Impact of virtual visits on primary care physician work flows.

OBJECTIVE: To understand the impact of virtual visits on primary care physician (PCP) work flows. DESIGN: Qualitative semistructured interviews. SETTING: Primary care practices within 5 regions in southern Ontario. PARTICIPANTS: Physicians representing primary care practices of various sizes and remuneration models (eg, capitation and fee-for-service models). METHODS: Interviews were conducted with PCPs involved in a large-scale pilot project implementing virtual visits (via a Web-based application) into clinical practices. Convenience and purposive sampling were used to recruit PCPs between January 2018 and March 2019. To obtain a representative sample, participants were sought from a variety of practice types and geographic regions. High and low users of virtual visits were included. Interviews were audiorecorded and transcribed. An inductive thematic analysis was used to identify prominent themes and subthemes. MAIN FINDINGS: Twenty-six physicians were interviewed (n=15 using convenience sampling and n=11 through purposive sampling). Four themes were identified: PCPs employ diverse approaches to integrate virtual care into their work flow; PCPs recognize that implementing virtual visits requires upfront time and effort but have variable perceptions regarding long-term impact of virtual care on processes; asynchronous messaging is preferable to synchronous audio or video visits; and strategies were identified to improve the integration of virtual visits. CONCLUSION: The potential of virtual care to improve work flow is dependent on the way these visits are implemented and used. Dedicated time for implementation, emphasis on using asynchronous secure messaging, and access to clinical champions and structured change management support were associated with more seamless integration of virtual visits.

Redesigning primary care: Provider perspectives on the clinical utility of virtual visits.

OBJECTIVE: To explore primary care physician (PCP) perspectives on the clinical utility of virtual visits. DESIGN: Qualitative design involving semistructured interviews. SETTING: Primary care practices within 5 regions in southern Ontario. PARTICIPANTS: Primary care physicians representing different practice sizes and remuneration models. METHODS: Interviews were conducted with PCPs who were involved in a large-scale pilot implementation of virtual visits (patient-provider asynchronous messaging, or synchronous audio or video communication). The first phase involved a convenience sample of users in the first 2 regions where the pilot was initiated; after implementation in all 5 regions, purposive sampling was used to ensure diversity within the sample (eg, physicians representing different use frequencies of virtual visits, regions, and remuneration models). Interviews were audiorecorded and transcribed. An inductive thematic analysis was used to identify prominent themes and subthemes. MAIN FINDINGS: Twenty-six physicians were interviewed. Fifteen were recruited using convenience sampling and 11 through purposive sampling. Four themes regarding the clinical utility of virtual visits were identified: virtual visits can effectively resolve many patient concerns, with some variation in PCP comfort using virtual visits for specific conditions; virtual visits are beneficial for a range of patients but some patients might overuse or inappropriately use them; PCPs prefer to use asynchronous messaging (eg, text or online messaging) because of its convenience and flexibility; and virtual visits can provide value at the patient, provider, and health system levels. CONCLUSION: While participants believed that virtual visits can be appropriately used to resolve a variety of clinical concerns, they found in practice that virtual visits are fundamentally different from face-to-face encounters. Professional guidelines on appropriate use cases should be established to develop a standard framework for virtual care.

Mailed Letter Versus Phone Call to Increase Diabetic-Related Retinopathy Screening Engagement by Patients in a Team-Based Primary Care Practice: Prospective, Single-Masked, Randomized Trial.

BACKGROUND: Vision loss from diabetic-related retinopathy (DR) is preventable through regular screening. OBJECTIVE: The purpose of this study was to test different patient engagement approaches to expand a teleophthalmology program at a primary care clinic in the city of Toronto, Canada. METHODS: A teleophthalmology program was set up in a large, urban, academic, team-based primary care practice. Patients older than 18 years with type 1 or type 2 diabetes were randomized to one of the following 4 engagement strategies: phone call, mail, mail plus phone call, or usual care. Outreach was conducted by administrative staff within the clinic. The primary outcome was booking an appointment for DR screening. RESULTS: A total of 23 patients in the phone, 28 in the mail, 32 in the mail plus phone call, and 27 in the control (usual care) group were included in the analysis. After the intervention and after excluding patients who said they were screened, 88% (15/17) of patients in the phone, 11% (2/18) in the mail, and 100% (21/21) in the mail and phone group booked an appointment with the teleophthalmology program compared to 0% (0/12) in the control group. Phoning patients positively predicted patients booking a teleophthalmology appointment (P<.001), whereas mailing a letter had no effect. CONCLUSIONS: Patient engagement to book DR screening via teleophthalmology in an urban, academic, team-based primary care practice using telephone calls was much more effective than patient engagement using letters or usual care. Practices that have access to a local DR screening program and have resources for such engagement strategies should consider using them as a means to improve their DR screening rates. TRIAL REGISTRATION: ClinicalTrials.gov NCT03927859; https://clinicaltrials.gov/ct2/show/NCT03927859.

Perceptions of a Teleophthalmology Screening Program for Diabetic Retinopathy in Adults With Type 1 and Type 2 Diabetes in Urban Primary Care Settings.

OBJECTIVES: Teleophthalmology has improved diabetic retinopathy screening, and should be expanded in urban areas, where most unscreened individuals reside. In this study we explored facilitators and barriers of teleophthalmology in primary care settings in Toronto, Canada. METHODS: Semistructured interviews were conducted with 7 health-care providers and 7 individuals with diabetes to explore their perspectives of teleophthalmology in urban primary care settings. Interview data were analyzed using interpretive thematic analysis to generate themes. RESULTS: Six themes were identified. Facilitators included patient-centred implementation, access to teleophthalmology at primary care sites and patients' trust in their providers' recommendations. Barriers included patients' lack of understanding of diabetic retinopathy and the health-care system, providers' lack of interest and the need to streamline administrative processes. CONCLUSIONS: Although teleophthalmology was well-received by patients, there was limited interest from primary care providers. Strategies for increasing uptake include increasing primary care providers' awareness of teleophthalmology's value in urban centres, improving administrative processes and centralizing patient recruitment.

Uptake and patient and provider communication modality preferences of virtual visits in primary care: a retrospective cohort study in Canada.

OBJECTIVES: To evaluate the uptake of a platform for virtual visits in primary care, examine patient and physician preferences for virtual communication methods and report on characteristics of visits and patients experience of care. DESIGN: A retrospective cohort study. SETTING: Primary care practices within five regions in Ontario, Canada after 18 months of access to virtual care services. PARTICIPANTS: 326 primary care providers and 14 291 registered patients. INTERVENTIONS: Providers used a platform that allowed them to connect with their patients through synchronous (audio/video) and/or asynchronous (secure messaging) communication. MAIN OUTCOME MEASURES: User-level data from the platforms including patient demographics, practice characteristics, communication modality used, visit characteristics and patients' satisfaction. RESULTS: Among the participants, 44% of registered patients and 60% of registered providers used the platform at least once. Among patient users, 51% completed at least one virtual visit. The majority of virtual visits (94%) involved secure messaging. The most common patient requests were for medication prescriptions (24%) and follow-up from previous appointment (22%). The most common provider request was to follow-up on test results (59%). Providers indicated that 81% of virtual visits required no follow-up for that issue and 99% of patients reported that they would use virtual care services again. CONCLUSIONS: While there are a growing number of primary care video visit services, our study found that both patients and providers in rostered practices prefer secure messaging over video. Despite fears that virtual visits would be overused by patients, when patients connected with their own primary care provider, many virtual visits appeared to replace in-person visits, and patients did not overwhelm physicians with requests. This approach may improve access and continuity in primary care.

A Web-Based Mental Health Platform for Individuals Seeking Specialized Mental Health Care Services: Multicenter Pragmatic Randomized Controlled Trial.

BACKGROUND: Web-based self-directed mental health applications are rapidly emerging to address health service gaps and unmet needs for information and support. OBJECTIVE: The aim of this study was to determine if a multicomponent, moderated Web-based mental health application could benefit individuals with mental health symptoms severe enough to warrant specialized mental health care. METHODS: A multicenter, pragmatic randomized controlled trial was conducted across several outpatient mental health programs affiliated with 3 hospital programs in Ontario, Canada. Individuals referred to or receiving treatment, aged 16 years or older, with access to the internet and an email address, and having the ability to navigate a Web-based mental health application were eligible. A total of 812 participants were randomized 2:1 to receive immediate (immediate treatment group, ITG) or delayed (delayed treatment group, DTG) access for 3 months to the Big White Wall (BWW), a multicomponent Web-based mental health intervention based in the United Kingdom and New Zealand. The primary outcome was the total score on the Recovery Assessment Scale, revised (RAS-r) which measures mental health recovery. Secondary outcomes were total scores on the Patient Health Questionnaire-9 item (PHQ-9), the Generalized Anxiety Disorder Questionnaire-7 item (GAD-7), the EuroQOL 5-dimension quality of life questionnaire (EQ-5D-5L), and the Community Integration Questionnaire. An exploratory analysis examined the association between actual BWW use (categorized into quartiles) and outcomes among study completers. RESULTS: Intervention participants achieved small, statistically significant increases in adjusted RAS-r score (4.97 points, 95% CI 2.90 to 7.05), and decreases in PHQ-9 score (-1.83 points, 95% CI -2.85 to -0.82) and GAD-7 score (-1.55 points, 95% CI -2.42 to -0.70). Follow-up was achieved for 55% (446/812) at 3 months, 48% (260/542) of ITG participants and 69% (186/270) of DTG participants. Only 58% (312/542) of ITG participants logged on more than once. Some higher BWW user groups had significantly greater improvements in PHQ-9 and GAD-7 relative to the lowest use group. CONCLUSIONS: The Web-based application may be beneficial; however, many participants did not engage in an ongoing way. This has implications for patient selection and engagement as well as delivery and funding structures for similar Web-based interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02896894; https://clinicaltrials.gov/ct2/show/NCT02896894 (Archived by WebCite at http://www.webcitation.org/78LIpnuRO).

Uptake and Scalability of a Peritoneal Dialysis Virtual Care Solution: Qualitative Study.

BACKGROUND: Early research in the area of virtual care solutions with peritoneal dialysis (PD) patients has focused on evaluating the outcomes and impact of these solutions. There has been less attention focused on understanding the factors influencing the uptake, usability, and scalability of virtual care for chronic kidney disease (CKD) patients receiving PD at home. OBJECTIVE: In this context, a study was undertaken to (1) assess and understand the factors influencing the uptake of a virtual care solution and (2) provide recommendations for the scalability of a virtual care solution aimed at enhancing CKD patients' outcomes and experiences. METHODS: This study used a qualitative design with semistructured interviews and a thematic analysis approach. A total of 25 stakeholders-6 patients and 3 caregivers, 6 health care providers, 2 vendors, and 8 health system decision makers-participated in this study. RESULTS: The following three primary mechanisms emerged to influence the usability of the virtual care solution: (1) receiving hands-on training and ongoing communication from a supportive team, (2) adapting to meet user needs and embedding them into workflow, and (3) being influenced by patient and caregiver characteristics. Further, two overarching recommendations were developed for considerations around scalability: (1) co-design locally, embed into the daily workflow, and deploy over time and (2) share the benefits and build the case. CONCLUSIONS: Study findings can be used by key stakeholders in their future efforts to enhance the implementation, uptake, and scalability of virtual care solutions for CKD and managing PD at home.

Extending access to a web-based mental health intervention: who wants more, what happens to use over time, and is it helpful? Results of a concealed, randomized controlled extension study.

BACKGROUND: Web-based mental health applications may be beneficial, but adoption is often low leaving optimal implementation and payment models unclear. This study examined which users were interested in extended access to a web-based application beyond an initial 3-month trial period and evaluated if an additional 3 months of access was beneficial. METHODS: This study was a concealed extension of a multi-center, pragmatic randomized controlled trial that assessed the benefit of 3 months of access to the Big White Wall (BWW), an anonymous web-based moderated, multi-component mental health application offering self-directed activities and peer support. Trial participants were 16 years of age or older, recruited from hospital-affiliated mental health programs. Participants who received access to the intervention in the main trial and completed 3-month outcome assessments were offered participation. We compared those who were and were not interested in an extension of the intervention, and re-randomized consenting participants 1:1 to receive extended access or not over the subsequent 3 months. Use of the intervention was monitored in the extension group and outcomes were measured at 3 months after re-randomization in both groups. The primary outcome was mental health recovery as assessed by total score on the Recovery Assessment Scale (RAS-r), as in the main trial. Linear mixed models were used to examine the time by group interaction to assess for differences in responses over the 3-month extension study. RESULTS: Of 233 main trial participants who responded, 119 (51.1%) indicated an interest in receiving extended BWW access. Those who were interested had significantly higher baseline anxiety symptoms compared to those who were not interested. Of the 119, 112 were re-randomized (55 to extended access, 57 to discontinuation). Only 21 of the 55 extended access participants (38.2%) used the intervention during the extension period. Change in RAS-r scores over time was not significantly different between groups (time by group, F(1,77) = 1.02; P = .31). CONCLUSIONS: Only half of eligible participants were interested in extended access to the intervention with decreasing use over time, and no evidence of added benefit. These findings have implications for implementation and payment models for this type of web-based mental health intervention. TRIAL REGISTRATION: Clinicaltrials.gov NCT02896894 . Registered retrospectively on September 12, 2016.

Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial.

BACKGROUND: As the increasing prevalence of type 2 diabetes mellitus has put pressure on health systems to appropriately manage these patients, there have been a growing number of mobile apps designed to improve the self-management of diabetes. One such app, BlueStar, has been shown to significantly reduce hemoglobin A1c (HbA1c) levels in small studies and is the first app in the United States to receive Food and Drug Administration approval as a mobile prescription therapy. However, the impact of the app across real-world population among different clinical sites and health systems remains unclear. OBJECTIVE: The primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA1c levels among diverse participants in real-life clinical contexts. We hypothesized that this mobile app would improve self-management and HbA1c levels compared with controls. METHODS: The study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The primary outcome was glucose control measured by HbA1c levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app. RESULTS: The results of an analysis of covariance controlling for baseline HbA1c levels did not show evidence of intervention impact on HbA1c levels at 3 months (mean difference [ITG-WLC] -0.42, 95% CI -1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA1c levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants' 3-month HbA1c levels (95% CI -0.03 to -0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51). CONCLUSIONS: The results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA1c levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed. TRIAL REGISTRATION: Clinicaltrials.gov NCT02813343; https://clinicaltrials.gov/ct2/show/NCT02813343 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02813343).

Improving safety and efficiency in care: multi-stakeholders' perceptions associated with a peritoneal dialysis virtual care solution.

BACKGROUND: Although there is a growing body of literature on the outcomes and impacts of remote home management with peritoneal dialysis (PD) patients, less is understood how this virtual care solution impacts the quality and efficiency of the healthcare system care. In this context, a study was undertaken to understand the perceptions of patients and their caregivers, healthcare providers, health system decision makers, and vendors associated with a remote monitoring and tracking solution aimed at enhancing the outcomes and experiences of chronic kidney disease (CKD) patients receiving PD at home. METHODS: A qualitative design using semi-structured interviews with 25 stakeholders was used in this study. Narrative data were analyzed by a thematic analysis approach. RESULTS: The following two themes emerged from the data: (1) leveraging data to monitor and intervene to keep patients safe and (2) increasing efficiencies and having control over supplies. DISCUSSION: Our study findings elucidated the ability of patients (and in some cases, caregivers) to monitor and trend their data and order and track directly on-line their dialysis supplies were key to their active participation in managing their CKD and keeping them safe at home. Their active participation and functionality of the virtual care solution also led to enhanced efficiencies (eg, process faster, easier, convenient, time savings) for both patients and healthcare providers. CONCLUSION: The virtual care solution showed promising signs of a patient-centric approach and may serve as a blueprint for other virtual care solutions for chronic disease management.

A Mobile App to Improve Self-Management of Individuals With Type 2 Diabetes: Qualitative Realist Evaluation.

BACKGROUND: The increasing use of Web-based solutions for health prevention and promotion presents opportunities to improve self-management and adherence to guideline-based therapy for individuals with type 2 diabetes (T2DM). Despite promising preliminary evidence, many users stop using Web-based solutions due to the burden of data entry, hidden costs, loss of interest, and a lack of comprehensive features. Evaluations tend to focus on effectiveness or impact and fail to evaluate the nuanced variables that may interact to contribute to outcome success (or failure). OBJECTIVE: This study aimed to evaluate a Web-based solution for improving self-management in T2DM to identify key combinations of contextual variables and mechanisms of action that explain for whom the solution worked best and in what circumstances. METHODS: A qualitative realist evaluation was conducted with one-on-one, semistructured telephonic interviews completed at baseline, and again toward the end of the intervention period (3 months). Topics included participants' experiences of using the Web-based solution, barriers and facilitators of self-management, and barriers and facilitators to effective use. Transcripts were analyzed using thematic analysis strategies, after which the key themes were used to develop statements of the relationships between the key contextual factors, mechanisms of action, and impact on the primary outcome (glycated hemoglobin, HbA1c). RESULTS: Twenty-six interviews (14 baseline, 12 follow-up) were completed with 16 participants with T2DM, and the following 3 key groups emerged: the easiest fit, the best fit, and those who failed to activate. Self-efficacy and willingness to engage with the solution facilitated improvement in HbA1c, whereas competing priorities and psychosocial issues created barriers to engagement. Individuals with high baseline self-efficacy who were motivated, took ownership for their actions, and prioritized diabetes management were early and eager adopters of the app and recorded improvements in HbA1c over the intervention period. Individuals with moderate baseline self-efficacy and no competing priorities, who identified gaps in understanding of how their actions influence their health, were slow to adopt use but recorded the greatest improvements in HbA1c. The final group had low baseline self-efficacy and identified a range of psychosocial issues and competing priorities. These participants were uncertain of the benefits of using a Web-based solution to support self-management, ultimately resulting in minimal engagement and no improvement in HbA1c. CONCLUSIONS: Self-efficacy, competing priorities, previous behavior change, and beliefs about Web-based solutions interact to determine engagement and impact on the clinical outcomes. Considering the balance of these patient characteristics is likely to help health care providers identify individuals who are apt to benefit from a Web-based solution to support self-management of T2DM. Web-based solutions could be modified to incorporate the existing screening measures to identify individuals who are at risk of suboptimal adherence to inform the provision of additional support(s) as needed.

Exploring the utility and scalability of a telehomecare intervention for patients with chronic kidney disease undergoing peritoneal dialysis-a study protocol.

BACKGROUND: Chronic Kidney Disease (CKD) is a pressing global health concern that is placing increased strain on health care resources. CKD patients regularly receive peritoneal dialysis as a common CKD treatment. An emerging technological solution is telehomecare as way to support patients receiving PD in their homes. This study protocol outlines a mixed methods evaluation exploring a telehomecare developed to enhance CKD patients' outcomes and experiences. The study aims to assess the usability, acceptability and scalability of this virtual care application. METHODS: A realist evaluation using an embedded case study design will be used to understand the usability, acceptability and scalability of a telehomecare application for patients with CKD undergoing PD. The realist evaluation that is further described in this paper is part of a larger evaluation of the eQ Connect™ intervention that includes a randomized, parallel-arm control trial aimed at determining if utilizing eQ Connect improves selected clinical outcomes for PD patients (CONNECT Trial). DISCUSSION: Potential implications of this study include elucidating which components of the intervention are most effective and under what conditions with a focus on the contextual influences. Collectively, our multi-method design will yield knowledge around how best to implement, sustain and spread the telehomecare application that will be useful to guide the development, implementation and evaluation of future virtual care applications aimed at improving the quality of care outcomes and experiences of patients. TRIAL REGISTRATION: NCT02670512 . Registered: January 18, 2016.

A randomized wait-list control trial to evaluate the impact of a mobile application to improve self-management of individuals with type 2 diabetes: a study protocol.

BACKGROUND: Management of diabetes through improved glycemic control and risk factor modification can help prevent long-term complications. Much diabetes management is self-management, in which healthcare providers play a supporting role. Well-designed e-Health solutions targeting behavior change can improve a range of measures, including glycemic control, perceived health, and a reduction in hospitalizations. METHODS: The primary objective of this study is to evaluate if a mobile application designed to improve self-management among patients with type 2 diabetes (T2DM) improves glycemic control compared to usual care. The secondary objectives are to determine the effects on patient experience and health system costs; evaluate how and why the intervention worked as observed; and gain insight into considerations for system-wide scale-up. This pragmatic, randomized, wait-list-control trial will recruit adult participants from three Diabetes Education Programs in Ontario, Canada. The primary outcome is glycemic control (measured by HbA1c). Secondary outcomes include patient-reported outcomes and patient-reported experience measures, health system utilization, and intervention usability. The primary outcome will be analyzed using an ANCOVA, with continuous secondary outcomes analyzed using Poisson regression. Direct observations will be conducted of the implementation and application-specific training sessions provided to each site. Semi-structured interviews will be conducted with participants, healthcare providers, organizational leaders, and system stakeholders as part of the embedded process evaluation. Thematic analysis will be applied to the qualitative data in order to describe the relationships between (a) key contextual factors, (b) the mechanisms by which they effect the implementation of the intervention, and (c) the impact on the outcomes of the intervention, according to the principles of Realist Evaluation. DISCUSSION: The use of mobile health and virtual tools is on the rise in health care, but the evidence of their effectiveness is mixed and their evaluation is often lacking key contextual data. Results from this study will provide much needed information about the clinical and cost-effectiveness of a mobile application to improve diabetes self-management. The process evaluation will provide valuable insight into the contextual factors that influence the application effectiveness, which will inform the potential for adoption and scale. TRIAL REGISTRATION: Clinicaltrials.gov NCT02813343 . Registered on 24 June 2016 (retrospectively registered). Trial Sponsor: Ontario Telemedicine Network.

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.

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. 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).