectiveness (reduced transmission, hospitalizations, mortality, and work absenteeism) of PPE against COVID-19 for health care workers; (2) estimate the financial cost of using PPE in the ED for the management of suspected or confirmed COVID-19 patients; and (3) estimate the ecological footprint of PPE use against COVID-19 in the ED. Methods: We will conduct a mixed method study to evaluate the eco-efficiency of PPE use in the 5 EDs of the CHU de Québec-Université Laval (Québec, Canada). To achieve our goals, the project will include four phases: systematic review of the literature to assess the clinical effectiveness of PPE (objective 1; phase 1); cost estimation of PPE use in the ED using a time-driven activity-based costing method (objective 2; phase 2); ecological footprint estimation of PPE use using a life cycle assessment approach (objective 3; phase 3); and cost-consequence analysis and focus groups (integration of objectives 1 to 3; phase 4). Results: The first 3 phases have started. The results of these phases will be available in 2023. Phase 4 will begin in 2023 and results will be available in 2024. Conclusions: While the benefits of PPE use are likely to diminish as health care workers? immunity increases, it is important to assess its economic and ecological impacts to develop recommendations to guide its eco-efficient use. Trial Registration: PROSPERO CRD42022302598; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=302598 International Registered Report Identifier (IRRID): DERR1-10.2196/50682 UR - https://www.researchprotocols.org/2023/1/e50682 UR - http://dx.doi.org/10.2196/50682 UR - http://www.ncbi.nlm.nih.gov/pubmed/38060296 ID - info:doi/10.2196/50682 ER - TY - JOUR AU - Guay-Bélanger, Sabrina AU - Aubin, Emmanuelle AU - Cimon, Marie AU - Archambault, Patrick AU - Blanchette, Virginie AU - Giguere, Anik AU - Gogovor, Amédé AU - Morin, Michèle AU - Ben Charif, Ali AU - Ben Gaied, Nouha AU - Bickerstaff, Julie AU - Chénard, Nancy AU - Emond, Julie AU - Gilbert, Julie AU - Violet, Isabelle AU - Légaré, France PY - 2023/11/20 TI - Engagement of Older Adults Receiving Home Care Services and Their Caregivers in Health Decisions in Partnership With Clinical Teams: Protocol for a Multimethod Study to Prioritize and Culturally Adapt Decision Aids for Home Care JO - JMIR Res Protoc SP - e53150 VL - 12 KW - shared decision making KW - patient-centered care KW - home care KW - older adults KW - caregivers KW - decision aids KW - scalability assessment KW - innovation scalability self-administered questionnaire KW - interprofessional KW - team based N2 - Background: Older adults (people aged 65 years and older) face many difficult decisions. Patient decision aids (PtDAs) can help them and their families make informed value-congruent decisions. Some PtDAs have been developed for the home care context, but little is known about scaling them for use with older adults in a different culture. Objective: This study aims to (1) assess the scalability of existing PtDAs for older adults in the home care context; (2) prioritize those that best match the decisional needs of older adults in home care; and (3) culturally adapt the prioritized PtDAs so they can be scaled successfully to the Quebec health care system. Methods: This multimethod study includes 3 phases. All phases will be overseen by a steering committee of older adults, caregivers, health professionals, decision makers, community organization representatives, and researchers with the needed expertise. In phase 1, we will use the Innovation Scalability Self-administered Questionnaire, a validated scalability self-assessment tool, to assess the scalability of 33 PtDAs previously identified in a systematic review. Based on their scalability, their quality (based on the International Patient Decision Aids Standards), and the importance of the decision point, we will retain approximately a third of these. In phase 2, we will conduct a 2-round web-based Delphi to prioritize the PtDAs selected in phase 1. Using a snowball recruitment strategy, we aim to recruit 60 Delphi participants in the province of Quebec, including older adults, caregivers, health professionals, decision makers involved in home care services, and PtDA experts. In the first round, we will ask participants to rate the importance of several PtDA decision points according to various criteria such as prevalence and difficulty on a 5-point Likert scale (1=not important to 5=very important). Approximately 6 of the highest-rated PtDAs will be retained for presentation in the second round, and we will select up to 3 PtDAs judged as having the highest priority for cultural adaptation. In phase 3, using the Chenel framework and user-centered design methods, we will update and adapt the PtDAs to the Quebec health care system and integrate these PtDAs into an interprofessional shared decision-making training program for home care teams. The adapted PtDAs will respect the International Patient Decision Aids Standards criteria. Results: This study was funded in March 2022 by the Canadian Institutes of Health Research. Data collection for the web-based Delphi began in October 2023. Results are expected to be published in May 2024. Conclusions: This project will provide relevant and culturally appropriate decision support tools for older adults making difficult decisions and their home care teams that will be ready for scaling across the province of Quebec. International Registered Report Identifier (IRRID): PRR1-10.2196/53150 UR - https://www.researchprotocols.org/2023/1/e53150 UR - http://dx.doi.org/10.2196/53150 UR - http://www.ncbi.nlm.nih.gov/pubmed/37889512 ID - info:doi/10.2196/53150 ER - TY - JOUR AU - Munce, EP Sarah AU - Steele Gray, Carolyn AU - Pomeroy, Claire Beverley AU - Bayley, Mark AU - Kokorelias, Marie Kristina AU - Luong, Dorothy AU - Biddiss, Elaine AU - Cave, Trish AU - Bragge, Peter AU - Chew-Graham, A. Carolyn AU - Colquhoun, Heather AU - Dadich, Ann AU - Dainty, N. Katie AU - Elliott, Mark AU - Feng, Patrick AU - Goldhar, Jodeme AU - Hamilton, B. Clayon AU - Harvey, Gillian AU - Kastner, Monika AU - Kothari, Anita AU - Langley, Joe AU - Jeffs, Lianne AU - Masterson, Daniel AU - Nelson, LA Michelle AU - Perrier, Laure AU - Riley, John AU - Sellen, Kate AU - Seto, Emily AU - Simpson, Robert AU - Staniszewska, Sophie AU - Srinivasan, Vasanthi AU - Straus, E. Sharon AU - Tricco, C. Andrea AU - Kuluski, Kerry PY - 2023/10/30 TI - Development of the Preferred Components for Co-Design in Research Guideline and Checklist: Protocol for a Scoping Review and a Modified Delphi Process JO - JMIR Res Protoc SP - e50463 VL - 12 KW - co-design KW - reporting KW - guidelines KW - complex health intervention KW - scoping review KW - consensus N2 - Background: There is increasing evidence that co-design can lead to more engaging, acceptable, relevant, feasible, and even effective interventions. However, no guidance is provided on the specific designs and associated methods or methodologies involved in the process. We propose the development of the Preferred Components for Co-design in Research (PRECISE) guideline to enhance the consistency, transparency, and quality of reporting co-design studies used to develop complex health interventions. Objective: The aim is to develop the first iteration of the PRECISE guideline. The purpose of the PRECISE guideline is to improve the consistency, transparency, and quality of reporting on studies that use co-design to develop complex health interventions. Methods: The aim will be achieved by addressing the following objectives: to review and synthesize the literature on the models, theories, and frameworks used in the co-design of complex health interventions to identify their common elements (components, values or principles, associated methods and methodologies, and outcomes); and by using the results of the scoping review, prioritize the co-design components, values or principles, associated methods and methodologies, and outcomes to be included in the PRECISE guideline. Results: The project has been funded by the Canadian Institutes of Health Research. Conclusions: The collective results of this project will lead to a ready-to-implement PRECISE guideline that outlines a minimum set of items to include when reporting the co-design of complex health interventions. The PRECISE guideline will improve the consistency, transparency, and quality of reports of studies. Additionally, it will include guidance on how to enact or enable the values or principles of co-design for meaningful and collaborative solutions (interventions). PRECISE might also be used by peer reviewers and editors to improve the review of manuscripts involving co-design. Ultimately, the PRECISE guideline will facilitate more efficient use of new results about complex health intervention development and bring better returns on research investments. International Registered Report Identifier (IRRID): PRR1-10.2196/50463 UR - https://www.researchprotocols.org/2023/1/e50463 UR - http://dx.doi.org/10.2196/50463 UR - http://www.ncbi.nlm.nih.gov/pubmed/37902812 ID - info:doi/10.2196/50463 ER - TY - JOUR AU - Howard, Michelle AU - Aubrey-Bassler, Kris AU - Drummond, Neil AU - Lussier, Marie-Thérèse AU - Queenan, A. John AU - Vanstone, Meredith AU - Nicholson, Kathryn AU - Ramdyal, Amanda AU - Lawson, Jennifer AU - Hafid, Shuaib AU - Freeman, Karla AU - Clark, Rebecca AU - Mangin, Dee PY - 2023/7/21 TI - Effects of the COVID-19 Pandemic on Primary Health Care for Chronic Conditions in Canada: Protocol for a Retrospective Pre-Post Study Using National Practice-Based Research Network Data JO - JMIR Res Protoc SP - e49131 VL - 12 KW - COVID-19 KW - chronic disease KW - primary health care KW - electronic health record KW - health services research KW - retrospective studies N2 - Background: Since the COVID-19 pandemic began, there have been concerns that interruptions to the health care system may have led to changes in primary care, especially for care of chronic conditions such as diabetes and heart failure. Such changes may have longer term implications for population health. Objective: This study aims to describe the impacts of the COVID-19 pandemic on indicators of primary care access, comprehensiveness, and appropriateness among adult patients, as well as on specific indictors of chronic conditions. Additionally, this study aims to determine whether any identified changes were associated with patient sociodemographic characteristics and multimorbidity. Methods: This is a retrospective, single-arm, pre-post study using Canadian Primary Care Sentinel Surveillance Network (CPCSSN) data. CPCSSN is a research network supported by a primary care electronic medical record database, comprising over 1500 physicians and nearly 2 million patients. We are examining changes in care (eg, frequency of contacts, laboratory tests and investigations, referrals, medications prescribed, etc) among adults. We will also examine indicators specific to evidence-based recommendations for care in patients with diabetes and those with heart failure. We will compare rates of outcomes during key periods of the pandemic between March 13, 2020, and December 31, 2022, with equal time periods before the pandemic. Differences will be examined among specific subgroups of adults, including by decade of age, number of comorbidities, and socioeconomic status. Regression models appropriate to outcome distributions will be used to estimate changes, adjusting for potential confounders. This analysis is part of a mixed-methods study with a qualitative component investigating how patients with diabetes with or without concurrent heart failure perceived the impact of the pandemic on access to primary care and health care?related decisions. This study was approved by the Hamilton Integrated Research Ethics Board (14782-C). Results: The start date of this study was October 5, 2022, and the prospective end date is January 31, 2024. As of May 2023, the study cohort (n=875,934) is defined, data cleaning is complete, and exploratory analyses have begun. Extended analyses using 2022 data are planned once the new data becomes available. We will disseminate results through peer-reviewed publications and academic conference, as well as creating evidence briefs, infographics, and a video for policy maker and patient audiences. Conclusions: This study will investigate whether the COVID-19 pandemic has resulted in changes in the provision of primary care in Canada and whether these potential changes have led to gaps in care. This study will also identify patient-level characteristics associated with changes in care patterns across the COVID-19 pandemic. Indicators specific to chronic conditions, namely diabetes and heart failure, will also be explored to determine whether there were changes in care of these conditions. Trial Registration: ClinicalTrials.gov NCT05813652; https://clinicaltrials.gov/ct2/show/NCT05813652 International Registered Report Identifier (IRRID): RR1-10.2196/49131 UR - https://www.researchprotocols.org/2023/1/e49131 UR - http://dx.doi.org/10.2196/49131 UR - http://www.ncbi.nlm.nih.gov/pubmed/37477967 ID - info:doi/10.2196/49131 ER - TY - JOUR AU - Drouin, Olivier AU - Perez, Tamara AU - Barnett, A. Tracie AU - Ducharme, M. Francine AU - Fleegler, Eric AU - Garg, Arvin AU - Lavoie, Kim AU - Li, Patricia AU - Métras, Marie-Élaine AU - Sultan, Serge AU - Tse, Man Sze AU - Zhao, Jiaying PY - 2023/3/7 TI - Impact of Unmet Social Needs, Scarcity, and Future Discounting on Adherence to Treatment in Children With Asthma: Protocol for a Prospective Cohort Study JO - JMIR Res Protoc SP - e37318 VL - 12 KW - asthma KW - adherence KW - unmet social needs KW - behavioral sciences KW - future discounting KW - scarcity KW - pediatrics N2 - Background: Asthma is one of the most prevalent chronic diseases of childhood and disproportionately affects children with lower socioeconomic status. Controller medications such as inhaled corticosteroids significantly reduce asthma exacerbations and improve symptoms. However, a large proportion of children still have poor asthma control, in part owing to suboptimal adherence. Financial barriers contribute to hindering adherence, as do behavioral factors related to low income. For example, unmet social needs for food, lodging, and childcare may create stress and worry in parents, negatively influencing medication adherence. These needs are also cognitively taxing and force families to focus on immediate needs, leading to scarcity and heightening future discounting; thus, there is the tendency to attribute greater value to the present than to the future in making decisions. Objective: In this project, we will investigate the relationship between unmet social needs, scarcity, and future discounting as well as their predictive power over time on medication adherence in children with asthma. Methods: This 12-month prospective observational cohort study will recruit 200 families of children aged 2 to 17 years at the Asthma Clinic of the Centre Hospitalier Universitaire Sainte-Justine, a tertiary care pediatric hospital in Montreal, Canada. The primary outcome will be adherence to controller medication, measured using the proportion of prescribed days covered during follow-up. Exploratory outcomes will include health care use. The main independent variables will be unmet social needs, scarcity, and future discounting, measured using validated instruments. These variables will be measured at recruitment as well as at 6- and 12-month follow-ups. Covariates will include sociodemographics, disease and treatment characteristics, and parental stress. Primary analysis will compare adherence to controller medication, measured using the proportion of prescribed days covered, between families with versus those without unmet social needs during the study period using multivariate linear regression. Results: The research activities of this study began in December 2021. Participant enrollment and data collection began in August 2022 and are expected to continue until September 2024. Conclusions: This project will allow the documentation of the impact of unmet social needs, scarcity, and future discounting on adherence in children with asthma using robust metrics of adherence and validated measures of scarcity and future discounting. If the relationship between unmet social needs, behavioral factors, and adherence is supported by our findings, this will suggest the potential for novel targets for integrated social care interventions to improve adherence to controller medication and reduce risk across the life course for vulnerable children with asthma. Trial Registration: ClinicalTrials.gov NCT05278000; https://clinicaltrials.gov/ct2/show/NCT05278000 International Registered Report Identifier (IRRID): PRR1-10.2196/37318 UR - https://www.researchprotocols.org/2023/1/e37318 UR - http://dx.doi.org/10.2196/37318 UR - http://www.ncbi.nlm.nih.gov/pubmed/36881458 ID - info:doi/10.2196/37318 ER - TY - JOUR AU - Crockett, Katie AU - Lovo, Stacey AU - Irvine, Alison AU - Trask, Catherine AU - Oosman, Sarah AU - McKinney, Veronica AU - McDonald, Terrence AU - Sari, Nazmi AU - Carnegie, Bertha AU - Custer, Marie AU - McIntosh, Stacey AU - Bath, Brenna PY - 2022/12/19 TI - Experiences of Health Care Access Challenges for Back Pain Care Across the Rural-Urban Continuum in Canada: Protocol for Cross-sectional Research JO - JMIR Res Protoc SP - e42484 VL - 11 IS - 12 KW - low back pain KW - rural health KW - rehabilitation KW - health services N2 - Background: Back pain is common and costly, with negative impacts on both individuals and the health care system. Rural, remote, and Indigenous populations are at greater risk of experiencing back pain compared to urban and non-Indigenous populations. Potential barriers to health care access among Canadians with chronic back pain (CBP) have been identified; however, no study has used lived experiences of people with CBP to drive the selection, analysis, and interpretation of variables most meaningful to patients. Objective: The aims of this study are to (1) engage with rural, remote, and urban Indigenous and non-Indigenous patients, health care providers, and health system decision makers to explore lived experiences among people with CBP in Saskatchewan, Canada; (2) cocreate meaningful indicators of CBP care access and effectiveness; and (3) identify program and policy recommendations to overcome access barriers to CBP care. Methods: In phase 1, one-on-one interviews with 30 people with current or past CBP and 10 health care providers residing or practicing in rural, remote, or urban Saskatchewan communities will be conducted. We will recruit Indigenous (n=10) and non-Indigenous (n=20) rural, remote, and urban people. In phase 2, findings from the interviews will inform development of a population-based telephone survey focused on access to health care barriers and facilitators among rural, remote, and urban people; this survey will be administered to 383 residents with CBP across Saskatchewan. In phase 3, phase 1 and 2 findings will be presented to provincial and national policy makers; health system decision makers; health care providers; rural, remote, and urban people with CBP and their communities; and other knowledge users at an interactive end-of-project knowledge translation event. A World Cafe? method will facilitate interactive dialogue designed to catalyze future patient-oriented research and pathways to improve access to CBP care. Patient engagement will be conducted, wherein people with lived experience of CBP, including Indigenous and non-Indigenous people from rural, remote, and urban communities (ie, patient partners), are equal members of the research team. Patient partners are engaged throughout the research process, providing unique knowledge to ensure more comprehensive collection of data while shaping culturally appropriate messages and methods of sharing findings to knowledge users. Results: Participant recruitment began in January 2021. Phase 1 interviews occurred between January 2021 and September 2022. Phase 2 phone survey was administered in May 2022. Final results are anticipated in late 2022. Conclusions: This study will privilege patient experiences to better understand current health care use and potential access challenges and facilitators among rural, remote, and urban people with CBP in Saskatchewan. We aim to inform the development of comprehensive measures that will be sensitive to geographical location and relevant to culturally diverse people with CBP, ultimately leading to enhanced access to more patient-centered care for CBP. International Registered Report Identifier (IRRID): DERR1-10.2196/42484 UR - https://www.researchprotocols.org/2022/12/e42484 UR - http://dx.doi.org/10.2196/42484 UR - http://www.ncbi.nlm.nih.gov/pubmed/36534454 ID - info:doi/10.2196/42484 ER - TY - JOUR AU - Guénette, Line AU - Kröger, Edeltraut AU - Bonnan, Dylan AU - Maheu, Anne AU - Morin, Michèle AU - Bélanger, Laurianne AU - Vedel, Isabelle AU - Wilchesky, Machelle AU - Sirois, Caroline AU - Durand, Etienne AU - Couturier, Yves AU - Sourial, Nadia AU - Dallaire, Clémence PY - 2022/11/17 TI - Reorganizing Pharmaceutical Care in Family Medicine Groups for Older Adults With or at Risk of Major Neurocognitive Disorders: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e42577 VL - 11 IS - 11 KW - primary care KW - older adults KW - neurocognitive disorders KW - pharmaceutical care KW - mixed method study N2 - Background: The latest global figures show that 55 million persons lived with major neurocognitive disorders (MNCDs) worldwide in 2021. In Quebec, Canada, most of these older adults are cared for by family physicians in interdisciplinary primary care clinics such as family medicine groups (FMG). When a person has a MNCD, taking potentially inappropriate medications or polypharmacy (5 different medications or more) increases their vulnerability to serious adverse events. With the recent arrival of pharmacists working in FMGs and their expanded scope of practice and autonomy, new possibilities for optimizing older adults? pharmacotherapy are opening. Objective: This project aims to evaluate the impact of involving these pharmacists in the care trajectory of older adults living with MNCD, in an interdisciplinary collaboration with the FMG team, as well as home care nurses and physicians. Pharmacists will provide medication reviews, interventions, and recommendations to improve the pharmacotherapy and support offered to these patients and their caregivers. Methods: This 2-step mixed methods study will include a quasi-experimental controlled trial (step 1) and semistructured interviews (step 2). Older adults undergoing cognitive assessment, recently diagnosed with MNCD, or receiving care for this at home will be identified and recruited in FMGs in 2 Quebec regions. FMGs implementing the intervention will involve pharmacists in these patients? care trajectory. Training and regular mentoring will be offered to these FMGs, especially to pharmacists. In control FMGs, no FMG pharmacist will be involved with these patients, and usual care will be provided. Results: Medication use (including appropriateness) and burden, satisfaction of care received, and quality of life will be assessed at study beginning and after 6 months of follow-up and compared between groups. At the end of the intervention study, we will conduct semistructured interviews with FMG care team members (pharmacists, nurses, and physicians) who have experienced the intervention. We will ask about the feasibility of integrating the intervention into practice and their satisfaction with and their perception of the intervention?s impacts for older adults and their families. We will assess the effect of improved pharmaceutical care for older adults with or at risk of MNCDs through the involvement of FMG pharmacists and a reorganization of pharmaceutical care. Conclusions: The inclusion of pharmacists in interdisciplinary care teams is recent and rising, strengthened by more substantial pharmacist practice roles. Results will inform the processes required to successfully involve pharmacists and implement developed tools and procedures transposable to other care settings to improve patient care. Trial Registration: ClinicalTrials.gov NCT04889794; https://clinicaltrials.gov/ct2/show/NCT04889794 International Registered Report Identifier (IRRID): DERR1-10.2196/42577 UR - https://www.researchprotocols.org/2022/11/e42577 UR - http://dx.doi.org/10.2196/42577 UR - http://www.ncbi.nlm.nih.gov/pubmed/36264995 ID - info:doi/10.2196/42577 ER - TY - JOUR AU - Estabrooks, Carole AU - Song, Yuting AU - Anderson, Ruth AU - Beeber, Anna AU - Berta, Whitney AU - Chamberlain, Stephanie AU - Cummings, Greta AU - Duan, Yinfei AU - Hayduk, Leslie AU - Hoben, Matthias AU - Iaconi, Alba AU - Lanham, Holly AU - Perez, Janelle AU - Wang, Jing AU - Norton, Peter PY - 2022/9/15 TI - The Influence of Context on Implementation and Improvement: Protocol for a Mixed Methods, Secondary Analyses Study JO - JMIR Res Protoc SP - e40611 VL - 11 IS - 9 KW - organizational context KW - facilitation KW - PARIHS framework KW - Promoting Action on Research Implementation in Health Services KW - implementation science N2 - Background: Caring for the well-being of older adults is one of the greatest challenges in modern societies. Improving the quality of care and life for older adults and the work lives of their care providers calls for effective knowledge translation of evidence-based best practices. Objective: This study?s purpose is to contribute to knowledge translation by better understanding the roles of organizational context (workplace environment) and facilitation (process or role) in implementation and improvement success. Our study has 2 goals: (1) to advance knowledge translation science by further developing and testing the Promoting Action on Research Implementation in Health Services framework (which outlines how implementation relies on the interplay of context, facilitation, and evidence) and (2) to advance research by optimizing implementation success via tailoring of modifiable elements of organizational context and facilitation. Methods: This is secondary analyses of 15 years of longitudinal data from the Translating Research in Elder Care (TREC) program?s multiple data sources. This research is ongoing in long-term care (LTC) homes in western Canada. TREC data include the following: 5 waves of survey collection, 2 clinical trials, and regular ongoing outcome data for LTC residents. We will use a sequential exploratory and confirmatory mixed methods design. We will analyze qualitative and quantitative data holdings in an iterative process: (1) comprehensive reanalysis of qualitative data to derive hypotheses, (2) quantitative modeling to test hypotheses, and (3) action cycles to further refine and integrate qualitative and quantitative analyses. The research team includes 4 stakeholder panels: (1) system decision- and policy makers, (2) care home managers, (3) direct care staff, and (4) a citizen engagement group of people living with dementia and family members of LTC residents. A fifth group is our panel of external scientific advisors. Each panel will engage periodically, providing their perspectives on project direction and findings. Results: This study is funded by the Canadian Institutes of Health Research. Ethics approval was obtained from the University of Alberta (Pro00096541). The results of the secondary analyses are expected by the end of 2023. Conclusions: The project will advance knowledge translation science by deepening our understanding of the roles of context, the interactions between context and facilitation, and their influence on resident and staff quality outcomes. Importantly, findings will inform understanding of the mechanisms by which context and facilitation affect the success of implementation and offer insights into factors that influence the implementation success of interventions in nursing homes. International Registered Report Identifier (IRRID): DERR1-10.2196/40611 UR - https://www.researchprotocols.org/2022/9/e40611 UR - http://dx.doi.org/10.2196/40611 UR - http://www.ncbi.nlm.nih.gov/pubmed/36107475 ID - info:doi/10.2196/40611 ER - TY - JOUR AU - Patel, Sunil AU - McClintock, Chad AU - Booth, Christopher AU - Merchant, Shaila AU - Heneghan, Carl AU - Bankhead, Clare PY - 2022/8/5 TI - The Variations in Care and Real-world Outcomes in Individuals With Rectal Cancer: Protocol for the Ontario Rectal Cancer Cohort JO - JMIR Res Protoc SP - e38874 VL - 11 IS - 8 KW - rectal cancer KW - survival KW - adherence to care KW - regional variability N2 - Background: Individuals with rectal cancer require a number of pretreatment investigations, often require multidisciplinary treatment, and require ongoing follow-ups after treatment is completed. Due to the complexity of treatments, large variations in practice patterns and outcomes have been identified. At present, few comprehensive, population-level data sets are available for assessing interventions and outcomes in this group. Objective: Our study aims to create a comprehensive database of individuals with rectal cancer who have been treated in a single-payer, universal health care system. This database will provide an excellent resource that investigators can use to study variations in the delivery of care to and real-world outcomes of this population. Methods: The Ontario Rectal Cancer Cohort database will include comprehensive details about the management and outcomes of individuals with rectal cancer who have been diagnosed in Ontario, Canada (population: 14.6 million), between 2010 and 2019. Linked administrative data sets will be used to construct this comprehensive database. Individual and care provider characteristics, investigations, treatments, follow-ups, and outcomes will be derived and linked. Surgical pathology details, including the stage of disease, histopathology characteristics, and the quality of surgical excision, will be included. Ethics approval for this study was obtained through the Queen?s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board. Results: Approximately 20,000 individuals who meet the inclusion criteria for this study have been identified. Data analysis is ongoing, with an expected completion date of March 2023. This study was funded through the Canadian Institute of Health Research Operating Grant. Conclusions: The Ontario Rectal Cancer Cohort will include a comprehensive data set of individuals with rectal cancer who received care within a single-payer, universal health care system. This cohort will be used to determine factors associated with regional variability and adherence to recommended care, and it will allow for an assessment of a number of understudied areas within the delivery of rectal cancer treatment. International Registered Report Identifier (IRRID): RR1-10.2196/38874 UR - https://www.researchprotocols.org/2022/8/e38874 UR - http://dx.doi.org/10.2196/38874 UR - http://www.ncbi.nlm.nih.gov/pubmed/35930352 ID - info:doi/10.2196/38874 ER - TY - JOUR AU - Archie, Suzanne AU - Palaniyappan, Lena AU - Olagunju, T. Andrew AU - Johnson, Natasha AU - Kozloff, Nicole AU - Sadeh, Elham AU - Bardell, Andrea AU - Baines, Alexandra AU - Anderson, K. Kelly AU - Ayonrinde, Oyedeji AU - Ferrari, Manuela PY - 2022/5/20 TI - Insights About Cannabis and Psychosis Using Video Games for Young People With a First Episode of Psychosis, Particularly Those From Black Racialized Communities: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e36758 VL - 11 IS - 5 KW - first-episode psychosis KW - cannabis use KW - knowledge translation KW - Black youth KW - video games N2 - Background: Cannabis use disorder among young people with a first episode of psychosis contributes to relapse, hospitalization, and impaired functioning. However, few studies have examined what young people with early phase psychosis, particularly those from Black racialized communities, understand or appreciate about this relationship, even though they may be at risk. There are no formally tested knowledge translation strategies that disseminate these research findings for young people with emerging psychosis from Black racialized communities. Objective: This study aims to conceptualize what young people with early phase psychosis/cannabis use disorder understand about the relationship between cannabis and psychosis, focusing on people from racialized backgrounds. This study also aims to assess whether the knowledge translation product, the ?Back to Reality Series,? increases awareness of the impact of cannabis use on psychosis from the perspectives of young people with emerging psychosis and cannabis use disorder from Black African and Caribbean communities. Methods: Qualitative analysis will reveal themes from qualitative interviews about cannabis and psychosis from the perspectives of young people with emerging psychosis and cannabis use disorder from Black African and Caribbean communities. Perceptions before and after exposure to the Back to Reality Series will be qualitatively analyzed. A control game will be used for comparison, and scores on a quiz after playing the Back to Reality Series will be quantitatively analyzed to establish whether the Back to Reality Series raises awareness of the effects of cannabis on psychosis. An advisory council involving young people from Black communities, family members, and clinicians will bring community perspectives to this research. Results: We began recruiting participants for this study in September 2021. We will complete data collection on demographic and clinical factors, qualitative interviews, and quantitative assessments of the Back to Reality Series. Conclusions: The voices of young people from racialized backgrounds will generate preliminary data to inform early psychosis programs, addressing cannabis use in this population. The findings may advance the use of a new knowledge translation product that deals with gaps in knowledge about cannabis use for people experiencing early phase psychosis, particularly those from racialized communities. International Registered Report Identifier (IRRID): DERR1-10.2196/36758 UR - https://www.researchprotocols.org/2022/5/e36758 UR - http://dx.doi.org/10.2196/36758 UR - http://www.ncbi.nlm.nih.gov/pubmed/35389874 ID - info:doi/10.2196/36758 ER - TY - JOUR AU - Tempelaar, Wanda AU - Barwick, Melanie AU - Crawford, Allison AU - Voineskos, Aristotle AU - Addington, Donald AU - Addington, Jean AU - Alexander, Tallan AU - Baluyut, Crystal AU - Bromley, Sarah AU - Durbin, Janet AU - Foussias, George AU - Ford, Catherine AU - de Freitas, Lauren AU - Jindani, Seharish AU - Kirvan, Anne AU - Kurdyak, Paul AU - Pauly, Kirstin AU - Polillo, Alexia AU - Roby, Rachel AU - Sockalingam, Sanjeev AU - Sosnowski, Alexandra AU - Villanueva, Victoria AU - Wang, Wei AU - Kozloff, Nicole PY - 2021/12/7 TI - Adapting Evidence-Based Early Psychosis Intervention Services for Virtual Delivery: Protocol for a Pragmatic Mixed Methods Implementation and Evaluation Study JO - JMIR Res Protoc SP - e34591 VL - 10 IS - 12 KW - virtual care delivery KW - early psychosis intervention KW - mixed methods implementation N2 - Background: Timely and comprehensive treatment in the form of early psychosis intervention (EPI) has become the standard of care for youth with psychosis. While EPI services were designed to be delivered in person, the COVID-19 pandemic required many EPI programs to rapidly transition to virtual delivery, with little evidence to guide intervention adaptations or to support the effectiveness and satisfaction with virtual EPI services. Objective: This study aims to explore the adaptations required to deliver NAVIGATE, a model of coordinated specialty care used in EPI, in a virtual format. This study will evaluate implementation of the NAVIGATE model delivered virtually by describing the nature of the adaptations to the intervention, assessing fidelity to the EPI model and the satisfaction of clients, family members, and care providers. We will investigate barriers and facilitators to virtual NAVIGATE implementation, service engagement, and health equity impacts of this work. Methods: The Centre for Addiction and Mental Health (Toronto, Ontario, Canada) transitioned to delivering NAVIGATE virtually early in the COVID-19 pandemic. The Framework for Reporting Adaptations and Modifications for Evidence-Based Interventions will be used to describe the adaptations required to deliver NAVIGATE virtually. Fidelity to the EPI model will be measured using the First Episode Psychosis Services Fidelity Scale and fidelity to NAVIGATE will be assessed by investigating adherence to its core components. Implementation facilitators and barriers will be explored using semistructured interviews with providers informed by the Consolidated Framework for Implementation Research. Satisfaction with virtually delivered NAVIGATE will be assessed with virtual client and provider experience surveys and qualitative interviews with clients, family members, and providers. Service engagement data will be collected through review of medical records, and potential impacts of virtually delivered NAVIGATE on different population groups will be assessed with the Health Equity Impact Assessment. Results: Virtual clinical delivery of NAVIGATE started in March 2020 with additional adaptations and data collection is ongoing. Data will be analyzed using descriptive statistics and survival analysis for quantitative data. Qualitative data will be analyzed using thematic content analysis. Integration of qualitative and quantitative data will occur at the data collection, interpretation, and reporting levels following a convergent design. Conclusions: This study will provide information regarding the type of intervention adaptations required for virtual delivery of NAVIGATE for youth with early psychosis, ensuring access to high-quality care for this population during the pandemic and beyond by guiding future implementation in similar contexts. International Registered Report Identifier (IRRID): DERR1-10.2196/34591 UR - https://www.researchprotocols.org/2021/12/e34591 UR - http://dx.doi.org/10.2196/34591 UR - http://www.ncbi.nlm.nih.gov/pubmed/34806990 ID - info:doi/10.2196/34591 ER - TY - JOUR AU - Gaboury, Isabelle AU - Tousignant, Michel AU - Corriveau, Hélène AU - Menear, Matthew AU - Le Dorze, Guylaine AU - Rochefort, Christian AU - Vachon, Brigitte AU - Rochette, Annie AU - Gosselin, Sylvie AU - Michaud, François AU - Bollen, Jessica AU - Dean, Sarah PY - 2021/10/28 TI - Effects of Telerehabilitation on Patient Adherence to a Rehabilitation Plan: Protocol for a Mixed Methods Trial JO - JMIR Res Protoc SP - e32134 VL - 10 IS - 10 KW - adherence KW - interprofessional shared decision making KW - rehabilitation KW - stroke KW - telerehabilitation N2 - Background: Strong evidence supports beginning stroke rehabilitation as soon as the patient?s medical status has stabilized and continuing following discharge from acute care. However, adherence to rehabilitation treatments over the rehabilitation phase has been shown to be suboptimal. Objective: The aim of this study is to assess the impact of a telerehabilitation platform on stroke patients? adherence to a rehabilitation plan and on their level of reintegration into normal social activities, in comparison with usual care. The primary outcome is patient adherence to stroke rehabilitation (up to 12 weeks), which is hypothesized to influence reintegration into normal living. Secondary outcomes for patients include functional recovery and independence, depression, adverse events related to telerehabilitation, use of services (up to 6 months), perception of interprofessional shared decision making, and quality of services received. Interprofessional collaboration as well as quality of interprofessional shared decision making will be measured with clinicians. Methods: In this interrupted time series with a convergent qualitative component, rehabilitation teams will be trained to develop rehabilitation treatment plans that engage the patient and family, while taking advantage of a telerehabilitation platform to deliver the treatment. The intervention will be comprised of 220 patients who will take part in stroke telerehabilitation with an interdisciplinary group of clinicians (telerehabilitation group) versus face-to-face standard of care (control group: n=110 patients). Results: Our Research Ethics Board approved the study in June 2020. Data collection for the control group is underway, with another year planned before we begin the intervention phase. Conclusions: This study will contribute to the minimization of both knowledge and practice gaps, while producing robust, in-depth data on the factors related to the effectiveness of telerehabilitation in a stroke rehabilitation continuum. Findings will inform best practice guidelines regarding telecare services and the provision of telerehabilitation, including recommendations for effective interdisciplinary collaboration regarding stroke rehabilitation. Trial Registration: ClinicalTrials.gov NCT04440215; https://clinicaltrials.gov/ct2/show/NCT04440215 International Registered Report Identifier (IRRID): DERR1-10.2196/32134 UR - https://www.researchprotocols.org/2021/10/e32134 UR - http://dx.doi.org/10.2196/32134 UR - http://www.ncbi.nlm.nih.gov/pubmed/34709196 ID - info:doi/10.2196/32134 ER - TY - JOUR AU - Engler-Stringer, Rachel AU - Black, Jennifer AU - Muhajarine, Nazeem AU - Martin, Wanda AU - Gilliland, Jason AU - McVittie, Janet AU - Kirk, Sara AU - Wittman, Hannah AU - Mousavi, Amin AU - Elliott, Sinikka AU - Tu, Sylvana AU - Hills, Brent AU - Androsoff, Gordon AU - Field, Debbie AU - Macdonald, Brit AU - Belt, Chelsea AU - Vatanparast, Hassan PY - 2021/9/21 TI - The Good Food for Learning Universal Curriculum-Integrated Healthy School Lunch Intervention: Protocol for a Two-Year Matched Control Pre-Post and Case Study JO - JMIR Res Protoc SP - e30899 VL - 10 IS - 9 KW - school food programs KW - Canada KW - nutrition KW - intervention research KW - mHealth N2 - Background: Good nutrition affects children?s health, well-being, and learning, and schools offer an important setting to promote healthy behaviors that can last a lifetime. Once children reach school age, they spend more of their waking hours in school than in any other environment. Children?s eating habits may be easier to influence than those of adults. In Canada, households with children are more likely to experience food insecurity, and school food programs that are universally available to all children can support the development of healthy eating patterns across groups of varying socioeconomic status. There is a significant gap in the rigorous community-engaged academic research on the impact of school meal programs, especially universal ones. Objective: The aim of this population health intervention research is to study the impact of a 2-year universal, curriculum-integrated healthy school lunch program in elementary schools in Saskatoon, Saskatchewan, Canada, on food consumption, dietary quality and food and nutrition-related knowledge, attitudes, and practices. Methods: This population health intervention study will be conducted in 2 intervention elementary schools matched with 2 control schools. We will collect preintervention data, including objective measurements of food eaten at school and food-related knowledge, attitudes, and behaviors. This will be followed by the intervention itself, along with qualitative case studies of the intervention process in the 2 intervention schools. Then, we will collect postintervention data similar to the preintervention data. Finally, we will finish the data analysis and complete the ongoing sharing of learning from the project. Results: This study was funded in April 2020 but because of the COVID-19 pandemic, data collection did not begin until May 2021. The intervention will begin in September 2021 and end in June 2023, with end point data collection occurring in May and June 2023. The case study research will begin in September 2021 and will be ongoing for the duration of the intervention. Conclusions: The opportunity we have to systematically and comprehensively study a curriculum-integrated school lunch program, as well as the promising practices for school food programs across Canada, is without precedent. International Registered Report Identifier (IRRID): DERR1-10.2196/30899 UR - https://www.researchprotocols.org/2021/9/e30899 UR - http://dx.doi.org/10.2196/30899 UR - http://www.ncbi.nlm.nih.gov/pubmed/34546171 ID - info:doi/10.2196/30899 ER - TY - JOUR AU - Alavi, Nazanin AU - Stephenson, Callum AU - Omrani, Mohsen AU - Gerritsen, Cory AU - Martin, S. Michael AU - Knyahnytskyi, Alex AU - Zhu, Yiran AU - Kumar, Anchan AU - Jagayat, Jasleen AU - Shirazi, Amirhossein AU - Moghimi, Elnaz AU - Patel, Charmy AU - Knyahnytska, Yuliya AU - Simpson, F. Alexander I. AU - Zaheer, Juveria AU - Andersen, Judith AU - Munshi, Alpna AU - Groll, Dianne PY - 2021/7/22 TI - Delivering an Online Cognitive Behavioral Therapy Program to Address Mental Health Challenges Faced by Correctional Workers and Other Public Safety Personnel: Protocol for a Mixed Methods Study JO - JMIR Res Protoc SP - e30845 VL - 10 IS - 7 KW - mental health KW - correctional workers KW - public safety personnel KW - depression KW - anxiety KW - psychotherapy KW - cognitive behavioral therapy KW - online KW - internet KW - treatment N2 - Background: Public safety personnel have regular and often intense exposure to potentially traumatic events at work, especially workplace violence in the case of correctional workers. Subsequently, correctional workers are at higher risk of developing mental health problems such as posttraumatic stress disorder. Public safety personnel are up to 4 times more likely to experience suicidal ideation, suicidal attempts, and death by suicide compared to the general population. Despite this high prevalence, help-seeking behaviors from public safety personnel are low due to stigma and irregular work hours limiting access to care. Innovative treatments are needed to address these challenges. Objective: This study will investigate the efficacy of an electronically delivered cognitive behavioral therapy (e-CBT) program tailored to correctional workers? mental health problems. Methods: This study is composed of 4 phases. In phase 1, we will interview correctional workers individually and in focus groups to identify personal, social, and cultural factors affecting their mental health and barriers to care. Phase 2 will use the information gathered from the interviews to develop gender- and diagnosis-specific e-CBT modules. These will be presented to a new group of participants who will provide further feedback on their usability and accessibility. In phase 3, we will randomly assign participants to either an e-CBT or treatment as usual arm. The program will be evaluated with validated symptomatology questionnaires and interviews. Phase 4 will use this additional information to fine-tune the e-CBT modules for a larger-scale randomized controlled trial design comparing the e-CBT program to in-person CBT. All e-CBT modules will be delivered through a secure online platform. Results: The study received ethics approval in December 2020, and participant recruitment began in March 2021. Participant recruitment has been conducted through targeted advertisements and physician referrals. To date, there have been 15 participants recruited for Phase 1, and it is expected to conclude in July 2021, with phase 2 beginning in September 2021. Complete data collection and analysis from all phases are expected to conclude by July 2023. Linear and binomial regression (for continuous and categorical outcomes, respectively) will be conducted along with interpretive qualitative methods. Conclusions: If proven efficacious and feasible, this e-CBT program can provide a high-quality and clinically validated resource to address the mental health problems of correctional workers. Additionally, findings can contribute to the development of innovative treatments for other public safety professions. Trial Registration: ClinicalTrials.gov NCT04666974; https://www.clinicaltrials.gov/ct2/show/NCT04666974 International Registered Report Identifier (IRRID): DERR1-10.2196/30845 UR - https://www.researchprotocols.org/2021/7/e30845 UR - http://dx.doi.org/10.2196/30845 UR - http://www.ncbi.nlm.nih.gov/pubmed/34088656 ID - info:doi/10.2196/30845 ER - TY - JOUR AU - van Allen, Zack AU - Bacon, L. Simon AU - Bernard, Paquito AU - Brown, Heather AU - Desroches, Sophie AU - Kastner, Monika AU - Lavoie, Kim AU - Marques, Marta AU - McCleary, Nicola AU - Straus, Sharon AU - Taljaard, Monica AU - Thavorn, Kednapa AU - Tomasone, R. Jennifer AU - Presseau, Justin PY - 2021/6/11 TI - Clustering of Unhealthy Behaviors: Protocol for a Multiple Behavior Analysis of Data From the Canadian Longitudinal Study on Aging JO - JMIR Res Protoc SP - e24887 VL - 10 IS - 6 KW - health behaviors KW - multiple behaviors KW - cluster analysis KW - network analysis KW - CLSA N2 - Background: Health behaviors such as physical inactivity, unhealthy eating, smoking tobacco, and alcohol use are leading risk factors for noncommunicable chronic diseases and play a central role in limiting health and life satisfaction. To date, however, health behaviors tend to be considered separately from one another, resulting in guidelines and interventions for healthy aging siloed by specific behaviors and often focused only on a given health behavior without considering the co-occurrence of family, social, work, and other behaviors of everyday life. Objective: The aim of this study is to understand how behaviors cluster and how such clusters are associated with physical and mental health, life satisfaction, and health care utilization may provide opportunities to leverage this co-occurrence to develop and evaluate interventions to promote multiple health behavior changes. Methods: Using cross-sectional baseline data from the Canadian Longitudinal Study on Aging, we will perform a predefined set of exploratory and hypothesis-generating analyses to examine the co-occurrence of health and everyday life behaviors. We will use agglomerative hierarchical cluster analysis to cluster individuals based on their behavioral tendencies. Multinomial logistic regression will then be used to model the relationships between clusters and demographic indicators, health care utilization, and general health and life satisfaction, and assess whether sex and age moderate these relationships. In addition, we will conduct network community detection analysis using the clique percolation algorithm to detect overlapping communities of behaviors based on the strength of relationships between variables. Results: Baseline data for the Canadian Longitudinal Study on Aging were collected from 51,338 participants aged between 45 and 85 years. Data were collected between 2010 and 2015. Secondary data analysis for this project was approved by the Ottawa Health Science Network Research Ethics Board (protocol ID #20190506-01H). Conclusions: This study will help to inform the development of interventions tailored to subpopulations of adults (eg, physically inactive smokers) defined by the multiple behaviors that describe their everyday life experiences. International Registered Report Identifier (IRRID): DERR1-10.2196/24887 UR - https://www.researchprotocols.org/2021/6/e24887 UR - http://dx.doi.org/10.2196/24887 UR - http://www.ncbi.nlm.nih.gov/pubmed/34114962 ID - info:doi/10.2196/24887 ER - TY - JOUR AU - Lokker, Cynthia AU - Jezrawi, Rita AU - Gabizon, Itzhak AU - Varughese, Jobin AU - Brown, Michael AU - Trottier, Dan AU - Alvarez, Elizabeth AU - Schwalm, Jon-David AU - McGillion, Michael AU - Ma, Jinhui AU - Bhagirath, Vinai PY - 2021/2/1 TI - Feasibility of a Web-Based Platform (Trial My App) to Efficiently Conduct Randomized Controlled Trials of mHealth Apps For Patients With Cardiovascular Risk Factors: Protocol For Evaluating an mHealth App for Hypertension JO - JMIR Res Protoc SP - e26155 VL - 10 IS - 2 KW - mHealth KW - mobile health KW - hypertension KW - app KW - patient-oriented KW - feasibility KW - cardiovascular disease KW - internet-administered KW - randomized controlled trial N2 - Background: Mobile health (mHealth) interventions can improve health by improving cardiovascular risk factors, but their adoption in care by physicians and patients is untapped. Few mHealth apps have been evaluated in clinical trials, and due to the fast pace of technological development, those previously evaluated are often outdated by the time trial results are available. Given the rapid pace of change in this field, it is not feasible to rigorously evaluate mHealth apps with current methodologies. Objective: The overall aim of this pilot study was to test the feasibility of using a web research platform called Trial My App to conduct efficient and rigorous web-based randomized controlled trials (RCTs) of mHealth apps relevant to patients with cardiovascular risk factors by evaluating an app that targets hypertension. Methods: For this study, 200 participants with suboptimally controlled hypertension will be recruited through advertisements in newsletters, media, and the internet, as well as through referrals from their health care providers. Screening, consent, randomization, and collection of patient-important health confidence and self-management ability outcomes will be conducted online through the Trial My App research platform. Participants will be randomized into 2 groups: 100 that will use an mHealth app for tracking hypertension and 100 that will be considered as an educational control. All participants will complete questionnaires at 0, 1, 3 and 6 months after enrolment. A substudy to validate the method of blood pressure readings and the consistency of data entered through Trial My App will be conducted with 40 participants. Results: The development of the Trial My App web platform has been completed. The creation of survey instruments has been completed in collaboration with our patient partners and advisory board. Recruitment is expected to begin in the first quarter of 2021; data collection and analysis are expected to be completed approximately 1 year after study commencement. Results will be disseminated through conferences and publications. The primary outcomes of this study include the feasibility of conducting an RCT using the Trial My App platform by reporting recruitment, retention, and completion statistics. We will validate app-entered data with a standard 7-day home blood pressure measurement method. Lastly, the pilot, nonblinded RCT will assess the effectiveness of the mHealth app in improving the control of hypertension compared with the control of hypertension in the educational control group. Conclusions: This study will determine if it is feasible to use the Trial My App web-based platform to evaluate the effectiveness of mHealth apps for patients with cardiovascular risk factors. As more mHealth apps are evaluated in RCTs, patients will be able to select apps that meet their needs and physicians will be able to make evidence-based recommendations to their patients for apps aimed at improving cardiovascular health. Trial Registration: ClinicalTrials.gov NCT04528654; https://clinicaltrials.gov/ct2/show/NCT04528654 International Registered Report Identifier (IRRID): PRR1-10.2196/26155 UR - https://www.researchprotocols.org/2021/2/e26155 UR - http://dx.doi.org/10.2196/26155 UR - http://www.ncbi.nlm.nih.gov/pubmed/33522978 ID - info:doi/10.2196/26155 ER - TY - JOUR AU - Kidd, Sean AU - McKenzie, Kwame AU - Wang, Wei AU - Agrawal, Sacha AU - Voineskos, Aristotle PY - 2021/1/25 TI - Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-Management and Provider Engagement: Protocol for a Feasibility Trial JO - JMIR Res Protoc SP - e24736 VL - 10 IS - 1 KW - schizophrenia KW - psychosis KW - digital health KW - mobile health KW - smartphone N2 - Background: In schizophrenia spectrum populations, adherence to treatment is poor, community-based supports are limited, and efforts to foster illness self-management have had limited success. These challenges contribute to frequent, lengthy, and costly hospital readmissions and poor functional outcomes. Digital health strategies, in turn, hold considerable promise in the effort to address these problems. Objective: This feasibility trial will examine a digital health platform called App4Independence (A4i), which was designed to enhance illness self-management and treatment engagement for individuals with schizophrenia. Methods: Feasibility metrics in this single-blind, randomized trial include study recruitment and retention, rate of technology use, safety, and utility in clinical interactions. Other outcome metrics include symptomatology, treatment adherence, patient-provider alliance, and quality of life. In this trial, 160 study participants with schizophrenia spectrum diagnoses will be randomized to either treatment or control conditions, with pretest-posttest outcomes measured over a 6-month period. Results: This study was funded by the Canadian Institutes of Health Research in January 2020 and received Institutional Review Board approval on August 13, 2020. This study plans to begin recruiting in January 2021 and will be completed within 3 years. Data collection is projected to begin in January 2021. Conclusions: This research will provide critical information for the development of this new technology in the larger effort to address a key problem in the schizophrenia field?how to leverage technology to enhance illness self-management and care engagement in resource-limited service contexts. International Registered Report Identifier (IRRID): PRR1-10.2196/24736 UR - http://www.researchprotocols.org/2021/1/e24736/ UR - http://dx.doi.org/10.2196/24736 UR - http://www.ncbi.nlm.nih.gov/pubmed/33492235 ID - info:doi/10.2196/24736 ER - TY - JOUR AU - Parsons Leigh, Jeanna AU - Brundin-Mather, Rebecca AU - Whalen-Browne, Liam AU - Kashyap, Devika AU - Sauro, Khara AU - Soo, Andrea AU - Petersen, Jennie AU - Taljaard, Monica AU - Stelfox, T. Henry PY - 2021/1/8 TI - Effectiveness of an Electronic Communication Tool on Transitions in Care From the Intensive Care Unit: Protocol for a Cluster-Specific Pre-Post Trial JO - JMIR Res Protoc SP - e18675 VL - 10 IS - 1 KW - patient transfers KW - interprovider communication KW - transitions in care KW - electronic charting KW - clinical documentation KW - discharge tools KW - patient discharge summaries KW - electronic transfer summaries KW - intensive care unit KW - electronic tool KW - ICU KW - protocol KW - effective KW - communication KW - transfer KW - patient KW - transition N2 - Background: Transitions in care are vulnerable periods in health care that can expose patients to preventable errors due to incomplete or delayed communication between health care providers. Transitioning critically ill patients from intensive care units (ICUs) to other patient care units (PCUs) is particularly risky, due to the high acuity of the patients and the diversity of health care providers involved in their care. Instituting structured documentation to standardize written communication between health care providers during transitions has been identified as a promising means to reduce communication breakdowns. We developed an evidence-informed, computer-enabled, ICU-specific structured tool?an electronic transfer (e-transfer) tool?to facilitate and standardize the composition of written transfer summaries in the ICUs of one Canadian city. The tool consisted of 10 primary sections with a user interface combination of structured, automated, and free-text fields. Objective: Our overarching goal is to evaluate whether implementation of our e-transfer tool will improve the completeness and timeliness of transfer summaries and streamline communications between health care providers during high-risk transitions. Methods: This study is a cluster-specific pre-post trial, with randomized and staggered implementation of the e-transfer tool in four hospitals in Calgary, Alberta. Hospitals (ie, clusters) were allocated randomly to cross over every 2 months from control (ie, dictation only) to intervention (ie, e-transfer tool). Implementation at each site was facilitated with user education, point-of-care support, and audit and feedback. We will compare transfer summaries randomly sampled over 6 months postimplementation to summaries randomly sampled over 6 months preimplementation. The primary outcome will be a binary composite measure of the timeliness and completeness of transfer summaries. Secondary measures will include overall completeness, timeliness, and provider ratings of transfer summaries; hospital and ICU lengths of stay; and post-ICU patient outcomes, including ICU readmission, adverse events, cardiac arrest, rapid response team activation, and mortality. We will use descriptive statistics (ie, medians and means) to describe demographic characteristics. The primary outcome will be compared within each hospital pre- and postimplementation using separate logistic regression models for each hospital, with adjustment for patient characteristics. Results: Participating hospitals were cluster randomized to the intervention between July 2018 and January 2019. Preliminary extraction of ICU patient admission lists was completed in September 2019. We anticipate that evaluation data collection will be completed by early 2021, with first results ready for publication in spring or summer 2021. Conclusions: This study will report the impact of implementing an evidence-informed, computer-enabled, ICU-specific structured transfer tool on communication and preventable medical errors among patients transferred from the ICU to other hospital care units. Trial Registration: ClinicalTrials.gov NCT03590002; https://www.clinicaltrials.gov/ct2/show/NCT03590002 International Registered Report Identifier (IRRID): DERR1-10.2196/18675 UR - https://www.researchprotocols.org/2021/1/e18675 UR - http://dx.doi.org/10.2196/18675 UR - http://www.ncbi.nlm.nih.gov/pubmed/33416509 ID - info:doi/10.2196/18675 ER - TY - JOUR AU - Steele Gray, Carolyn AU - Tang, Terence AU - Armas, Alana AU - Backo-Shannon, Mira AU - Harvey, Sarah AU - Kuluski, Kerry AU - Loganathan, Mayura AU - Nie, X. Jason AU - Petrie, John AU - Ramsay, Tim AU - Reid, Robert AU - Thavorn, Kednapa AU - Upshur, Ross AU - Wodchis, P. Walter AU - Nelson, Michelle PY - 2020/11/25 TI - Building a Digital Bridge to Support Patient-Centered Care Transitions From Hospital to Home for Older Adults With Complex Care Needs: Protocol for a Co-Design, Implementation, and Evaluation Study JO - JMIR Res Protoc SP - e20220 VL - 9 IS - 11 KW - digital health technology KW - care transitions KW - multimorbidity KW - pragmatic trial KW - co-design KW - hospital KW - primary care N2 - Background: Older adults with multimorbidity and complex care needs (CCN) are among those most likely to experience frequent care transitions between settings, particularly from hospital to home. Transition periods mark vulnerable moments in care for individuals with CCN. Poor communication and incomplete information transfer between clinicians and organizations involved in the transition from hospital to home can impede access to needed support and resources. Establishing digitally supported communication that enables person-centered care and supported self-management may offer significant advantages as we support older adults with CCN transitioning from hospital to home. Objective: This protocol outlines the plan for the development, implementation, and evaluation of a Digital Bridge co-designed to support person-centered health care transitions for older adults with CCN. The Digital Bridge builds on the foundation of two validated technologies: Care Connector, designed to improve interprofessional communication in hospital, and the electronic Patient-Reported Outcomes (ePRO) tool, designed to support goal-oriented care planning and self-management in primary care settings. This project poses three overarching research questions that focus on adapting the technology to local contexts, evaluating the impact of the Digital Bridge in relation to the quadruple aim, and exploring the potential to scale and spread the technology. Methods: The study includes two phases: workflow co-design (phase 1), followed by implementation and evaluation (phase 2). Phase 1 will include iterative co-design working groups with patients, caregivers, hospital providers, and primary care providers to develop a transition workflow that will leverage the use of Care Connector and ePRO to support communication through the transition process. Phase 2 will include implementation and evaluation of the Digital Bridge within two hospital systems in Ontario in acute and rehab settings (600 patients: 300 baseline and 300 implementation). The primary outcome measure for this study is the Care Transitions Measure?3 to assess transition quality. An embedded ethnography will be included to capture context and process data to inform the implementation assessment and development of a scale and spread strategy. An Integrated Knowledge Translation approach is taken to inform the study. An advisory group will be established to provide insight and feedback regarding the project design and implementation, leading the development of the project knowledge translation strategy and associated outputs. Results: This project is underway and expected to be complete by Spring 2024. Conclusions: Given the real-world implementation of Digital Bridge, practice changes in the research sites and variable adherence to the implementation protocols are likely. Capturing and understanding these considerations through a mixed-methods approach will help identify the range of factors that may influence study results. Should a favorable evaluation suggest wide adoption of the proposed intervention, this project could lead to positive impact at patient, clinician, organizational, and health system levels. Trial Registration: ClinicalTrials.gov NCT04287192; https://clinicaltrials.gov/ct2/show/NCT04287192 International Registered Report Identifier (IRRID): PRR1-10.2196/20220 UR - https://www.researchprotocols.org/2020/11/e20220 UR - http://dx.doi.org/10.2196/20220 UR - http://www.ncbi.nlm.nih.gov/pubmed/33237037 ID - info:doi/10.2196/20220 ER - TY - JOUR AU - Archambault, Michel Patrick AU - Rivard, Josée AU - Smith, Y. Pascal AU - Sinha, Samir AU - Morin, Michèle AU - LeBlanc, Annie AU - Couturier, Yves AU - Pelletier, Isabelle AU - Ghandour, Kebir El AU - Légaré, France AU - Denis, Jean-Louis AU - Melady, Don AU - Paré, Daniel AU - Chouinard, Josée AU - Kroon, Chantal AU - Huot-Lavoie, Maxime AU - Bert, Laetitia AU - Witteman, O. Holly AU - Brousseau, Audrey-Anne AU - Dallaire, Clémence AU - Sirois, Marie-Josée AU - Émond, Marcel AU - Fleet, Richard AU - Chandavong, Sam AU - PY - 2020/8/5 TI - Learning Integrated Health System to Mobilize Context-Adapted Knowledge With a Wiki Platform to Improve the Transitions of Frail Seniors From Hospitals and Emergency Departments to the Community (LEARNING WISDOM): Protocol for a Mixed-Methods Implementation Study JO - JMIR Res Protoc SP - e17363 VL - 9 IS - 8 KW - implementation science KW - knowledge translation KW - context adaptation KW - interrupted time series KW - care transitions KW - elderly KW - older persons KW - health care utilization KW - frailty KW - learning health systems KW - Wiki KW - collaborative writing applications N2 - Background: Elderly patients discharged from hospital experience fragmented care, repeated and lengthy emergency department (ED) visits, relapse into their earlier condition, and rapid cognitive and functional decline. The Acute Care for Elders (ACE) program at Mount Sinai Hospital in Toronto, Canada uses innovative strategies, such as transition coaches, to improve the care transition experiences of frail elderly patients. The ACE program reduced the lengths of hospital stay and readmission for elderly patients, increased patient satisfaction, and saved the health care system over Can $4.2 million (US $2.6 million) in 2014. In 2016, a context-adapted ACE program was implemented at one hospital in the Centre intégré de santé et de services sociaux de Chaudière-Appalaches (CISSS-CA) with a focus on improving transitions between hospitals and the community. The quality improvement project used an intervention strategy based on iterative user-centered design prototyping and a ?Wiki-suite? (free web-based database containing evidence-based knowledge tools) to engage multiple stakeholders. Objective: The objectives of this study are to (1) implement a context-adapted CISSS-CA ACE program in four hospitals in the CISSS-CA and measure its impact on patient-, caregiver-, clinical-, and hospital-level outcomes; (2) identify underlying mechanisms by which our context-adapted CISSS-CA ACE program improves care transitions for the elderly; and (3) identify underlying mechanisms by which the Wiki-suite contributes to context-adaptation and local uptake of knowledge tools. Methods: Objective 1 will involve staggered implementation of the context-adapted CISSS-CA ACE program across the four CISSS-CA sites and interrupted time series to measure the impact on hospital-, patient-, and caregiver-level outcomes. Objectives 2 and 3 will involve a parallel mixed-methods process evaluation study to understand the mechanisms by which our context-adapted CISSS-CA ACE program improves care transitions for the elderly and by which our Wiki-suite contributes to adaptation, implementation, and scaling up of geriatric knowledge tools. Results: Data collection started in January 2019. As of January 2020, we enrolled 1635 patients and 529 caregivers from the four participating hospitals. Data collection is projected to be completed in January 2022. Data analysis has not yet begun. Results are expected to be published in 2022. Expected results will be presented to different key internal stakeholders to better support the effort and resources deployed in the transition of seniors. Through key interventions focused on seniors, we are expecting to increase patient satisfaction and quality of care and reduce readmission and ED revisit. Conclusions: This study will provide evidence on effective knowledge translation strategies to adapt best practices to the local context in the transition of care for elderly people. The knowledge generated through this project will support future scale-up of the ACE program and our wiki methodology in other settings in Canada. Trial Registration: ClinicalTrials.gov NCT04093245; https://clinicaltrials.gov/ct2/show/NCT04093245. International Registered Report Identifier (IRRID): DERR1-10.2196/17363 UR - https://www.researchprotocols.org/2020/8/e17363 UR - http://dx.doi.org/10.2196/17363 UR - http://www.ncbi.nlm.nih.gov/pubmed/32755891 ID - info:doi/10.2196/17363 ER - TY - JOUR AU - Burchell, N. Ann AU - Lisk, Ryan AU - Yeung, Anna AU - Rana, Jayoti AU - Bacon, Jean AU - Brunetta, Jason AU - Gilbert, Mark AU - Gesink, Dionne AU - Grewal, Ramandip AU - Guiang, B. Charlie AU - Kwag, Michael AU - Logie, H. Carmen AU - Mitterni, Leo AU - Shahin, Rita AU - Tan, HS Darrell PY - 2019/07/04 TI - Community-Directed Bacterial Sexually Transmitted Infection Testing Interventions Among Men Who Have Sex With Men: Protocol for an E-Delphi Study in Toronto, Canada JO - JMIR Res Protoc SP - e13801 VL - 8 IS - 7 KW - sexual and gender minorities KW - sexually transmitted diseases KW - community-based research KW - mass screening KW - patient acceptance of health care N2 - Background: HIV-positive and HIV-negative (gay, bisexual, and other) men who have sex with men (MSM) have experienced a dramatic increase in bacterial sexually transmitted infections (STIs)?syphilis, gonorrhea, and chlamydia. STI testing and treatment mitigate adverse health outcomes and substantially reduce transmission; yet, testing rates remain below recommended levels. Innovation is needed to produce the required increases in testing levels, frequency, and the use of appropriate testing technologies in ways that are engaging, nonstigmatizing, and acceptable to men. Objective: The aim of this study is to build consensus with regard to interventions with the greatest potential for improving local STI testing services for MSM communities in Toronto, Canada. Methods: Following a literature review of evidence regarding the effectiveness of novel testing interventions, and focus groups, and surveys to describe local barriers and facilitators of testing among MSM, we will conduct a Web-based, modified Delphi study (e-Delphi). We will form expert panels of community members and STI test providers. Panelists will rate potential interventions in terms of their priority, using a 7-point Likert scale from definitely not a priority to definitely a priority. They will also rank their preferences by selecting their top 3 preferred interventions. Surveys will be distributed in 3 rounds, with feedback on the distribution of responses from preceding rounds provided in rounds 2 and 3. We will define consensus as having ?60% (18/30) members indicate a preference within 2 adjacent response points. Qualitative data on disagreements will be obtained using open-ended text responses to explain for ratings and rankings that are different from the majority. Results: On the basis of a literature review and identification of barriers and facilitators to STI testing among community members and test providers in Toronto, we have selected 8 potential interventions for inclusion in the e-Delphi panel surveys. These include 4 interventions that streamline STI testing for asymptomatic individuals, 2 interventions that are targeted at clients and 2 interventions that are targeted at providers. Conclusions: Findings will provide community direction for informed decision making regarding the implementation of STI testing interventions in this setting. They will characterize the intervention climate for innovation to STI testing services, including perceived needs for changes to test delivery, relative priorities for change, and readiness for implementation. These methods may be transferable to other urban jurisdictions experiencing similar epidemics and for other contexts where stakeholder input is needed to manage sensitive areas of concern. International Registered Report Identifier (IRRID): PRR1-10.2196/13801 UR - https://www.researchprotocols.org/2019/7/e13801/ UR - http://dx.doi.org/10.2196/13801 UR - http://www.ncbi.nlm.nih.gov/pubmed/31274111 ID - info:doi/10.2196/13801 ER - TY - JOUR AU - Quigley, Adria AU - O'Brien, K. Kelly AU - Brouillette, Marie-Josée AU - MacKay-Lyons, Marilyn PY - 2019/05/21 TI - Evaluating the Feasibility and Impact of a Yoga Intervention on Cognition, Physical Function, Physical Activity, and Affective Outcomes in People Living With HIV: Protocol for a Randomized Pilot Trial JO - JMIR Res Protoc SP - e13818 VL - 8 IS - 5 KW - HIV KW - AIDS KW - yoga KW - cognition N2 - Background: Despite lower mortality rates due to combination antiretroviral therapy, people living with HIV (PLWH) are grappling with increasingly complex health issues, including cognitive impairments in areas such as memory, attention, processing speed, and motor function. Yoga has been shown to be an effective form of exercise and mindfulness-based stress reduction for many clinical populations. However, no randomized trials have evaluated the impact of yoga on cognitive and physical function among PLWH. Objective: The aim of this pilot randomized trial was to determine the feasibility of a yoga intervention to lay the groundwork for a full-scale, multisite, community-based trial for PLWH. Specific objectives are to (1) assess the feasibility of study protocol and procedures, (2) compare cognition in the yoga group with the usual care control group after 12 weeks of the intervention in PLWH, and (3) compare the effects of the 12-week yoga intervention versus control on balance, walking speed, physical activity, mental health, medication adherence, and quality of life among PLWH. Methods: We propose a pilot randomized trial with 2 parallel groups (yoga versus control). We will recruit 25 PLWH (>35 years) from community and health organizations in Halifax, Canada. After baseline assessment with blinded assessors, participants will be randomly assigned to the yoga or control group, using a random computer generator. Participants in the yoga group will engage in supervised 60-min group-based yoga sessions 3 times a week for 12 weeks at a yoga studio. Participants in the control group will maintain their current physical activity levels throughout the study. Results: As per the Consolidated Standards of Reporting Trials extension for pilot studies, means of all outcomes, mean change, and 95% CIs will be calculated for each group separately. Two-tailed independent t tests and Fisher exact tests will be used to compare groups at baseline. We will analyze quantitative postintervention questionnaire responses using Chi-square tests, and open-ended responses will be analyzed thematically. Intention-to-treat and per-protocol analyses will be used to analyze secondary variables. Changes in outcome variables will be examined between groups and within groups. Effect sizes will be reported for each outcome. A priori adherence and satisfaction criteria will be met if participants attend >70% of the yoga sessions and if >70% of the participants are satisfied with the intervention as determined by a postparticipation questionnaire. Study enrollment began in January 2018, with results expected for October 2019. Conclusions: This pilot randomized trial will be the first to investigate the feasibility and effect of a yoga intervention on cognitive and physical outcomes among PLWH. This work will inform the feasibility of further investigations in terms of capacity building, participant recruitment and retention, and assessment and intervention protocols. Trial Registration: ClinicalTrials.gov NCT03071562; https://clinicaltrials.gov/ct2/show/NCT03071562 (Archived by WebCite at http://www.webcitation.org/785sfhWkw) International Registered Report Identifier (IRRID): DERR1-10.2196/13818 UR - http://www.researchprotocols.org/2019/5/e13818/ UR - http://dx.doi.org/10.2196/13818 UR - http://www.ncbi.nlm.nih.gov/pubmed/31115343 ID - info:doi/10.2196/13818 ER - TY - JOUR AU - Tilahun, Binyam AU - Smillie, Kirsten AU - Bardosh, Louis Kevin AU - Murray, Melanie AU - Fitzgerald, Mark AU - Cook, Victoria AU - Poureslami, Iraj AU - Forrest, Jamie AU - Lester, Richard PY - 2018/07/03 TI - Identifying Barriers and Facilitators of 13 mHealth Projects in North America and Africa: Protocol for a 5-Year Implementation Science Study JO - JMIR Res Protoc SP - e162 VL - 7 IS - 7 KW - mobile health KW - mHealth KW - text messaging KW - digital health KW - implementation science KW - Africa KW - North America N2 - Background: Although many mHealth interventions have shown efficacy in research, few have been effectively implemented and sustained in real-world health system settings. Despite this programmatic gap, there is limited conclusive evidence identifying the factors that affect the implementation and successful integration of mHealth into a health system. Objective: The aim of this study is to examine the individual, organizational, and external level factors associated with the effective implementation of WelTel, an mHealth intervention designed to support outpatient medication adherence and engagement in care in Africa and North America. Methods: We will adopt the Consolidated Framework for Implementation Research (CFIR) constructs for evaluation of mHealth implementation including a scoring and monitoring system. We will apply the adapted tool to identify facilitators and barriers to implementation of the WelTel mHealth intervention in order to determine how the technology platform is perceived, diffused, adapted, and used by different mHealth project teams and health system actors in Africa and North America. We will use a mixed-methods approach to quantitatively test whether the factors identified in the CFIR framework are associated with the successful uptake of the mHealth intervention toward implementation goals. We will triangulate these data through interviews and focus group discussion with project stakeholders, exploring factors associated with successful implementation and sustainment of these interventions. Results: The development of the customized CFIR is finalized and currently is in pilot testing. The initial results of the use of the tool in those 13 implementations will be available in 2019. Continuous conference and peer- reviewed publications will be published in the coming years. Conclusions: The results of this study will provide an in-depth understanding of individual, organizational, and external level factors that influence the successful implementation of mHealth in different health systems and geographic contexts over time. Via the tool?s unique scoring system connected to qualitative descriptors, these data will inform the most critical implementation targets and contribute to the tailoring of strategies that will assist the health system in overcoming barriers to implementation, and ultimately, improve treatment adherence and engagement in care. Registered Report Identifier: RR1-10.2196/9633 UR - http://www.researchprotocols.org/2018/7/e162/ UR - http://dx.doi.org/10.2196/resprot.9633 UR - http://www.ncbi.nlm.nih.gov/pubmed/29970360 ID - info:doi/10.2196/resprot.9633 ER - TY - JOUR AU - Seto, Emily AU - Ware, Patrick AU - Logan, G. Alexander AU - Cafazzo, A. Joseph AU - Chapman, R. Kenneth AU - Segal, Phillip AU - Ross, J. Heather PY - 2017/11/21 TI - Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol JO - JMIR Res Protoc SP - e229 VL - 6 IS - 11 KW - mHealth KW - smartphone KW - multiple chronic diseases KW - randomized controlled trial N2 - Background: The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology. Objective: The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions. Methods: A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73). Results: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018. Conclusions: This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions. Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC) UR - http://www.researchprotocols.org/2017/11/e229/ UR - http://dx.doi.org/10.2196/resprot.8367 UR - http://www.ncbi.nlm.nih.gov/pubmed/29162557 ID - info:doi/10.2196/resprot.8367 ER - TY - JOUR AU - Beauchamp, K. Marla AU - Brooks, Dina AU - Ellerton, Cindy AU - Lee, Annemarie AU - Alison, Jennifer AU - Camp, G. Pat AU - Dechman, Gail AU - Haines, Kimberley AU - Harrison, L. Samantha AU - Holland, E. Anne AU - Marques, Alda AU - Moineddin, Rahim AU - Skinner, H. Elizabeth AU - Spencer, Lissa AU - Stickland, K. Michael AU - Xie, Feng AU - Goldstein, S. Roger PY - 2017/11/20 TI - Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e228 VL - 6 IS - 11 KW - COPD KW - pulmonary rehabilitation KW - balance KW - exercise KW - falls KW - economic analysis N2 - Background: Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality worldwide. A growing body of evidence shows that individuals with COPD have important deficits in balance control that may be associated with an increased risk of falls. Pulmonary rehabilitation (PR) is a key therapeutic intervention for individuals with COPD; however, current international guidelines do not include balance training and fall prevention strategies. Objective: The primary aim of this trial is to determine the effects of PR with balance training compared to PR with no balance training on the 12-month rate of falls in individuals with COPD. Secondary aims are to determine the effects of the intervention on balance, balance confidence, and functional lower body strength, and to estimate the cost-effectiveness of the program. Methods: A total of 400 individuals from nine PR centers across Canada, Europe, and Australia will be recruited to participate in a randomized controlled trial. Individuals with COPD who have a self-reported decline in balance, a fall in the last 2 years, or recent near fall will be randomly assigned to an intervention or control group. The intervention group will undergo tailored balance training in addition to PR and will receive a personalized home-based balance program. The control group will receive usual PR and a home program that does not include balance training. All participants will receive monthly phone calls to provide support and collect health care utilization and loss of productivity data. Both groups will receive home visits at 3, 6, and 9 months to ensure proper technique and progression of home exercise programs. The primary outcome will be incidence of falls at 12-month follow-up. Falls will be measured using a standardized definition and recorded using monthly self-report fall diary calendars. Participants will be asked to record falls and time spent performing their home exercise program on the fall diary calendars. Completed calendars will be returned to the research centers in prepaid envelopes each month. Secondary measures collected by a blinded assessor at baseline (pre-PR), post-PR, and 12-month follow-up will include clinical measures of balance, balance confidence, functional lower body strength, and health status. The cost-effectiveness of the intervention group compared with the control group will be evaluated using the incremental cost per number of falls averted and the incremental cost per quality-adjusted life years gained. Results: Recruitment for the study began in January 2017 and is anticipated to be complete by December 2019. Results are expected to be available in 2020. Conclusions: Findings from this study will improve our understanding of the effectiveness and resource uses of tailored balance training for reducing falls in individuals with COPD. If effective, the intervention represents an opportunity to inform international guidelines and health policy for PR in individuals with COPD who are at risk of falling. Trial Registration: ClinicalTrials.gov NCT02995681; https://clinicaltrials.gov/ct2/show/NCT02995681 (Archived by WebCite at http://www.webcitation.org/6ukhxgAsg) UR - http://www.researchprotocols.org/2017/11/e228/ UR - http://dx.doi.org/10.2196/resprot.8178 UR - http://www.ncbi.nlm.nih.gov/pubmed/29158206 ID - info:doi/10.2196/resprot.8178 ER - TY - JOUR AU - Gilron, Ian AU - Tu, Dongsheng AU - Holden, Ronald AU - Towheed, Tanveer AU - Vandenkerkhof, Elizabeth AU - Milev, Roumen PY - 2017/08/04 TI - Combination Analgesic Development for Enhanced Clinical Efficacy (CADENCE Trial): Study Protocol for a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of an Alpha-Lipoic Acid ? Pregabalin Combination for the Treatment of Fibromyalgia Pain JO - JMIR Res Protoc SP - e154 VL - 6 IS - 8 KW - fibromyalgia KW - alpha-lipoic acid KW - antioxidant KW - pregabalin KW - anticonvulsant N2 - Background: Fibromyalgia is a clinical disorder commonly presenting with chronic widespread pain as well as sleep disturbance, fatigue, depression, and cognitive dysfunction. There is an urgent need for treatment strategies that provide better pain relief and fewer adverse effects (AEs). Efforts to develop rational combinations of specific fibromyalgia treatments have demonstrated potential for measurable improvements in pain relief, quality of life, and health care utilization. More than half of fibromyalgia patients receive 2 or more analgesics but current combination use is based on limited evidence. As an early proof-of-concept project from the Canadian Institutes of Health Research?Strategy on Patient-Oriented Research Chronic Pain Network, this trial protocol is expected to advance the field by rigorously evaluating a new treatment combination for fibromyalgia. Objective: We will test the hypothesis that analgesic combinations containing at least one nonsedating agent would be as safe but more effective than either monotherapy because of additive pain relief without increasing overall AEs. Pregabalin (PGB), a sedating anticonvulsant, is proven effective for fibromyalgia, and the antioxidant, alpha-lipoic acid (ALA), one of the only nonsedating systemic agents proven effective for neuropathic pain, is currently being evaluated in fibromyalgia. Thus, we will conduct a clinical trial to compare a PGB+ALA combination to each monotherapy for fibromyalgia. Methods: Using a double-blind, double-dummy, crossover design, 54 adults with fibromyalgia will be randomly allocated to 1 of 6 sequences of treatment with PGB, ALA, and PGB+ALA combination. During each of 3 different treatment periods, participants will take 2 sets of capsules containing (1) ALA (or placebo) and (2) PGB (or placebo) for 31 days, followed by an 11-day taper/washout period. The primary outcome will be mean daily pain intensity (0 to 10 scale) at maximal tolerated doses (MTDs) during each period. Secondary outcomes, assessed at MTD, will include global improvement, adverse events, mood, and quality of life. Results: This trial attained ethics approval March 6, 2017 (Queen?s University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-313-17), and recruitment is set to start in August 2017. Conclusions: This trial will provide rigorous evidence comparing the efficacy of a PGB-ALA combination to PGB alone and ALA alone in the treatment of fibromyalgia. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN14939460; https://www.isrctn.com/ ISRCTN1493946 (Archived by WebCite at http://www.webcitation.org/6sFqAjxkt) UR - http://www.researchprotocols.org/2017/8/e154/ UR - http://dx.doi.org/10.2196/resprot.8001 UR - http://www.ncbi.nlm.nih.gov/pubmed/28778847 ID - info:doi/10.2196/resprot.8001 ER - TY - JOUR AU - PY - 2016/12/18 TI - Supporting Heart Failure Patient Transitions From Acute to Community Care With Home Telemonitoring Technology: A Protocol for a Provincial Randomized Controlled Trial (TEC4Home) JO - JMIR Res Protoc SP - e198 VL - 5 IS - 4 KW - heart failure KW - telemedicine KW - remote sensing technology KW - emergency service, hospital KW - hospitalization KW - quality of life N2 - Background: Seniors with chronic diseases such as heart failure have complex care needs. They are vulnerable to their condition deteriorating and, without timely intervention, may require multiple emergency department visits and/or repeated hospitalizations. Upon discharge, the transition from the emergency department to home can be a vulnerable time for recovering patients with disruptions in the continuity of care. Remote monitoring of heart failure patients using home telemonitoring, coupled with clear communication protocols between health care professionals, can be effective in increasing the safety and quality of care for seniors with heart failure discharged from the emergency department. Objective: The aim of the Telehealth for Emergency-Community Continuity of Care Connectivity via Home Telemonitoring (TEC4Home) study is to generate evidence through a programmatic evaluation and a clinical trial to determine how home telemonitoring may improve care and increase patient safety during the transition of care and determine how it is best implemented to support patients with heart failure within this context. Methods: This 4-year project consists of 3 studies to comprehensively evaluate the outcomes and effectiveness of TEC4Home. Study 1 is a feasibility study with 90 patients recruited from 2 emergency department sites to test implementation and evaluation procedures. Findings from the feasibility study will be used to refine protocols for the larger trial. Study 2 is a cluster randomized controlled trial that will include 30 emergency department sites and 900 patients across British Columbia. The primary outcome of the randomized controlled trial will be emergency department revisits and hospital readmission rates. Secondary outcomes include health care resource utilization/costs, communication between members of the care team, and patient quality of life. Study 3 will run concurrently to study 2 and test the effectiveness of predictive analytic software to detect patient deterioration sooner. Results: It is hypothesized that TEC4Home will be a cost-effective strategy to decrease 90-day emergency department revisits and hospital admission rates and improve comfort and quality of life for seniors with heart failure. The results from this project will also help establish an innovation pathway for rapid and rigorous introduction of innovation into the health system. Conclusions: While there is some evidence about the effectiveness of home telemonitoring for some patients and conditions, the TEC4Home project will be one of the first protocols that implements and evaluates the technology for patients with heart failure as they transition from the emergency department to home care. The results from this research are expected to inform the full scale and spread of the home monitoring approach throughout British Columbia and Canada and to other chronic diseases. ClinicalTrial: ClinicalTrials.gov NCT02821065; https://clinicaltrials.gov/ct2/show/NCT02821065 (Archived by WebCite at http://www.webcitation.org/6ml2iwKax) UR - http://www.researchprotocols.org/2016/4/e198/ UR - http://dx.doi.org/10.2196/resprot.5856 UR - http://www.ncbi.nlm.nih.gov/pubmed/27977002 ID - info:doi/10.2196/resprot.5856 ER - TY - JOUR AU - Wilansky, Pamela AU - Eklund, Mikael J. AU - Milner, Tracy AU - Kreindler, David AU - Cheung, Amy AU - Kovacs, Tim AU - Shooshtari, Shahin AU - Astell, Arlene AU - Ohinmaa, Arto AU - Henderson, Joanna AU - Strauss, John AU - Mills, SL Rosemary PY - 2016/11/10 TI - Cognitive Behavior Therapy for Anxious and Depressed Youth: Improving Homework Adherence Through Mobile Technology JO - JMIR Res Protoc SP - e209 VL - 5 IS - 4 KW - mHealth KW - mobile app KW - youth KW - anxiety KW - depression KW - cognitive behavior therapy KW - homework N2 - Background: Anxiety and mood disorders are the most common mental illnesses, peaking during adolescence and affecting approximately 25% of Canadians aged 14-17 years. If not successfully treated at this age, they often persist into adulthood, exerting a great social and economic toll. Given the long-term impact, finding ways to increase the success and cost-effectiveness of mental health care is a pressing need. Cognitive behavior therapy (CBT) is an evidence-based treatment for mood and anxiety disorders throughout the lifespan. Mental health technologies can be used to make such treatments more successful by delivering them in a format that increases utilization. Young people embrace technologies, and many want to actively manage their mental health. Mobile software apps have the potential to improve youth adherence to CBT and, in turn, improve outcomes of treatment. Objective: The purpose of this project is to improve homework adherence in CBT for youth anxiety and/or depression. The objectives are to (1) design and optimize the usability of a mobile app for delivering the homework component of CBT for youth with anxiety and/or depression, (2) assess the app?s impact on homework completion, and (3) implement the app in CBT programs. We hypothesize that homework adherence will be greater in the app group than in the no-app group. Methods: Phase 1: exploratory interviews will be conducted with adolescents and therapists familiar with CBT to obtain views and perspectives on the requirements and features of a usable app and the challenges involved in implementation. The information obtained will guide the design of a prototype. The prototype will be optimized via think-aloud procedures involving an iterative process of evaluation, modification, and re-evaluation, culminating in a fully functional version of the prototype that is ready for optimization in a clinical context. Phase 2: a usability study will be conducted to optimize the prototype in the context of treatment at clinics that provide CBT treatment for youth with anxiety and/or depression. This phase will result in a usable app that is ready to be tested for its effectiveness in increasing homework adherence. Phase 3: a pragmatic clinical trial will be conducted at several clinics to evaluate the impact of the app on homework adherence. Participants in the app group are expected to show greater homework completion than those in the no-app group. Results: Phase 3 will be completed by September 2019. Conclusions: The app will be a unique adjunct to treatment for adolescents in CBT, focusing on both anxiety and depression, developed in partnership with end users at every stage from design to implementation, customizable for different cognitive profiles, and designed with depression symptom tracking measures for youth made interoperable with electronic medical records. UR - http://www.researchprotocols.org/2016/4/e209/ UR - http://dx.doi.org/10.2196/resprot.5841 UR - http://www.ncbi.nlm.nih.gov/pubmed/27833071 ID - info:doi/10.2196/resprot.5841 ER - TY - JOUR AU - Meguerditchian, Ari AU - Tamblyn, Robyn AU - Meterissian, Sarkis AU - Law, Susan AU - Prchal, Jaroslav AU - Winslade, Nancy AU - Stern, Donna PY - 2016/11/07 TI - Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study JO - JMIR Res Protoc SP - e199 VL - 5 IS - 4 KW - administrative claims KW - health care KW - breast neoplasms KW - medical informatics applications KW - aromatase inhibitors KW - telemedicine KW - health services for the aged KW - medication adherence N2 - Background: In women with hormone receptor positive breast cancer, adjuvant endocrine therapy (AET) is associated with a significant survival advantage. Nonadherence is a particular challenge in older women, even though they stand to benefit the most from AET. Therefore, a novel eHealth tool (OPTIMUM) that integrates real-time analysis of health administrative claims data was developed to provide point-of-care decision support for clinicians. Objectives: The objectives of the study are to determine the effectiveness of a patient-specific, real-time eHealth alert delivered at point-of-care in reducing rates of AET discontinuation and to understand patient-level factors related to AET discontinuation as well as to assess integration of eHealth alerts regarding deviations from best practices in administration of AET by cancer care teams. Methods: A prospective, 2-group controlled comparison pilot study will be conducted at 2 urban, McGill University?affiliated hospitals, the Royal Victoria Hospital and St. Mary?s Hospital. A minimum of 43 patients per study arm will be enrolled through site-level allocation. Follow-up is 1.5 years. Health care professionals at the intervention site will have access to the eHealth tool, which will report to them in real-time medical events with known associations to AET discontinuation, an AET adherence monitor, and a discontinuation alert. Cox proportional hazard ratios with 95% confidence intervals will estimate risks of AET discontinuation. Tests for significance will be 2-sided with a significance level of P<.05. Results: This protocol has been approved and funded by the Canadian Institutes of Health Research. The study will evaluate site-level differences between AET discontinuation and AET adherence and assess care team actions at the intervention site. Participant enrollment into this project is expected to start September 2016 with primary data ready to present by June 2018. Conclusion: This study will offer an opportunity to verify the feasibility of integrating an eHealth tool that aims to improve the long-term management of breast cancer in a high-risk population by allowing more timely intervention to prevent or rapidly address AET discontinuation. UR - http://www.researchprotocols.org/2016/4/e199/ UR - http://dx.doi.org/10.2196/resprot.6519 UR - http://www.ncbi.nlm.nih.gov/pubmed/27821385 ID - info:doi/10.2196/resprot.6519 ER - TY - JOUR AU - McGillion, Michael AU - Yost, Jennifer AU - Turner, Andrew AU - Bender, Duane AU - Scott, Ted AU - Carroll, Sandra AU - Ritvo, Paul AU - Peter, Elizabeth AU - Lamy, Andre AU - Furze, Gill AU - Krull, Kirsten AU - Dunlop, Valerie AU - Good, Amber AU - Dvirnik, Nazari AU - Bedini, Debbie AU - Naus, Frank AU - Pettit, Shirley AU - Henry, Shaunattonie AU - Probst, Christine AU - Mills, Joseph AU - Gossage, Elaine AU - Travale, Irene AU - Duquette, Janine AU - Taberner, Christy AU - Bhavnani, Sanjeev AU - Khan, S. James AU - Cowan, David AU - Romeril, Eric AU - Lee, John AU - Colella, Tracey AU - Choinière, Manon AU - Busse, Jason AU - Katz, Joel AU - Victor, Charles J. AU - Hoch, Jeffrey AU - Isaranuwatchai, Wanrudee AU - Kaasalainen, Sharon AU - Ladak, Salima AU - O'Keefe-McCarthy, Sheila AU - Parry, Monica AU - Sessler, I. Daniel AU - Stacey, Michael AU - Stevens, Bonnie AU - Stremler, Robyn AU - Thabane, Lehana AU - Watt-Watson, Judy AU - Whitlock, Richard AU - MacDermid, C. Joy AU - Leegaard, Marit AU - McKelvie, Robert AU - Hillmer, Michael AU - Cooper, Lynn AU - Arthur, Gavin AU - Sider, Krista AU - Oliver, Susan AU - Boyajian, Karen AU - Farrow, Mark AU - Lawton, Chris AU - Gamble, Darryl AU - Walsh, Jake AU - Field, Mark AU - LeFort, Sandra AU - Clyne, Wendy AU - Ricupero, Maria AU - Poole, Laurie AU - Russell-Wood, Karsten AU - Weber, Michael AU - McNeil, Jolene AU - Alpert, Robyn AU - Sharpe, Sarah AU - Bhella, Sue AU - Mohajer, David AU - Ponnambalam, Sem AU - Lakhani, Naeem AU - Khan, Rabia AU - Liu, Peter AU - Devereaux, PJ PY - 2016/08/01 TI - Technology-Enabled Remote Monitoring and Self-Management ? Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol JO - JMIR Res Protoc SP - e149 VL - 5 IS - 3 KW - technology-enabled self-management KW - remote automated external monitoring KW - usability testing KW - randomized controlled trial N2 - Background: Tens of thousands of cardiac and vascular surgeries (CaVS) are performed on seniors in Canada and the United Kingdom each year to improve survival, relieve disease symptoms, and improve health-related quality of life (HRQL). However, chronic postsurgical pain (CPSP), undetected or delayed detection of hemodynamic compromise, complications, and related poor functional status are major problems for substantial numbers of patients during the recovery process. To tackle this problem, we aim to refine and test the effectiveness of an eHealth-enabled service delivery intervention, TecHnology-Enabled remote monitoring and Self-MAnagemenT?VIsion for patient EmpoWerment following Cardiac and VasculaR surgery (THE SMArTVIEW, CoVeRed), which combines remote monitoring, education, and self-management training to optimize recovery outcomes and experience of seniors undergoing CaVS in Canada and the United Kingdom. Objective: Our objectives are to (1) refine SMArTVIEW via high-fidelity user testing and (2) examine the effectiveness of SMArTVIEW via a randomized controlled trial (RCT). Methods: CaVS patients and clinicians will engage in two cycles of focus groups and usability testing at each site; feedback will be elicited about expectations and experience of SMArTVIEW, in context. The data will be used to refine the SMArTVIEW eHealth delivery program. Upon transfer to the surgical ward (ie, post-intensive care unit [ICU]), 256 CaVS patients will be reassessed postoperatively and randomly allocated via an interactive Web randomization system to the intervention group or usual care. The SMArTVIEW intervention will run from surgical ward day 2 until 8 weeks following surgery. Outcome assessments will occur on postoperative day 30; at week 8; and at 3, 6, 9, and 12 months. The primary outcome is worst postop pain intensity upon movement in the previous 24 hours (Brief Pain Inventory-Short Form), averaged across the previous 14 days. Secondary outcomes include a composite of postoperative complications related to hemodynamic compromise?death, myocardial infarction, and nonfatal stroke? all-cause mortality and surgical site infections, functional status (Medical Outcomes Study Short Form-12), depressive symptoms (Geriatric Depression Scale), health service utilization-related costs (health service utilization data from the Institute for Clinical Evaluative Sciences data repository), and patient-level cost of recovery (Ambulatory Home Care Record). A linear mixed model will be used to assess the effects of the intervention on the primary outcome, with an a priori contrast of weekly average worst pain intensity upon movement to evaluate the primary endpoint of pain at 8 weeks postoperation. We will also examine the incremental cost of the intervention compared to usual care using a regression model to estimate the difference in expected health care costs between groups. Results: Study start-up is underway and usability testing is scheduled to begin in the fall of 2016. Conclusions: Given our experience, dedicated industry partners, and related RCT infrastructure, we are confident we can make a lasting contribution to improving the care of seniors who undergo CaVS. UR - http://www.researchprotocols.org/2016/3/e149/ UR - http://dx.doi.org/10.2196/resprot.5763 UR - http://www.ncbi.nlm.nih.gov/pubmed/27480247 ID - info:doi/10.2196/resprot.5763 ER - TY - JOUR AU - Padwal, Raj AU - McAlister, Aleck Finlay AU - Wood, William Peter AU - Boulanger, Pierre AU - Fradette, Miriam AU - Klarenbach, Scott AU - Edwards, L. Alun AU - Holroyd-Leduc, M. Jayna AU - Alagiakrishnan, Kannayiram AU - Rabi, Doreen AU - Majumdar, Ranjan Sumit PY - 2016/06/24 TI - Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial JO - JMIR Res Protoc SP - e107 VL - 5 IS - 2 KW - blood pressure KW - hypertension KW - seniors KW - telemonitoring KW - randomized controlled trial KW - case management N2 - Background: Diabetes and hypertension are devastating, deadly, and costly conditions that are very common in seniors. Controlling hypertension in seniors with diabetes dramatically reduces hypertension-related complications. However, blood pressure (BP) must be lowered carefully because seniors are also susceptible to low BP and attendant harms. Achieving ?optimal BP control? (ie, avoiding both undertreatment and overtreatment) is the ultimate therapeutic goal in such patients. Regular BP monitoring is required to achieve this goal. BP monitoring at home is cheap, convenient, widely used, and guideline endorsed. However, major barriers prevent proper use. These may be overcome through use of BP telemonitoring?the secure teletransmission of BP readings to a health portal, where BP data are summarized for provider and patient use, with or without protocolized case management. Objective: To examine the incremental effectiveness, safety, cost-effectiveness, usability, and acceptability of home BP telemonitoring, used with or without protocolized case management, compared with ?enhanced usual care? in community-dwelling seniors with diabetes and hypertension. Methods: A 300-patient, 3-arm, pragmatic randomized controlled trial with blinded outcome ascertainment will be performed in seniors with diabetes and hypertension living independently in seniors? residences in greater Edmonton. Consenting patients will be randomized to usual care, home BP telemonitoring alone, or home BP telemonitoring plus protocolized pharmacist case management. Usual care subjects will receive a home BP monitor but neither they nor their providers will have access to teletransmitted data. In both telemonitored arms, providers will receive telemonitored BP data summaries. In the case management arm, pharmacist case managers will be responsible for reviewing teletransmitted data and initiating guideline-concordant and protocolized changes in BP management. Results: Outcomes will be ascertained at 6 and 12 months. Within-study-arm change scores will be calculated and compared between study arms. These include: (1) clinical outcomes: proportion of subjects with a mean 24-hour ambulatory systolic BP in the optimal range (110-129 mmHg in patients 65-79 years and 110-139 mmHg in those ?80 years: primary outcome); additional ambulatory and home BP outcomes; A1c and lipid profile; medications, cognition, health care use, cardiovascular events, and mortality. (2) Safety outcomes: number of serious episodes of hypotension, syncope, falls, and electrolyte disturbances (requiring third party assistance or medical attention). (3) Humanistic outcomes: quality of life, satisfaction, and medication adherence. (4) Economic outcomes: incremental costs, incremental cost-utility, and cost per mmHg change in BP of telemonitoring ± case management compared with usual care (health payor and societal perspectives). (5) Intervention usability and acceptability to patients and providers. Conclusion: The potential benefits of telemonitoring remain largely unstudied and unproven in seniors. This trial will comprehensively assess the impact of home BP telemonitoring across a range of outcomes. Results will inform the value of implementing home-based telemonitoring within supportive living residences in Canada. Trial Registration: Clinicaltrials.gov NCT02721667; https://clinicaltrials.gov/ct2/show/NCT02721667 (Archived by Webcite at http://www.webcitation.org/6i8tB20Mc) UR - http://www.researchprotocols.org/2016/2/e107/ UR - http://dx.doi.org/10.2196/resprot.5775 UR - http://www.ncbi.nlm.nih.gov/pubmed/27343147 ID - info:doi/10.2196/resprot.5775 ER - TY - JOUR AU - Steele Gray, Carolyn AU - Wodchis, P. Walter AU - Upshur, Ross AU - Cott, Cheryl AU - McKinstry, Brian AU - Mercer, Stewart AU - Palen, E. Ted AU - Ramsay, Tim AU - Thavorn, Kednapa AU - PY - 2016/06/24 TI - Supporting Goal-Oriented Primary Health Care for Seniors with Complex Care Needs Using Mobile Technology: Evaluation and Implementation of the Health System Performance Research Network, Bridgepoint Electronic Patient Reported Outcome Tool JO - JMIR Res Protoc SP - e126 VL - 5 IS - 2 KW - eHealth/mHealth solutions KW - complex care needs KW - seniors KW - patient-centered care KW - goal-oriented care KW - primary health care KW - implementation KW - pragmatic trial KW - health outcomes KW - cost-effectiveness analysis N2 - Background: Older adults experiencing multiple chronic illnesses are at high risk of hospitalization and health decline if they are unable to manage the significant challenges posed by their health conditions. Goal-oriented care approaches can provide better care for these complex patients, but clinicians find the process of ascertaining goals ?too complex and too-time consuming,? and goals are often not agreed upon between complex patients and their providers. The electronic patient reported outcomes (ePRO) mobile app and portal offers an innovative approach to creating and monitoring goal-oriented patient-care plans to improve patient self-management and shared decision-making between patients and health care providers. The ePRO tool also supports proactive patient monitoring by the patient, caregiver(s), and health care provider. It was developed with and for older adults with complex care needs as a means to improve their quality of life. Objective: Our proposed project will evaluate the use, effectiveness, and value for money of the ePRO tool in a 12-month multicenter, randomized controlled trial in Ontario; targeting individuals 65 or over with two or more chronic conditions that require frequent health care visits to manage their health conditions. Methods: Intervention groups using the ePRO tool will be compared with control groups on measures of quality of life, patient experience, and cost-effectiveness. We will also evaluate the implementation of the tool. Results: The proposed project presented in this paper will be funded through the Canadian Institute for Health Research (CIHR) eHealth Innovation Partnerships Program (eHIPP) program (CIHR?143559). The expected completion date of the study is November, 2019. Conclusions: We anticipate our program of work will support improved quality of life and patient self-management, improved patient-centered primary care delivery, and will encourage the adoption of goal-oriented care approaches across primary health care systems. We have partnered with family health teams and quality improvement organizations in Ontario to ensure that our research is practical and that findings are shared widely. We will work with our established international network to develop an implementation framework to support continued adaptation and adoption across Canada and internationally. UR - http://www.researchprotocols.org/2016/2/e126/ UR - http://dx.doi.org/10.2196/resprot.5756 UR - http://www.ncbi.nlm.nih.gov/pubmed/27341765 ID - info:doi/10.2196/resprot.5756 ER - TY - JOUR AU - Desveaux, Laura AU - Beauchamp, K. Marla AU - Lee, Annemarie AU - Ivers, Noah AU - Goldstein, Roger AU - Brooks, Dina PY - 2016/05/11 TI - Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation JO - JMIR Res Protoc SP - e63 VL - 5 IS - 2 KW - COPD KW - pulmonary rehabilitation KW - exercise training KW - maintenance KW - community N2 - Objectives: This manuscript (1) outlines the intervention, (2) describes how its effectiveness is being evaluated in a pragmatic randomized controlled trial, and (3) summarizes the embedded process evaluation aiming to understand key barriers and facilitators for implementation in new environments. Methods: Participating centers refer eligible individuals with COPD following discharge from their local PR program. Consenting patients are assigned to a year-long community exercise program or usual care using block randomization and stratifying for supplemental oxygen use. Patients in the intervention arm are asked to attend an exercise session at least twice per week at their local community facility where their progress is supervised by a case manager. Each exercise session includes a component of aerobic exercise, and activities designed to optimize balance, flexibility, and strength. All study participants will have access to routine follow-up appointments with their respiratory physician, and additional health care providers as part of their usual care. Assessments will be completed at baseline (post-PR), 6, and 12 months, and include measures of functional exercise capacity, quality of life, self-efficacy, and health care usage. Intervention effectiveness will be assessed by comparing functional exercise capacity between intervention and control groups. A mixed-methods process evaluation will be conducted to better understand intervention implementation, guided by Normalization Process Theory and the Consolidated Framework for Implementation Research. Results: Based on results from our pilot work, we anticipate a maintenance of exercise capacity and improved health-related quality of life in the intervention group, compared with a decline in exercise capacity in the usual care group. Discussion: Findings from this study will improve our understanding of the effectiveness of community-based exercise programs for maintaining benefits following PR in patients with COPD and provide information on how best to implement them. If effective, the intervention represents an opportunity to transition patients from institutionally-based rehabilitative management to community-based care. The results of the process evaluation will contribute to the science of translating evidence-based programs into regular practice. UR - http://www.researchprotocols.org/2016/2/e63/ UR - http://dx.doi.org/10.2196/resprot.5435 UR - http://www.ncbi.nlm.nih.gov/pubmed/27169436 ID - info:doi/10.2196/resprot.5435 ER - TY - JOUR AU - Engler-Stringer, Rachel AU - Muhajarine, Nazeem AU - Ridalls, Tracy AU - Abonyi, Sylvia AU - Vatanparast, Hassan AU - Whiting, Susan AU - Walker, Ryan PY - 2016/04/14 TI - The Good Food Junction: a Community-Based Food Store Intervention to Address Nutritional Health Inequities JO - JMIR Res Protoc SP - e52 VL - 5 IS - 2 KW - food environments KW - intervention KW - natural experiment N2 - Background: This is a 2-year study to assess the early impacts of a new grocery store intervention in a former food desert. Objective: The purpose of the study is to understand the early health effects of the introduction of a large-scale food and nutrition-focused community-based population health intervention, the Good Food Junction (GFJ) Cooperative Store, in a geographically bounded group of socially disadvantaged neighborhoods (the ?core neighborhoods?) in a midsized Canadian city. The GFJ grocery store was tasked with improving the access of residents to healthy, affordable food. The 5 research questions are: (1) What is the awareness and perception of the GFJ store among residents of the core neighborhoods? (2) Are there differences in awareness and perception among those who do and do not shop at the GFJ? (3) Will healthy food purchasing at the GFJ by residents of the core neighborhoods change over time, and what purchases are these individuals making at this store? (4) What early impact(s) will the GFJ have on key health-related outcomes (such as household food security status, vegetable and fruit intake, key aspects of self-reported mental health, self-reported health)? and (5) Are the effects of the intervention seen for specific vulnerable population groups, such as Aboriginal people, seniors (65 years old or older) and new immigrants (settled in Saskatoon for less than 5 years)? Methods: The research project examined initial impacts of the GFJ on the health of the residents in surrounding neighborhoods through a door-to-door cross-sectional survey of food access and household demographics; an examination of GFJ sales data by location of shoppers' residences; and a 1-year, 3-time-point longitudinal study of self-reported health of GFJ shoppers. Results: Analyses are on-going, but preliminary results show that shoppers are using the store for its intended purpose, which is to improve access to healthy food in a former food desert. Conclusions: To our knowledge this is the first large-scale study of a full-service grocery store intervention in a former food desert in Canada that has used multiple data sources, as well as longitudinal analyses, to examine its effects. Its findings will contribute significantly to the knowledge base on food environment interventions. UR - http://www.researchprotocols.org/2016/2/e52/ UR - http://dx.doi.org/10.2196/resprot.5303 UR - http://www.ncbi.nlm.nih.gov/pubmed/27079140 ID - info:doi/10.2196/resprot.5303 ER - TY - JOUR AU - Newton, S. Amanda AU - Wozney, Lori AU - Bagnell, Alexa AU - Fitzpatrick, Eleanor AU - Curtis, Sarah AU - Jabbour, Mona AU - Johnson, David AU - Rosychuk, J. Rhonda AU - Young, Michael AU - Ohinmaa, Arto AU - Joyce, Anthony AU - McGrath, Patrick PY - 2016/01/29 TI - Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial JO - JMIR Res Protoc SP - e18 VL - 5 IS - 1 KW - anxiety KW - etherapy KW - cognitive behavioral therapy KW - adolescents KW - mental health KW - Internet KW - intervention KW - pilot KW - randomized controlled trial N2 - Background: There is a demand to make first-line treatments, including cognitive behavioural therapy (CBT) for adolescent anxiety disorders, more widely available. Internet-based CBT is proposed to circumvent access and availability barriers and reduce health care system costs. Recent reviews suggest more evidence is needed to establish the treatment effects of Internet-based CBT in children and adolescents and to determine related economic impacts. Objective: This pilot trial aims to collect the necessary data to inform the planning of a full-scale RCT to test the effectiveness of the Internet-based CBT program Breathe (Being Real, Easing Anxiety: Tools Helping Electronically). Methods: We are conducting a 27-month, 2-arm parallel-group, pilot randomized controlled trial (RCT). Outcomes will inform the planning of a full-scale RCT aimed to test the effectiveness of Internet-based CBT with a population of adolescents with moderate to mild anxiety problems. In the pilot RCT we will: (1) define a minimal clinically important difference (MCID) for the primary outcome measure (total anxiety score using the Multidimensional Anxiety Scale for Children); (2) determine a sample size for the full-scale RCT; (3) estimate recruitment and retention rates; (4) measure intervention acceptability to inform critical intervention changes; (5) determine the use of co-interventions; and (6) conduct a cost-consequence analysis to inform a cost-effectiveness analysis in the full-scale RCT. Adolescents aged 13-17 years seeking care for an anxiety complaint from a participating emergency department, mobile or school-based crisis team, or primary care clinic are being screened for interest and eligibility. Enrolled adolescents are being randomly allocated to either 8 weeks of Internet-based CBT with limited telephone and e-mail support, or a control group with access to a static webpage listing anxiety resources. Adolescents are randomly assigned using a computer generated allocation sequence. Data are being collected at baseline, treatment completion, and at a 3-month follow-up. Results: Currently, adolescents are being enrolled in the study. Enrolment is taking place between March 2014 and February 2016; data collection will conclude May 2016. We expect that analysis and results will be available by August 2016. Conclusions: In many communities, the resources available for front-line anxiety treatment are outweighed by the need for care. This pilot RCT is an essential step to designing a robust RCT to evaluate the effectiveness of an Internet-based CBT program for adolescents with moderate to mild anxiety problems. Trial Registration: Clinicaltrials.gov NCT02059226; http://clinicaltrials.gov/ct2/show/NCT02059226 (Archived by WebCite at http://www.webcitation.org/6epF8v7k4) UR - http://www.researchprotocols.org/2016/1/e18/ UR - http://dx.doi.org/10.2196/resprot.4428 UR - http://www.ncbi.nlm.nih.gov/pubmed/26825111 ID - info:doi/10.2196/resprot.4428 ER - TY - JOUR AU - Turner, Karen AU - Reynolds, N. James AU - McGrath, Patrick AU - Lingley-Pottie, Patricia AU - Huguet, Anna AU - Hewitt, Amy AU - Green, Courtney AU - Wozney, Lori AU - Mushquash, Christopher AU - Muhajarine, Nazeem AU - Sourander, Andre AU - Caughey, Heather AU - Roane, Jessica PY - 2015/10/13 TI - Guided Internet-Based Parent Training for Challenging Behavior in Children With Fetal Alcohol Spectrum Disorder (Strongest Families FASD): Study Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e112 VL - 4 IS - 4 KW - fetal alcohol spectrum disorder KW - neurobehavioral disorder KW - prenatal alcohol exposure KW - disruptive behavior KW - children KW - Strongest Families KW - parenting KW - randomized controlled trial KW - eHealth KW - Web-based intervention N2 - Background: Fetal alcohol spectrum disorder (FASD) is a term used to encompass the full range of neurobehavioral and cognitive dysfunction that may occur as a consequence of prenatal alcohol exposure. There is relatively little research on intervention strategies that specifically target the behavioral problems of children with FASD. Availability and access to services are barriers to timely and effective care for families. The Strongest Families FASD intervention was recently adapted from the Strongest Families ?Parenting the Active Child? program to include FASD-specific content delivered via an Internet-based application in conjunction with 11 telephone coaching sessions. Objective: Our objectives are to (1) evaluate the effectiveness of Strongest Families FASD in reducing externalizing problems (primary outcome), internalizing problems, and parent distress (secondary outcomes) in children aged between 4 and 12 years diagnosed with FASD when compared to a control group with access to a static resource Web page; (2) evaluate the effectiveness of Strongest Families FASD in improving social competence (secondary outcome) in school-aged children aged between 6 and 12 diagnosed with FASD when compared with an online psychoeducation control; and (3) explore parental satisfaction with the Strongest Families FASD online parenting program. Methods: Parents and caregivers (N=200) of children diagnosed with FASD who have significant behavioral challenges, ages 4-12, are being recruited into a 2-arm randomized trial. The trial is designed to evaluate the effectiveness of the Web-based Strongest Families FASD parenting intervention on child behavior and caregiver distress, compared to a control group receiving access to a static resource Web page (ie, a list of FASD-specific websites, readings, videos, and organizations). Results: The primary outcome will be externalizing problems measured by the Child Behavior Checklist (CBCL). Secondary outcomes include (1) internalizing problems and (2) social competence, both measured by the CBCL; and (3) parental distress measured by the Depression Anxiety Stress Scale-21. The Client Satisfaction Questionnaire-8 (CSQ-8) and the Satisfaction Survey are completed by the intervention group at the end of session 11. Results will be reported using the standards set out in the Consolidated Standards of Reporting Trials (CONSORT) Statement. Conclusions: It is hypothesized that the Strongest Families FASD intervention group will improve child behavior and parental distress. Caregiver satisfaction is anticipated to be positive. Advancing evidence on the effectiveness and acceptance of distance services can inform policy and adoption of eHealth programs. ClinicalTrial: ClinicalTrials.gov NCT02210455; https://clinicaltrials.gov/ct2/show/NCT02210455(Archived by WebCite at http://www.webcitation.org/6bbW5BSsT) UR - http://www.researchprotocols.org/2015/4/e112/ UR - http://dx.doi.org/10.2196/resprot.4723 UR - http://www.ncbi.nlm.nih.gov/pubmed/26462968 ID - info:doi/10.2196/resprot.4723 ER - TY - JOUR AU - Armstrong, A. Kathleen AU - Coyte, C. Peter AU - Bhatia, Sacha R. AU - Semple, L. John PY - 2015/06/03 TI - The Effect of Mobile App Home Monitoring on Number of In-Person Visits Following Ambulatory Surgery: Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e65 VL - 4 IS - 2 KW - mobile apps KW - randomized controlled trial, cost-effectiveness KW - ambulatory surgical procedures KW - ambulatory monitoring KW - technology assessment N2 - Background: Women?s College Hospital, Toronto, Canada, offers specialized ambulatory surgical procedures. Patients often travel great distances to undergo surgery. Most patients receiving ambulatory surgery have a low rate of postoperative events necessitating clinic visits. However, regular follow-up is still considered important in the early postoperative phase. Increasingly, telemedicine is used to overcome the distance patients must travel to receive specialized care. Telemedicine data suggest that mobile monitoring and follow-up care is valued by patients and can reduce costs to society. Women?s College Hospital has used a mobile app (QoC Health Inc) to complement in-person postoperative follow-up care for breast reconstruction patients. Preliminary studies suggest that mobile app follow-up care is feasible, can avert in-person follow-up care, and is cost-effective from a societal and health care system perspective. Objective: We hope to expand the use of mobile app follow-up care through its formal assessment in a randomized controlled trial. In postoperative ambulatory surgery patients at Women?s College Hospital (WCH), can we avert in-person follow-up care through the use of mobile app follow-up care compared to conventional, in-person follow-up care in the first 30 days after surgery. Methods: This will be a pragmatic, single-center, open, controlled, 2-arm parallel-group superiority randomized trial comparing mobile app and in-person follow-up care over the first month following surgery. The patient population will comprise all postoperative ambulatory surgery patients at WCH undergoing breast reconstruction. The intervention consists of a postoperative mobile app follow-up care using the quality of recovery-9 (QoR9) and a pain visual analog scale (VAS), surgery-specific questions, and surgical site photos submitted daily for the first 2 weeks and weekly for the following 2 weeks. The primary outcome is the total number of physician visits related to the surgery over the first 30-days postoperative. The secondary outcomes include (1) the total number of phone calls and emails to a health care professional related to surgery, (2) complication rate, (3) societal and health care system costs, and (4) patient satisfaction over the first 30 days postoperative. Permutated-block randomization will be conducted by blocks of 4-6 using the program ralloc in Stata. This is an open study due to the nature of the intervention. Results: A sample of 72 (36 patients per group) will provide an E-test for count data with a power of 95% (P=.05) to detect a difference of 1 visit between groups, assuming a 10% drop out rate. Count variables will be analyzed using Poisson regression. Categorical variables will be tested using a chi-square test. Cost-effectiveness will be analyzed using net benefit regression. Outcomes will be assessed over the first 30 days following surgery. Conclusions: We hope to show that the use of a mobile app in follow-up care minimizes the need for in-person visits for postoperative patients. Trial Registration: Clinicaltrials.gov NCT02318953; https://clinicaltrials.gov/ct2/show/NCT02318953 (Archived by WebCite at http://www.webcitation.org/6Yifzdjph). UR - http://www.researchprotocols.org/2015/2/e65/ UR - http://dx.doi.org/10.2196/resprot.4352 UR - http://www.ncbi.nlm.nih.gov/pubmed/26040252 ID - info:doi/10.2196/resprot.4352 ER - TY - JOUR AU - Avis, LS Jillian AU - Cave, L. Andrew AU - Donaldson, Stephanie AU - Ellendt, Carol AU - Holt, L. Nicholas AU - Jelinski, Susan AU - Martz, Patricia AU - Maximova, Katerina AU - Padwal, Raj AU - Wild, Cameron T. AU - Ball, DC Geoff PY - 2015/03/25 TI - Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study JO - JMIR Res Protoc SP - e35 VL - 4 IS - 1 KW - body weight KW - Canada KW - child KW - childhood obesity KW - Internet KW - parents KW - prevention KW - primary health care N2 - Background: Parents play a central role in preventing childhood obesity. There is a need for innovative, scalable, and evidence-based interventions designed to enhance parents? motivation to support and sustain healthy lifestyle behaviors in their children, which can facilitate obesity prevention. Objective: (1) Develop an online screening, brief intervention, and referral to treatment (SBIRT) eHealth tool to enhance parents? concern for, and motivation to, support children?s healthy lifestyle behaviors, (2) refine the SBIRT eHealth tool by assessing end-user acceptability, satisfaction, and usability through focus groups, and (3) determine feasibility and preliminary effectiveness of the refined SBIRT eHealth tool through a randomized controlled trial. Methods: This is a three-phase, multi-method study that includes SBIRT eHealth tool development (Phase I), refinement (Phase II), and testing (Phase III). Phase I: Theoretical underpinnings of the SBIRT tool, entitled the Resource Information Program for Parents on Lifestyle and Education (RIPPLE), will be informed by concepts applied within existing interventions, and content will be based on literature regarding healthy lifestyle behaviors in children. The SBIRT platform will be developed in partnership between our research team and a third-party intervention development company. Phase II: Focus groups with parents, as well as health care professionals, researchers, and trainees in pediatrics (n=30), will explore intervention-related perceptions and preferences. Qualitative data from the focus groups will inform refinements to the aesthetics, content, structure, and function of the SBIRT. Phase III: Parents (n=200) of children?boys and girls, 5 to 17 years old?will be recruited from a primary care pediatric clinic while they await their children?s clinical appointment. Parents will be randomly assigned to one of five groups?four intervention groups and one control group?as they complete the SBIRT. The randomization function is built into the tool. Parents will complete the eHealth SBIRT using a tablet that will be connected to the Internet. Subsequently, parents will be contacted via email at 1-month follow-up to assess (1) change in concern for, and motivation to, support children?s dietary and physical activity behaviors (primary outcome), and (2) use of online resources and referrals to health services for obesity prevention (secondary outcome). Results: This research was successfully funded and received ethics approval. Development of the SBIRT started in summer 2012, and we expect all study-related activities to be completed by fall 2016. Conclusions: The proposed research is timely and applies a novel, technology-based application designed to enhance parents concern for, and motivation to, support children?s healthy lifestyle behaviors and encourage use of online resources and community services for childhood obesity prevention. Overall, this research builds on a foundation of evidence supporting the application of SBIRTs to encourage or ?nudge? individuals to make healthy lifestyle choices. Findings from Phase III of this project will directly inform a cluster randomized controlled trial to study the effectiveness of our intervention across multiple primary care-based settings. Trial Registration: ClinicalTrials.gov NCT02330588; http://clinicaltrials.gov/ct2/show/NCT02330588 (Archived by WebCite at http://www.webcitation.org/6WyUOeRlr). UR - http://www.researchprotocols.org/2015/1/e35/ UR - http://dx.doi.org/10.2196/resprot.4147 UR - http://www.ncbi.nlm.nih.gov/pubmed/25831265 ID - info:doi/10.2196/resprot.4147 ER - TY - JOUR AU - Dallaire, Clémence AU - St-Pierre, Michèle AU - Juneau, Lucille AU - Legault-Mercier, Samuel AU - Bernardino, Elizabeth PY - 2015/02/16 TI - Secondary Care Clinic for Chronic Disease: Protocol JO - JMIR Res Protoc SP - e12 VL - 4 IS - 1 KW - delivery of health care KW - integrated KW - chronic disease KW - secondary care KW - tertiary health care KW - ambulatory care KW - research design KW - models KW - theoretical N2 - Background: The complexity of chronic disease management activities and the associated financial burden have prompted the development of organizational models, based on the integration of care and services, which rely on primary care services. However, since the institutions providing these services are continually undergoing reorganization, the Centre hospitalier affilié universitaire de Québec wanted to innovate by adapting the Chronic Care Model to create a clinic for the integrated follow-up of chronic disease that relies on hospital-based specialty care. Objective: The aim of the study is to follow the project in order to contribute to knowledge about the way in which professional and management practices are organized to ensure better care coordination and the successful integration of the various follow-ups implemented. Methods: The research strategy adopted is based on the longitudinal comparative case study with embedded units of analysis. The case study uses a mixed research method. Results: We are currently in the analysis phase of the project. The results will be available in 2015. Conclusions: The project?s originality lies in its consideration of the macro, meso, and micro contexts structuring the creation of the clinic in order to ensure the integration process is successful and to allow a theoretical generalization of the reorganization of practices to be developed. UR - http://www.researchprotocols.org/2015/1/e12/ UR - http://dx.doi.org/10.2196/resprot.3902 UR - http://www.ncbi.nlm.nih.gov/pubmed/25689840 ID - info:doi/10.2196/resprot.3902 ER - TY - JOUR AU - Imam, Bita AU - Miller, C. William AU - Finlayson, C. Heather AU - Eng, J. Janice AU - Payne, WC Michael AU - Jarus, Tal AU - Goldsmith, H. Charles AU - Mitchell, M. Ian PY - 2014/12/22 TI - A Telehealth Intervention Using Nintendo Wii Fit Balance Boards and iPads to Improve Walking in Older Adults With Lower Limb Amputation (Wii.n.Walk): Study Protocol for a Randomized Controlled Trial JO - JMIR Res Protoc SP - e80 VL - 3 IS - 4 KW - amputation KW - adult KW - aged KW - randomized controlled trial KW - telemedicine KW - walking N2 - Background: The number of older adults living with lower limb amputation (LLA) who require rehabilitation for improving their walking capacity and mobility is growing. Existing rehabilitation practices frequently fail to meet this demand. Nintendo Wii Fit may be a valuable tool to enable rehabilitation interventions. Based on pilot studies, we have developed ?Wii.n.Walk?, an in-home telehealth Wii Fit intervention targeted to improve walking capacity in older adults with LLA. Objective: The objective of this study is to determine whether the Wii.n.Walk intervention enhances walking capacity compared to an attention control group. Methods: This project is a multi-site (Vancouver BC, London ON), parallel, evaluator-blind randomized controlled trial. Participants include community-dwelling older adults over the age of 50 years with unilateral transtibial or transfemoral amputation. Participants will be stratified by site and block randomized in triplets to either the Wii.n.Walk intervention or an attention control group employing the Wii Big Brain cognitive software. This trial will include both supervised and unsupervised phases. During the supervised phase, both groups will receive 40-minute sessions of supervised group training three times per week for a duration of 4 weeks. Participants will complete the first week of the intervention in groups of three at their local rehabilitation center with a trainer. The remaining 3 weeks will take place at participants? homes using remote supervision by the trainer using Apple iPad technology. At the end of 4 weeks, the supervised period will end and the unsupervised period will begin. Participants will retain the Wii console and be encouraged to continue using the program for an additional 4 weeks? duration. The primary outcome measure will be the ?Two-Minute Walk Test? to measure walking capacity. Outcome measures will be evaluated for all participants at baseline, after the end of both the supervised and unsupervised phases, and after 1-year follow up. Results: Study staff have been hired and trained at both sites and recruitment is currently underway. No participants have been enrolled yet. Conclusions: Wii.n.Walk is a promising in-home telehealth intervention that may have useful applications for older adults with LLA who are discharged from rehabilitation or live in remote areas having limited or no access to existing rehabilitation programs. Trial Registration: Clinicaltrial.gov NCT01942798; http://clinicaltrials.gov/ct2/show/NCT01942798 (Archived by WebCite at http://www.webcitation.org/6V0w8baKP). UR - http://www.researchprotocols.org/2014/4/e80/ UR - http://dx.doi.org/10.2196/resprot.4031 UR - http://www.ncbi.nlm.nih.gov/pubmed/25533902 ID - info:doi/10.2196/resprot.4031 ER -