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.

[1]  C. Holly Structured telephone support or telemonitoring programmes for patients with chronic heart failure , 2011 .

[2]  N. Gale,et al.  Using the framework method for the analysis of qualitative data in multi-disciplinary health research , 2013, BMC Medical Research Methodology.

[3]  Karen Cimon,et al.  Home telemonitoring for congestive heart failure: a systematic review and meta-analysis , 2010, Journal of telemedicine and telecare.

[4]  S. Yusuf,et al.  The burden of disease in older people and implications for health policy and practice , 2015, The Lancet.

[5]  M. Sandelowski Sample size in qualitative research. , 1995, Research in nursing & health.

[6]  J. Lowery,et al.  Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science , 2009, Implementation science : IS.

[7]  Steve Wheeler,et al.  How smartphones are changing the face of mobile and participatory healthcare: an overview, with example from eCAALYX , 2011, Biomedical engineering online.

[8]  Candice Bowman,et al.  The role of formative evaluation in implementation research and the QUERI experience , 2006, Journal of General Internal Medicine.

[9]  J. Cohn,et al.  Assessment of patient outcome with the Minnesota Living with Heart Failure questionnaire: reliability and validity during a randomized, double-blind, placebo-controlled trial of pimobendan. Pimobendan Multicenter Research Group. , 1992, American heart journal.

[10]  Richard J Holden,et al.  The patient work system: an analysis of self-care performance barriers among elderly heart failure patients and their informal caregivers. , 2015, Applied ergonomics.

[11]  Edgar Erdfelder,et al.  G*Power 3: A flexible statistical power analysis program for the social, behavioral, and biomedical sciences , 2007, Behavior research methods.

[12]  Da Tao,et al.  The effectiveness of the use of consumer health information technology in patients with heart failure: A meta-analysis and narrative review of randomized controlled trials , 2017, Journal of telemedicine and telecare.

[13]  G. Paré,et al.  Clinical Effects of Home Telemonitoring in the Context of Diabetes, Asthma, Heart Failure and Hypertension: A Systematic Review , 2010, Journal of medical Internet research.

[14]  A. Strömberg,et al.  Heart Failure Telemonitoring in Japan and Sweden: A Cross-Sectional Survey , 2015, Journal of medical Internet research.

[15]  P. Armstrong,et al.  A systematic review of randomized trials of disease management programs in heart failure. , 2001, The American journal of medicine.

[16]  S. Liu,et al.  Meta-analysis and meta-regression of telehealth programmes for patients with chronic heart failure , 2013, Journal of telemedicine and telecare.

[17]  Hiroshi Iseki,et al.  A meta-analysis of remote patient monitoring for chronic heart failure patients , 2014, Journal of telemedicine and telecare.

[18]  Hai-Feng Zhang,et al.  Clinical effectiveness of telemedicine for chronic heart failure: a systematic review and meta-analysis , 2017, Journal of Investigative Medicine.

[19]  I. Piña,et al.  Forecasting the Impact of Heart Failure in the United States: A Policy Statement From the American Heart Association , 2013, Circulation. Heart failure.

[20]  C. Gudex,et al.  Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study , 2012, Quality of Life Research.

[21]  E. Walters,et al.  Self-management education for patients with chronic obstructive pulmonary disease. , 2007, The Cochrane database of systematic reviews.

[22]  Sally Inglis Structured telephone support or telemonitoring programmes for patients with chronic heart failure , 2010 .

[23]  D. DeWalt,et al.  A heart failure self-management program for patients of all literacy levels: A randomized, controlled trial [ISRCTN11535170] , 2006, BMC Health Services Research.

[24]  Viswanath Venkatesh,et al.  Consumer Acceptance and Use of Information Technology: Extending the Unified Theory of Acceptance and Use of Technology , 2012, MIS Q..

[25]  Aleksandra Jovicic,et al.  Effects of Self-Management Intervention on Health Outcomes of Patients with Heart Failure: A Systematic Review of Randomized Controlled Trials , 2006 .

[26]  Alicia C. Bunger,et al.  Outcomes for Implementation Research: Conceptual Distinctions, Measurement Challenges, and Research Agenda , 2010, Administration and Policy in Mental Health and Mental Health Services Research.

[27]  J. Grimshaw,et al.  What is an adequate sample size? Operationalising data saturation for theory-based interview studies , 2010, Psychology & health.

[28]  G. Eysenbach,et al.  An Internet-Based Counseling Intervention With Email Reminders that Promotes Self-Care in Adults With Chronic Heart Failure: Randomized Controlled Trial Protocol , 2014, JMIR research protocols.

[29]  Ron Koymans,et al.  COST-EFFECTIVENESS OF TELEHEALTH INTERVENTIONS FOR CHRONIC HEART FAILURE PATIENTS: A LITERATURE REVIEW , 2014, International Journal of Technology Assessment in Health Care.

[30]  Christine Nadel,et al.  Case Study Research Design And Methods , 2016 .

[31]  B. Riegel,et al.  An Update on the Self-care of Heart Failure Index , 2009, The Journal of cardiovascular nursing.

[32]  G. Bonsel,et al.  Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) , 2011, Quality of Life Research.

[33]  John W. Creswell,et al.  Designing and Conducting Mixed Methods Research , 2006 .

[34]  D. Scherr,et al.  Effect of Home-Based Telemonitoring Using Mobile Phone Technology on the Outcome of Heart Failure Patients After an Episode of Acute Decompensation: Randomized Controlled Trial , 2009, Journal of medical Internet research.

[35]  D. Mozaffarian,et al.  The Seattle Heart Failure Model: Prediction of Survival in Heart Failure , 2006, Circulation.

[36]  Heather J Ross,et al.  Mobile Phone-Based Telemonitoring for Heart Failure Management: A Randomized Controlled Trial , 2012, Journal of medical Internet research.

[37]  H. Krumholz,et al.  Telemonitoring in patients with heart failure. , 2010, The New England journal of medicine.

[38]  H. Vrijhoef,et al.  Implementing Telemonitoring in Heart Failure Care: Barriers from the Perspectives of Patients, Healthcare Professionals and Healthcare Organizations , 2013, Current Heart Failure Reports.

[39]  J. Howie-Esquivel,et al.  Is “Teach-Back” Associated With Knowledge Retention and Hospital Readmission in Hospitalized Heart Failure Patients? , 2013, The Journal of cardiovascular nursing.

[40]  E. Seto,et al.  Accounting for Complexity in Home Telemonitoring: A Need for Context-Centred Evidence. , 2018, The Canadian journal of cardiology.

[41]  N. Chavannes,et al.  Integrated disease management interventions for patients with chronic obstructive pulmonary disease. , 2013, The Cochrane database of systematic reviews.

[42]  M. Konstam,et al.  A multicenter randomized controlled evaluation of automated home monitoring and telephonic disease management in patients recently hospitalized for congestive heart failure: the SPAN-CHF II trial. , 2010, Journal of cardiac failure.

[43]  J. Cleland,et al.  Which components of heart failure programmes are effective? A systematic review and meta‐analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: Abridged Cochrane Review , 2011, European journal of heart failure.

[44]  Majid Sarrafzadeh,et al.  Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. , 2016, JAMA internal medicine.

[45]  G. Wells,et al.  Comparative Effectiveness of Different Forms of Telemedicine for Individuals with Heart Failure (HF): A Systematic Review and Network Meta-Analysis , 2015, PloS one.

[46]  J. Cleland,et al.  Structured telephone support or non-invasive telemonitoring for patients with heart failure , 2016, Heart.

[47]  Nathaniel S. Borenstein,et al.  IBM ® , 2009 .