Heart Failure Clinical Trial

Mobile Integrated Health in Heart Failure

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.

View Full Description

Full Description

High 30-day readmission rates among heart failure (HF) patients (25% nationally) inflict substantial burden on both health systems and patients. The majority of hospital readmissions occur in the first seven days following a hospitalization for HF and are driven by lack of improvement in persistent symptoms. While early, proactive follow-up after hospital discharge can improve health outcomes and patient-reported quality of life, barriers within health systems (lack of appointment availability, transportation, limited ability to deliver medical therapies in the home) have hampered efforts to provide comprehensive follow-up. Evidence suggests that Mobile Integrated Health (MIH), involving community paramedicine coupled with telemedicine, may be an effective intervention to reduce readmissions. The long-term goal of this research is to provide rigorous evidence of MIH with a diverse, representative sample. In this pragmatic randomized clinical trial the investigators will compare MIH to a Transitions of Care Coordinator (TOCC) intervention.

Specifically, the investigators aim to compare the effectiveness of MIH versus TOCC on healthcare utilization (aim 1), patient-reported outcomes (PROs; aim 2), and healthcare quality (aim 3). The investigators will also evaluate the factors that support the adoption, implementation, and maintenance from the perspective of multiple key stakeholders (aim 4). Participants in this RCT will be randomized 1:1 to either MIH (intervention) or TOCC (comparator). All participants will be enrolled and randomized during a hospitalization for HF. Participants in MIH will receive a follow-up phone call and access to community paramedics who provide a comprehensive assessment in the home, and specific medical therapies while consulting with an emergency room physician in real-time via telemedicine. Participants in TOCC will receive a follow-up phone call within 48-72 hours of discharge and connection to appropriate services (social work, care coordination, home care) as needed. Participants in both groups will complete PROs using a rigorously developed, visually enhanced mobile PRO reporting system.

The study population will include patients at NewYork-Presbyterian (NYP) and Mount Sinai health systems, which are part of the New York City-based INSIGHT PCORI-funded clinical research network. The targeted sample size across the two sites is 2,100 patients (1,050 per arm). This record is for the parent PCORI-funded trial evaluating MIH among HF patients. There is a separate sub-study being conducted locally at NYP which is described in another record.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study is for people with:

Heart Failure

Estimated Enrollment:

2100

Study ID:

NCT04662541

Recruitment Status:

Recruiting

Sponsor:

Columbia University

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 3 Locations for this study

See Locations Near You

Mount Sinai Health System
New York New York, 10029, United States More Info
Roland Merchant, MD, MPH, ScD
Contact
212-824-9814
[email protected]
Roland Merchant, MD, MPH, ScD
Principal Investigator
Columbia University Irving Medical Center
New York New York, 10032, United States
New York Presbyterian/Weill Cornell Medicine
New York New York, 10065, United States More Info
Brock Daniels, MD, MPH
Contact
212-746-0780
[email protected]
Brock Daniels, MD, MPH
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

2100

Study ID:

NCT04662541

Recruitment Status:

Recruiting

Sponsor:


Columbia University

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.