Challenges of Telemonitoring Programs for Complex Chronic Conditions: Randomized Controlled Trial With an Embedded Qualitative Study.

BACKGROUND: Despite the growing prevalence of people with complex conditions and evidence of the positive impact of telemonitoring for single conditions, little research exists on telemonitoring for this population. OBJECTIVE: This randomized controlled trial and embedded qualitative study aims to evaluate the impact on and experiences of patients and health care providers (HCPs) using a telemonitoring system with decision support to manage patients with complex conditions, including those with multiple chronic conditions, compared with the standard of care. METHODS: A pragmatic, unblinded, 6-month randomized controlled trial sought to recruit 146 patients with ≥1 diagnosis of heart failure (HF), uncontrolled hypertension (HT), and insulin-requiring diabetes mellitus (DM) from outpatient specialty settings in Toronto, Ontario, Canada. Participants were randomized into the control and telemonitoring groups, with the latter being instructed to take readings relevant to their conditions. The telemonitoring system contained an algorithm that generated decision support in the form of actionable self-care directives to patients and alerts to HCPs. The primary outcome was health status (36-Item Short Form Health Survey questionnaire). Secondary outcomes included anxiety and depression, self-efficacy in chronic disease management, and self-reported health service use. HF-related quality of life and self-care measures were also collected from patients followed for HF. Within- and between-group change scores were analyzed for statistical significance (P<.05). A convenience sample of HCPs and patients in the intervention group was interviewed about their experiences. RESULTS: A total of 96 patients were recruited and randomized. Recruitment was terminated early because of implementation challenges and the onset of the COVID-19 pandemic. No significant within- and between-group differences were found for the main primary and secondary outcomes. However, a within-group analysis of patients with HF found improvements in self-care maintenance (P=.04) and physical quality of life (P=.046). Opinions expressed by the 5 HCPs and 13 patients who were interviewed differed based on the monitored conditions. Although patients with HF reported benefitting from actionable self-care guidance and meaningful interactions with their HCPs, patient and HCP users of the DM and HT modules did not think telemonitoring improved the clinical management of those conditions to the same degree. These differing experiences were largely attributed to the siloed nature of specialty care and the design of the decision support, whereby fluctuations in the status of HT and DM typically required less urgent interventions compared with patients with HF. CONCLUSIONS: We recommend that future research conceive telemonitoring as a program and that self-management and clinical decision support are necessary but not sufficient components of such programs for patients with complex conditions and lower acuity. We conclude that telemonitoring for patients with complex conditions or within multidisciplinary care settings may be best operationalized through nurse-led models of care. TRIAL REGISTRATION: ClinicalTrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.8367.

Adoption of COVID-19 Contact Tracing Apps: A Balance Between Privacy and Effectiveness.

With the relative ubiquity of smartphones, contact tracing and exposure notification apps have been looked to as novel methods to help reduce the transmission of COVID-19. Many countries have created apps that lie across a spectrum from privacy-first approaches to those that have very few privacy measures. The level of privacy incorporated into an app is largely based on the societal norms and values of a particular country. Digital health technologies can be highly effective and preserve privacy at the same time, but in the case of contact tracing and exposure notification apps, there is a trade-off between increased privacy measures and the effectiveness of the app. In this article, examples from various countries are used to highlight how characteristics of contract tracing and exposure notification apps contribute to the perceived levels of privacy awarded to citizens and how this impacts an app's effectiveness. We conclude that finding the right balance between privacy and effectiveness, while critical, is challenging because it is highly context-specific.

Expanding Telemonitoring in a Virtual World: A Case Study of the Expansion of a Heart Failure Telemonitoring Program During the COVID-19 Pandemic.

BACKGROUND: To minimize the spread and risk of a COVID-19 outbreak, societal norms have been challenged with respect to how essential services are delivered. With pressures to reduce the number of in-person ambulatory visits, innovative models of telemonitoring have been used during the pandemic as a necessary alternative to support access to care for patients with chronic conditions. The pandemic has led health care organizations to consider the adoption of telemonitoring interventions for the first time, while others have seen existing programs rapidly expand. OBJECTIVE: At the Toronto General Hospital in Ontario, Canada, the rapid expansion of a telemonitoring program began on March 9, 2020, in response to COVID-19. The objective of this study was to understand the experiences related to the expanded role of a telemonitoring program under the changing conditions of the pandemic. METHODS: A single-case qualitative study was conducted with 3 embedded units of analysis. Semistructured interviews probed the experiences of patients, clinicians, and program staff from the Medly telemonitoring program at a heart function clinic in Toronto, Canada. Data were analyzed using inductive thematic analysis as well as Eakin and Gladstone's value-adding approach to enhance the analytic interpretation of the study findings. RESULTS: A total of 29 participants were interviewed, including patients (n=16), clinicians (n=9), and operational staff (n=4). Four themes were identified: (1) providing care continuity through telemonitoring; (2) adapting telemonitoring operations for a more virtual health care system; (3) confronting virtual workflow challenges; and (4) fostering a meaningful patient-provider relationship. Beyond supporting virtual visits, the program's ability to provide a more comprehensive picture of the patient's health was valued. However, issues relating to the lack of system integration and alert-driven interactions jeopardized the perceived sustainability of the program. CONCLUSIONS: With the reduction of in-person visits during the pandemic, virtual services such as telemonitoring have demonstrated significant value. Based on our study findings, we offer recommendations to proactively adapt and scale telemonitoring programs under the changing conditions of an increasingly virtual health care system. These include revisiting the scope and expectations of telemedicine interventions, streamlining virtual patient onboarding processes, and personalizing the collection of patient information to build a stronger virtual relationship and a more holistic assessment of patient well-being.

Developing theory-informed knowledge translation strategies to facilitate the use of patient-reported outcome measures in interdisciplinary low back pain clinical practices in Quebec: mixed methods study.

BACKGROUND: There is a growing interest among healthcare providers (HCPs) to use Patient Reported Outcome Measures (PROMs) in clinical care. PROMs can help improve patient-care provider communication and may be used to inform the need for interdisciplinary care for Low Back Pain (LBP). However, PROM implementation to support clinical decision-making is complex and requires knowledge translation (KT) interventions that will overcome barriers to using PROMs in interdisciplinary clinical settings. OBJECTIVES: to 1) identify potential barriers and enablers to using PROMs in primary care LBP clinical practice from the perspective of healthcare team members, and 2) develop a theory-based tailored KT intervention to facilitate the use of PROMs in interdisciplinary clinical practice. METHODS: We invited 25 HCPs working in an interdisciplinary team to complete a self-administered survey designed based on the Theoretical Domain Framework (TDF) to identify the barriers and enablers to using PROM scores in LBP clinical practice. The questionnaire consisted of 30 questions rated on a 5-point Likert scale (quantitative) and included open-ended questions (qualitative). Quantitative and qualitative data were analysed to estimate the frequency of barriers and enablers. Findings were then reviewed by a panel of four KT experts who mapped behaviour change techniques to barriers identified that informed the design of a KT intervention. RESULTS: Eighteen HCPs responded to the survey. Factors identified as likely to restrict the use of PROM scores included knowledge, skills, social/professional role and identity, goals, decision processes, beliefs about consequences, environmental context and resources, behavioural regulation, and social influence. A multi-component evidence-based KT intervention was proposed by the panel of experts to address these barriers: a training workshop; educational materials; and use of PROM score reports to HCPs that were all delivered by an opinion leader. CONCLUSION: The routine use of PROMs in clinical practice may optimize the quality of LBP care and improve patients' outcomes. The proposed multi-component KT intervention is expected to be an effective strategy to increase HCPs' ability to integrate PROMs into clinical decision-making and to engage patients in their care.

Outcomes of a Heart Failure Telemonitoring Program Implemented as the Standard of Care in an Outpatient Heart Function Clinic: Pretest-Posttest Pragmatic Study.

BACKGROUND: Telemonitoring (TM) can improve heart failure (HF) outcomes by facilitating patient self-care and clinical decisions. The Medly program enables patients to use a mobile phone to record daily HF readings and receive personalized self-care messages generated by a clinically validated algorithm. The TM system also generates alerts, which are immediately acted upon by the patients' existing care team. This program has been operating for 3 years as part of the standard of care in an outpatient heart function clinic in Toronto, Canada. OBJECTIVE: This study aimed to evaluate the 6-month impact of this TM program on health service utilization, clinical outcomes, quality of life (QoL), and patient self-care. METHODS: This pragmatic quality improvement study employed a pretest-posttest design to compare 6-month outcome measures with those at program enrollment. The primary outcome was the number of HF-related hospitalizations. Secondary outcomes included all-cause hospitalizations, emergency department visits (HF related and all cause), length of stay (HF related and all cause), and visits to the outpatient clinic. Clinical outcomes included bloodwork (B-type natriuretic peptide [BNP], creatinine, and sodium), left ventricular ejection fraction, and predicted survival score using the Seattle Heart Failure Model. QoL was measured using the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the 5-level EuroQol 5-dimensional questionnaire. Self-care was measured using the Self-Care of Heart Failure Index (SCHFI). The difference in outcome scores was analyzed using negative binomial distribution and Poisson regressions for the health service utilization outcomes and linear regressions for all other outcomes to control for key demographic and clinical variables. RESULTS: Available data for 315 patients enrolled in the TM program between August 2016 and January 2019 were analyzed. A 50% decrease in HF-related hospitalizations (incidence rate ratio [IRR]=0.50; P<.001) and a 24% decrease in the number of all-cause hospitalizations (IRR=0.76; P=.02) were found when comparing the number of events 6 months after program enrollment with the number of events 6 months before enrollment. With regard to clinical outcomes at 6 months, a 59% decrease in BNP values was found after adjusting for control variables. Moreover, 6-month MLHFQ total scores were 9.8 points lower than baseline scores (P<.001), representing a clinically meaningful improvement in HF-related QoL. Similarly, the MLHFQ physical and emotional subscales showed a decrease of 5.4 points (P<.001) and 1.5 points (P=.04), respectively. Finally, patient self-care after 6 months improved as demonstrated by a 7.8-point (P<.001) and 8.5-point (P=.01) increase in the SCHFI maintenance and management scores, respectively. No significant changes were observed in the remaining secondary outcomes. CONCLUSIONS: This study suggests that an HF TM program, which provides patients with self-care support and active monitoring by their existing care team, can reduce health service utilization and improve clinical, QoL, and patient self-care outcomes.

Correction: Exploring an Innovative Care Model and Telemonitoring for the Management of Patients with Complex Chronic Needs: Qualitative Description Study.

[This corrects the article DOI: 10.2196/15691.].

Experiences and Perceptions of Patients and Providers Participating in Remote Titration of Heart Failure Medication Facilitated by Telemonitoring: Qualitative Study.

BACKGROUND: Guideline-directed medical therapy (GDMT), optimized to target doses, improves health outcomes in patients with heart failure. However, GDMT remains underused, with <25% of patients receiving target doses in clinical practice. A randomized controlled trial was conducted at the Peter Munk Cardiac Centre in Toronto to compare a remote GDMT titration intervention with standard in-office titration. This randomized controlled trial found that remote titration increased the proportion of patients who achieved optimal GDMT doses, decreased the time to dose optimization, and reduced the number of essential clinic visits. This paper presents findings from the qualitative component of the mixed methods study, which evaluated the implementation of the remote titration intervention. OBJECTIVE: The objective of the qualitative component is to assess the perceptions and experiences of clinicians and patients with heart failure who participated in the remote titration intervention to identify factors that affected the implementation of the intervention. METHODS: We conducted semistructured interviews with clinicians (n=5) and patients (n=11) who participated in the remote titration intervention. Questions probed the experiences of the participants to identify factors that can serve as barriers and facilitators to its implementation. Conventional content analysis was first used to analyze the interviews and gain direct information based on the participants' unique perspectives. Subsequently, the generated themes were delineated and mapped following a multilevel framework. RESULTS: Patients and clinicians indicated that the intervention was easy to use, integrated well into their routines, and removed practical barriers to titration. Key implementation facilitators from the patients' perspective included the reduction in clinic visits and daily monitoring of their condition, whereas clinicians emphasized the benefits of rapid drug titration and efficient patient management. Key implementation barriers included the resources necessary to support the intervention and lack of physician remuneration. CONCLUSIONS: This study presents results from a real-world implementation assessment of remote titration facilitated by telemonitoring. It is among the first to provide insight into the perception of the remote titration process by clinicians and patients. Our findings indicate that the relative advantages that remote titration presents over standard care strongly appeal to both clinicians and patients. However, to ensure uptake and adherence, it is important to ensure that suitable patients are enrolled and the impact on the physicians' workload is minimized. The implementation of remote titration is now more critical than ever, as it can help provide access to care for patients during times when physical distancing is required. TRIAL REGISTRATION: ClinicalTrials.gov NCT04205513; https://clinicaltrials.gov/ct2/show/NCT04205513. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/19705.

The Resilience of Cardiac Care Through Virtualized Services During the COVID-19 Pandemic: Case Study of a Heart Function Clinic.

BACKGROUND: Virtual care has historically faced barriers to widespread adoption. However, the COVID-19 pandemic has necessitated the rapid adoption and expansion of virtual care technologies. Although the intense and prolonged nature of the COVID-19 pandemic has renewed people's interest in health systems resilience, which includes how services adapt or transform in response to shocks, evidence regarding the role of virtual care technologies in health systems resilience is scarce. OBJECTIVE: At Toronto General Hospital in Ontario, Canada, the rapid virtualization of cardiac care began on March 9, 2020, as a response to the pandemic. The objective of this study was to understand people's experiences with and the barriers and facilitators of the rapid virtualization and expansion of cardiac care resulting from the pandemic. METHODS: A single-case study was conducted with 3 embedded units of analysis. Patients, clinicians, and staff were recruited purposively from an existing mobile, phone-based telemonitoring program at a heart function clinic in Toronto, Canada. Individual, semistructured phone interviews were conducted by two researchers and transcribed verbatim. An inductive thematic analysis at the semantic level was used to analyze transcripts and develop themes. RESULTS: A total of 29 participants were interviewed, including patients (n=16), clinicians (n=9), and staff (n=4). The following five themes were identified: (1) patient safety as a catalyst for virtual care adoption; (2) piecemeal virtual care solutions; (3) confronting new roles and workloads; (4) missing pieces in virtual care; and (5) the inequity paradox. The motivation to protect patient safety and a piecemeal approach to virtual care adoption facilitated the absorptive and adaptive resilience of cardiac care during the COVID-19 pandemic. However, ad hoc changes to clinic roles and workflows, challenges in building relationships through remote methods, and widened inequities were barriers that threatened virtual care sustainment. CONCLUSIONS: We contend that sustaining virtual care hinges upon transformative actions (rather than adaptive actions) that strengthen health systems so that they can face the dynamic and emergent challenges associated with COVID-19 and other shocks. Based on the barriers and facilitators we identified, we present the lessons we learned and recommend transformations for sustaining virtual care during and beyond the COVID-19 pandemic.

Exploring an Innovative Care Model and Telemonitoring for the Management of Patients With Complex Chronic Needs: Qualitative Description Study.

BACKGROUND: The growing number of patients with complex chronic conditions presents an urgent challenge across the Canadian health care system. Current care delivery models are overburdened, struggling to monitor and stabilize the complex needs of this growing patient population. OBJECTIVE: This qualitative study aimed to explore the needs and perspectives of patients and members of the care team to inform the development of an innovative integrated model of care and the needs of telemonitoring (TM) for patients with complex chronic conditions. Furthermore, we explored how these needs could be successfully embedded to support this novel model of complex chronic care. METHODS: A qualitative description design was utilized to conduct and analyze 29 semistructured interviews with patients (n=16) and care team members (CTM) (n=13) involved in developing the model of care in an ambulatory care facility in Southern Ontario. Participants were identified through purposive sampling. Two researchers performed an iterative thematic analysis using NVivo 12 (QSR International; Melbourne, Australia) to gain insights from examining multiple perspectives of different participants on complex chronic care needs. RESULTS: The analysis revealed 3 themes and 13 subthemes, including the following: (1) adequate health care delivery remains challenging for patients with complex care needs, (2) insights into how to structure an integrated care model, and (3) opportunities for TM in an integrated model of care. Participants not only identified continued challenges in accessing and navigating care in a fragmented and disconnected delivery system but also identified the need for more self-management support. Patients and CTM described the structure of an integrated model of care, including the need for a clear referral and triage processes and composing a tight-knit circle of collaborating interdisciplinary providers led by a nurse practitioner (NP). Finally, opportunities for TM in an integrated model of care were identified, including increasing access and communication, the ability to monitor specific signs and symptoms, and building a clinical workflow around TM-enabled care. CONCLUSIONS: Despite entrenched health care service delivery models, a new model of care is acutely needed to care for patients with complex chronic needs (CCN). NPs are in a unique position to lead TM-enabled integrated models of care. TM can facilitate frequent and necessary monitoring of patients with CCN with more than one condition in integrated models of care.

A Mobile Phone-Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial.

BACKGROUND: Patients with heart failure (HF) are at the highest risk for hospital readmissions during the first few weeks after discharge when patients are transitioning from hospital to home. Telemonitoring (TM) for HF management has been found to reduce mortality risk and hospital readmissions if implemented appropriately; however, the impact of TM targeted for patients recently discharged from hospital, for whom TM might have the biggest benefit, is still unknown. Medly, a mobile phone-based TM system that is currently being used as a standard of care for HF at a large Canadian hospital, may be an effective tool for the management of HF in patients recently discharged from hospital. OBJECTIVE: The objective of the Medly-After an Incidence of acute Decompensation (Medly-AID) trial is to determine the effect of Medly on the self-care and quality of life of patients with HF who have been recently discharged from hospital after an HF-related decompensation. METHODS: A multisite multimethod randomized controlled trial (RCT) will be conducted at 2 academic hospitals and at least one community hospital to evaluate the impact of Medly-enabled HF management on the outcomes of patients with HF who had been hospitalized for HF-related decompensation and discharged during the 2 weeks before recruitment. The trial will include 144 participants with HF (74 in each control and intervention groups). Control patients will receive standard of care, whereas patients in the intervention group will receive standard of care and Medly. Specifically, patients in the intervention group will record daily weight, blood pressure, and heart rate and answer symptom-related questions via the Medly app. Medly will generate automated patient self-care messages such as to adjust diuretic medications, based on the rules-based algorithm personalized to the individual patient, and send real-time alerts to their health care providers as necessary. All patients will be followed for 3 months. Primary outcome measures are self-care and quality of life as measured through the validated questionnaires Self-Care of Heart Failure Index, EQ-5D-5L, and the Kansas City Cardiomyopathy Questionnaire-12. Secondary outcome measures for this study include cost of health care services used and health outcomes. RESULTS: Patient recruitment began in November 2018 at the Sunnybrook Health Sciences Centre, with a total of 35 participants recruited by July 30, 2019 (17 in the intervention group and 18 in the control group). The final analysis is expected to occur in the fall of 2020. CONCLUSIONS: This RCT will be the first to assess the effectiveness of the Medly TM system for use following discharge from hospital after a HF-related decompensation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03358303; https://clinicaltrials.gov/ct2/show/NCT03358303. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/15753.

Patient Adherence to a Mobile Phone-Based Heart Failure Telemonitoring Program: A Longitudinal Mixed-Methods Study.

BACKGROUND: Telemonitoring (TM) can improve heart failure (HF) outcomes by facilitating patient self-care and clinical decision support. However, these outcomes are only possible if patients consistently adhere to taking prescribed home readings. OBJECTIVE: The objectives of this study were to (1) quantify the degree to which patients adhered to taking prescribed home readings in the context of a mobile phone-based TM program and (2) explain longitudinal adherence rates based on the duration of program enrollment, patient characteristics, and patient perceptions of the TM program. METHODS: A mixed-methods explanatory sequential design was used to meet the 2 research objectives, and all explanatory methods were guided by the unified theory of acceptance and use of technology 2 (UTAUT2). Overall adherence rates were calculated as the proportion of days patients took weight, blood pressure, heart rate, and symptom readings over the total number of days they were enrolled in the program up to 1 year. Monthly adherence rates were also calculated as the proportion of days patients took the same 4 readings over each 30-day period following program enrollment. Next, simple and multivariate regressions were performed to determine the influence of time, age, sex, and disease severity on adherence rates. Additional explanatory methods included questionnaires at 6 and 12 months probing patients on the perceived benefits and ease of use of the TM program, an analysis of reasons for patients leaving the program, and semistructured interviews conducted with a purposeful sampling of patients (n=24) with a range of adherence rates and demographics. RESULTS: Overall average adherence was 73.6% (SD 25.0) with average adherence rates declining over time at a rate of 1.4% per month (P<.001). The multivariate regressions found no significant effect of sex and disease severity on adherence rates. When grouping patients' ages by decade, age was a significant predictor (P=.04) whereby older patients had higher adherence rates over time. Adherence rates were further explained by patients' perceptions with regard to the themes of (1) performance expectancy (improvements in HF management and peace of mind), (2) effort expectancy (ease of use and technical issues), (3) facilitating conditions (availability of technical support and automated adherence calls), (4) social influence (support from family, friends, and trusted clinicians), and (5) habit (degree to which taking readings became automatic). CONCLUSIONS: The decline in adherence rates over time is consistent with findings from other studies. However, this study also found adherence to be the highest and most consistent over time in older age groups and progressively lower over time for younger age groups. These findings can inform the design and implementation of TM interventions that maximize patient adherence, which will enable a more accurate evaluation of impact and optimization of resources. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/resprot.9911.

Accounting for Complexity in Home Telemonitoring: A Need for Context-Centred Evidence.

Heart failure represents a significant burden for patients and the Canadian health care system. Home telemonitoring is proposed as an intervention that can improve heart failure outcomes by identifying opportunities for earlier clinical intervention and by providing patients with self-management support between scheduled clinic visits. The objective of this review is to provide clarity with respect to the most recent evidence of the effect of home telemonitoring on heart failure outcomes. Despite some strong evidence that telemonitoring can reduce the risk of mortality and heart failure-related hospitalizations, important inconsistencies exist in the evidence. This article proposes that much of the inconsistency results from differences in the patient population being studied, the type of home telemonitoring intervention, and the implementation setting. Also important is the degree to which intervention fidelity is maintained throughout the course of a study; this is emphasized through a review of the factors that influence the degree to which patients and health care providers use home telemonitoring interventions as intended. In this article we propose that for researchers to produce definitive answers regarding the effect of home telemonitoring on heart failure outcomes, interventions and studies need to be designed and tailored according to the characteristics of the target patient population and the implementation context.

Implementation and Evaluation of a Smartphone-Based Telemonitoring Program for Patients With Heart Failure: Mixed-Methods Study Protocol.

BACKGROUND: Meta-analyses of telemonitoring for patients with heart failure conclude that it can lower the utilization of health services and improve health outcomes compared with the standard of care. A smartphone-based telemonitoring program is being implemented as part of the standard of care at a specialty care clinic for patients with heart failure in Toronto, Canada. OBJECTIVE: The objectives of this study are to (1) evaluate the impact of the telemonitoring program on health service utilization, patient health outcomes, and their ability to self-care; (2) identify the contextual barriers and facilitators of implementation at the physician, clinic, and institutional level; (3) describe patient usage patterns to determine adherence and other behaviors in the telemonitoring program; and (4) evaluate the costs associated with implementation of the telemonitoring program from the perspective of the health care system (ie, public payer), hospital, and patient. METHODS: The evaluation will use a mixed-methods approach. The quantitative component will include a pragmatic pre- and posttest study design for the impact and cost analyses, which will make use of clinical data and questionnaires administered to at least 108 patients at baseline and 6 months. Furthermore, outcome data will be collected at 1, 12, and 24 months to explore the longitudinal impact of the program. In addition, quantitative data related to implementation outcomes and patient usage patterns of the telemonitoring system will be reported. The qualitative component involves an embedded single case study design to identify the contextual factors that influenced the implementation. The implementation evaluation will be completed using semistructured interviews with clinicians, and other program staff at baseline, 4 months, and 12 months after the program start date. Interviews conducted with patients will be triangulated with usage data to explain usage patterns and adherence to the system. RESULTS: The telemonitoring program was launched in August 2016 and patient enrollment is ongoing. CONCLUSIONS: The methods described provide an example for conducting comprehensive evaluations of telemonitoring programs. The combination of impact, implementation, and cost evaluations will inform the quality improvement of the existing program and will yield insights into the sustainability of smartphone-based telemonitoring programs for patients with heart failure within a specialty care setting.

User-Centered Adaptation of an Existing Heart Failure Telemonitoring Program to Ensure Sustainability and Scalability: Qualitative Study.

BACKGROUND: Telemonitoring interventions for the management of heart failure have seen limited adoption in Canadian health systems, but isolated examples of telemonitoring programs do exist. An example of such a program was launched in a specialty heart failure clinic in Toronto, Canada, and a recent implementation evaluation concluded that reducing the cost of delivering the program is necessary to ensure its sustainability and scalability. OBJECTIVE: The objectives of this study were to (1) understand which components of the telemonitoring program could be modified to reduce costs and adapted to other contexts while maintaining program fidelity and (2) describe the changes made to the telemonitoring program to enable its sustainability within the initial implementation site and scalability to other health organizations. METHODS: Semistructured interviews probed the experiences of patients (n=23) and clinicians (n=8) involved in the telemonitoring program to identify opportunities for cost reduction and resource optimization. Ideas for adapting the program were informed by the interview results and prioritized based on (1) potential impact for sustainability and scalability, (2) feasibility, and (3) perceived risks to negatively impacting the program's ability to yield desired health outcomes. RESULTS: A total of 5 themes representing opportunities for cost reduction were discussed, including (1) Bring Your Own Device (BYOD), (2) technical support, (3) clinician role, (4) duration of enrollment, and (5) intensity of monitoring. The hardware used for the telemonitoring system and the modalities of providing technical support were found to be highly adaptable, which supported the decision to implement a BYOD model, whereby patients used their own smartphone, weight scale, and blood pressure cuff. Changes also included the development of a website aimed at reducing the burden on a technical support telehealth analyst. In addition, the interviews suggested that although it is important to have a clinician who is part of a patient's circle of care monitoring telemonitoring alerts, the skill level and experience were moderately adaptable. Thus, a registered nurse was determined to be more cost-effective and was hired to replace the existing nurse practitioners in the frontline management of telemonitoring alerts and take over the technical support role from a telehealth analyst. CONCLUSIONS: This study provides a user-centered example of how necessary cost-reduction actions can be taken to ensure the sustainability and scalability of telemonitoring programs. In addition, the findings offer insights into what components of a telemonitoring program can be safely adapted to ensure its integration in various clinical settings.

Evaluating the Implementation of a Mobile Phone-Based Telemonitoring Program: Longitudinal Study Guided by the Consolidated Framework for Implementation Research.

BACKGROUND: Telemonitoring has shown promise for alleviating the burden of heart failure on individuals and health systems. However, real-world implementation of sustained programs is rare. OBJECTIVE: The objective of this study was to evaluate the implementation of a mobile phone-based telemonitoring program, which has been implemented as part of standard care in a specialty heart function clinic by answering two research questions: (1) To what extent was the telemonitoring program successfully implemented? (2) What were the barriers and facilitators to implementing the telemonitoring program? METHODS: We conducted a longitudinal single case study. The implementation success was evaluated using the following four implementation outcomes: adoption, penetration, feasibility, and fidelity. Semistructured interviews based on the Consolidated Framework for Implementation Research (CFIR) were conducted at 0, 4, and 12 months with 12 program staff members to identify the barriers and facilitators of the implementation. RESULTS: One year after the implementation, 98 patients and 8 clinicians were enrolled in the program. Despite minor technical issues, the intervention was used as intended. We obtained qualitative data from clinicians (n=8) and implementation staff members (n=4) for 24 CFIR constructs. A total of 12 constructs were facilitators clustered in the CFIR domains of inner setting (culture, tension for change, compatibility, relative priority, learning climate, leadership engagement, and available resources), characteristics of individuals (knowledge and beliefs about the intervention and self-efficacy), and process (engaging and reflecting and evaluating). In addition, we identified other notable facilitators from the characteristics of the intervention domain (relative advantage and adaptability) and the outer setting (patient needs and resources). Four constructs were perceived as minor barriers- the complexity of the intervention, cost, inadequate communication among high-level stakeholders, and the absence of a formal implementation plan. The remaining CFIR constructs had a neutral impact on the overall implementation. CONCLUSIONS: This is the first comprehensive evaluation of the implementation of a mobile phone-based telemonitoring program. Although the acceptability of the telemonitoring system was high, the strongest facilitators to the implementation success were related to the implementation context. By identifying what works and what does not in a real-world clinical context using a framework-guided approach, this work will inform the design of telemonitoring services and implementation strategies of similar telemonitoring interventions.

Self-Management and Clinical Decision Support for Patients With Complex Chronic Conditions Through the Use of Smartphone-Based Telemonitoring: Randomized Controlled Trial Protocol.

BACKGROUND: The rising prevalence of chronic illnesses hinders the sustainability of the health care system because of the high cost of frequent hospitalizations of patients with complex chronic conditions. Clinical trials have demonstrated that telemonitoring can improve health outcomes, but they have generally been limited to single conditions such as diabetes, hypertension, or heart failure. Few studies have examined the impact of telemonitoring on complex patients with multiple chronic conditions, although these patients may benefit the most from this technology. OBJECTIVE: The aim of this study is to investigate the impact of a smartphone-based telemonitoring system on the clinical care and health outcomes of complex patients across several chronic conditions. METHODS: A mixed-methods, 6-month randomized controlled trial (RCT) of a smartphone-based telemonitoring system is being conducted in specialty clinics. The study will include patients who have been diagnosed with one or more of any of the following conditions: heart failure, chronic obstructive pulmonary disease, chronic kidney disease, uncontrolled hypertension, or insulin-requiring diabetes. The primary outcome will be the health status of patients as measured with SF-36. Patients will be randomly assigned to either the control group receiving usual care (n=73) or the group using the smartphone-based telemonitoring system in addition to usual care (n=73). RESULTS: Participants are currently being recruited for the trial. Data collection is anticipated to be completed by the fall of 2018. CONCLUSIONS: This RCT will be among the first trials to provide evidence of the impact of telemonitoring on costs and health outcomes of complex patients who may have multiple chronic conditions. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number (ISRCTN): 41238563; http://www.isrctn.com/ISRCTN41238563 (Archived by WebCite at http://www.webcitation.org/6ug2Sk0af) and Clinicaltrials.gov NCT03127852; https://clinicaltrials.gov/ct2/show/NCT03127852 (Archived by WebCite at http://www.webcitation.org/6uvjNosBC).

Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 8: patient-reported outcomes in electronic health records can inform clinical and policy decisions.

BACKGROUND: Given that the goal of health care systems is to improve and maintain the health of the populations they serve, the indicators of performance must include outcomes that are meaningful to patients. The growth of health technologies provides an unprecedented opportunity to integrate the patient voice into clinical care by linking electronic health records (EHRs) to patient-reported outcome (PRO) data collection. However, PRO data must be relevant, meaningful, and actionable for those who will have to invest the time and effort to collect it. OBJECTIVE: In this study, we highlight opportunities to integrate PRO data collection into EHRs. We consider how stakeholder perspectives should influence the selection of PROs and ways to enhance engagement in and commitment to PRO implementation. We propose a research and policy agenda to address unanswered questions and facilitate the widespread adoption of PRO data collection into EHRs. DISCUSSION: Building a learning health care system that gathers PRO data in ways that can inform individual patient care, quality improvement, and comparative effectiveness research has the potential to accelerate the application of new evidence and knowledge to patient care.

Using eHealth Technologies: Interests, Preferences, and Concerns of Older Adults.

BACKGROUND: The Internet and eHealth technologies represent new opportunities for managing health. Age, sex, socioeconomic status, and current technology use are some of the known factors that influence individuals' uptake of eHealth; however, relatively little is known about facilitators and barriers to eHealth uptake specific to older adults, particularly as they relate to their experiences in accessing health care. OBJECTIVE: The aim of our study was to explore the interests, preferences, and concerns of older adults in using the Internet and eHealth technologies for managing their health in relation to their experiences with the current health care system. METHODS: Two focus groups (n=15) were conducted with adults aged 50+ years. Pragmatic thematic analysis using an inductive approach was conducted to identify the interests, preferences, and concerns of using the Internet and eHealth technologies. RESULTS: Five themes emerged that include (1) Difficulty in identifying credible and relevant sources of information on the Web; (2) Ownership, access, and responsibility for medical information; (3) Peer communication and support; (4) Opportunities to enhance health care interactions; and (5) Privacy concerns. These findings support the potential value older adults perceive in eHealth technologies, particularly in their ability to provide access to personal health information and facilitate communication between providers and peers living with similar conditions. However, in order to foster acceptance, these technologies will need to provide personal and general health information that is secure, readily accessible, and easily understood. CONCLUSIONS: Older adults have diverse needs and preferences that, in part, are driven by their experiences and frustrations with the health care system. Results can help inform the design and implementation of technologies to address gaps in care and access to health information for older adults with chronic conditions who may benefit the most from this approach.

Montreal Accord on Patient-Reported Outcomes (PROs) use series - Paper 3: patient-reported outcomes can facilitate shared decision-making and guide self-management.

BACKGROUND: There is a shift toward making health care patient centered, whereby patients are part of medical decision-making and take responsibility for managing their health. Patient-reported outcomes (PROs) capture the patient voice and can be used to engage patients in medical decision-making. OBJECTIVE: The objective of this paper is to present important factors from patients', clinicians', researchers', and decision-makers' perspectives that influence successful adoption of PROs in clinical practice. Factors recommended in this paper were informed by a patient partner. DISCUSSION: Based on themes arising from the Montreal Accord proceedings, we describe factors that influence the adoption of PROs and how PROs can have a positive effect by enhancing communication and providing opportunities to engage patients, carers, and clinicians in care. Consideration of patient factors (e.g., health literacy), family support and networks (e.g., peer-support networks), technology (e.g., e-health), and health care system factors (e.g., resources to implement PROs) is necessary to ensure PROs are successfully adopted. PRO evaluation plans most likely to succeed over the long term are those incorporating PROs identified by patients as necessary for self-management and that coincide with providers' needs for collaboratively developing treatment plans with patients and families.

Doing more with less: New markers for sarcoma diagnosis and their applicability to cytology specimens.

Sarcomas are a rare and extremely diverse set of neoplasms that are often a challenge to diagnose for pathologists. For a number of reasons, primary diagnosis of soft tissue neoplasms is increasingly being performed on small biopsy specimens including fine needle aspiration (FNA) and core needle biopsy (CNB). In the last several years, there has been a significant increase in our understanding of the molecular pathogenesis of this group of tumors. New insights into the genetic mechanisms of tumor formation have been exploited to create a new generation of diagnostic markers that are accessible to most laboratories. This review describes a number of new ancillary markers, and how they can facilitate accurate diagnosis of soft tissue neoplasms on FNA/CNB.