JMIR Publications

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  RCTs - Protocols/Proposals (eHealth)

  May 17, 2019

  Evaluating a Web-Based Mental Health Service for Secondary School Students in Australia: Protocol for a Cluster Randomized Controlled Trial

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  Authors List:

  • Bridianne O'Dea  
  • Catherine King  
  • Mirjana Subotic-Kerry  
  • Melissa Anderson  
  • Melinda Rose Achilles  
  • Belinda Parker  
  • Andrew Mackinnon  
  • Josey Anderson  
  • Nicole Cockayne  
  • Helen Christensen  

  Abstract:

  Background: Mental health problems are prevalent among Australian secondary school youth; however, help-seeking is low. Schools offer an ideal setting to address these concerns. The Black Dog Institute has developed a Web-based mental health service for secondary schools that is modeled on the principles of stepped care. The Smooth Sailing service aims to improve help-seeking and reduce anxiety and depressive symptoms in secondary school students. The acceptability of this service has been demonstrated in a pilot study. A full trial is now warranted. Objective: This study protocol for a cluster randomized controlled trial (RCT) aims to evaluate the effectiveness of the Smooth Sailing Web-based service for improving help-seeking intentions and behavior, and reducing depressive and anxiety symptoms, alongside other mental health outcomes, when compared with a school-as-usual control condition in secondary school youth. Methods: This RCT aims to recruit 1600 students from 16 secondary schools in regional and urban locations throughout New South Wales, Australia. Schools are randomly assigned to the intervention or school-as-usual control condition at the school level. Approximately 100 students from 1 or multiple grades are recruited from each participating school. Participants complete measures at 3 timepoints: baseline, 6 weeks post, and 12 weeks post, with the primary outcome assessed at 12 weeks posttest. Participants assigned to the intervention condition register to the Web-based service at baseline and receive care in accordance with the service model. Participants in the control condition receive school-as-usual. Results: The first baseline assessment occurred on February 22, 2018, with the 12-week endpoint assessments completed on Friday, June 29, 2018. Control schools are currently receiving the service, due for completion by June 30, 2019. The trial results are expected to demonstrate improved help-seeking intentions and behavior among students assigned to the intervention condition, alongside improvements in symptoms of depression, anxiety, distress, and other mental health outcomes when compared with students assigned to the control condition. Conclusions: To our knowledge, this is the first time that a Web-based mental health service based on the principles of stepped care will have been integrated into, and evaluated in, the Australian school context. The findings of this trial will have implications for the suitability of this type of service model in Australian schools and for the delivery of school-based mental health services more broadly. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12618001539224 https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821&isReview=true (Archived by WebCite at http://www.webcitation.org/77N3MDGS6) International Registered Report Identifier (IRRID): DERR1-10.2196/12892

  • JMIR Res Protoc 2019;8(5):e12892

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  RCTs - Protocols/Proposals (funded,...

  May 16, 2019

  Implementing Systematic Screening and Structured Care for Distressed Callers Using Cancer Council’s Telephone Services: Protocol for a Randomized...

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  Authors List:

  • Elizabeth A Fradgley  
  • Anna Boltong  
  • Lorna O'Brien  
  • Allison W Boyes  
  • Katherine Lane  
  • Annette Beattie  
  • Tara Clinton-McHarg  
  • Paul B Jacobsen  
  • Christopher Doran  
  • Daniel Barker  
  • Della Roach  
  • Jo Taylor  
  • Christine L Paul  

  Abstract:

  Background: Structured distress management, comprised a 2-stage screening and referral model, can direct supportive care resources toward individuals who are most likely to benefit. This structured approach has yet to be trialed in Australian community-based services such as Cancer Council New South Wales (NSW) and Victoria Cancer Information and Support (CIS) 13 11 20 lines who care for a large community of cancer patients and caregivers. Objective: The aim of this study was to evaluate the effectiveness of structured screening and referral in (1) increasing the proportion of distressed CIS callers who accept supportive care referrals and (2) reducing distress levels at 6-month follow-up. Methods: In this stepped-wedge trial, Cancer Council NSW and Victoria CIS consultants are randomized to deliver structured care during inbound 13 11 20 calls in accordance with 3 intervention periods. Eligible callers are patients or caregivers who score 4 or more on the Distress Thermometer; NSW or Victorian residents; aged 18 years or older; and English proficient. Study data are collected via computer-assisted telephone interviews (CATIs) at 3- and 6-month follow-up and CIS record audit. CATIs include demographic and service use items and the General Health Questionnaire (GHQ-28) to assess distress. An economic analysis of the structured care model will be completed. Results: The structured care model was developed by guideline review and identification of service characteristics to guide mapping decisions; place-card methodology; and clinical vignettes with think-aloud methodology to confirm referral appropriateness. The model includes an additional screening tool (Patient Health Questionnaire-4) and a referral model with 16-20 CIS services. Descriptive statistics will be used to assess referral uptake rates. Differences between GHQ-28 scores for structured and usual care callers will be tested using a generalized linear mixed model with fixed effects for intervention and each time period. The trial will recruit 1512 callers. The sample size will provide the study with approximately 80% power to detect a difference of 0.3 SD in the mean score of the GHQ-28 at an alpha level of .05 and assuming an intra-cluster correlation of .04. A random sample of recorded calls will be reviewed to assess intervention fidelity and contamination. To date, 1835 distressed callers have been invited to participate with 60.71% (1114/1835) enrolled in the study. A total of 692 participants have completed 6-month CATIs. Recruitment is anticipated to end in late 2019. Conclusions: This trial is among the first to rigorously test the outcomes of a community-based structured approach to distress management. The model is evidence-informed, practice-ready, and trialed in a real-world setting. The study outcomes will advance the understanding of distress management internationally for both patients and caregivers. Trial Registration: Australian New Zealand Clinical Trial Registry ACTRN12617000352303; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372105&isReview=true (Archived by WebCite on http://www.webcitation.org/78AW0Ba09) International Registered Report Identifier (IRRID): DERR1-10.2196/12473

  • JMIR Res Protoc 2019;8(5):e12473

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  RCTs - Protocols/Proposals (eHealth)

  May 15, 2019

  Web-Based Skin Cancer Prevention Training for Massage Therapists: Protocol for the Massage Therapists Skin Health Awareness, Referral, and Education Study

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  Authors List:

  • Lois J Loescher  
  • Kelly M Heslin  
  • Laura A Szalacha  
  • Graciela E Silva  
  • Myra L Muramoto  

  Abstract:

  Background: Skin cancer, the most common cancer in the United States, is costly and potentially deadly. Its burden can be reduced by early detection and prevention activities. The scope of skin cancer requires going beyond traditional health care providers to promote risk reduction. Partnering with the nonbiomedical workforce, such as massage therapists (MTs), may reach more individuals at risk. MTs see much of their clients’ skin and are amenable to performing skin cancer risk reduction activities during massage appointments. Objective: The objective of this study is to describe the Massage Therapists Skin Health Awareness, Referral, and Education protocol, presenting an overview of our systematic approach to developing rigorous e-training for MTs to enable them to be partners in skin cancer risk reduction. We also describe procedures for usability and feasibility testing of the training. Methods: We developed an integrated electronic learning system that includes electronic training (e-training) technology, simulated client interactions, online data collection instruments, and in-person assessment of MTs’ application of their training. Results: A total of 20 participants nationally scored the e-training as high for usability and satisfaction. We have screened an additional 77 MTs in Arizona for interest and eligibility, and currently have 37 enrolled participants, of whom 32 have completed the Web-based training. Conclusions: The structured and rigorous development approach for this skin cancer risk reduction and brief behavioral intervention e-training for MTs begins to fill a gap in skin cancer risk reduction research. Iterative usability testing of our asynchronous Web-based training resulted in positive participant response. Our e-training approach offers greater learner accessibility, increased convenience, and greater scalability than the few existing programs and has the potential to reach many MTs nationally. International Registered Report Identifier (IRRID): DERR1-10.2196/13480

  • JMIR Res Protoc 2019;8(5):e13480

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  RCTs - Protocols/Proposals (funded,...

  May 13, 2019

  A Mobile and Web-Based Self-Directed Complementary and Integrative Health Program for Veterans and Their Partners (Mission Reconnect): Protocol for a...

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  Authors List:

  • Jolie N Haun  
  • Lisa M Ballistrea  
  • Christine Melillo  
  • Maisha Standifer  
  • Kevin Kip  
  • Jacquelyn Paykel  
  • Jennifer L Murphy  
  • Carol E Fletcher  
  • Allison Mitchinson  
  • Leila Kozak  
  • Stephanie L Taylor  
  • Shirley M Glynn  
  • Matthew Bair  

  Abstract:

  Background: Complementary and integrative health (CIH) is a viable solution to PTSD and chronic pain. Many veterans believe CIH can be performed only by licensed professionals in a health care setting. Health information technology can bring effective CIH to veterans and their partners. Objective: This paper describes the rationale, design, and methods of the Mission Reconnect protocol to deliver mobile and Web-based complementary and integrative health programs to veterans and their partners (eg, spouse, significant other, caregiver, or family member). Methods: This three-site, 4-year mixed-methods randomized controlled trial uses a wait-list control to determine the effects of mobile and Web-based CIH programs for veterans and their partners, or dyads. The study will use two arms (ie, treatment intervention arm and wait-list control arm) in a clinical sample of veterans with comorbid pain and posttraumatic stress disorder, and their partners. The study will evaluate the effectiveness and perceived value of the Mission Reconnect program in relation to physical and psychological symptoms, global health, and social outcomes. Results: Funding for the study began in November 2018, and we are currently in the process of recruitment screening and data randomization for the study. Primary data collection will begin in May 2019 and continue through May 2021. Projected participants per site will be 76 partners/dyads, for a total of 456 study participants. Anticipated study results will be published in November 2022. Conclusions: This work highlights innovative delivery of CIH to veterans and their partners for treatment of posttraumatic stress disorder and chronic pain. Trial Registration: ClinicalTrials.gov NCT03593772; https://clinicaltrials.gov/ct2/show/NCT03593772 (Archived by WebCite at http://www.webcitation.org/77Q2giwtw) International Registered Report Identifier (IRRID): PRR1-10.2196/13666

  • JMIR Res Protoc 2019;8(5):e13666

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  RCTs - Protocols/Proposals (non-eHealth)

  May 13, 2019

  Communicating Uncertainty From Limitations in Quality of Evidence to the Public in Written Health Information: Protocol for a Web-Based Randomized Controlled...

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  Authors List:

  • Roland Brian Büchter  
  • Cornelia Betsch  
  • Martina Ehrlich  
  • Dennis Fechtelpeter  
  • Ulrich Grouven  
  • Sabine Keller  
  • Regina Meuer  
  • Constanze Rossmann  
  • Andreas Waltering  

  Abstract:

  Background: Uncertainty is integral to evidence-informed decision making and is of particular importance for preference-sensitive decisions. Communicating uncertainty to patients and the public has long been identified as a goal in the informed and shared decision-making movement. Despite this, there is little quantitative research on how uncertainty in health information is perceived by readers. Objective: The objective of this study is to design an experiment to examine how different degrees of uncertainty (Q1) and different types of uncertainty (Q2) impact patients’ perception of treatment effectiveness, the body of evidence, text quality, and hypothetical treatment intention. The experiment also examines whether there is an additive effect when multiple sources of uncertainty are communicated (Q3). Methods: We developed 8 variations of a research summary set in a hypothetical scenario for a treatment decision in the context of tinnitus. These were modified only in the degree of uncertainty relating to the evidence of the presented treatment. We recruited members of the German public from a Web-based research panel and randomized them to one of 8 variations of the research summary to examine the 3 research questions. The trial was only open to the members of the research panel. The outcomes are perception of the effectiveness of the treatment (primary), certainty in the judgement of treatment effectiveness, perception of the body of evidence relating to the treatment, text quality, and decisional intention (secondary). Outcomes were self-assessed. We aimed to recruit 1500 participants to the trial. The recruitment and data collection was fully automated. Ethical approval was waivered by an ethics committee because of the negligible risk to participants. Results: This protocol is retrospectively published in its original format. In the meantime, the trial was set up and the data collection was completed. Data collection was conducted in May 2018. A total of 1727 eligible panel members were enrolled. Conclusions: We aim to publish the results in a peer-reviewed journal by the end of 2019. In addition, results will be presented at conferences and disseminated among developers of guidance for the development of evidence-based health information and decision aids. Trial Registration: German Clinical Trials Register DRKS00015911; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00015911 (Archived by WebCite at http://www.webcitation.org/77zyZTGzk) International Registered Report Identifier (IRRID): RR1-10.2196/13425

  • JMIR Res Protoc 2019;8(5):e13425

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  Non-Randomized Study Protocols and...

  May 9, 2019

  Household Surveys in the General Population and Web-Based Surveys in IQOS Users Registered at the Philip Morris International IQOS User Database: Protocols...

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  Authors List:

  • Zheng Sponsiello-Wang  
  • Peter Langer  
  • Luis Prieto  
  • Mariia Dobrynina  
  • Dimitra Skiada  
  • Nathalie Camille  
  • Rolf Weitkunat  
  • Frank Lüdicke  

  Abstract:

  Background: Philip Morris International (PMI) has developed a novel heat-not-burn tobacco product, Tobacco Heating System (THS), which is marketed under the brand name of IQOS with HEETS (IQOS). The aerosol generated by THS has substantially fewer toxicants than combustible cigarette smoke, although the extent of the reduction of harmful and potentially harmful constituents reported varies between studies. To evaluate the potential harm reduction associated with IQOS use, the assessment of the uptake and continued use of IQOS in the context of all other tobacco- and nicotine-containing products is crucial. In March 2018, PMI launched cross-sectional surveys in Germany, Italy, and the United Kingdom (Greater London) to estimate the prevalence and use patterns of IQOS and other tobacco- and nicotine-containing products use in these 3 markets following the commercialization of IQOS. This study describes the protocol of the surveys. Objective: The objectives of these surveys are to estimate the prevalence of tobacco- and nicotine-containing products use; describe past and current patterns of use; and explore their associations with self-reported health, motivation to use, risk perceptions, and perceived aesthetic changes. Methods: The overall design of the surveys is similar in all 3 countries. Repeated cross-sectional surveys are being conducted annually over 3 consecutive years (2018 to 2020) and in 2 samples: a representative sample of the general population and a sample of IQOS users. A total of 6085 adults per year will be selected from the general population for each survey through multistage stratified sampling, and participants will respond to face-to-face computer-assisted personal interviews. In addition, 1404, 1384, and 1246 IQOS users per year in Germany, Italy, and Greater London, respectively, will be randomly selected from the PMI IQOS user database and will be invited to complete the Web-based survey using computer-assisted self-interviews. The Smoking Questionnaire is used to assess the tobacco use patterns of the participants. Results: The recruitment of the general population sample began in March 2018 and that of the IQOS user sample began in April 2018. The data collection is ongoing, and the results of the first year data analysis are expected to be available by June 2019. Conclusions: As the design of the 3 surveys is similar, the results will allow for cross-countries comparison of the prevalence of IQOS and other tobacco- and nicotine-containing products use as well as patterns of use and associated factors. International Registered Report Identifier (IRRID): DERR1-10.2196/12061

  • JMIR Res Protoc 2019;8(5):e12061

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  Non-Randomized Study Protocols and...

  May 8, 2019

  Testing a Communication Assessment Tool for Ethically Sensitive Scenarios: Protocol of a Validation Study

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  Authors List:

  • Thierry Daboval  
  • Natalie Ward  
  • Jordan R Schoenherr  
  • Gregory P Moore  
  • Caitlin Carew  
  • Alicia Lambrinakos-Raymond  
  • Emanuela Ferretti  

  Abstract:

  Background: Although well-designed instruments to assess communication during medical interviews and complex encounters exist, assessment tools that differentiate between communication, empathy, decision-making, and moral judgment are needed to assess different aspects of communication during situations defined by ethical conflict. To address this need, we developed an assessment tool that differentiates competencies associated with practice in ethically challenging situations. The competencies are grouped into three distinct categories: communication skills, civility and respectful behavior, clinical and ethical judgment and decision-making. Objective: The overall objective of this project is to develop an assessment tool for ethically sensitive scenarios that measures the degree of respect for the attitudes and beliefs of patients and family members, the demands of clinical decision-making, and the success in dealing with ethical conflicts in the clinical context. In this article, we describe the research method we will use during the pilot-test study using the neonatal context to provide validity evidence to support the features of the Assessment Communication Tool for Ethics (ACT4Ethics) instrument. Methods: This study is part of a multiphase project designed according to modern validity principles including content, response process, internal structure, relation to other variables, and social consequences. The design considers threats to validity such as construct underrepresentation and factors exerting nonrandom influence on scores. This study consists of two primary steps: (1) train the raters in the use of the new tool and (2) pilot-test a simulation using an Objective Structured Clinical Examination. We aim to obtain a total of 90 independent assessments based on the performance of 30 trainees rated by 15 trained raters for analysis. A comparison of raters’ responses will allow us to compute a measure of interrater reliability. We will additionally compare the results of ACT4Ethics with another existing instrument. Results: This study will take approximately 18 months to complete and the results should be available by September 2019. Conclusions: ACT4Ethics should allow clinician-teachers to assess and monitor the development of competency of trainees’ judgments and communication skills when facing ethically sensitive clinical situations. The instrument will also guide the provision of meaningful feedback to ensure that trainees develop specific communication, empathy, decision-making, and ethical competencies. International Registered Report Identifier (IRRID): PRR1-10.2196/12039

  • JMIR Res Protoc 2019;8(5):e12039

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  Non-Randomized Study Protocols and...

  May 7, 2019

  The Adverse Drug Reactions From Patient Reports in Social Media Project: Protocol for an Evaluation Against a Gold Standard

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  Authors List:

  • Armelle Arnoux-Guenegou  
  • Yannick Girardeau  
  • Xiaoyi Chen  
  • Myrtille Deldossi  
  • Rim Aboukhamis  
  • Carole Faviez  
  • Badisse Dahamna  
  • Pierre Karapetiantz  
  • Sylvie Guillemin-Lanne  
  • Agnès Lillo-Le Louët  
  • Nathalie Texier  
  • Anita Burgun  
  • Sandrine Katsahian  

  Abstract:

  Background: Social media is a potential source of information on postmarketing drug safety surveillance that still remains unexploited nowadays. Information technology solutions aiming at extracting adverse reactions (ADRs) from posts on health forums require a rigorous evaluation methodology if their results are to be used to make decisions. First, a gold standard, consisting of manual annotations of the ADR by human experts from the corpus extracted from social media, must be implemented and its quality must be assessed. Second, as for clinical research protocols, the sample size must rely on statistical arguments. Finally, the extraction methods must target the relation between the drug and the disease (which might be either treated or caused by the drug) rather than simple co-occurrences in the posts. Objective: We propose a standardized protocol for the evaluation of a software extracting ADRs from the messages on health forums. The study is conducted as part of the Adverse Drug Reactions from Patient Reports in Social Media project. Methods: Messages from French health forums were extracted. Entity recognition was based on Racine Pharma lexicon for drugs and Medical Dictionary for Regulatory Activities terminology for potential adverse events (AEs). Natural language processing–based techniques automated the ADR information extraction (relation between the drug and AE entities). The corpus of evaluation was a random sample of the messages containing drugs and/or AE concepts corresponding to recent pharmacovigilance alerts. A total of 2 persons experienced in medical terminology manually annotated the corpus, thus creating the gold standard, according to an annotator guideline. We will evaluate our tool against the gold standard with recall, precision, and f-measure. Interannotator agreement, reflecting gold standard quality, will be evaluated with hierarchical kappa. Granularities in the terminologies will be further explored. Results: Necessary and sufficient sample size was calculated to ensure statistical confidence in the assessed results. As we expected a global recall of 0.5, we needed at least 384 identified ADR concepts to obtain a 95% CI with a total width of 0.10 around 0.5. The automated ADR information extraction in the corpus for evaluation is already finished. The 2 annotators already completed the annotation process. The analysis of the performance of the ADR information extraction module as compared with gold standard is ongoing. Conclusions: This protocol is based on the standardized statistical methods from clinical research to create the corpus, thus ensuring the necessary statistical power of the assessed results. Such evaluation methodology is required to make the ADR information extraction software useful for postmarketing drug safety surveillance. International Registered Report Identifier (IRRID): RR1-10.2196/11448

  • JMIR Res Protoc 2019;8(5):e11448

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  Non-Randomized Studies (funded,...

  May 6, 2019

  Quality of Life and Clinical Outcome After Traumatic Spleen Injury (SPLENIQ Study): Protocol for an Observational Retrospective and Prospective Cohort Study

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  Authors List:

  • Claudia PAM Raaijmakers  
  • Paul NM Lohle  
  • Paul Lodder  
  • Jolanda de Vries  

  Abstract:

  Background: Little is known about the effect of a splenic rupture on the quality of life (QOL) of patients, although the spleen is one of the most frequently injured organs in blunt abdominal trauma. It is essential to obtain more knowledge about QOL after traumatic spleen injury so that this can be taken into account when choosing treatment. Objective: The primary objective of the SPLENic Injury and Quality of life (SPLENIQ) study is to determine QOL after treatment for traumatic spleen injury. The secondary objective is to investigate clinical and imaging outcome in relation to QOL. Methods: A combination of a retrospective single-center and a prospective multicenter observational cohort study will be conducted. Patients in the retrospective study have had a splenic injury after blunt abdominal trauma and were admitted for treatment to the ETZ Hospital (Elisabeth-TweeSteden Ziekenhuis) in Tilburg between January 2005 and February 2017. Concerning the prospective cohort study, patients with splenic injury admitted to 1 of the 10 participating hospitals between March 2017 and December 2018 will be asked to participate. The follow-up period will be 1 year regarding QOL, clinical symptoms, and imaging. Patients in the retrospective study will complete 2 questionnaires: World Health Organization QOL assessment instrument-Bref (WHOQOL-Bref) and 12-Item Short-Form Health Survey (SF-12). Patients in the prospective study will complete 5 questionnaires at 1 week, 1 month, 3 months, 6 months, and 12 months after treatment: WHOQOL-Bref, SF-12, Euroqol 5-Dimensional 5-Level (EQ-5D-5L) questionnaire, Institute for Medical Technology Assessment (iMTA) Productivity Cost Questionnaire (iPCQ), and iMTA Medical Consumption Questionnaire (iMCQ). In both the retrospective and prospective study, patients treated with splenic artery embolization will undergo magnetic resonance imaging (MRI). The retrospective group will undergo MRI once, and the prospective group will undergo MRI 1 month and 1 year after treatment. Treatment of splenic injury depends on the severity of the splenic injury, the hemodynamic condition of the patient, and the hospital’s or doctor’s preference. This study is observational in nature without randomization. Concerning the retrospective data, multivariate analysis of covariance will be done. With regard to the prospective data, mixed linear modeling will be performed. Results: This project was funded in April 2015 by ZonMw. The results of the retrospective study will be expected in March 2019. With regard to the prospective study, inclusion of patients was completed in December 2018 and data collection will be completed in December 2019. The first results will be expected in 2019. Conclusions: To our knowledge, this is the first study that examines QOL in patients with a traumatic spleen injury. The SPLENIQ study responds to the shortage of information about QOL after treatment for traumatic spleen injury and may result in the development of a patient-oriented protocol. Trial Registration: ClinicalTrials.gov NCT03099798; https://clinicaltrials.gov/ct2/show/NCT03099798 (Archived by WebCite at http://www.webcitation.org/714ZKV6A0). International Registered Report Identifier (IRRID): DERR1-10.2196/12391

  • JMIR Res Protoc 2019;8(5):e12391

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  RCTs - Protocols/Proposals (funded,...

  May 3, 2019

  Improving Treatment of Elderly Patients by Interprofessional Education in a Quality Network of Geriatric Medicine: Protocol for Evaluating an Educational...

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  Authors List:

  • Daisy Huenefeld  
  • Sibyll Rodde  
  • Gertrud Bureick  
  • Barbara Elkeles  
  • Joachim Hasebrook  

  Abstract:

  Background: All statistics on the development of demand for care for multimorbid elderly patients highlight the acute pressure to act to adequately respond to the expected increase in geriatric patient population in the next 15 years. Against this background, great importance must be attached to the improvement of cross-occupational group and cross-sector treatment of these patients. In addition, many professionals in the health care sector often have little knowledge about the special treatment and care needs of the elderly. Objective: The Quality Network of Geriatric Medicine in north-west Germany is the body responsible for the project; with its member organizations, it provides care for over 400,000 inpatients and is thus one of the largest associations for geriatrics in Germany. The Quality Network conducts binding evaluated qualification measures for staff involved in the treatment and care of multimorbid elderly patients. The training offers are especially intended for staff who have not yet been trained in working with elderly patients. This approach is intended to improve the expertise of various occupational groups on different hierarchy levels, to include patients and their family members in the evaluation process, and to initiate changes within the organizations. Methods: Various instruments are used in the evaluation of qualification measures: besides written surveys and questionnaires, structured work groups (consensus groups) and interviews are conducted. The evaluation starts before the qualification measures to determine the starting point and then continues during the measure and after its completion. This allows major findings to be integrated directly into the ongoing qualification program. At least 100 trainings on geriatric topics, 80 consensus groups, and 120 patients (and family members) are going to be included in the study. Results: The evaluation of the educational initiative is funded by the State of Northrhine-Westfalia (Germany; LZG TG 71 001 / 2015 and LZG TG 71 002 / 2015). The results of the study will be published after review and approval by the state authorities – presumably by the end of 2019. The before and after comparison of the treatment-related outcomes at the beginning and near the completion of the educational initiative gives insights into how transfer-oriented education can improve the treatment of elderly patients across sector lines for inpatients as well as outpatients. The evaluation of the implementation of educational content in day-to-day work and occupational groups is to facilitate recommendations about economically sensible use of educational resources and about further adjustments to the training content. Conclusions: The evaluation develops the foundation for targeted and needs-oriented qualification measures as well as transfer in cross-sector, multiprofessional networks. Instruments and results will be published and provided to other health care networks and institutions. The Quality Network will implement the results of the evaluation process in its member institutions. International Registered Report Identifier (IRRID): DERR1-10.2196/11067

  • JMIR Res Protoc 2019;8(5):e11067

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  Non-randomized Protocols and Methods...

  May 2, 2019

  Acceptability and Feasibility of Self-Collecting Biological Specimens for HIV, Sexually Transmitted Infection, and Adherence Testing Among High-Risk...

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  Authors List:

  • Akshay Sharma  
  • Rob Stephenson  
  • Gregory Sallabank  
  • Leland Merrill  
  • Stephen Sullivan  
  • Monica Gandhi  

  Abstract:

  Background: Men who have sex with men (MSM) in the United States experience a disproportionate burden of HIV and bacterial sexually transmitted infections (STIs), such as gonorrhea and chlamydia. Screening levels among MSM remain inadequate owing to barriers to testing such as stigma, privacy and confidentiality concerns, transportation issues, insufficient clinic time, and limited access to health care. Self-collection of specimens at home and their return by mail for HIV and bacterial STI testing, as well as pre-exposure prophylaxis (PrEP) adherence monitoring, could be a resource-efficient option that might mitigate some of these barriers. Objective: Project Caboodle! is a mixed-methods study that explores the acceptability and feasibility of self-collecting and returning a bundle of 5 different specimens for HIV and bacterial STI testing, as well as PrEP adherence monitoring, among sexually active HIV-negative or unknown status MSM in the United States aged 18 to 34 years. Methods: Participants will be recruited using age, race, and ethnicity varied advertising on social networking websites and mobile gay dating apps. In Phase 1, we will send 100 participants a box containing materials for self-collecting and potentially returning a finger-stick blood sample (for HIV testing), pharyngeal swab, rectal swab, and urine specimen (for gonorrhea and chlamydia testing), and hair sample (to assess adequacy for potential PrEP adherence monitoring). Specimen return will not be incentivized, and participants can choose to mail back all, some, or none of the specimens. Test results will be delivered back to participants by trained counselors over the phone. In Phase 2, we will conduct individual in-depth interviews using a video-based teleconferencing software (VSee) with 32 participants from Phase 1 (half who returned all specimens and half who returned some or no specimens) to examine attitudes toward and barriers to completing various study activities. Results: Project Caboodle! was funded in May 2018, and participant recruitment began in March 2019. The processes of designing a study logo, creating advertisements, programming Web-based surveys, and finalizing step-by-step written instructions accompanied by color images for specimen self-collection have been completed. The boxes containing 5 self-collection kits affixed with unique identification stickers are being assembled, and shipping procedures (for mailing out boxes to participants and for specimen return by participants using prepaid shipping envelopes) and payment procedures for completing the surveys and in-depth interviews are being finalized. Conclusions: Self-collection of biological specimens at home and their return by mail for HIV and bacterial STI testing, as well as PrEP adherence monitoring, might offer a practical and convenient solution to improve comprehensive prevention efforts for high-risk MSM. The potentially reduced time, expense, and travel associated with this approach could facilitate a wider implementation of screening algorithms and remote monitoring strategies. International Registered Report Identifier (IRRID): PRR1-10.2196/13647

  • JMIR Res Protoc 2019;8(5):e13647

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  RCTs - Protocols/Proposals (non-eHealth)

  May 2, 2019

  Effective Information Provision About the Side Effects of Treatment for Malignant Lymphoma: Protocol of a Randomized Controlled Trial Using Video Vignettes

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  Authors List:

  • Nanon Labrie  
  • Sandra van Dulmen  
  • Marie José Kersten  
  • Hanneke JCM de Haes  
  • Arwen H Pieterse  
  • Julia CM van Weert  
  • Dick Johan van Spronsen  
  • Ellen MA Smets  
  • INSTRUCT Group

  Abstract:

  Background: Informing patients with cancer about the possible implications of prospective treatment is a crucial yet challenging task. Unfortunately, patients’ recall of medical information is generally poor and their information needs are not met. Effective information giving entails that oncologists help patients understand and recall the implications of their treatment, meanwhile fostering a trusting physician-patient relationship. Communication strategies that are often suggested to be effective are structuring and tailoring (cognition-oriented) but also are oncologists’ expressions of caring or empathy (affect-oriented). Objective: The aim of this study is to provide evidence concerning the pathways linking physician communication to (improved) consultation outcomes for patients. More specifically, the aim is to determine the effects of information structuring and information tailoring, combined with physician caring, on information recall, satisfaction with information, and trust in the physician (primary objective) and on symptom distress (secondary objective). Methods: A randomized controlled trial, systematically testing the effects of information structuring and information tailoring, each combined with caring, in 2 video-vignette experiments (2×2 and 2×2×2 design). Using an online survey platform, participants will be randomly allocated (blinded) to 1 of 12 conditions in which they are asked to view a video vignette (intervention) in which an oncologist discusses a treatment plan for malignant lymphoma with a patient. The independent variables of interest are systematically varied across conditions. The outcome measures are assessed in a survey, using validated instruments. Study participants are (former) patients with cancer and their relatives recruited via online panels and patient organizations. This protocol discusses the trial design, including the video-vignette design, intervention pretesting, and a pilot study. Results: Data collection has now been completed, and preliminary analyses will be available in Spring 2019. A total of 470 participants completed the first part of the survey and were randomized to receive the intervention. Conclusions: The results of the proposed trial will provide evidence concerning the pathways linking physician information, giving skills to (improved) consultation outcomes for patients. Trial Registration: Netherlands Trial Register NTR6153; https://www.trialregister.nl/trial/6022 (Archived by Webcite at http://www.webcitation.org/76xVV9xC8). International Registered Report Identifier (IRRID): DERR1-10.2196/12453

  • JMIR Res Protoc 2019;8(5):e12453

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