A pragmatic randomized control trial and realist evaluation on the implementation and effectiveness of an internet application to support self-management among individuals seeking specialized mental health care: a study protocol

BMC Psychiatry

Study Protocol

Peter Cram¹  Joshua Tepper²  Walter P. Wodchis³  Muhammad Mamdani⁴  Ashley Cohen⁵  Lianne Jeffs⁵  Anita McGahan⁶  Ivy Wong⁷  Nike Onabajo⁷  Rebecca Yang⁷  Payal Agarwal⁷  Trevor Jamieson⁷  Darren Larsen⁸  Jennifer M. Hensel⁹  Geetha Mukerji^1,10  Laura Desveaux^1,11  Jay Shaw^1,11  Noah M. Ivers^1,12  R. Sacha Bhatia^1,13 

[1] Division of General Internal Medicine and Geriatrics, University Health Network and Sinai Health System, and University of Toronto, 600 University Ave, Toronto, ON, Canada;Institute for Health Policy, Management and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada;Department of Family and Community Medicine, University of Toronto, 500 University Ave, Toronto, ON, Canada;Institute for Health Policy, Management and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada;Institute for Clinical Evaluative Sciences, 2075 Bayview Ave, Toronto, ON, Canada;Institute for Health Policy, Management and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada;Li Ka Shing Centre for Healthcare Analytics Research and Training, St. Michael’s Hospital, 209 Victoria St, Toronto, ON, Canada;Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College St, Toronto, ON, Canada;Li Ka Shing Knowledge Institute, St. Michael’s Hospital, 209 Victoria St, Toronto, ON, Canada;Rotman School of Management, University of Toronto, 105 St. George St, Toronto, ON, Canada;Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Department of Family and Community Medicine, University of Toronto, 500 University Ave, Toronto, ON, Canada;Women’s College Hospital Family Health Centre, 77 Grenville St, Toronto, ON, Canada;OntarioMD, 150 Bloor St, Toronto, ON, Canada;Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Department of Psychiatry, Women’s College Hospital and University of Toronto, 76 Grenville St, Toronto, ON, Canada;Women’s College Research Institute, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Institute for Health Policy, Management and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada;Department of Medicine, University of Toronto, 1 King’s College Circle #3172, Toronto, ON, Canada;Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Women’s College Research Institute, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Women’s College Research Institute, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Department of Family and Community Medicine, Women’s College Hospital and University of Toronto, 76 Grenville St, Toronto, ON, Canada;Institute for Health Policy, Management and Evaluation, University of Toronto, 155 College St, Toronto, ON, Canada;Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Women’s College Research Institute, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada;Department of Medicine, University of Toronto, 1 King’s College Circle #3172, Toronto, ON, Canada;

关键词: Web-based;    Internet;    Virtual care;    Implementation;    Self-management;    Recovery;   

DOI  :  10.1186/s12888-016-1057-5

 received in 2016-09-09, accepted in 2016-09-30,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundMental illness is a substantial and rising contributor to the global burden of disease. Access to and utilization of mental health care, however, is limited by structural barriers such as specialist availability, time, out-of-pocket costs, and attitudinal barriers including stigma. Innovative solutions like virtual care are rapidly entering the health care domain. The advancement and adoption of virtual care for mental health, however, often occurs in the absence of rigorous evaluation and adequate planning for sustainability and spread.MethodsA pragmatic randomized controlled trial with a nested comparative effectiveness arm, and concurrent realist process evaluation to examine acceptability, effectiveness, and cost-effectiveness of the Big White Wall (BWW) online platform for mental health self-management and peer support among individuals aged 16 and older who are accessing mental health services in Ontario, Canada. Participants will be randomized to 3 months of BWW or treatment as usual. At the end of the 3 months, participants in the intervention group will have the opportunity to opt-in to an intervention extension arm. Those who opt-in will be randomized to receive an additional 3 months of BWW or no additional intervention. The primary outcome is recovery at 3 months as measured by the Recovery Assessment Scale-revised (RAS-r). Secondary outcomes include symptoms of depression and anxiety measured with the Personal Health Questionnaire-9 item (PHQ-9) and the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7) respectively, quality of life measured with the EQ-5D-5L, and community integration assessed with the Community Integration Questionnaire. Cost-effectiveness evaluations will account for the cost of the intervention and direct health care costs. Qualitative interviews with participants and stakeholders will be conducted throughout.DiscussionUnderstanding the impact of virtual strategies, such as BWW, on patient outcomes and experience, and health system costs is essential for informing whether and how health system decision-makers can support these strategies system-wide. This requires clear evidence of effectiveness and an understanding of how the intervention works, for whom, and under what circumstances. This study will produce such effectiveness data for BWW, while simultaneously exploring the characteristics and experiences of users for whom this and similar online interventions could be helpful.Trial registrationClinicaltrials.gov NCT02896894. Registered on 31 August 2016 (retrospectively registered).

【 授权许可】

CC BY   
© The Author(s). 2016