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

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 am...

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Main Authors: Ivan Díaz, Mark Weiner, Dhruv Khullar, Rainu Kaushal, Parag Goyal, Meghan Reading Turchioe, David Slotwiner, Crispin Goytia, Ruth M. Masterson Creber, Brock Daniels, Kevin Munjal, Leah Shafran Topaz, Jiani Yu, Kumudha Ramasubbu
Format: Article
Language:English
Published: BMJ Publishing Group 2022-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/3/e054956.full
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author Ivan Díaz
Mark Weiner
Dhruv Khullar
Rainu Kaushal
Parag Goyal
Meghan Reading Turchioe
David Slotwiner
Crispin Goytia
Ruth M. Masterson Creber
Brock Daniels
Kevin Munjal
Leah Shafran Topaz
Jiani Yu
Kumudha Ramasubbu
author_facet Ivan Díaz
Mark Weiner
Dhruv Khullar
Rainu Kaushal
Parag Goyal
Meghan Reading Turchioe
David Slotwiner
Crispin Goytia
Ruth M. Masterson Creber
Brock Daniels
Kevin Munjal
Leah Shafran Topaz
Jiani Yu
Kumudha Ramasubbu
author_sort Ivan Díaz
collection DOAJ
description 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.
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spelling doaj-art-6e6b472d8fcf4a9fbb437b5d9c9a4a402025-08-20T01:48:11ZengBMJ Publishing GroupBMJ Open2044-60552022-03-0112310.1136/bmjopen-2021-054956Using Mobile Integrated Health and telehealth to support transitions of care among patients with heart failure (MIGHTy-Heart): protocol for a pragmatic randomised controlled trialIvan Díaz0Mark Weiner1Dhruv Khullar2Rainu Kaushal3Parag Goyal4Meghan Reading Turchioe5David Slotwiner6Crispin Goytia7Ruth M. Masterson Creber8Brock Daniels9Kevin Munjal10Leah Shafran Topaz11Jiani Yu12Kumudha Ramasubbu13Population Health Sciences, Weill Cornell Medicine, New York, New York, USAPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USAPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USAPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USA10 Division of General Internal Medicine, Weill Cornell Medicine, New York, New York, USAPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USACardiology, NewYork-Presbyterian Queens Hospital, Flushing, New York, USAEmergency Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USAPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USAEmergency Medicine, NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York, New York, USAEmergency Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USAPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USAPopulation Health Sciences, Weill Cornell Medicine, New York, New York, USACardiology, NewYork-Presbyterian Brooklyn Methodist Hospital, Brooklyn, New York, USAIntroduction 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.https://bmjopen.bmj.com/content/12/3/e054956.full
spellingShingle Ivan Díaz
Mark Weiner
Dhruv Khullar
Rainu Kaushal
Parag Goyal
Meghan Reading Turchioe
David Slotwiner
Crispin Goytia
Ruth M. Masterson Creber
Brock Daniels
Kevin Munjal
Leah Shafran Topaz
Jiani Yu
Kumudha Ramasubbu
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
BMJ Open
title 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url https://bmjopen.bmj.com/content/12/3/e054956.full
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