Mobile Integrated Health in Heart Failure

NCT04662541 | Completed

• 3 other identifiers: AAAU2716IHS-2019C2-1737320-08022605-01
• Study Type: interventional
• Target: 2,005
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study is to compare how two different types of care after a hospitalization reduce hospital readmissions and symptom burden. The two types of care are a Transitions of Care Coordinator and Mobile Integrated Health. In the Transitions of Care Coordinator group, participants will receive a phone call from a care coordinator right after they go home following a hospitalization to check in. In the Mobile Integrated Health group, participants will be offered access to a community paramedic in case they need medical care while they are recovering at home after a hospitalization. The community paramedic will come to their home to perform an evaluation and set up a visit with an emergency physician via video conference. They may receive treatment at home or be transported to the emergency department. The investigators will be compare how well a Transitions of Care Coordinator and Mobile Integrated Health reduce readmissions to the hospital within 30 days of discharge and improve patient-reported health-related quality of life. The investigators hypothesize that participants in the Mobile Integrated Health group will have fewer readmissions to the hospital within 30 days of discharge and better health-related quality of life compared to participants in the Transitions of Care Coordinator group.

Conditions

Heart Failure

Keywords

Mobile Health; Mobile Integrated Health (MIH); Heart Failure (HF); mHealth

Outcome Measures

Primary Outcomes (2)

• Number of all-cause hospital readmissions

  Number of readmissions to the hospital for any reason following a hospitalization

  30 days

• Patient-reported health-related quality of life score assessed using the KCCQ

  Patient-reported health-related quality of life score assessed using the Kansas City Cardiomyopathy Questionnaire 23-item scale (KCCQ-23). KCCQ-23 scores range from 0 to 100, with lower scores (closer to 0) indicating worse symptoms and physical functioning, and higher scores (closer to 100) indicating better symptoms and physical functioning.

  30 days

Secondary Outcomes (20)

• Number of preventable emergency department visits

  30 days

• Number of preventable emergency department visits

  60 days

• Number of preventable emergency department visits

  90 days

• Number of preventable emergency department visits

  6 months

• Number of unplanned hospital readmissions

  30 days

Study Arms (2)

Mobile Integrated Health (MIH)

EXPERIMENTAL

Patients with urgent medical needs are seen and treated in the home by trained community paramedics. The community paramedics perform a standardized assessment, including a physical examination, vital signs, home safety evaluation, and medication reconciliation. During the MIH encounter, the emergency medicine physician at each site is contacted via telemedicine. Physicians can access clinical notes, discharge summaries, and medication lists via the institutional EHR. Adjustments to outpatient medications can be e-prescribed and follow-up appointments can be scheduled with primary care clinicians.

Other: Mobile Integrated Health (MIH)

Transitions of care coordinator (TOCC)

ACTIVE COMPARATOR

Patients receive a follow-up phone calls for a nurse coordinator within 48-72 hours of hospital discharge. Phone calls include clinical/social needs assessment with escalation to primary care team, emergency care, or social work as needed; patient education; and reminder about follow-up appointments.

Other: Transitions of care coordinator (TOCC)

Interventions

Mobile Integrated Health (MIH) OTHER

MIH leverages paramedics in the community and telemedicine (technology-enabled communication for health purposes) to provide medical care to heart failure patients in the home.

Mobile Integrated Health (MIH)

Transitions of care coordinator (TOCC) OTHER

The TOCC group will receive a follow-up phone call shortly after discharge in which the patient is assessed and connected to clinical and social services as needed and patient education is reinforced.

Transitions of care coordinator (TOCC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medicare or Medicaid recipient
• Current diagnosis of HF
• Receiving inpatient care at NewYork Presbyterian or Mount Sinai Health Systems
• Live in NYC

You may not qualify if:

• Non-English, Spanish, Mandarin, or French speaking
• Diagnosis of dementia or psychosis
• Anticipated discharge to, or current residence in, skilled nursing facility or rehab center
• Anticipated discharge to, or currently receiving, hospice including home hospice
• Current candidate for and awaiting heart transplant
• Current left ventricular assist device (LVAD)

Sponsors & Collaborators

• Columbia University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (3)

Mount Sinai Health System

New York, New York, 10029, United States

Location

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

New York Presbyterian/Weill Cornell Medicine

New York, New York, 10065, United States

Location

Related Publications (2)

• Masterson Creber R, Daniels B, Reading Turchioe M, Shafran Topaz L, Zhao Y, Choi J, Ellison M, Merchant RC, Blutinger E, Goyal P, Yu J, Weiner MG, Sholle E, Ramasubbu K, Alishetti S, Axsom K, Slotwiner D, Rao M, Diaz I, Spertus JA, Sharma R, Kaushal R. Mobile Integrated Health vs a Transitions of Care Coordinator for Patients Discharged After Heart Failure: The Mighty-Heart Randomized Clinical Trial. JAMA Intern Med. 2025 Nov 1;185(11):1341-1348. doi: 10.1001/jamainternmed.2025.4483.

  PMID: 40952734 DERIVED

• Masterson Creber RM, Daniels B, Munjal K, Reading Turchioe M, Shafran Topaz L, Goytia C, Diaz I, Goyal P, Weiner M, Yu J, Khullar D, Slotwiner D, Ramasubbu K, Kaushal R. 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. 2022 Mar 10;12(3):e054956. doi: 10.1136/bmjopen-2021-054956.

  PMID: 35273051 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Ruth M. Masterson Creber, PhD, MSc, RN

  Columbia University

  PRINCIPAL INVESTIGATOR

• Leah Shafran Topaz, BPT, MSc

  Weill Medical College of Cornell University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Nursing

Study Record Dates

• First Submitted: December 4, 2020
• First Posted: December 10, 2020
• Study Start: January 4, 2021
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)