TY - JOUR
T1 - Using Mobile Integrated Health and telehealth to support transitions of care among patients with heart failure (MIGHTy-Heart)
T2 - Protocol for a pragmatic randomised controlled trial
AU - Masterson Creber, Ruth M.
AU - Daniels, Brock
AU - Munjal, Kevin
AU - Reading Turchioe, Meghan
AU - Shafran Topaz, Leah
AU - Goytia, Crispin
AU - Diáz, Iván
AU - Goyal, Parag
AU - Weiner, Mark
AU - Yu, Jiani
AU - Khullar, Dhruv
AU - Slotwiner, David
AU - Ramasubbu, Kumudha
AU - Kaushal, Rainu
N1 - Funding Information:
Funding This work was supported by the Patient-Centred Outcomes Research Institute (PCORI), Award HS-2019C2-17373. 1828 L L Street, NW, Suite 900, Washington, DC 20036, Phone: (202) 827–7700 | Fax: (202) 355–9558, info@pcori. org.
Publisher Copyright:
©
PY - 2022/3/10
Y1 - 2022/3/10
N2 - 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.
AB - 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.
KW - adult cardiology
KW - health policy
KW - heart failure
KW - protocols & guidelines
KW - quality in health care
KW - telemedicine
UR - http://www.scopus.com/inward/record.url?scp=85126401908&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-054956
DO - 10.1136/bmjopen-2021-054956
M3 - Article
C2 - 35273051
AN - SCOPUS:85126401908
VL - 12
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 3
M1 - e054956
ER -