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

Hensel et al. BMC Psychiatry (2016) 16:350 DOI 10.1186/s12888-016-1057-5 STUDY PROTOCOL Open Access 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 Jennifer M. Hensel1,2,3*, Jay Shaw1,3, Lianne Jeffs4, Noah M. Ivers1,3,5,6, Laura Desveaux1,3, Ashley Cohen4, Payal Agarwal1, Walter P. Wodchis6,7, Joshua Tepper6,8, Darren Larsen1,8,9,10, Anita McGahan11, Peter Cram12, Geetha Mukerji1,6,13, Muhammad Mamdani6,14,15, Rebecca Yang1, Ivy Wong1, Nike Onabajo1, Trevor Jamieson1 and R. Sacha Bhatia1,3,13 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-ofpocket 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. (Continued on next page) * Correspondence: 1 Women’s College Hospital Institute for Health Systems Solutions and Virtual Care, Women’s College Hospital, 76 Grenville St, Toronto, ON, Canada 2 Department of Psychiatry, Women’s College Hospital and University of Toronto, 76 Grenville St, Toronto, ON, Canada Full list of author information is available at the end of the article © 2016 The Author(s). Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Hensel et al. BMC Psychiatry (2016) 16:350 Page 2 of 11 (Continued from previous page) Discussion: 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. Trial registration: Clinicaltrials.gov NCT02896894. Registered on 31 August 2016 (retrospectively registered). Keywords: Web-based, Internet, Virtual care, Implementation, Self-management, Recovery Background Mental illness is a substantial and rising contributor to the global burden of disease [1]. In Canada, 1 in 5 people are affected by this leading cause of disability, associated with more than $51 billion CAD in annual costs [2]. Utilization of mental health care, however, is limited by structural barriers such as specialist availability, geography, time, outof-pocket costs for patients [3, 4], and attitudinal barriers including stigma [4]. It is estimated that under-recognition and/or stigma act as obstacles to accessing care for at least 50 % of those affected [4–6]. Innovative solutions such as virtual care, broadly defined as any remote interaction between patients and/ or health care providers using any form of information technology to enhance healthcare [7, 8], are rapidly entering the health care domain. While these innovative solutions may address some mental health care access issues through components such as anonymity and rapid availability, their advancement and adoption often occurs in the absence of rigorous evaluation and adequate planning for sustainability and spread [9]. Studies evaluating virtual mental health applications have demonstrated conflicting findings, with some trials demonstrating no benefits [10] and others demonstrating substantial improvement among participants [11]. These conflicting findings illustrate the importance of studying the processes of implementation, including contextual factors, and the mechanisms of action that help to determine whether and how virtual mental health applications have effects on patient outcomes [12]. Although a wide variety of theories and methods are available to focus attention on key issues in the adoption and scale-up of new technologies, these are only recently being applied in large implementation studies [13, 14]. In the province of Ontario, Canada, the Ontario Telemedicine Network (OTN), a non-profit and governmentfunded organization, is the largest provider of telemedicine services [15]. In 2015, OTN conducted a selection process to initiate a series of pilot telehomecare interventions for patients with chronic conditions, ultimately choosing to test Big White Wall (BWW) for those struggling with mental health. This manuscript describes the approach to the evaluation of this virtual mental health application within the local health care system in Ontario, Canada. Virtual care application: Big white wall BWW is an internet-based application, built on evidencebased components of mental health care (eg. peer support (...truncated)