The Implementation of Federated Digital Identifiers in Health Care: Rapid Review.

BACKGROUND: Federated digital identifiers (FDIs) have been cited to improve the interoperability of data and information management while enhancing the privacy of individuals verifying their identity on the web. Many countries around the world have implemented FDIs in various sectors, such as banking and government. Similarly, FDIs could improve the experience for those wanting to access their health care information; however, they have only been introduced in a few jurisdictions around the world, and their impact remains unclear. OBJECTIVE: The main objective of this environmental scan was to describe how FDIs have been established and implemented to enable patients' access to health care. METHODS: We conducted this study in 2 stages, with the primary stage being a rapid review, which was supplemented by a targeted gray literature search. Specifically, the rapid review was conducted through a database search of MEDLINE and Embase, which generated a list of countries and their services that use FDIs in health care. This list was then used to conduct a targeted gray literature search using the Google search engine. RESULTS: A total of 93 references from the database and targeted Google searches were included in this rapid review. FDIs were implemented in health care in 11 countries (Australia, Belgium, Canada, Denmark, Estonia, Finland, Iceland, Norway, Singapore, Sweden, and Taiwan) and exclusively used with a patient-accessible electronic health record system through a single sign-on interface. The most common FDIs were implemented nationally or provincially, and establishing them usually required individuals to visit a bank or government office in person. In contrast, some countries, such as Australia, allow individuals to verify their identities entirely on the web. We found that despite the potential of FDIs for use in health care to facilitate the amalgamation of health information from different data sources into one platform, the adoption of most health care services that use FDIs remained below 30%. The exception to this was Australia, which had an adoption rate of 90%, which could be correlated with the fact that it leveraged an opt-out consent model. CONCLUSIONS: This rapid review highlights key features of FDIs across regions and elements associated with higher adoption of the patient-accessible electronic health record systems that use them, like opt-out registration. Although FDIs have been reported to facilitate the collation of data from multiple sources through a single sign-on interface, there is little information on their impact on care or patient experience. If FDIs are used to their fullest potential and implemented across sectors, adoption rates within health care may also improve.

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.

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.

Building the foundation for a practice-based research network: supporting primary care research across Canada.

Context: The Strategy for Patient Oriented Research (SPOR) was designed to engage previously passive stakeholders in the research process to ensure that the most urgent health challenges are addressed with evidence-based solutions that are feasible and scalable. The Primary and Integrated Health Care Innovations Network (PIHCIN), one of multiple SPOR entities, is rooted in community-based primary health care and meant to support transformation of primary and integrated care to improve patient experiences and health. Objective: To describe key components of building the foundation for a cross-jurisdictional, practice-based research network. Design: Cross-sectional survey and PIHCI network documentation review. Setting: SPOR PIHCI networks within British Columbia; Alberta; Saskatchewan; Manitoba; Ontario; Quebec; New Brunswick; Nova Scotia; Prince Edward Island; Newfoundland and Labrador; and the Northwest Territories. Participants: Responses were received from 11 networks who completed a template asking about their governance, capacity building, stakeholder engagement and patient partners. Responses were also received from the SPOR PIHCIN Pan-Canadian Patient Council. Outcome Measures: Thematic analysis across responses and documents for key components foundational to PIHCIN: types of stakeholders engaged, types of capacity building activities, knowledge translation and exchange activities. Results: Tripartite (clinician, scientist, decision-maker) leadership was used to align more closely with provincial and territorial needs in bringing practice and research closer together. PIHCIN enabled a unique pan-Canadian forum for government staff responsible for primary care. Individual networks and the PIHCIN patient-partners were actively engaged in research and governance on all levels including leading their own research. PIHCIN built research capacity by partnering with the Transdisciplinary Understanding and Training on Research Primary Health Care (TUTOR-PHC) and embedding fellows within the network. The PIHCI network undertook two separate learning series featuring patients, policy makers and scientists that were open to the public and demonstrated clear impact. Conclusion: Foundational components of embedded patients-partners, tripartite leadership, capacity building and knowledge translation and exchange have led to the formation of the PIHCI network providing an excellent base to build a pan-Canadian practice-based research and learning platform.

Innovation Centers in Health Care Delivery Systems: Structures for Success.

The need to support innovation in health care delivery was prompted by payment reforms and access to digital tools and has been accelerated by the shift to virtual care as part of the COVID-19 pandemic response. Prior to the pandemic, a growing number of health systems set up innovation centers to focus on creating new services and exploring new business models relevant to value-based care. This is distinct from process improvement or implementation science, and often needs a different set of incentives to succeed within a large organization. We used a national survey to identify a diverse sample of innovation centers, and interviewed leaders to describe their aims, organizational structures, and activities. They all aim to improve patient outcomes and experience while reducing costs, but their strategic focus may differ. The centers also vary in their reporting structure, how they build internal capacity, and how they measure success. We highlight the range of strategies through examples of projects that improve quality, reduce costs, and generate new revenue. While the optimal forms and impact of innovation centers are still emerging, the fiscal pressures and the rapid uptake of digital technologies present opportunities for the redesign of health services in the postpandemic era. The experiences of these centers illustrate a set of approaches to increase any organization's capacity for innovation.

Patient and Provider Experiences With Virtual Care in a Large, Ambulatory Care Hospital in Ontario, Canada During the COVID-19 Pandemic: Observational Study.

BACKGROUND: Virtual care use increased during the COVID-19 pandemic. The impact of that shift on patient and provider experiences is unclear. OBJECTIVE: We evaluated patient and provider experiences with virtual visits across an academic, ambulatory hospital in Toronto, Canada and assessed predictors of positive experience with virtual care. METHODS: Survey data were analyzed from consenting patients who attended at least one virtual visit (video or telephone) and from consenting providers who delivered at least one virtual visit. Distributions for demographic variables and responses to survey questions are reported, with statistical significance assessed using chi-square tests and t tests. Ordinal logistic regression analysis was used to identify any patient predictors of responses. RESULTS: During the study period, 253 patients (mean age 45.1, SD 15.6 years) completed 517 video visit surveys, and 147 patients (mean age 41.6, SD 16.4 years) completed 209 telephone visit surveys. A total of 75 and 94 providers completed the survey in June 2020 and June 2021, respectively. On a scale from 1 to 10 regarding likelihood to recommend virtual care to others, fewer providers rated a score of 8 or above compared with patients (providers: 62/94, 66% for video and 49/94, 52% for telephone; patients: 415/517, 80% for video and 150/209, 72% for telephone). Patients of non-White ethnicity had lower odds of rating a high score of 9 or 10 compared with White patients (odds ratio 0.52, 95% CI 0.28-0.99). CONCLUSIONS: Patient experiences with virtual care were generally positive, but provider experiences were less so. Findings suggest potential differences in patient experience by ethnicity, warranting further investigation into equity concerns with virtual care.

Closing the Virtual Gap in Health Care: A Series of Case Studies Illustrating the Impact of Embedding Evaluation Alongside System Initiatives.

Early decisions relating to the implementation of virtual care relied on necessity and clinical judgement, but there is a growing need for the generation of evidence to inform policy and practice designs. The need for stronger partnerships between researchers and decision-makers is well recognized, but how these partnerships can be structured and how research can be embedded alongside existing virtual care initiatives remain unclear. We present a series of case studies that illustrate how embedded research can inform policy decisions related to the implementation of virtual care, where decisions are either to (1) discontinue (red light), (2) redesign (yellow light), or (3) scale up existing initiatives (green light). Data were collected through document review and informal interviews with key study personnel. Case 1 involved an evaluation of a mobile diabetes platform that demonstrated a mismatch between the setting and the technology (decision outcome: discontinue). Case 2 involved an evaluation of a mental health support platform that suggested evidence-based modifications to the delivery model (decision outcome: redesign). Case 3 involved an evaluation of video visits that generated evidence to inform the ideal model of implementation at scale (decision outcome: scale up). In this paper, we highlight the characteristics of the partnership and the process that enabled success and use the cases to illustrate how these characteristics were operationalized. Structured communication included monthly check-ins and iterative report development. We also outline key characteristics of the partnership (ie, trust and shared purpose) and the process (ie, timeliness, tailored reporting, and adaptability) that drove the uptake of evidence in decision-making. Across each case, the evaluation was designed to address policy questions articulated by our partners. Furthermore, structured communication provided opportunities for knowledge mobilization. Structured communication was operationalized through monthly meetings as well as the delivery of interim and final reports. These case studies demonstrate the importance of partnering with health system decision-makers to generate and mobilize scientific evidence. Embedded research partnerships founded on a shared purpose of system service provided an effective strategy to bridge the oft-cited gap between science and policy. Structured communication provided a mechanism for collaborative problem-solving and real-time feedback, and it helped contextualize emerging insights.

Building Health Services in a Rapidly Changing Landscape: Lessons in Adaptive Leadership and Pivots in a COVID-19 Remote Monitoring Program.

Adaptive leadership has become an essential skill for leaders in health systems to respond to the COVID-19 pandemic as new knowledge emerges and case counts rise, fall, and rise again. This leadership approach has been described as an iterative process of taking a wide view of the situation, interpreting the meaning of incoming data from multiple directions, and taking real-time action. This process is also common in start-ups, which attempt to create new products or services of uncertain value for consumer markets that may not yet exist. Start-ups manage uncertainty through "pivots," which can include changes in the target group, need, features, or intended benefit of a product or service. Pivots are large changes that account for the high likelihood of getting something wrong during development, and they are distinct from the "tweaks" or small tests of change that define quality improvement methodology. This case study describes three pivots in the launch of a remote monitoring program for COVID-19. Adaptive leadership helped inform strategic decisions, with pivots providing a framework for internal and external stakeholders to articulate options for changes to address shifting needs. There is considerable uncertainty in the appropriate design and implementation of health services, and although this case example focuses on the use of adaptive leadership and pivots during a pandemic, these strategies are relevant for health care leaders at any time.

Correction: Building Health Services in a Rapidly Changing Landscape: Lessons in Adaptive Leadership and Pivots in a COVID-19 Remote Monitoring Program.

[This corrects the article DOI: 10.2196/25507.].

Evaluating the Implementation of a Remote-Monitoring Program for Chronic Obstructive Pulmonary Disease: Qualitative Methods from a Service Design Perspective.

BACKGROUND: Implementing digital health technologies is complex but can be facilitated by considering the features of the tool that is being implemented, the team that will use it, and the routines that will be affected. OBJECTIVE: The goal of this study was to assess the implementation of a remote-monitoring initiative for patients with chronic obstructive pulmonary disease in Ontario, Canada using the Tool+Team+Routine framework and to refine this approach to conceptualize the adoption of technologies in health care. METHODS: This study was a qualitative research project that took place alongside a randomized controlled trial comparing a technology-enabled self-monitoring program with a technology-enabled self- and remote-monitoring program in patients with chronic obstructive pulmonary disease and with standard care. This study included interviews with 5 remote-monitoring patients, 3 self-monitoring patients, 2 caregivers, 5 health care providers, and 3 hospital administrators. The interview questions were structured around the 3 main concepts of the Tool+Team+Routine framework. RESULTS: Findings emphasized that (1) technologies can alter relationships between providers and patients, and that these relationships drove the development of a new service arising from the technology, in our case, and (2) technologies can create additional work that is not visible to management as a result of not being considered within the scope of the service. CONCLUSIONS: Literature on the implementation of digital health technologies has still not reconciled the importance of interpersonal relationships to conventional implementation strategies. By acknowledging the centrality of such relationships, implementation teams can better plan for the adaptations required in order to make new technologies work for patients and health care providers. Further work will need to address how specific individuals administering a remote-monitoring program work to build relationships, and how these relationships and other sources of activity might lead to technological scope creep-an unanticipated expanding scope of work activities in relation to the function of the tool.

Technology-Enabled Self-Management of Chronic Obstructive Pulmonary Disease With or Without Asynchronous Remote Monitoring: Randomized Controlled Trial.

BACKGROUND: Chronic obstructive pulmonary disease (COPD) is a leading cause of mortality and leads to frequent hospital admissions and emergency department (ED) visits. COPD exacerbations are an important patient outcome, and reducing their frequency would result in significant cost savings. Remote monitoring and self-monitoring could both help patients manage their symptoms and reduce the frequency of exacerbations, but they have different resource implications and have not been directly compared. OBJECTIVE: This study aims to compare the effectiveness of implementing a technology-enabled self-monitoring program versus a technology-enabled remote monitoring program in patients with COPD compared with a standard care group. METHODS: We conducted a 3-arm randomized controlled trial evaluating the effectiveness of a remote monitoring and a self-monitoring program relative to standard care. Patients with COPD were recruited from outpatient clinics and a pulmonary rehabilitation program. Patients in both interventions used a Bluetooth-enabled device kit to monitor oxygen saturation, blood pressure, temperature, weight, and symptoms, but only patients in the remote monitoring group were monitored by a respiratory therapist. All patients were assessed at baseline and at 3 and 6 months after program initiation. Outcomes included self-management skills, as measured by the Partners in Health (PIH) Scale; patient symptoms measured with the St George's Respiratory Questionnaire (SGRQ); and the Bristol COPD Knowledge Questionnaire (BCKQ). Patients were also asked to self-report on health system use, and data on health use were collected from the hospital. RESULTS: A total of 122 patients participated in the study: 40 in the standard care, 41 in the self-monitoring, and 41 in the remote monitoring groups. Although all 3 groups improved in PIH scores, BCKQ scores, and SGRQ impact scores, there were no significant differences among any of the groups. No effects were observed on the SGRQ activity or symptom scores or on hospitalizations, ED visits, or clinic visits. CONCLUSIONS: Despite regular use of the technology, patients with COPD assigned to remote monitoring or self-monitoring did not have any improvement in patient outcomes such as self-management skills, knowledge, or symptoms, or in health care use compared with each other or with a standard care group. This may be owing to low health care use at baseline, the lack of structured educational components in the intervention groups, and the lack of integration of the action plan with the technology. TRIAL REGISTRATION: ClinicalTrials.gov NCT03741855; https://clinicaltrials.gov/ct2/show/ NCT03741855.

The mismeasurement of complexity: provider narratives of patients with complex needs in primary care settings.

PURPOSE: Chronic disease is a global concern. While ample research has aimed to identify the epidemiology of multimorbidity and patient complexity using administrative data, little attention has been paid to the processes of care that treating complex patients entail. Consequently, the concept of patient complexity itself does not directly speak to how challenging it may be to care for a given patient. The purpose of this study was to investigate how primary care providers define, encounter, and manage complex patients, especially those with chronic pain. To our knowledge, this is the first study to move beyond general narrative descriptions of complexity towards an interrogation that is grounded in the work practices of caring for these patients. METHODS: We undertook an institutional ethnography (IE) in Ontario, Canada. IE uses people's everyday work problems as the starting point for an exploration of the often-invisible social relations that orient experiences. Grounded in the everyday experience of primary care providers, we draw here on 51 interviews that were collected as part of our larger IE study, to interrogate the utility of definitions of patient complexity as medical multimorbidity. FINDINGS: Care providers consider patients challenging due to their socio-economic status more so than their medical problems alone. Our data shows that patients' issues are often bound up with poverty, trauma, and mental health concerns, and are challenging for health care providers in part because the interventions needed exceed the scope of their medical expertise, while social issues render the treatment of potentially straightforward medical problems complicated. This was especially so for patients with chronic pain. CONCLUSION: Defining patient complexity as morbidity alone is inadequate; such models neglect syndromes and conditions that are not included in formal disease classifications. Chronic pain should be included among the chronic conditions that are considered to constitute multimorbidity. In order to provide effective patient-centered care, discussions of patient complexity must also attend to the complex social and economic circumstances in which many patients live and include broader issues of inequity and social justice. This approach would enable policies to better support primary care providers who struggle to manage their patients with complex needs across domains of physiological health, mental health, and the quality of their living conditions, and in so doing improve the care that patients receive.

Using Human-Centered Design to Build a Digital Health Advisor for Patients With Complex Needs: Persona and Prototype Development.

BACKGROUND: Twenty years ago, a "Guardian Angel" or comprehensive digital health advisor was proposed to empower patients to better manage their own health. This is now technically feasible, but most digital applications have narrow functions and target the relatively healthy, with few designed for those with the greatest needs. OBJECTIVE: The goal of the research was to identify unmet needs and key features of a general digital health advisor for frail elderly and people with multiple chronic conditions and their caregivers. METHODS: In-depth interviews were used to develop personas and use cases, and iterative feedback from participants informed the creation of a low-fidelity prototype of a digital health advisor. Results were shared with developers, investors, regulators, and health system leaders for suggestions on how this could be developed and disseminated. RESULTS: Patients highlighted the following goals: "live my life," "love my life," "manage my health," and "feel understood." Patients and caregivers reported interest in four functions to address these goals: tracking and insights, advice and information, providing a holistic picture of the patient, and coordination and communication. Experts and system stakeholders felt the prototype was technically feasible, and that while health care delivery organizations could help disseminate such a tool, it should be done in partnership with consumer-focused organizations. CONCLUSIONS: This study describes the key features of a comprehensive digital health advisor, but to spur its development, we need to clarify the business case and address the policy, organizational, and cultural barriers to creating tools that put patients and their goals at the center of the health system.

Criteria to assess potential reverse innovations: opportunities for shared learning between high- and low-income countries.

BACKGROUND: Low- and middle-income countries (LMICs) are developing novel approaches to healthcare that may be relevant to high-income countries (HICs). These include products, services, organizational processes, or policies that improve access, cost, or efficiency of healthcare. However, given the challenge of replication, it is difficult to identify innovations that could be successfully adapted to high-income settings. We present a set of criteria for evaluating the potential impact of LMIC innovations in HIC settings. METHODS: An initial framework was drafted based on a literature review, and revised iteratively by applying it to LMIC examples from the Center for Health Market Innovations (CHMI) program database. The resulting criteria were then reviewed using a modified Delphi process by the Reverse Innovation Working Group, consisting of 31 experts in medicine, engineering, management and political science, as well as representatives from industry and government, all with an expressed interest in reverse innovation. RESULTS: The resulting 8 criteria are divided into two steps with a simple scoring system. First, innovations are assessed according to their success within the LMIC context according to metrics of improving accessibility, cost-effectiveness, scalability, and overall effectiveness. Next, they are scored for their potential for spread to HICs, according to their ability to address an HIC healthcare challenge, compatibility with infrastructure and regulatory requirements, degree of novelty, and degree of current collaboration with HICs. We use examples to illustrate where programs which appear initially promising may be unlikely to succeed in a HIC setting due to feasibility concerns. CONCLUSIONS: This study presents a framework for identifying reverse innovations that may be useful to policymakers and funding agencies interested in identifying novel approaches to addressing cost and access to care in HICs. We solicited expert feedback and consensus on an empirically-derived set of criteria to create a practical tool for funders that can be used directly and tested prospectively using current databases of LMIC programs.

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.