title: 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.
abstract: BACKGROUND
  Mental 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.
  
  
  METHODS
  A 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.
  
  
  CONCLUSIONS
  Understanding 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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT02896894 . Registered on 31 August 2016 (retrospectively registered).
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, Canada. jennifer.hensel@wchospital.ca.|Department of Psychiatry, Women's College Hospital and University of Toronto, 76 Grenville St, Toronto, ON, Canada. jennifer.hensel@wchospital.ca.|Women's College Research Institute, Women's College Hospital, 76 Grenville St, Toronto, ON, Canada. jennifer.hensel@wchospital.ca.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Hensel
authors.affiliation: 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.
authors.forename: Jay
authors.initials: J
authors.lastname: Shaw
authors.affiliation: Li Ka Shing Knowledge Institute, St. Michael's Hospital, 209 Victoria St, Toronto, ON, Canada.
authors.forename: Lianne
authors.initials: L
authors.lastname: Jeffs
authors.affiliation: 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.
authors.forename: Noah M
authors.initials: NM
authors.lastname: Ivers
authors.affiliation: 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.
authors.forename: Laura
authors.initials: L
authors.lastname: Desveaux
authors.affiliation: Li Ka Shing Knowledge Institute, St. Michael's Hospital, 209 Victoria St, Toronto, ON, Canada.
authors.forename: Ashley
authors.initials: A
authors.lastname: Cohen
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, Canada.
authors.forename: Payal
authors.initials: P
authors.lastname: Agarwal
authors.affiliation: 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.
authors.forename: Walter P
authors.initials: WP
authors.lastname: Wodchis
authors.affiliation: 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.
authors.forename: Joshua
authors.initials: J
authors.lastname: Tepper
authors.affiliation: 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.
authors.forename: Darren
authors.initials: D
authors.lastname: Larsen
authors.affiliation: Rotman School of Management, University of Toronto, 105 St. George St, Toronto, ON, Canada.
authors.forename: Anita
authors.initials: A
authors.lastname: McGahan
authors.affiliation: Division of General Internal Medicine and Geriatrics, University Health Network and Sinai Health System, and University of Toronto, 600 University Ave, Toronto, ON, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Cram
authors.affiliation: 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.
authors.forename: Geetha
authors.initials: G
authors.lastname: Mukerji
authors.affiliation: 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.
authors.forename: Muhammad
authors.initials: M
authors.lastname: Mamdani
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, Canada.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Yang
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, Canada.
authors.forename: Ivy
authors.initials: I
authors.lastname: Wong
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, Canada.
authors.forename: Nike
authors.initials: N
authors.lastname: Onabajo
authors.affiliation: Women's College Hospital Institute for Health Systems Solutions and Virtual Care, Women's College Hospital, 76 Grenville St, Toronto, ON, Canada.
authors.forename: Trevor
authors.initials: T
authors.lastname: Jamieson
authors.affiliation: 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.
authors.forename: R Sacha
authors.initials: RS
authors.lastname: Bhatia
mesh_terms: D000368:Aged; D001007:Anxiety / Q000523:psychology / Q000628:therapy*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D003863:Depression / Q000523:psychology / Q000628:therapy*; D005260:Female; D017048:Health Care Costs; D006801:Humans; D020407:Internet; D001523:Mental Disorders / Q000523:psychology / Q000628:therapy*; D008603:Mental Health; D008605:Mental Health Services / Q000191:economics*; D009864:Ontario; D011788:Quality of Life; D012107:Research Design; D012648:Self Care; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
keywords: Implementation; Internet; Recovery; Self-management; Virtual care; Web-based