Mapping Theories, Models, and Frameworks to Evaluate Digital Health Interventions: Scoping Review.

BACKGROUND: Digital health interventions (DHIs) are a central focus of health care transformation efforts, yet their uptake in practice continues to fall short of their potential. In order to achieve their desired outcomes and impact, DHIs need to reach their target population and need to be used. Many factors can rapidly intersect between this dynamic of users and interventions. The application of theories, models, and frameworks (TMFs) can facilitate the systematic understanding and explanation of the complex interactions between users, practices, technology, and health system factors that underpin research questions. There remains a gap in our understanding of how TMFs have been applied to guide the evaluation of DHIs with real-world health system operations. OBJECTIVE: This study aims to map TMFs used in studies to guide the evaluation of DHIs. The objectives are to (1) describe the TMFs and the constructs they target, (2) identify how TMFs have been prospectively used (ie, their roles) in primary studies to evaluate DHIs, and (3) to reflect on the relevance and utility of our findings for knowledge users. METHODS: This scoping review was conducted in partnership with knowledge users using an integrated knowledge translation approach. We included papers (eg, reports; empirical quantitative, qualitative, and mixed methods studies; conference proceedings; and dissertations) if primary insights resulting from the application of TMFs were presented. Any type of DHI was eligible. Papers published from 2000 and onward were mainly identified from the following databases: MEDLINE (Ovid), CINAHL Complete (EBSCOhost), PsycINFO (Ovid), EBM Reviews (Ovid), and Embase (Ovid). RESULTS: A total of 156 studies published between 2000 and 2022 were included. A total of 68 distinct TMFs were identified across 85 individual studies. In more than half (85/156, 55%) of the included studies, 1 of following 6 prevailing TMFs were reported: Consolidated Framework for Implementation Research (n=39); the Reach, Effectiveness, Adoption, Implementation, and Maintenance Framework (n=17); the Technology of Acceptance Model (n=16); the Unified Theory on Acceptance and Use of Technology (n=12); the Diffusion of Innovation Theory (n=10); and Normalization Process Theory (n=9). The most common intended roles of the 6 TMFs were to inform data collection (n=86), to inform data analysis (n=69), and to identify key constructs that may serve as barriers and facilitators (n=52). CONCLUSIONS: As TMFs are most often reported to be applied to support data collection and analysis, researchers should consider more clearly synthesizing key insights as practical use cases to both increase the relevance and digestibility of their findings. There is also a need to adapt or develop guidelines for better reporting DHIs and the use of TMFs to guide evaluation. Hence, it would contribute to ensuring ongoing technology transformation efforts are evidence and theory informed rather than anecdotally driven.

Up-to-date on cancer screening among Ontario patients seen by walk-in clinic physicians: A retrospective cohort study.

Walk-in clinics are typically viewed as high-volume locations for managing acute issues but also may serve as a location for primary care, including cancer screening, for patients without a family physician. In this population-based cohort study, we compared breast, cervical and colorectal cancer screening up-to-date status for people living in the Canadian province of Ontario who were formally enrolled to a family physician versus those not enrolled but who had at least one encounter with a walk-in clinic physician in the previous year. Using provincial administrative databases, we created two mutually exclusive groups: i) those who were formally enrolled to a family physician, ii) those who were not enrolled but had at least one visit with a walk-in clinic physician from April 1, 2019 to March 31, 2020. We compared up to date status for three cancer screenings as of April 1, 2020 among screen-eligible people. We found that people who were not enrolled and had seen a walk-in clinic physician in the previous year consistently were less likely to be up to date on cancer screening than Ontarians who were formally enrolled with a family physician (46.1% vs. 67.4% for breast, 45.8% vs. 67.4% for cervical, 49.5% vs. 73.1% for colorectal). They were also more likely to be foreign-born and to live in structurally marginalized neighbourhoods. New methods are needed to enable screening for people who are reliant on walk-in clinics and to address the urgent need in Ontario for more primary care providers who deliver comprehensive, longitudinal care.

Practice Facilitation to Support Family Physicians in Encouraging COVID-19 Vaccine Uptake: A Multimethod Process Evaluation.

PURPOSE: We offered a practice facilitation intervention to family physicians in Ontario, Canada, known to have large numbers of patients not yet vaccinated against coronavirus disease 2019 (COVID-19). METHODS: We conducted a multimethod process evaluation embedded within a randomized controlled trial (clinical trial #NCT05099497). We collected descriptive statistics regarding engagement and qualitative interview data from family physicians and practice facilitators, as well as data from facilitator field notes. We analyzed and triangulated the data using thematic analysis and mapped barriers to and enablers for implementation to structural, organizational, physician, and patient factors. RESULTS: Of the 300 approached, 90 family physicians (30%) accepted facilitation. Of these, 57% received technical support to identify unvaccinated patients, 29% used trained medical student volunteers to contact patients on their behalf, and 30% used automated calling to reach patients. Key factors affecting engagement with the intervention were staff shortages owing to COVID-19 (structural), clinic characteristics such as technical issues and gatekeeping by staff, which prevented facilitators from talking with physicians (organizational), burnout (physician), and specialized populations that required targeted resources (patient). The facilitator's ability to address technical issues and connect family physicians with medical students helped with engagement. CONCLUSIONS: Strategies to help underresourced family physicians serving high-needs populations for issues of public health importance, such as vaccine promotion, must acknowledge the scarcity of physicians' time and provide new resources. To successfully engage family physicians, practice facilitators should seek to build trust and relationships over time, including with front-office staff.

Perceived guideline clarity impacts guideline-concordant care for breast cancer screening in women age 40-49.

BACKGROUND: Canadian and US Task Forces recommend against routine mammography screening for women age 40-49 at average breast cancer risk as harms outweigh benefits. Both suggest individualized decisions based on the relative value women place on potential screening benefits and harms. Population-based data reveal variation in primary care professionals (PCPs) mammography rates in this age group after adjusting for sociodemographic factors, highlighting the need to explore PCP screening perspectives and how this informs clinical behaviours. Results from this study will inform interventions that can improve guideline concordant breast screening for this age group. METHODS: Qualitative semi-structured interviews were performed with PCPs in Ontario, Canada. Interviews were structured using the theoretical domains framework (TDF) to explore determinants of breast cancer screening best-practice behaviours: (1) risk assessment; (2) discussion regarding benefits and harms; and (3) referral for screening. ANALYSIS: Interviews were transcribed and analyzed iteratively until saturation. Transcripts were coded deductively by behaviour and TDF domain. Data that did not fit within a TDF code were coded inductively. The research team met repeatedly to identify potential themes that influenced or were important consequences of the screening behaviours. The themes were tested against further data, disconfirming cases, and different PCP demographics. RESULTS: Eighteen physicians were interviewed. The theme of perceived guideline clarity (a lack of clarity on guideline-concordant practices) influenced all behaviours and moderated the extent to which the risk assessment and discussion occurred. Many were unaware of how risk-assessment factored into the guidelines and/or did not perceive that a shared-care discussion was guideline-concordant. Deferral to patient preference (screening referral without a complete discussion of benefits and harms) occurred when the PCPs had low knowledge regarding harms and/or if they experienced regret (TDF domain: emotion) resulting from prior clinical experiences. Older providers described patient's influence impacting their decisions and physicians trained outside Canada, practicing in higher-resourced areas, and female physicians described being influenced by beliefs about consequences of benefits of screening. CONCLUSION: Perceived guideline clarity is an important driver of physician behaviour. Improving guideline concordant care should start by clarifying the guideline itself. Thereafter, targeted strategies include building skills in identifying and overcoming emotional factors and communication skills important for evidence-based screening discussions.

Characteristics and Health Care Use of Patients Attending Virtual Walk-in Clinics in Ontario, Canada: Cross-sectional Analysis.

BACKGROUND: Funding changes in response to the COVID-19 pandemic supported the growth of direct-to-consumer virtual walk-in clinics in several countries. Little is known about patients who attend virtual walk-in clinics or how these clinics contribute to care continuity and subsequent health care use. OBJECTIVE: The objective of the present study was to describe the characteristics and measure the health care use of patients who attended virtual walk-in clinics compared to the general population and a subset that received any virtual family physician visit. METHODS: This was a retrospective, cross-sectional study in Ontario, Canada. Patients who had received a family physician visit at 1 of 13 selected virtual walk-in clinics from April 1 to December 31, 2020, were compared to Ontario residents who had any virtual family physician visit. The main outcome was postvisit health care use. RESULTS: Virtual walk-in patients (n=132,168) had fewer comorbidities and lower previous health care use than Ontarians with any virtual family physician visit. Virtual walk-in patients were also less likely to have a subsequent in-person visit with the same physician (309/132,168, 0.2% vs 704,759/6,412,304, 11%; standardized mean difference [SMD] 0.48), more likely to have a subsequent virtual visit (40,030/132,168, 30.3% vs 1,403,778/6,412,304, 21.9%; SMD 0.19), and twice as likely to have an emergency department visit within 30 days (11,003/132,168, 8.3% vs 262,509/6,412,304, 4.1%; SMD 0.18), an effect that persisted after adjustment and across urban/rural resident groups. CONCLUSIONS: Compared to Ontarians attending any family physician virtual visit, virtual walk-in patients were less likely to have a subsequent in-person physician visit and were more likely to visit the emergency department. These findings will inform policy makers aiming to ensure the integration of virtual visits with longitudinal primary care.

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.

Impacts of two behavior change interventions on determinants of medication adherence: process evaluation applying the health action process approach and habit theory alongside a randomized controlled trial.

Investigating the mechanisms of behavior change interventions provides a more fulsome understanding of how and why interventions work (or don't work). We assessed mechanisms of two interventions (mailouts alone, and mailouts plus telephone support, informed by the Health Action Process Approach (HAPA) and Habit Theory), designed to increase medication adherence after myocardial infarction. We conducted a process evaluation alongside a pragmatic trial. Medication adherence was assessed via self-report at 12-months in the trial, and participants in all trial groups were invited to contemporaneously complete an additional questionnaire assessing targeted mechanisms (HAPA constructs and automaticity). We used multiple regression-based mediation models to investigate indirect effects. Of 589 respondents, 497 were analyzed (92 excluded due to missing data). Mailouts plus telephone support had statistically significant but small effects on intention, social support, action planning, coping planning, and automaticity. There were no indirect effects of interventions on medication adherence via these constructs. Therefore, while this intervention led to changes in proposed mechanisms, these changes were not great enough to lead to behavior change. Refinements (and subsequent evaluation) of the interventions are warranted, and our findings indicate that this could involve offering more intensive support to form plans and identify cues for taking medications, in addition to providing physical supports to encourage self-monitoring, feedback, and habit formation. Trial registration: ClinicalTrials.gov: NCT02382731.

Variation in Patient-Described Barriers to and Facilitators of Diabetes Management by Individual-Level Characteristics: A Cross-Sectional, Open-Ended Survey.

This study analyzed patient-described barriers and facilitators related to diabetes management, focusing on how these differ by glycemia and across individual characteristics. A cross-sectional telephone survey was conducted with adult patients with diabetes in Alberta, Canada, asking two open-ended questions to describe the most helpful and difficult components of their diabetes management. Responses were analyzed using directed content analysis using the Theoretical Domains Framework as a template. The most frequently cited facilitator was care context and information, and the most frequently cited barriers were cognitive challenges and structural barriers, with patient-perceived barriers and facilitators varying by individual-level factors.

Developing an explanatory theoretical model for engagement with a web-based mental health platform: results of a mixed methods study.

BACKGROUND: With the growing need for accessible, high-quality mental health services, especially during the COVID-19 pandemic, there has been increasing development and uptake of web-based interventions in the form of self-directed mental health platforms. The Big White Wall (BWW) is a web-based platform for people experiencing mental illness and addiction that offers a range of evidence-based self-directed treatment strategies. Drawing on existing data from a large-scale evaluation of the implementation of BWW in Ontario, Canada (which involved a pragmatic randomized controlled trail with an embedded qualitative process evaluation), we sought to investigate the influences on the extent to which people engage with BWW. METHODS: In this paper we drew on BWW trial participants' usage data (number of logins) and the qualitative data from the process evaluation that explored participants' experiences, engagement with and reactions to BWW. RESULTS: Our results showed that there were highly complex relationships between the influences that contributed to the level of engagement with BWW intervention. We found that a) how people expected to benefit from using a platform like BWW was an important indicator of their future usage, b) moderate perceived symptoms were linked with higher engagement; whereas fewer actual depressive symptoms predicted use and anxiety had a positive linear relationship with usage, and that c) usage depended on positive early experiences with the platform. CONCLUSIONS: Our findings suggest that the nature of engagement with platforms such as BWW is not easily predicted. We propose a theoretical framework for explaining the level of user engagement with BWW that might also be generalizable to other similar platforms.

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.

Implementation Strategies to Improve Engagement With a Multi-Institutional Patient Portal: Multimethod Study.

BACKGROUND: Comprehensive multi-institutional patient portals that provide patients with web-based access to their data from across the health system have been shown to improve the provision of patient-centered and integrated care. However, several factors hinder the implementation of these portals. Although barriers and facilitators to patient portal adoption are well documented, there is a dearth of evidence examining how to effectively implement multi-institutional patient portals that transcend traditional boundaries and disparate systems. OBJECTIVE: This study aims to explore how the implementation approach of a multi-institutional patient portal impacted the adoption and use of the technology and to identify the lessons learned to guide the implementation of similar patient portal models. METHODS: This multimethod study included an analysis of quantitative and qualitative data collected during an evaluation of the multi-institutional MyChart patient portal that was deployed in Southwestern Ontario, Canada. Descriptive statistics were performed to understand the use patterns during the first 15 months of implementation (between August 2018 and October 2019). In addition, 42 qualitative semistructured interviews were conducted with 18 administrative stakeholders, 16 patients, 7 health care providers, and 1 informal caregiver to understand how the implementation approach influenced user experiences and to identify strategies for improvement. Qualitative data were analyzed using an inductive thematic analysis approach. RESULTS: Between August 2018 and October 2019, 15,271 registration emails were sent, with 67.01% (10,233/15,271) registered for an account across 38 health care sites. The median number of patients registered per site was 19, with considerable variation (range 1-2114). Of the total number of sites, 55% (21/38) had ≤30 registered patients, whereas only 2 sites had over 1000 registered patients. Interview participants perceived that the patient experience of the portal would have been improved by enhancing the data comprehensiveness of the technology. They also attributed the lack of enrollment to the absence of a broad rollout and marketing strategy across sites. Participants emphasized that provider engagement, change management support, and senior leadership endorsement were central to fostering uptake. Finally, many stated that regional alignment and policy support should have been sought to streamline implementation efforts across participating sites. CONCLUSIONS: Without proper management and planning, multi-institutional portals can suffer from minimal adoption. Data comprehensiveness is the foundational component of these portals and requires aligned policies and a key base of technology infrastructure across all participating sites. It is important to look beyond the category of the technology (ie, patient portal) and consider its functionality (eg, data aggregation, appointment scheduling, messaging) to ensure that it aligns with the underlying strategic priorities of the deployment. It is also critical to establish a clear vision and ensure buy-ins from organizational leadership and health care providers to support a cultural shift that will enable a meaningful and widespread engagement.

Family Physician Perceptions of Their Role in Managing the Opioid Crisis.

PURPOSE: We examined the perspectives of family physicians (FPs) on opioid prescribing and management of chronic pain to better understand the barriers to safer prescribing in primary care and differences in perspectives that may be potential drivers of practice variation. METHODS: We used an exploratory qualitative study design. Semistructured interviews were conducted in June and July 2017 with 22 FPs in Ontario and coded inductively. Thematic analysis was used to identify themes, and a framework analysis explored the influence of physician demographics on prescribing experience. RESULTS: Three key themes emerged: the discrepancy between FPs' training and current practice, the tension between the FP's role and patient and system expectations, and the influence of length of time in practice and strength of therapeutic relationships on perspectives on opioid prescribing. There was an overarching sentiment among participants that FPs are unsupported in their efforts to manage chronic pain. More years in practice (≥15 years) seems to influence practice patterns by increasing trust in therapeutic relationships and decreasing reliance on emergent guidelines (vs clinical experience). CONCLUSION: Number of years in practice influences FPs' response to emergent evidence, requiring initiatives to include strategies tailored to individual beliefs. Initiatives must move beyond dissemination and education to equip FPs with the skills they need to navigate emotionally charged conversations. External pressures and misaligned system and patient expectations place FPs at the center of a challenging situation, which may result in a higher risk of burnout compared with that of their specialist colleagues.

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.

Identifying and Overcoming Policy-Level Barriers to the Implementation of Digital Health Innovation: Qualitative Study.

BACKGROUND: High-level policy barriers impede widespread adoption for even the most well-positioned innovations. Most of the work in this field assumes rather than analyzes the driving forces of health innovation. Objective: The aim of this study was to explore the challenges and opportunities experienced by health system stakeholders in the implementation of digital health innovation in Ontario. OBJECTIVE: The aim of this study was to explore the challenges and opportunities experienced by health system stakeholders in the implementation of digital health innovation in Ontario. METHODS: We completed semistructured interviews with 10 members of senior leadership across key organizations that are engaged in health care-related digital health activities. Data were analyzed using qualitative description. RESULTS: A total of 6 key policy priorities emerged, including the need for (1) a system-level definition of innovation, (2) a clear overarching mission, and (3) clearly defined organizational roles. Operationally, there is a need to (4) standardize processes, (5) shift the emphasis to change management, and (6) align funding structures. CONCLUSIONS: These findings emphasize the critical role of the government in developing a vision and creating the foundation upon which innovation activities will be modeled.

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).

Comparing the application of two theoretical frameworks to describe determinants of adverse medical device event reporting: secondary analysis of qualitative interview data.

BACKGROUND: Post-market surveillance of medical devices is reliant on physician reporting of adverse medical device events (AMDEs). Few studies have examined factors that influence whether and how physicians report AMDEs, an essential step in the development of behaviour change interventions. This study was a secondary analysis comparing application of the Theoretical Domains Framework (TDF) and the Tailored Implementation for Chronic Diseases (TICD) framework to identify potential behaviour change interventions that correspond to determinants of AMDE reporting. METHODS: A previous study involving qualitative interviews with Canadian physicians that implant medical devices identified themes reflecting AMDE reporting determinants. In this secondary analysis, themes that emerged from the primary analysis were independently mapped to the TDF and TICD. Determinants and corresponding intervention options arising from both frameworks (and both mappers) were compared. RESULTS: Both theoretical frameworks were useful for identifying interventions corresponding to behavioural determinants of AMDE reporting. Information or education strategies that provide evidence about AMDEs, and audit and feedback of AMDE data were identified as interventions to target the theme of physician beliefs; improving information systems, and reminder cues, prompts and awards were identified as interventions to address determinants arising from the organization or systems themes; and modifying financial/non-financial incentives and sharing data on outcomes associated with AMDEs were identified as interventions to target device market themes. Numerous operational challenges were encountered in the application of both frameworks including a lack of clarity about how directly relevant to themes the domains/determinants should be, how many domains/determinants to select, if and how to resolve discrepancies across multiple mappers, and how to choose interventions from among the large number associated with selected domains/determinants. CONCLUSIONS: Given discrepancies in mapping themes to determinants/domains and the resulting interventions offered by the two frameworks, uncertainty remains about how to choose interventions that best match behavioural determinants in a given context. Further research is needed to provide more nuanced guidance on the application of TDF and TICD for a broader audience, which is likely to increase the utility and uptake of these frameworks in practice.

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.

Interventions Supporting Long-term Adherence aNd Decreasing cardiovascular events (ISLAND): Pragmatic randomized trial protocol.

BACKGROUND: Guidelines recommend cardiac rehabilitation and long-term use of cardiac medications for most patients who have had a myocardial infarction (MI), but adherence to these secondary prevention treatments is suboptimal. METHODS: This is a multicenter, pragmatic, 3-arm randomized trial. Eligible patients (n = 2,742) with obstructive coronary artery disease are randomized post-MI to usual care or 1 of 2 intervention arms. Patients in the first intervention arm receive mail-outs sent on behalf of their cardiologist at 4, 8, 20, 32, and 44 weeks post-MI; content is designed to address determinants of adherence and facilitate discussion between the patient and their health care team. Patients in the second intervention arm receive mail-outs plus automated interactive voice response system telephone calls 2 weeks after each letter, as well as a telephone call by trained lay health workers if the interactive voice response system identifies challenges with adherence. Outcomes are assessed 12 months post-MI via patient self-report and administrative data sources. Co-primary outcomes are adherence to cardiac medications and completion of cardiac rehabilitation. Secondary outcomes include cardiovascular events and mortality. An embedded, theory-informed process evaluation will explore the mechanism of action; an economic evaluation is also planned. CONCLUSIONS: We describe a complete program evaluation of a highly pragmatic, health-system intervention to support adherence to recommended treatments. Research ethics boards approved waiver of consent for patients enrolled in the trial with provision of multiple opportunities to opt out and a debrief at the time of outcome assessment. The methods used here may provide a model for similar interventions.

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.