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.

Outpatient visit trends for internal medicine ambulatory care sensitive conditions after the COVID-19 pandemic: a time-series analysis.

BACKGROUND: The COVID-19 pandemic led to a dramatic shift in the delivery of outpatient medicine with reduced in-person visits and a transition to predominantly virtual visits. We sought to understand trends in visit patterns for ambulatory care sensitive conditions (ACSCs) commonly seen in internal medicine clinics. METHODS: We included adult outpatients seen for an ACSC between March 15th, 2017 and March 14th, 2021 at a single-centre in Ontario, Canada. Monthly visits were assessed by visit type (new consultation, follow-up), diagnosis, and clinic. Time series analyses compared visit volumes pre- and post-pandemic. Proportion of virtual visits were compared before and during the pandemic. Patient and visit factors were compared between in-person and virtual visits. RESULTS: 8274 patients with 34,021 visits were included. Monthly visits increased by 15% during the pandemic (p <  0.0001). New consultations decreased by 10% (p = 0.0053) but follow-up visits increased by 21% (p <  0.0001). Monthly heart failure visits increased by 43% (p <  0.0001) whereas atrial fibrillation visits decreased. Pre- pandemic, < 1% of visits were virtual compared to 82% during the pandemic (p <  0.0001). Less than half of heart failure visits were virtual whereas > 95% of diabetes visits were virtual. CONCLUSIONS: We found a significant increase in overall visits to internal medicine clinics driven by increased volumes of follow-up visits, which more than offset decreased new consultations. There was variability in visit trends and uptake of virtual care by visit diagnosis, which may indicate challenges with delivery of virtual care for certain conditions.

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.

Operationalizing and Evaluating Synchronous Virtual Group Health Interventions: Wide-Scale Implementation at a Tertiary Care Academic Hospital.

Group-based health interventions are an important component of health promotion and management. To provide continuity of care throughout the COVID-19 pandemic, our institution undertook a rapid pivot to delivering group-based health interventions via a videoconferencing service which was securely embedded into both the electronic medical record and the patient portal to sustainably address immediate health service delivery needs during the pandemic and beyond. In this paper, we (1) describe the institutionally driven operationalization of a system to provide integrated synchronous video group visits across our hospital and (2) present a proposed strategy to comprehensively evaluate outcomes regarding their implementation, quality, and impact. Lessons for other institutions and the potential future role of synchronous video group visits to enhance how care can be scaled for delivery are discussed.

In vitro functional genetic modification of canine adenovirus type 2 genome by CRISPR/Cas9.

Genetically modified oncolytic adenoviruses have been proposed as a vehicle for cancer therapy. However, several concerns, such as toxicity to normal cells and organs, lack of suitable cell surface receptors to allow viral entry to the desired cell type(s), and activation of both innate and adaptive immune systems in patients, restrict the successful clinical application of adenoviral-mediated cancer gene therapy. Successful virotherapy will require efficient transductional and transcriptional targeting to enhance therapeutic efficacy by ensuring targeted adenoviral infection, replication, and/or therapeutic transgene expression. Targeted modification of viral components, such as viral capsid, fiber knob, and the insertion of transgenes for expression, are prerequisites for the necessary transductional and transcriptional targeting of adenovirus. However, the conventional approach to modify the adenoviral genome is complex, time consuming, and expensive. It is dependent on the presence of unique restriction enzyme sites that may or may not be present in the target location. Clustered regularly interspaced short palindromic repeat (CRISPR) along with the RNA-guided nuclease Cas9 (CRISPR/Cas9) is one of the most powerful tools that has been adopted for precise genome editing in a variety of cells and organisms. However, the ability of the CRISPR/Cas9 system to precisely and efficiently make genetic modification, as well as introduce gene replacements, in adenoviral genomes, remains essentially unknown. Herein the ability of in vitro CRISPR/CAS9-mediated editing of the canine adenovirus type 2 (CAV2) genome to promote targeted modification of the viral genome was assessed. To demonstrate the feasibility of this goal, CRISPR/Cas9 has been used to successfully insert the RFP (red fluorescent protein) reporter construct into the CAV2 genome. Initial results demonstrated high efficiency and accuracy for in vitro CRISPR-mediated editing of the large CAV2 genome. Furthermore, this application was expanded, using multiple guide RNAs, to conduct gene replacement in the CAV2 genome by substituting a portion of the E3 gene with a construct designed to express a single chain antibody to canine PD-1. Thus, this work provides a significantly improved and efficient method for targeted editing of adenoviruses to generate altered and potentially therapeutic viral genomes in the shortest possible time.

Clinical learnings from a virtual primary care program monitoring mild to moderate COVID-19 patients at home.

BACKGROUND: Virtual consults have replaced in-person visits for many home-isolated patients with COVID-19 disease. OBJECTIVES: To describe the natural history, clinical management and outcomes of community-dwelling patients with COVID-19, who received support from a family medicine-led, virtual CovidCare@Home program in Toronto, Ontario, Canada. METHODS: Observational, descriptive study conducted by retrospective chart review of 98 patients enrolled during the first 5 weeks of program implementation (8 April-11 May 2020); 73 patients with laboratory-confirmed COVID-19, with symptom onset ≤ 14 days before initial consult were included for analysis. Patients were classified as mild, moderate or severe based on WHO Criteria. RESULTS: All patients in the program experienced mild (88%) or moderate (12.3%) disease. No patients were hospitalized or died. Patients were mainly female (70%); with mean age of 43.3 years. Most patients (82.2%) worked in higher risk, healthcare settings. Almost 40% had no medical co-morbidities. Common symptoms were cough (65.8%), fatigue (60.3%), headache (42.5%) and myalgia (39.7%), followed by fever (32.9%), sore throat (21.9%), nasal congestion (21.9%) and rhinorrhea (20.5%). Headache (51%) and anosmia (45.1%) were common among females; fever and breathlessness among males (40.9%). Nine patients (12.3%) experienced worsening of symptoms (mainly respiratory) or exacerbation of co-morbidities, which required care outside the virtual service. CONCLUSION: Patients with mild to moderate COVID-19 disease can be managed safely and effectively in a family medicine-led virtual program. Some sex differences in symptoms were observed. Future work should focus on long-term follow up in view of the existence of so-called 'long-haulers'.

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.

Feasibility of an Electronic Health Tool to Promote Physical Activity in Primary Care: Pilot Cluster Randomized Controlled Trial.

BACKGROUND: Physical inactivity is associated with increased health risks. Primary care providers (PCPs) are well positioned to support increased physical activity (PA) levels through screening and provision of PA prescriptions. However, PCP counseling on PA is not common. OBJECTIVE: This study aimed to assess the feasibility of implementing an electronic health (eHealth) tool to support PA counseling by PCPs and estimate intervention effectiveness on patients' PA levels. METHODS: A pragmatic pilot study was conducted using a stepped wedge cluster randomized trial design. The study was conducted at a single primary care clinic, with 4 pre-existing PCP teams. Adult patients who had a periodic health review (PHR) scheduled during the study period were invited to participate. The eHealth tool involved an electronic survey sent to participants before their PHR via an email or a tablet; data were used to automatically produce tailored resources and a PA prescription in the electronic medical record of participants in the intervention arm. Participants assigned to the control arm received usual care from their PCP. Feasibility was assessed by the proportion of completed surveys and patient-reported acceptability and fidelity measures. The primary effectiveness outcome was patient-reported PA at 4 months post-PHR, measured as metabolic equivalent of task (MET) minutes per week. Secondary outcomes assessed determinants of PA, including self-efficacy and intention to change based on the Health Action Process Approach behavior change theory. RESULTS: A total of 1028 patients receiving care from 34 PCPs were invited to participate and 530 (51.55%) consented (intervention [n=296] and control [n=234]). Of the participants who completed a process evaluation, almost half (88/178, 49.4%) stated they received a PA prescription, with only 42 receiving the full intervention including tailored resources from their PCP. A cluster-level linear regression analysis yielded a non-statistically significant positive difference in MET-minutes reported per week at follow-up between intervention and control conditions (mean difference 1027; 95% CI -155 to 2209; P=.09). No statistically significant differences were observed for secondary outcomes. CONCLUSIONS: Our results suggest that it is feasible to build an eHealth tool that screens and provides tailored resources for PA in a primary care setting but suboptimal intervention fidelity suggests greater work must be done to address PCP barriers to resource distribution. Participant responses to the primary effectiveness outcome (MET-minutes) were highly variable, reflecting a need for more robust measures of PA in future trials to address limitations in patient-reported data. TRIAL REGISTRATION: ClinicalTrials.gov NCT03181295; https://clinicaltrials.gov/ct2/show/NCT03181295.

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.

Telemedicine in the driver's seat: new role for primary care access in Brazil and Canada: The Besrour Papers: a series on the state of family medicine in Canada and Brazil.

OBJECTIVE: To contrast how Brazil's and Canada's different jurisdictional and judicial realities have led to different types of telemedicine and how further scale and improvement can be achieved. COMPOSITION OF THE COMMITTEE: A subgroup of the Besrour Centre of the College of Family Physicians of Canada and Canadian telemedicine experts developed connections with colleagues in Porto Alegre, Brazil, and collaborated to undertake a between-country comparison of their respective telemedicine programs. METHODS: Following a literature review, the authors collectively reflected on their experiences in an attempt to explore the past and current state of telemedicine in Canada and Brazil. REPORT: Both Brazil and Canada share expansive geographies, creating substantial barriers to health for rural patients. Telemedicine is an important part of a universal health system. Both countries have achieved telemedicine programs that have scaled up across large regions and are showing important effects on health care costs and outcomes. However, each system is unique in design and implementation and faces unique challenges for further scale and improvement. Addressing regional differences, the normalization of telemedicine, and potential alignment of telemedicine and artificial intelligence technologies for health care are seen as promising approaches to scaling up and improving telemedicine in both countries.

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.

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).

How should family physicians provide physical activity advice? Qualitative study to inform the design of an e-health intervention.

OBJECTIVE: To explore patient attitudes toward interacting with family physicians regarding physical activity in order to inform the development of an e-health intervention aimed at helping family physicians support patients in becoming more physically active. DESIGN: Qualitative study. SETTING: Women's College Hospital in Toronto, Ont. PARTICIPANTS: Ten patients recruited from the academic family practice health centre. METHODS: Semistructured interviews were conducted with patients using maximum variation sampling until thematic saturation was reached. Interviews explored past experiences and preferences for receiving physical activity advice from family physicians, and tools or techniques that might support increasing physical activity. Interviews were audiorecorded, transcribed, and coded independently by members of the research team before undergoing thematic analysis. MAIN FINDINGS: Patient interviews revealed 4 overarching themes that offered insight to physical activity discussions. Family physicians might provide more meaningful and useful physical activity advice to patients by providing individualized recommendations focused on proximal (ie, near-term) health and functional goals; recognizing and addressing unique environmental and social factors influencing physical activity levels; balancing candour and sensitivity in advice provision while incorporating a broad definition of physical activity; and recommending tools that incorporate planning, goal-setting, and goal-monitoring features. CONCLUSION: Ultimately, physical activity recommendations from family physicians cannot make a difference if patients do not act on them. This study elicits input from patients to develop preliminary strategies that might help family physicians provide physical activity advice in a more patient-centred fashion. Further research is needed to test interventions that help implement these strategies and to assess their effect.

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 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).

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.