@Article{info:doi/10.2196/66338,
author="Keefe, M. Janice
and McCloskey, Rose
and Hodgins, J. Marilyn
and McArthur, Caitlin
and MacKenzie, Adrian
and Weeks, E. Lori
and Estabrooks, A. Carole",
title="Examining Quality of Work Life in Atlantic Canadian Long-Term Care Homes: Protocol for a Cross-Sectional Survey Study",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="31",
volume="14",
pages="e66338",
keywords="residential long-term care",
keywords="care staff",
keywords="Atlantic Canada",
keywords="quality of work life",
keywords="work environment",
keywords="health and well-being",
abstract="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 ",
doi="10.2196/66338",
url="https://www.researchprotocols.org/2025/1/e66338"
}


@Article{info:doi/10.2196/65733,
author="Munce, P. Sarah E.
and Jarrett, Clementine
and Senthilnathan, Vjura
and Luong, Dorothy
and Allemang, Brooke
and Bailey, Katherine
and Biddiss, Elaine
and Britto, T. Maria
and Buchanan, Francine
and Cassidy, Christine
and Cross, Andrea
and Cunningham, Jessie
and Dimitropoulos, Gina
and Hadland, E. Scott
and Kastner, Monika
and Killackey, Tieghan
and Kokorelias, Kristina
and Macarthur, Colin
and Micsinszki, Samantha
and Niles, Chavon
and Wright, Virginia F.
and Toulany, Alene",
title="Development of a Framework for Youth- and Family-Specific Engagement in Research: Proposal for a Scoping Review and Qualitative Descriptive Study",
journal="JMIR Res Protoc",
year="2025",
month="Mar",
day="28",
volume="14",
pages="e65733",
keywords="youth and family engagement",
keywords="frameworks",
keywords="implementation science",
keywords="scoping review",
keywords="qualitative",
abstract="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 ",
doi="10.2196/65733",
url="https://www.researchprotocols.org/2025/1/e65733"
}


@Article{info:doi/10.2196/60672,
author="G{\'e}linas, C{\'e}line
and Shahiri T, Shiva
and Wang, Ting Han
and Gallani, Cecilia Maria
and Oulehri, Walid
and Laporta, Denny
and Richeb{\'e}, Philippe",
title="Validation of the Nociception Level Index for the Detection of Nociception and Pain in Critically Ill Adults: Protocol for an Observational Study",
journal="JMIR Res Protoc",
year="2025",
month="Feb",
day="28",
volume="14",
pages="e60672",
keywords="validation",
keywords="NOL",
keywords="Nociception Level",
keywords="nociception",
keywords="pain",
keywords="intensive care unit",
keywords="ICU",
keywords="critical care",
keywords="protocol",
abstract="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 ",
doi="10.2196/60672",
url="https://www.researchprotocols.org/2025/1/e60672",
url="http://www.ncbi.nlm.nih.gov/pubmed/40053798"
}


@Article{info:doi/10.2196/54451,
author="Heels-Ansdell, Diane
and Kelly, Laurel
and O'Grady, K. Heather
and Farley, Christopher
and Reid, C. Julie
and Berney, Sue
and Pastva, M. Amy
and Burns, EA Karen
and D'Aragon, Fr{\'e}d{\'e}rick
and Herridge, S. Margaret
and Seely, Andrew
and Rudkowski, Jill
and Rochwerg, Bram
and Fox-Robichaud, Alison
and Ball, Ian
and Lamontagne, Francois
and Duan, H. Erick
and Tsang, Jennifer
and Archambault, M. Patrick
and Verceles, C. Avelino
and Muscedere, John
and Mehta, Sangeeta
and English, W. Shane
and Karachi, Tim
and Serri, Karim
and Reeve, Brenda
and Thabane, Lehana
and Cook, Deborah
and Kho, E. Michelle",
title="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",
journal="JMIR Res Protoc",
year="2024",
month="Oct",
day="28",
volume="13",
pages="e54451",
keywords="rehabilitation",
keywords="mechanical ventilation",
keywords="cycle ergometry",
keywords="critical illness",
keywords="exercise therapy",
keywords="recovery of function",
abstract="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 ",
doi="10.2196/54451",
url="https://www.researchprotocols.org/2024/1/e54451"
}


@Article{info:doi/10.2196/64216,
author="Taylor, Marin
and Bondi, Christina Bianca
and Andrade, F. Brendan
and Au-Young, H. Stephanie
and Chau, Vann
and Danguecan, Ashley
and D{\'e}sir{\'e}, Naddley
and Guo, Ting
and Ostojic-Aitkens, Dragana
and Wade, Shari
and Miller, Steven
and Williams, Samantha Tricia",
title="Stepped-Care Web-Based Parent Support Following Congenital Heart Disease: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2024",
month="Oct",
day="4",
volume="13",
pages="e64216",
keywords="congenital heart disease",
keywords="neurodevelopmental outcomes",
keywords="web-based mental health care",
keywords="stepped care",
keywords="positive parenting",
keywords="family well-being",
keywords="mental health",
keywords="I-InTERACT-North",
abstract="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 ",
doi="10.2196/64216",
url="https://www.researchprotocols.org/2024/1/e64216",
url="http://www.ncbi.nlm.nih.gov/pubmed/39365658"
}


@Article{info:doi/10.2196/60860,
author="Toulany, Alene
and Khodyakov, Dmitry
and Mooney, Sarah
and Stromquist, Lisa
and Bailey, Katherine
and Barber, EH Claire
and Batthish, Michelle
and Cleverley, Kristin
and Dimitropoulos, Gina
and Gorter, Willem Jan
and Grahovac, Danijela
and Grimes, Ruth
and Guttman, Beverly
and H{\'e}bert, L. Mich{\`e}le
and John, Tomisin
and Lo, Lisha
and Luong, Dorothy
and MacGregor, Laura
and Mukerji, Geetha
and Pidduck, Jacklynn
and Senthilnathan, Vjura
and Shulman, Rayzel
and Trbovich, Patricia
and Munce, EP Sarah",
title="Quality Indicators for Transition from Pediatric to Adult Care for Youth With Chronic Conditions: Proposal for an Online Modified Delphi Study",
journal="JMIR Res Protoc",
year="2024",
month="Sep",
day="10",
volume="13",
pages="e60860",
keywords="transition to adult care",
keywords="adolescent health",
keywords="chronic conditions",
keywords="quality indicators",
keywords="consensus",
keywords="caregivers",
keywords="adolescent",
keywords="stakeholder engagement",
keywords="patient engagement",
keywords="Delphi",
abstract="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 ",
doi="10.2196/60860",
url="https://www.researchprotocols.org/2024/1/e60860",
url="http://www.ncbi.nlm.nih.gov/pubmed/38889353"
}


@Article{info:doi/10.2196/50682,
author="Berthelot, Simon
and Longtin, Yves
and Margni, Manuele
and Guertin, Robert Jason
and LeBlanc, Annie
and Marx, Tania
and Mangou, Khadidiatou
and Bluteau, Ariane
and Mantovani, Diego
and Mikhaylin, Sergey
and Bergeron, Fr{\'e}d{\'e}ric
and Dancause, Val{\'e}rie
and Desjardins, Anne
and Lahrichi, Nadia
and Martin, Danielle
and Sossa, J{\'e}r{\^o}me Charles
and Lachapelle, Philippe
and Genest, Isabelle
and Schaal, St{\'e}phane
and Gignac, Anne
and Tremblay, St{\'e}phane
and Hufty, {\'E}ric
and B{\'e}langer, Lynda
and Beatty, Erica",
title="Postpandemic Evaluation of the Eco-Efficiency of Personal Protective Equipment Against COVID-19 in Emergency Departments: Proposal for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2023",
month="Dec",
day="7",
volume="12",
pages="e50682",
keywords="COVID-19",
keywords="SARS-CoV-2",
keywords="personal protective equipment",
keywords="emergency department",
keywords="health care workers",
keywords="systematic review",
keywords="cost-consequence analysis",
keywords="time-driven activity-based costing",
keywords="life cycle assessment",
keywords="ecological footprint",
abstract="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 Qu{\'e}bec-Universit{\'e} Laval (Qu{\'e}bec, 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 ",
doi="10.2196/50682",
url="https://www.researchprotocols.org/2023/1/e50682",
url="http://www.ncbi.nlm.nih.gov/pubmed/38060296"
}


@Article{info:doi/10.2196/53150,
author="Guay-B{\'e}langer, Sabrina
and Aubin, Emmanuelle
and Cimon, Marie
and Archambault, Patrick
and Blanchette, Virginie
and Giguere, Anik
and Gogovor, Am{\'e}d{\'e}
and Morin, Mich{\`e}le
and Ben Charif, Ali
and Ben Gaied, Nouha
and Bickerstaff, Julie
and Ch{\'e}nard, Nancy
and Emond, Julie
and Gilbert, Julie
and Violet, Isabelle
and L{\'e}gar{\'e}, France",
title="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",
journal="JMIR Res Protoc",
year="2023",
month="Nov",
day="20",
volume="12",
pages="e53150",
keywords="shared decision making",
keywords="patient-centered care",
keywords="home care",
keywords="older adults",
keywords="caregivers",
keywords="decision aids",
keywords="scalability assessment",
keywords="innovation scalability self-administered questionnaire",
keywords="interprofessional",
keywords="team based",
abstract="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 ",
doi="10.2196/53150",
url="https://www.researchprotocols.org/2023/1/e53150",
url="http://www.ncbi.nlm.nih.gov/pubmed/37889512"
}


@Article{info:doi/10.2196/50463,
author="Munce, EP Sarah
and Steele Gray, Carolyn
and Pomeroy, Claire Beverley
and Bayley, Mark
and Kokorelias, Marie Kristina
and Luong, Dorothy
and Biddiss, Elaine
and Cave, Trish
and Bragge, Peter
and Chew-Graham, A. Carolyn
and Colquhoun, Heather
and Dadich, Ann
and Dainty, N. Katie
and Elliott, Mark
and Feng, Patrick
and Goldhar, Jodeme
and Hamilton, B. Clayon
and Harvey, Gillian
and Kastner, Monika
and Kothari, Anita
and Langley, Joe
and Jeffs, Lianne
and Masterson, Daniel
and Nelson, LA Michelle
and Perrier, Laure
and Riley, John
and Sellen, Kate
and Seto, Emily
and Simpson, Robert
and Staniszewska, Sophie
and Srinivasan, Vasanthi
and Straus, E. Sharon
and Tricco, C. Andrea
and Kuluski, Kerry",
title="Development of the Preferred Components for Co-Design in Research Guideline and Checklist: Protocol for a Scoping Review and a Modified Delphi Process",
journal="JMIR Res Protoc",
year="2023",
month="Oct",
day="30",
volume="12",
pages="e50463",
keywords="co-design",
keywords="reporting",
keywords="guidelines",
keywords="complex health intervention",
keywords="scoping review",
keywords="consensus",
abstract="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 ",
doi="10.2196/50463",
url="https://www.researchprotocols.org/2023/1/e50463",
url="http://www.ncbi.nlm.nih.gov/pubmed/37902812"
}


@Article{info:doi/10.2196/49131,
author="Howard, Michelle
and Aubrey-Bassler, Kris
and Drummond, Neil
and Lussier, Marie-Th{\'e}r{\`e}se
and Queenan, A. John
and Vanstone, Meredith
and Nicholson, Kathryn
and Ramdyal, Amanda
and Lawson, Jennifer
and Hafid, Shuaib
and Freeman, Karla
and Clark, Rebecca
and Mangin, Dee",
title="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",
journal="JMIR Res Protoc",
year="2023",
month="Jul",
day="21",
volume="12",
pages="e49131",
keywords="COVID-19",
keywords="chronic disease",
keywords="primary health care",
keywords="electronic health record",
keywords="health services research",
keywords="retrospective studies",
abstract="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 ",
doi="10.2196/49131",
url="https://www.researchprotocols.org/2023/1/e49131",
url="http://www.ncbi.nlm.nih.gov/pubmed/37477967"
}


@Article{info:doi/10.2196/37318,
author="Drouin, Olivier
and Perez, Tamara
and Barnett, A. Tracie
and Ducharme, M. Francine
and Fleegler, Eric
and Garg, Arvin
and Lavoie, Kim
and Li, Patricia
and M{\'e}tras, Marie-{\'E}laine
and Sultan, Serge
and Tse, Man Sze
and Zhao, Jiaying",
title="Impact of Unmet Social Needs, Scarcity, and Future Discounting on Adherence to Treatment in Children With Asthma: Protocol for a Prospective Cohort Study",
journal="JMIR Res Protoc",
year="2023",
month="Mar",
day="7",
volume="12",
pages="e37318",
keywords="asthma",
keywords="adherence",
keywords="unmet social needs",
keywords="behavioral sciences",
keywords="future discounting",
keywords="scarcity",
keywords="pediatrics",
abstract="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 ",
doi="10.2196/37318",
url="https://www.researchprotocols.org/2023/1/e37318",
url="http://www.ncbi.nlm.nih.gov/pubmed/36881458"
}


@Article{info:doi/10.2196/42484,
author="Crockett, Katie
and Lovo, Stacey
and Irvine, Alison
and Trask, Catherine
and Oosman, Sarah
and McKinney, Veronica
and McDonald, Terrence
and Sari, Nazmi
and Carnegie, Bertha
and Custer, Marie
and McIntosh, Stacey
and Bath, Brenna",
title="Experiences of Health Care Access Challenges for Back Pain Care Across the Rural-Urban Continuum in Canada: Protocol for Cross-sectional Research",
journal="JMIR Res Protoc",
year="2022",
month="Dec",
day="19",
volume="11",
number="12",
pages="e42484",
keywords="low back pain",
keywords="rural health",
keywords="rehabilitation",
keywords="health services",
abstract="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 ",
doi="10.2196/42484",
url="https://www.researchprotocols.org/2022/12/e42484",
url="http://www.ncbi.nlm.nih.gov/pubmed/36534454"
}


@Article{info:doi/10.2196/42577,
author="Gu{\'e}nette, Line
and Kr{\"o}ger, Edeltraut
and Bonnan, Dylan
and Maheu, Anne
and Morin, Mich{\`e}le
and B{\'e}langer, Laurianne
and Vedel, Isabelle
and Wilchesky, Machelle
and Sirois, Caroline
and Durand, Etienne
and Couturier, Yves
and Sourial, Nadia
and Dallaire, Cl{\'e}mence",
title="Reorganizing Pharmaceutical Care in Family Medicine Groups for Older Adults With or at Risk of Major Neurocognitive Disorders: Protocol for a Mixed Methods Study",
journal="JMIR Res Protoc",
year="2022",
month="Nov",
day="17",
volume="11",
number="11",
pages="e42577",
keywords="primary care",
keywords="older adults",
keywords="neurocognitive disorders",
keywords="pharmaceutical care",
keywords="mixed method study",
abstract="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 ",
doi="10.2196/42577",
url="https://www.researchprotocols.org/2022/11/e42577",
url="http://www.ncbi.nlm.nih.gov/pubmed/36264995"
}


@Article{info:doi/10.2196/40611,
author="Estabrooks, Carole
and Song, Yuting
and Anderson, Ruth
and Beeber, Anna
and Berta, Whitney
and Chamberlain, Stephanie
and Cummings, Greta
and Duan, Yinfei
and Hayduk, Leslie
and Hoben, Matthias
and Iaconi, Alba
and Lanham, Holly
and Perez, Janelle
and Wang, Jing
and Norton, Peter",
title="The Influence of Context on Implementation and Improvement: Protocol for a Mixed Methods, Secondary Analyses Study",
journal="JMIR Res Protoc",
year="2022",
month="Sep",
day="15",
volume="11",
number="9",
pages="e40611",
keywords="organizational context",
keywords="facilitation",
keywords="PARIHS framework",
keywords="Promoting Action on Research Implementation in Health Services",
keywords="implementation science",
abstract="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 ",
doi="10.2196/40611",
url="https://www.researchprotocols.org/2022/9/e40611",
url="http://www.ncbi.nlm.nih.gov/pubmed/36107475"
}


@Article{info:doi/10.2196/38874,
author="Patel, Sunil
and McClintock, Chad
and Booth, Christopher
and Merchant, Shaila
and Heneghan, Carl
and Bankhead, Clare",
title="The Variations in Care and Real-world Outcomes in Individuals With Rectal Cancer: Protocol for the Ontario Rectal Cancer Cohort",
journal="JMIR Res Protoc",
year="2022",
month="Aug",
day="5",
volume="11",
number="8",
pages="e38874",
keywords="rectal cancer",
keywords="survival",
keywords="adherence to care",
keywords="regional variability",
abstract="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 ",
doi="10.2196/38874",
url="https://www.researchprotocols.org/2022/8/e38874",
url="http://www.ncbi.nlm.nih.gov/pubmed/35930352"
}


@Article{info:doi/10.2196/36758,
author="Archie, Suzanne
and Palaniyappan, Lena
and Olagunju, T. Andrew
and Johnson, Natasha
and Kozloff, Nicole
and Sadeh, Elham
and Bardell, Andrea
and Baines, Alexandra
and Anderson, K. Kelly
and Ayonrinde, Oyedeji
and Ferrari, Manuela",
title="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",
journal="JMIR Res Protoc",
year="2022",
month="May",
day="20",
volume="11",
number="5",
pages="e36758",
keywords="first-episode psychosis",
keywords="cannabis use",
keywords="knowledge translation",
keywords="Black youth",
keywords="video games",
abstract="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 ",
doi="10.2196/36758",
url="https://www.researchprotocols.org/2022/5/e36758",
url="http://www.ncbi.nlm.nih.gov/pubmed/35389874"
}


@Article{info:doi/10.2196/34591,
author="Tempelaar, Wanda
and Barwick, Melanie
and Crawford, Allison
and Voineskos, Aristotle
and Addington, Donald
and Addington, Jean
and Alexander, Tallan
and Baluyut, Crystal
and Bromley, Sarah
and Durbin, Janet
and Foussias, George
and Ford, Catherine
and de Freitas, Lauren
and Jindani, Seharish
and Kirvan, Anne
and Kurdyak, Paul
and Pauly, Kirstin
and Polillo, Alexia
and Roby, Rachel
and Sockalingam, Sanjeev
and Sosnowski, Alexandra
and Villanueva, Victoria
and Wang, Wei
and Kozloff, Nicole",
title="Adapting Evidence-Based Early Psychosis Intervention Services for Virtual Delivery: Protocol for a Pragmatic Mixed Methods Implementation and Evaluation Study",
journal="JMIR Res Protoc",
year="2021",
month="Dec",
day="7",
volume="10",
number="12",
pages="e34591",
keywords="virtual care delivery",
keywords="early psychosis intervention",
keywords="mixed methods implementation",
abstract="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 ",
doi="10.2196/34591",
url="https://www.researchprotocols.org/2021/12/e34591",
url="http://www.ncbi.nlm.nih.gov/pubmed/34806990"
}


@Article{info:doi/10.2196/32134,
author="Gaboury, Isabelle
and Tousignant, Michel
and Corriveau, H{\'e}l{\`e}ne
and Menear, Matthew
and Le Dorze, Guylaine
and Rochefort, Christian
and Vachon, Brigitte
and Rochette, Annie
and Gosselin, Sylvie
and Michaud, Fran{\c{c}}ois
and Bollen, Jessica
and Dean, Sarah",
title="Effects of Telerehabilitation on Patient Adherence to a Rehabilitation Plan: Protocol for a Mixed Methods Trial",
journal="JMIR Res Protoc",
year="2021",
month="Oct",
day="28",
volume="10",
number="10",
pages="e32134",
keywords="adherence",
keywords="interprofessional shared decision making",
keywords="rehabilitation",
keywords="stroke",
keywords="telerehabilitation",
abstract="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 ",
doi="10.2196/32134",
url="https://www.researchprotocols.org/2021/10/e32134",
url="http://www.ncbi.nlm.nih.gov/pubmed/34709196"
}


@Article{info:doi/10.2196/30899,
author="Engler-Stringer, Rachel
and Black, Jennifer
and Muhajarine, Nazeem
and Martin, Wanda
and Gilliland, Jason
and McVittie, Janet
and Kirk, Sara
and Wittman, Hannah
and Mousavi, Amin
and Elliott, Sinikka
and Tu, Sylvana
and Hills, Brent
and Androsoff, Gordon
and Field, Debbie
and Macdonald, Brit
and Belt, Chelsea
and Vatanparast, Hassan",
title="The Good Food for Learning Universal Curriculum-Integrated Healthy School Lunch Intervention: Protocol for a Two-Year Matched Control Pre-Post and Case Study",
journal="JMIR Res Protoc",
year="2021",
month="Sep",
day="21",
volume="10",
number="9",
pages="e30899",
keywords="school food programs",
keywords="Canada",
keywords="nutrition",
keywords="intervention research",
keywords="mHealth",
abstract="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 ",
doi="10.2196/30899",
url="https://www.researchprotocols.org/2021/9/e30899",
url="http://www.ncbi.nlm.nih.gov/pubmed/34546171"
}


@Article{info:doi/10.2196/30845,
author="Alavi, Nazanin
and Stephenson, Callum
and Omrani, Mohsen
and Gerritsen, Cory
and Martin, S. Michael
and Knyahnytskyi, Alex
and Zhu, Yiran
and Kumar, Anchan
and Jagayat, Jasleen
and Shirazi, Amirhossein
and Moghimi, Elnaz
and Patel, Charmy
and Knyahnytska, Yuliya
and Simpson, F. Alexander I.
and Zaheer, Juveria
and Andersen, Judith
and Munshi, Alpna
and Groll, Dianne",
title="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",
journal="JMIR Res Protoc",
year="2021",
month="Jul",
day="22",
volume="10",
number="7",
pages="e30845",
keywords="mental health",
keywords="correctional workers",
keywords="public safety personnel",
keywords="depression",
keywords="anxiety",
keywords="psychotherapy",
keywords="cognitive behavioral therapy",
keywords="online",
keywords="internet",
keywords="treatment",
abstract="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 ",
doi="10.2196/30845",
url="https://www.researchprotocols.org/2021/7/e30845",
url="http://www.ncbi.nlm.nih.gov/pubmed/34088656"
}


@Article{info:doi/10.2196/24887,
author="van Allen, Zack
and Bacon, L. Simon
and Bernard, Paquito
and Brown, Heather
and Desroches, Sophie
and Kastner, Monika
and Lavoie, Kim
and Marques, Marta
and McCleary, Nicola
and Straus, Sharon
and Taljaard, Monica
and Thavorn, Kednapa
and Tomasone, R. Jennifer
and Presseau, Justin",
title="Clustering of Unhealthy Behaviors: Protocol for a Multiple Behavior Analysis of Data From the Canadian Longitudinal Study on Aging",
journal="JMIR Res Protoc",
year="2021",
month="Jun",
day="11",
volume="10",
number="6",
pages="e24887",
keywords="health behaviors",
keywords="multiple behaviors",
keywords="cluster analysis",
keywords="network analysis",
keywords="CLSA",
abstract="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 ",
doi="10.2196/24887",
url="https://www.researchprotocols.org/2021/6/e24887",
url="http://www.ncbi.nlm.nih.gov/pubmed/34114962"
}


@Article{info:doi/10.2196/26155,
author="Lokker, Cynthia
and Jezrawi, Rita
and Gabizon, Itzhak
and Varughese, Jobin
and Brown, Michael
and Trottier, Dan
and Alvarez, Elizabeth
and Schwalm, Jon-David
and McGillion, Michael
and Ma, Jinhui
and Bhagirath, Vinai",
title="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",
journal="JMIR Res Protoc",
year="2021",
month="Feb",
day="1",
volume="10",
number="2",
pages="e26155",
keywords="mHealth",
keywords="mobile health",
keywords="hypertension",
keywords="app",
keywords="patient-oriented",
keywords="feasibility",
keywords="cardiovascular disease",
keywords="internet-administered",
keywords="randomized controlled trial",
abstract="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 ",
doi="10.2196/26155",
url="https://www.researchprotocols.org/2021/2/e26155",
url="http://www.ncbi.nlm.nih.gov/pubmed/33522978"
}


@Article{info:doi/10.2196/24736,
author="Kidd, Sean
and McKenzie, Kwame
and Wang, Wei
and Agrawal, Sacha
and Voineskos, Aristotle",
title="Examining a Digital Health Approach for Advancing Schizophrenia Illness Self-Management and Provider Engagement: Protocol for a Feasibility Trial",
journal="JMIR Res Protoc",
year="2021",
month="Jan",
day="25",
volume="10",
number="1",
pages="e24736",
keywords="schizophrenia",
keywords="psychosis",
keywords="digital health",
keywords="mobile health",
keywords="smartphone",
abstract="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 ",
doi="10.2196/24736",
url="http://www.researchprotocols.org/2021/1/e24736/",
url="http://www.ncbi.nlm.nih.gov/pubmed/33492235"
}


@Article{info:doi/10.2196/18675,
author="Parsons Leigh, Jeanna
and Brundin-Mather, Rebecca
and Whalen-Browne, Liam
and Kashyap, Devika
and Sauro, Khara
and Soo, Andrea
and Petersen, Jennie
and Taljaard, Monica
and Stelfox, T. Henry",
title="Effectiveness of an Electronic Communication Tool on Transitions in Care From the Intensive Care Unit: Protocol for a Cluster-Specific Pre-Post Trial",
journal="JMIR Res Protoc",
year="2021",
month="Jan",
day="8",
volume="10",
number="1",
pages="e18675",
keywords="patient transfers",
keywords="interprovider communication",
keywords="transitions in care",
keywords="electronic charting",
keywords="clinical documentation",
keywords="discharge tools",
keywords="patient discharge summaries",
keywords="electronic transfer summaries",
keywords="intensive care unit",
keywords="electronic tool",
keywords="ICU",
keywords="protocol",
keywords="effective",
keywords="communication",
keywords="transfer",
keywords="patient",
keywords="transition",
abstract="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 ",
doi="10.2196/18675",
url="https://www.researchprotocols.org/2021/1/e18675",
url="http://www.ncbi.nlm.nih.gov/pubmed/33416509"
}


@Article{info:doi/10.2196/20220,
author="Steele Gray, Carolyn
and Tang, Terence
and Armas, Alana
and Backo-Shannon, Mira
and Harvey, Sarah
and Kuluski, Kerry
and Loganathan, Mayura
and Nie, X. Jason
and Petrie, John
and Ramsay, Tim
and Reid, Robert
and Thavorn, Kednapa
and Upshur, Ross
and Wodchis, P. Walter
and Nelson, Michelle",
title="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",
journal="JMIR Res Protoc",
year="2020",
month="Nov",
day="25",
volume="9",
number="11",
pages="e20220",
keywords="digital health technology",
keywords="care transitions",
keywords="multimorbidity",
keywords="pragmatic trial",
keywords="co-design",
keywords="hospital",
keywords="primary care",
abstract="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 ",
doi="10.2196/20220",
url="https://www.researchprotocols.org/2020/11/e20220",
url="http://www.ncbi.nlm.nih.gov/pubmed/33237037"
}


@Article{info:doi/10.2196/17363,
author="Archambault, Michel Patrick
and Rivard, Jos{\'e}e
and Smith, Y. Pascal
and Sinha, Samir
and Morin, Mich{\`e}le
and LeBlanc, Annie
and Couturier, Yves
and Pelletier, Isabelle
and Ghandour, Kebir El
and L{\'e}gar{\'e}, France
and Denis, Jean-Louis
and Melady, Don
and Par{\'e}, Daniel
and Chouinard, Jos{\'e}e
and Kroon, Chantal
and Huot-Lavoie, Maxime
and Bert, Laetitia
and Witteman, O. Holly
and Brousseau, Audrey-Anne
and Dallaire, Cl{\'e}mence
and Sirois, Marie-Jos{\'e}e
and {\'E}mond, Marcel
and Fleet, Richard
and Chandavong, Sam
and ",
title="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",
journal="JMIR Res Protoc",
year="2020",
month="Aug",
day="5",
volume="9",
number="8",
pages="e17363",
keywords="implementation science",
keywords="knowledge translation",
keywords="context adaptation",
keywords="interrupted time series",
keywords="care transitions",
keywords="elderly",
keywords="older persons",
keywords="health care utilization",
keywords="frailty",
keywords="learning health systems",
keywords="Wiki",
keywords="collaborative writing applications",
abstract="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 int{\'e}gr{\'e} de sant{\'e} et de services sociaux de Chaudi{\`e}re-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 ",
doi="10.2196/17363",
url="https://www.researchprotocols.org/2020/8/e17363",
url="http://www.ncbi.nlm.nih.gov/pubmed/32755891"
}


@Article{info:doi/10.2196/13801,
author="Burchell, N. Ann
and Lisk, Ryan
and Yeung, Anna
and Rana, Jayoti
and Bacon, Jean
and Brunetta, Jason
and Gilbert, Mark
and Gesink, Dionne
and Grewal, Ramandip
and Guiang, B. Charlie
and Kwag, Michael
and Logie, H. Carmen
and Mitterni, Leo
and Shahin, Rita
and Tan, HS Darrell",
title="Community-Directed Bacterial Sexually Transmitted Infection Testing Interventions Among Men Who Have Sex With Men: Protocol for an E-Delphi Study in Toronto, Canada",
journal="JMIR Res Protoc",
year="2019",
month="Jul",
day="04",
volume="8",
number="7",
pages="e13801",
keywords="sexual and gender minorities",
keywords="sexually transmitted diseases",
keywords="community-based research",
keywords="mass screening",
keywords="patient acceptance of health care",
abstract="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 ",
doi="10.2196/13801",
url="https://www.researchprotocols.org/2019/7/e13801/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31274111"
}


@Article{info:doi/10.2196/13818,
author="Quigley, Adria
and O'Brien, K. Kelly
and Brouillette, Marie-Jos{\'e}e
and MacKay-Lyons, Marilyn",
title="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",
journal="JMIR Res Protoc",
year="2019",
month="May",
day="21",
volume="8",
number="5",
pages="e13818",
keywords="HIV",
keywords="AIDS",
keywords="yoga",
keywords="cognition",
abstract="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 ",
doi="10.2196/13818",
url="http://www.researchprotocols.org/2019/5/e13818/",
url="http://www.ncbi.nlm.nih.gov/pubmed/31115343"
}


@Article{info:doi/10.2196/resprot.9633,
author="Tilahun, Binyam
and Smillie, Kirsten
and Bardosh, Louis Kevin
and Murray, Melanie
and Fitzgerald, Mark
and Cook, Victoria
and Poureslami, Iraj
and Forrest, Jamie
and Lester, Richard",
title="Identifying Barriers and Facilitators of 13 mHealth Projects in North America and Africa: Protocol for a 5-Year Implementation Science Study",
journal="JMIR Res Protoc",
year="2018",
month="Jul",
day="03",
volume="7",
number="7",
pages="e162",
keywords="mobile health",
keywords="mHealth",
keywords="text messaging",
keywords="digital health",
keywords="implementation science",
keywords="Africa",
keywords="North America",
abstract="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 ",
doi="10.2196/resprot.9633",
url="http://www.researchprotocols.org/2018/7/e162/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29970360"
}


@Article{info:doi/10.2196/resprot.8367,
author="Seto, Emily
and Ware, Patrick
and Logan, G. Alexander
and Cafazzo, A. Joseph
and Chapman, R. Kenneth
and Segal, Phillip
and Ross, J. Heather",
title="Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol",
journal="JMIR Res Protoc",
year="2017",
month="Nov",
day="21",
volume="6",
number="11",
pages="e229",
keywords="mHealth",
keywords="smartphone",
keywords="multiple chronic diseases",
keywords="randomized controlled trial",
abstract="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) ",
doi="10.2196/resprot.8367",
url="http://www.researchprotocols.org/2017/11/e229/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29162557"
}


@Article{info:doi/10.2196/resprot.8178,
author="Beauchamp, K. Marla
and Brooks, Dina
and Ellerton, Cindy
and Lee, Annemarie
and Alison, Jennifer
and Camp, G. Pat
and Dechman, Gail
and Haines, Kimberley
and Harrison, L. Samantha
and Holland, E. Anne
and Marques, Alda
and Moineddin, Rahim
and Skinner, H. Elizabeth
and Spencer, Lissa
and Stickland, K. Michael
and Xie, Feng
and Goldstein, S. Roger",
title="Pulmonary Rehabilitation With Balance Training for Fall Reduction in Chronic Obstructive Pulmonary Disease: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2017",
month="Nov",
day="20",
volume="6",
number="11",
pages="e228",
keywords="COPD",
keywords="pulmonary rehabilitation",
keywords="balance",
keywords="exercise",
keywords="falls",
keywords="economic analysis",
abstract="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) ",
doi="10.2196/resprot.8178",
url="http://www.researchprotocols.org/2017/11/e228/",
url="http://www.ncbi.nlm.nih.gov/pubmed/29158206"
}


@Article{info:doi/10.2196/resprot.8001,
author="Gilron, Ian
and Tu, Dongsheng
and Holden, Ronald
and Towheed, Tanveer
and Vandenkerkhof, Elizabeth
and Milev, Roumen",
title="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",
journal="JMIR Res Protoc",
year="2017",
month="Aug",
day="04",
volume="6",
number="8",
pages="e154",
keywords="fibromyalgia",
keywords="alpha-lipoic acid",
keywords="antioxidant",
keywords="pregabalin",
keywords="anticonvulsant",
abstract="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) ",
doi="10.2196/resprot.8001",
url="http://www.researchprotocols.org/2017/8/e154/",
url="http://www.ncbi.nlm.nih.gov/pubmed/28778847"
}



@Article{info:doi/10.2196/resprot.5841,
author="Wilansky, Pamela
and Eklund, Mikael J.
and Milner, Tracy
and Kreindler, David
and Cheung, Amy
and Kovacs, Tim
and Shooshtari, Shahin
and Astell, Arlene
and Ohinmaa, Arto
and Henderson, Joanna
and Strauss, John
and Mills, SL Rosemary",
title="Cognitive Behavior Therapy for Anxious and Depressed Youth: Improving Homework Adherence Through Mobile Technology",
journal="JMIR Res Protoc",
year="2016",
month="Nov",
day="10",
volume="5",
number="4",
pages="e209",
keywords="mHealth",
keywords="mobile app",
keywords="youth",
keywords="anxiety",
keywords="depression",
keywords="cognitive behavior therapy",
keywords="homework",
abstract="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. ",
doi="10.2196/resprot.5841",
url="http://www.researchprotocols.org/2016/4/e209/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27833071"
}


@Article{info:doi/10.2196/resprot.6519,
author="Meguerditchian, Ari
and Tamblyn, Robyn
and Meterissian, Sarkis
and Law, Susan
and Prchal, Jaroslav
and Winslade, Nancy
and Stern, Donna",
title="Adjuvant Endocrine Therapy in Breast Cancer: A Novel e-Health Approach in Optimizing Treatment for Seniors (OPTIMUM): A Two-Group Controlled Comparison Pilot Study",
journal="JMIR Res Protoc",
year="2016",
month="Nov",
day="07",
volume="5",
number="4",
pages="e199",
keywords="administrative claims",
keywords="health care",
keywords="breast neoplasms",
keywords="medical informatics applications",
keywords="aromatase inhibitors",
keywords="telemedicine",
keywords="health services for the aged",
keywords="medication adherence",
abstract="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. ",
doi="10.2196/resprot.6519",
url="http://www.researchprotocols.org/2016/4/e199/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27821385"
}


@Article{info:doi/10.2196/resprot.5763,
author="McGillion, Michael
and Yost, Jennifer
and Turner, Andrew
and Bender, Duane
and Scott, Ted
and Carroll, Sandra
and Ritvo, Paul
and Peter, Elizabeth
and Lamy, Andre
and Furze, Gill
and Krull, Kirsten
and Dunlop, Valerie
and Good, Amber
and Dvirnik, Nazari
and Bedini, Debbie
and Naus, Frank
and Pettit, Shirley
and Henry, Shaunattonie
and Probst, Christine
and Mills, Joseph
and Gossage, Elaine
and Travale, Irene
and Duquette, Janine
and Taberner, Christy
and Bhavnani, Sanjeev
and Khan, S. James
and Cowan, David
and Romeril, Eric
and Lee, John
and Colella, Tracey
and Choini{\`e}re, Manon
and Busse, Jason
and Katz, Joel
and Victor, Charles J.
and Hoch, Jeffrey
and Isaranuwatchai, Wanrudee
and Kaasalainen, Sharon
and Ladak, Salima
and O'Keefe-McCarthy, Sheila
and Parry, Monica
and Sessler, I. Daniel
and Stacey, Michael
and Stevens, Bonnie
and Stremler, Robyn
and Thabane, Lehana
and Watt-Watson, Judy
and Whitlock, Richard
and MacDermid, C. Joy
and Leegaard, Marit
and McKelvie, Robert
and Hillmer, Michael
and Cooper, Lynn
and Arthur, Gavin
and Sider, Krista
and Oliver, Susan
and Boyajian, Karen
and Farrow, Mark
and Lawton, Chris
and Gamble, Darryl
and Walsh, Jake
and Field, Mark
and LeFort, Sandra
and Clyne, Wendy
and Ricupero, Maria
and Poole, Laurie
and Russell-Wood, Karsten
and Weber, Michael
and McNeil, Jolene
and Alpert, Robyn
and Sharpe, Sarah
and Bhella, Sue
and Mohajer, David
and Ponnambalam, Sem
and Lakhani, Naeem
and Khan, Rabia
and Liu, Peter
and Devereaux, PJ",
title="Technology-Enabled Remote Monitoring and Self-Management --- Vision for Patient Empowerment Following Cardiac and Vascular Surgery: User Testing and Randomized Controlled Trial Protocol",
journal="JMIR Res Protoc",
year="2016",
month="Aug",
day="01",
volume="5",
number="3",
pages="e149",
keywords="technology-enabled self-management",
keywords="remote automated external monitoring",
keywords="usability testing",
keywords="randomized controlled trial",
abstract="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. ",
doi="10.2196/resprot.5763",
url="http://www.researchprotocols.org/2016/3/e149/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27480247"
}


@Article{info:doi/10.2196/resprot.5775,
author="Padwal, Raj
and McAlister, Aleck Finlay
and Wood, William Peter
and Boulanger, Pierre
and Fradette, Miriam
and Klarenbach, Scott
and Edwards, L. Alun
and Holroyd-Leduc, M. Jayna
and Alagiakrishnan, Kannayiram
and Rabi, Doreen
and Majumdar, Ranjan Sumit",
title="Telemonitoring and Protocolized Case Management for Hypertensive Community-Dwelling Seniors With Diabetes: Protocol of the TECHNOMED Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2016",
month="Jun",
day="24",
volume="5",
number="2",
pages="e107",
keywords="blood pressure",
keywords="hypertension",
keywords="seniors",
keywords="telemonitoring",
keywords="randomized controlled trial",
keywords="case management",
abstract="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 {\textpm} 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) ",
doi="10.2196/resprot.5775",
url="http://www.researchprotocols.org/2016/2/e107/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27343147"
}


@Article{info:doi/10.2196/resprot.5756,
author="Steele Gray, Carolyn
and Wodchis, P. Walter
and Upshur, Ross
and Cott, Cheryl
and McKinstry, Brian
and Mercer, Stewart
and Palen, E. Ted
and Ramsay, Tim
and Thavorn, Kednapa
and ",
title="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",
journal="JMIR Res Protoc",
year="2016",
month="Jun",
day="24",
volume="5",
number="2",
pages="e126",
keywords="eHealth/mHealth solutions",
keywords="complex care needs",
keywords="seniors",
keywords="patient-centered care",
keywords="goal-oriented care",
keywords="primary health care",
keywords="implementation",
keywords="pragmatic trial",
keywords="health outcomes",
keywords="cost-effectiveness analysis",
abstract="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. ",
doi="10.2196/resprot.5756",
url="http://www.researchprotocols.org/2016/2/e126/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27341765"
}


@Article{info:doi/10.2196/resprot.5435,
author="Desveaux, Laura
and Beauchamp, K. Marla
and Lee, Annemarie
and Ivers, Noah
and Goldstein, Roger
and Brooks, Dina",
title="Effects of a Community-Based, Post-Rehabilitation Exercise Program in COPD: Protocol for a Randomized Controlled Trial With Embedded Process Evaluation",
journal="JMIR Res Protoc",
year="2016",
month="May",
day="11",
volume="5",
number="2",
pages="e63",
keywords="COPD",
keywords="pulmonary rehabilitation",
keywords="exercise training",
keywords="maintenance",
keywords="community",
abstract="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. ",
doi="10.2196/resprot.5435",
url="http://www.researchprotocols.org/2016/2/e63/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27169436"
}


@Article{info:doi/10.2196/resprot.5303,
author="Engler-Stringer, Rachel
and Muhajarine, Nazeem
and Ridalls, Tracy
and Abonyi, Sylvia
and Vatanparast, Hassan
and Whiting, Susan
and Walker, Ryan",
title="The Good Food Junction: a Community-Based Food Store Intervention to Address Nutritional Health Inequities",
journal="JMIR Res Protoc",
year="2016",
month="Apr",
day="14",
volume="5",
number="2",
pages="e52",
keywords="food environments",
keywords="intervention",
keywords="natural experiment",
abstract="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. ",
doi="10.2196/resprot.5303",
url="http://www.researchprotocols.org/2016/2/e52/",
url="http://www.ncbi.nlm.nih.gov/pubmed/27079140"
}


@Article{info:doi/10.2196/resprot.4428,
author="Newton, S. Amanda
and Wozney, Lori
and Bagnell, Alexa
and Fitzpatrick, Eleanor
and Curtis, Sarah
and Jabbour, Mona
and Johnson, David
and Rosychuk, J. Rhonda
and Young, Michael
and Ohinmaa, Arto
and Joyce, Anthony
and McGrath, Patrick",
title="Increasing Access to Mental Health Care With Breathe, an Internet-Based Program for Anxious Adolescents: Study Protocol for a Pilot Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2016",
month="Jan",
day="29",
volume="5",
number="1",
pages="e18",
keywords="anxiety",
keywords="etherapy",
keywords="cognitive behavioral therapy",
keywords="adolescents",
keywords="mental health",
keywords="Internet",
keywords="intervention",
keywords="pilot",
keywords="randomized controlled trial",
abstract="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) ",
doi="10.2196/resprot.4428",
url="http://www.researchprotocols.org/2016/1/e18/",
url="http://www.ncbi.nlm.nih.gov/pubmed/26825111"
}


@Article{info:doi/10.2196/resprot.4723,
author="Turner, Karen
and Reynolds, N. James
and McGrath, Patrick
and Lingley-Pottie, Patricia
and Huguet, Anna
and Hewitt, Amy
and Green, Courtney
and Wozney, Lori
and Mushquash, Christopher
and Muhajarine, Nazeem
and Sourander, Andre
and Caughey, Heather
and Roane, Jessica",
title="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",
journal="JMIR Res Protoc",
year="2015",
month="Oct",
day="13",
volume="4",
number="4",
pages="e112",
keywords="fetal alcohol spectrum disorder",
keywords="neurobehavioral disorder",
keywords="prenatal alcohol exposure",
keywords="disruptive behavior",
keywords="children",
keywords="Strongest Families",
keywords="parenting",
keywords="randomized controlled trial",
keywords="eHealth",
keywords="Web-based intervention",
abstract="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) ",
doi="10.2196/resprot.4723",
url="http://www.researchprotocols.org/2015/4/e112/",
url="http://www.ncbi.nlm.nih.gov/pubmed/26462968"
}


@Article{info:doi/10.2196/resprot.4352,
author="Armstrong, A. Kathleen
and Coyte, C. Peter
and Bhatia, Sacha R.
and Semple, L. John",
title="The Effect of Mobile App Home Monitoring on Number of In-Person Visits Following Ambulatory Surgery: Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2015",
month="Jun",
day="03",
volume="4",
number="2",
pages="e65",
keywords="mobile apps",
keywords="randomized controlled trial, cost-effectiveness",
keywords="ambulatory surgical procedures",
keywords="ambulatory monitoring",
keywords="technology assessment",
abstract="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). ",
doi="10.2196/resprot.4352",
url="http://www.researchprotocols.org/2015/2/e65/",
url="http://www.ncbi.nlm.nih.gov/pubmed/26040252"
}


@Article{info:doi/10.2196/resprot.4147,
author="Avis, LS Jillian
and Cave, L. Andrew
and Donaldson, Stephanie
and Ellendt, Carol
and Holt, L. Nicholas
and Jelinski, Susan
and Martz, Patricia
and Maximova, Katerina
and Padwal, Raj
and Wild, Cameron T.
and Ball, DC Geoff",
title="Working With Parents to Prevent Childhood Obesity: Protocol for a Primary Care-Based eHealth Study",
journal="JMIR Res Protoc",
year="2015",
month="Mar",
day="25",
volume="4",
number="1",
pages="e35",
keywords="body weight",
keywords="Canada",
keywords="child",
keywords="childhood obesity",
keywords="Internet",
keywords="parents",
keywords="prevention",
keywords="primary health care",
abstract="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). ",
doi="10.2196/resprot.4147",
url="http://www.researchprotocols.org/2015/1/e35/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25831265"
}


@Article{info:doi/10.2196/resprot.3902,
author="Dallaire, Cl{\'e}mence
and St-Pierre, Mich{\`e}le
and Juneau, Lucille
and Legault-Mercier, Samuel
and Bernardino, Elizabeth",
title="Secondary Care Clinic for Chronic Disease: Protocol",
journal="JMIR Res Protoc",
year="2015",
month="Feb",
day="16",
volume="4",
number="1",
pages="e12",
keywords="delivery of health care",
keywords="integrated",
keywords="chronic disease",
keywords="secondary care",
keywords="tertiary health care",
keywords="ambulatory care",
keywords="research design",
keywords="models",
keywords="theoretical",
abstract="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 affili{\'e} universitaire de Qu{\'e}bec 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. ",
doi="10.2196/resprot.3902",
url="http://www.researchprotocols.org/2015/1/e12/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25689840"
}


@Article{info:doi/10.2196/resprot.4031,
author="Imam, Bita
and Miller, C. William
and Finlayson, C. Heather
and Eng, J. Janice
and Payne, WC Michael
and Jarus, Tal
and Goldsmith, H. Charles
and Mitchell, M. Ian",
title="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",
journal="JMIR Res Protoc",
year="2014",
month="Dec",
day="22",
volume="3",
number="4",
pages="e80",
keywords="amputation",
keywords="adult",
keywords="aged",
keywords="randomized controlled trial",
keywords="telemedicine",
keywords="walking",
abstract="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). ",
doi="10.2196/resprot.4031",
url="http://www.researchprotocols.org/2014/4/e80/",
url="http://www.ncbi.nlm.nih.gov/pubmed/25533902"
}