Using Mobile Integrated Health and telehealth to support transitions of care among patients with heart failure (MIGHTy-Heart): protocol for a pragmatic randomised controlled trial

Ruth M Masterson Creber, Brock Daniels, Kevin Munjal, Meghan Reading Turchioe, Leah Shafran Topaz, Crispin Goytia, Iván Díaz, Parag Goyal, Mark Weiner, Jiani Yu, Dhruv Khullar, David Slotwiner, Kumudha Ramasubbu, Rainu Kaushal, Ruth M Masterson Creber, Brock Daniels, Kevin Munjal, Meghan Reading Turchioe, Leah Shafran Topaz, Crispin Goytia, Iván Díaz, Parag Goyal, Mark Weiner, Jiani Yu, Dhruv Khullar, David Slotwiner, Kumudha Ramasubbu, Rainu Kaushal

Abstract

Introduction: Nearly one-quarter of patients discharged from the hospital with heart failure (HF) are readmitted within 30 days, placing a significant burden on patients, families and health systems. The objective of the 'Using Mobile Integrated Health and Telehealth to support transitions of care among patients with Heart failure' (MIGHTy-Heart) study is to compare the effectiveness of two postdischarge interventions on healthcare utilisation, patient-reported outcomes and healthcare quality among patients with HF.

Methods and analysis: The MIGHTy-Heart study is a pragmatic comparative effectiveness trial comparing two interventions demonstrated to improve the hospital to home transition for patients with HF: mobile integrated health (MIH) and transitions of care coordinators (TOCC). The MIH intervention bundles home visits from a community paramedic (CP) with telehealth video visits by emergency medicine physicians to support the management of acute symptoms and postdischarge care coordination. The TOCC intervention consists of follow-up phone calls from a registered nurse within 48-72 hours of discharge to assess a patient's clinical status, identify unmet clinical and social needs and reinforce patient education (eg, medication adherence and lifestyle changes). MIGHTy-Heart is enrolling and randomising (1:1) 2100 patients with HF who are discharged to home following a hospitalisation in two New York City (NY, USA) academic health systems. The coprimary study outcomes are all-cause 30-day hospital readmissions and quality of life measured with the Kansas City Cardiomyopathy Questionnaire 30 days after hospital discharge. The secondary endpoints are days at home, preventable emergency department visits, unplanned hospital admissions and patient-reported symptoms. Data sources for the study outcomes include patient surveys, electronic health records and claims submitted to Medicare and Medicaid.

Ethics and dissemination: All participants provide written or verbal informed consent prior to randomisation in English, Spanish, French, Mandarin or Russian. Study findings are being disseminated to scientific audiences through peer-reviewed publications and presentations at national and international conferences. This study has been approved by: Biomedical Research Alliance of New York (BRANY #20-08-329-380), Weill Cornell Medicine Institutional Review Board (20-08022605) and Mt. Sinai Institutional Review Board (20-01901).

Trial registration number: Clinicaltrials.gov, NCT04662541.

Keywords: adult cardiology; health policy; heart failure; protocols & guidelines; quality in health care; telemedicine.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Overview of study design. ED, emergency department; MIH, mobile integrated health; TOCC, transition of care coordinator.
Figure 2
Figure 2
Modified accelerator model for Stakeholder engagement. MIGHTy-HEART, Using Mobile Integrated Health and Telehealth to Support Transitions of Care among Heart Failure Patients.
Figure 3
Figure 3
Data sources across theUsing Mobile Integrated Health and Telehealth to Support Transitions of Care among Heart Failure Patients study. CMS, Centers for Medicare and Medicaid Services; CP, community paramedic; EHR, electronic health record; NYP, NewYork-Presbyterian.
Figure 4
Figure 4
Follow-up methods.

References

    1. Khan RF, Feder S, Goldstein NE, et al. . Symptom burden among patients who were hospitalized for heart failure. JAMA Intern Med 2015;175:1713–5. 10.1001/jamainternmed.2015.3871
    1. Dharmarajan K, Chaudhry SI. New approaches to reduce readmissions in patients with heart failure. JAMA Intern Med 2016;176:318. 10.1001/jamainternmed.2015.7993
    1. Krumholz HM, Hsieh A, Dreyer RP, et al. . Trajectories of risk for specific readmission diagnoses after hospitalization for heart failure, acute myocardial infarction, or pneumonia. PLoS One 2016;11:e0160492. 10.1371/journal.pone.0160492
    1. Shah T, Churpek MM, Coca Perraillon M, et al. . Understanding why patients with COPD get readmitted: a large national study to delineate the Medicare population for the readmissions penalty expansion. Chest 2015;147:1219–26. 10.1378/chest.14-2181
    1. Krumholz HM. Post-hospital syndrome--an acquired, transient condition of generalized risk. N Engl J Med 2013;368:100–2. 10.1056/NEJMp1212324
    1. Hospital readmissions reduction program (HRRP), 2020. Available: [Accessed 26 May 2021].
    1. Wasfy JH, Zigler CM, Choirat C, et al. . Readmission rates after passage of the hospital readmissions reduction program: a pre-post analysis. Ann Intern Med 2017;166:324–31. 10.7326/M16-0185
    1. Feltner C, Jones CD, Cené CW, et al. . Transitional care interventions to prevent readmissions for persons with heart failure: a systematic review and meta-analysis. Ann Intern Med 2014;160:774–84. 10.7326/M14-0083
    1. Baker H, Oliver-McNeil S, Deng L, et al. . Regional hospital collaboration and outcomes in Medicare heart failure patients: see you in 7. JACC Heart Fail 2015;3:765–73. 10.1016/j.jchf.2015.06.007
    1. Hernandez AF, Greiner MA, Fonarow GC, et al. . Relationship between early physician follow-up and 30-day readmission among Medicare beneficiaries hospitalized for heart failure. JAMA 2010;303:1716–22. 10.1001/jama.2010.533
    1. Anthony M. Hospital-at-Home. home Healthc now. Vol 39, 2021: 127.
    1. DeVore AD, Cox M, Eapen ZJ. Temporal trends and variation in early scheduled follow-up after a hospitalization for heart failure: findings from get with the Guidelines-Heart failure. Circ Heart Fail 2016;9. 10.1161/CIRCHEARTFAILURE.115.002344
    1. Telemedicine and Telehealth.. Available: [Accessed 26 May 2021].
    1. Alvandi M. Telemedicine and its role in revolutionizing healthcare delivery. Am J Accountable Care 2017;5:e1–5
    1. Kitsiou S, Vatani H, Paré G, et al. . Effectiveness of Mobile Health Technology Interventions for Patients With Heart Failure: Systematic Review and Meta-analysis. Can J Cardiol 2021;37:1248–59. 10.1016/j.cjca.2021.02.015
    1. Ong MK, Romano PS, Edgington S, 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. JAMA Intern Med 2016;176:310–8. 10.1001/jamainternmed.2015.7712
    1. Kitsiou S, Paré G, Jaana M. Effects of home telemonitoring interventions on patients with chronic heart failure: an overview of systematic reviews. J Med Internet Res 2015;17:e63. 10.2196/jmir.4174
    1. Pandor A, Thokala P, Gomersall T, et al. . Home telemonitoring or structured telephone support programmes after recent discharge in patients with heart failure: systematic review and economic evaluation. Health Technol Assess 2013;17. 10.3310/hta17320
    1. Chaudhry SI, Mattera JA, Curtis JP, et al. . Telemonitoring in patients with heart failure. N Engl J Med 2010;363:2301–9. 10.1056/NEJMoa1010029
    1. Choi BY, Blumberg C, Williams K. Mobile integrated health care and community Paramedicine: an emerging emergency medical services concept. Ann Emerg Med 2016;67:361–6. 10.1016/j.annemergmed.2015.06.005
    1. Pang PS, Litzau M, Liao M, et al. . Limited data to support improved outcomes after community paramedicine intervention: a systematic review. Am J Emerg Med 2019;37:960–4. 10.1016/j.ajem.2019.02.036
    1. Chellappa DK, DeCherrie LV, Escobar C, et al. . Supporting the on-call primary care physician with community paramedicine. Intern Med J 2018;48:1261–4. 10.1111/imj.14049
    1. Insight CRN. Available: [Accessed 26 May 2021].
    1. Home, 2020. Available: [Accessed 26 May 2021].
    1. Moore KL, van der Laan MJ. Increasing power in randomized trials with right censored outcomes through covariate adjustment. J Biopharm Stat 2009;19:1099–131. 10.1080/10543400903243017
    1. Groff AC, Colla CH, Lee TH. Days Spent at Home - A Patient-Centered Goal and Outcome. N Engl J Med 2016;375:1610–2. 10.1056/NEJMp1607206
    1. Centers for Medicare & Medicaid Services . 2015 measure information about the 30-day all-cause Hospital readmission measurecalculated for the value-based payment modifier program, 2017. Available:
    1. Billings J, Parikh N, Mijanovich T. Emergency department use: the new York story. Issue Brief 2000:1–12.
    1. Hays RD, Spritzer KL, Schalet BD, et al. . PROMIS®-29 v2.0 profile physical and mental health summary scores. Qual Life Res 2018;27:1885–91. 10.1007/s11136-018-1842-3
    1. Vellone E, De Maria M, Iovino P, et al. . The self-care of heart failure index version 7.2: further psychometric testing. Res Nurs Health 2020;43:640–50. 10.1002/nur.22083
    1. Díaz I, Colantuoni E, Hanley DF, et al. . Improved precision in the analysis of randomized trials with survival outcomes, without assuming proportional hazards. Lifetime Data Anal 2019;25:439–68. 10.1007/s10985-018-9428-5
    1. Flynn KE, Lin L, Ellis SJ, et al. . Outcomes, health policy, and managed care: relationships between patient-reported outcome measures and clinical measures in outpatients with heart failure. Am Heart J 2009;158:S64–71. 10.1016/j.ahj.2009.07.010
    1. US Department of Health & Human Services . HHS launches innovative payment model with new treatment and transport options to more appropriately and effectively meet beneficiaries’ emergency needs, 2019. Available:

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