Mobile Integrated Health for Heart Failure

Not currently recruiting at 2 trial locations

Overseen By Brock Daniels, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Disqualifiers: Dementia, Psychosis, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two methods to assist people with heart failure after hospital discharge. One group receives phone check-ins from a Transitions of Care Coordinator, while the other has access to a community paramedic through Mobile Integrated Health, who can visit their home and connect them with an emergency doctor via video if needed. The trial aims to determine which method more effectively reduces hospital readmissions and improves quality of life. Individuals currently hospitalized for heart failure in New York City with Medicare or Medicaid may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies and potentially improve health outcomes.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, but you should confirm with the trial coordinators.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these care methods are safe for patients with heart failure?

Research has shown that Mobile Integrated Health (MIH) and community paramedicine programs can benefit patients after hospital discharge. In these programs, trained paramedics visit patients at home to check vital signs, perform physical exams, and ensure home safety. They can also connect with doctors through video calls if needed.

Most studies focus on how these programs help prevent hospital readmissions and improve quality of life. However, detailed information about safety is limited. Few reports of serious side effects suggest that these programs are generally safe.

These programs have been used in similar situations without major safety issues, indicating they are likely safe for most patients. However, discussing any concerns with a doctor before joining a trial is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Integrated Health (MIH) approach for heart failure because it brings healthcare directly to patients' homes through community paramedics. Unlike traditional treatments that often require frequent visits to clinics or hospitals, MIH offers a personalized, in-home care experience that includes a comprehensive health assessment and medication adjustments via telemedicine with an emergency physician. This innovative method not only enhances accessibility but also aims to reduce hospital readmissions by ensuring continuous and convenient care. Additionally, the Transitions of Care Coordinator (TOCC) provides crucial follow-up support through phone calls, addressing patients' clinical and social needs shortly after hospital discharge, which is a proactive step to prevent complications. These approaches collectively offer a more integrated and patient-centered care model, which could greatly improve outcomes for individuals with heart failure.

What evidence suggests that this trial's treatments could be effective for reducing hospital readmissions in heart failure patients?

Research has shown that Mobile Integrated Health (MIH), one of the treatment arms in this trial, can assist people with heart failure by providing home care, potentially improving recovery. Some studies have found that community paramedic visits to patients' homes can help predict and possibly reduce the likelihood of hospital readmissions within 30 days. While one program did not observe a significant decrease in hospital returns, another study suggested that MIH can facilitate the transition from hospital to home care and might enhance patient health. This approach allows for quick medical assistance and adjustments to treatment plans without requiring a hospital visit. Overall, MIH aims to smooth recovery and possibly reduce the need for hospital readmission. ^{2 5 6 7 8}

Who Is on the Research Team?

Leah Shafran Topaz, BPT, MSc

Principal Investigator

Weill Medical College of Cornell University

Ruth M. Masterson Creber, PhD, MSc, RN

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for Medicare or Medicaid recipients with heart failure in NYC (Manhattan, Brooklyn, Queens, Bronx) who are getting out of the hospital. It's not for those who don't speak English, Spanish, Mandarin, or French; have dementia/psychosis; will go to/receive care from a nursing facility/rehab/hospice; or await a heart transplant/LVAD.

Inclusion Criteria

Live in NYC

I am currently receiving care at NewYork Presbyterian or Mount Sinai.

I receive Medicare or Medicaid benefits.

Exclusion Criteria

I will be, or am currently living in, a skilled nursing facility or rehab center.

Current left ventricular assist device (LVAD)

I am on the waiting list for a heart transplant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

During hospitalization

Treatment

Participants receive either Mobile Integrated Health or Transitions of Care Coordinator interventions after hospital discharge

30 days

Follow-up phone calls and home visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Integrated Health
• Transitions of Care Coordinator

Trial Overview

The study compares two post-hospitalization care methods: phone check-ins by a Transitions of Care Coordinator and at-home medical services by Mobile Integrated Health with community paramedics and video calls with doctors. The goal is to see which method better reduces hospital readmissions and improves life quality within 30 days after discharge.

How Is the Trial Designed?

Group I: Mobile Integrated Health (MIH) Experimental Treatment 1 Intervention

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.

Group II: Transitions of care coordinator (TOCC) Active Control 1 Intervention

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.

Mobile Integrated Health is already approved in United States for the following indications:

Approved in United States as Mobile Integrated Health for:

• Congestive Heart Failure
• Chronic Obstructive Pulmonary Disease (COPD)
• Pneumonia
• Cellulitis
• Dehydration
• COVID-19
• Behavioral Health Conditions

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Effective coordination of care during patient transitions between healthcare settings is essential to prevent fragmented care and reduce hospital readmissions.

Implementing evidence-based communication strategies can significantly improve patient outcomes and lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Transitional Care: Evidence-Based Strategies for Improving Provider Communication and Reducing Readmissions. Mansukhani, RP., Bridgeman, MB., Candelario, D., et al.[2020]

Implementing multicomponent transition management (TM) services within a Patient Centered Medical Home (PCMH) model significantly reduced the 30-day hospital readmission rate from 17.9% to 8.0% among 118 patients.

The average time to hospital readmission was extended from 95 days to 115 days, indicating that integrated care coordination can improve patient outcomes after hospital discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an integrated transition management program in primary care on hospital readmissions. Farrell, TW., Tomoaia-Cotisel, A., Scammon, DL., et al.[2016]

The MIH-CP transitional care program did not significantly reduce 30-day inpatient readmissions compared to matched controls, indicating that the program may not have the intended impact on short-term hospital utilization.

However, patients enrolled in the MIH-CP program experienced a higher rate of observation hospitalizations within 30 days of discharge, suggesting that while the program did not lower readmissions, it may have led to increased short-term monitoring in a hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of a mobile integrated health program on health care cost and utilization. Gingold, DB., Liang, Y., Stryckman, B., et al.[2022]

Mobile integrated health care and community paramedicine utilize EMS personnel to address gaps in local health care, with community paramedics requiring additional training for chronic disease management and communication skills.

Preliminary data suggest these programs may help prevent readmissions for congestive heart failure, decrease frequent EMS transports, and lower emergency department visits, but more research is needed to confirm their clinical and economic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Integrated Health Care and Community Paramedicine: An Emerging Emergency Medical Services Concept. Choi, BY., Blumberg, C., Williams, K.[2018]

Despite improvements from health care reform, significant inefficiencies and communication gaps remain, particularly affecting patients with multiple chronic conditions during transitions of care.

Mobile Integrated Healthcare is a promising new model that utilizes a physician-led interprofessional team to provide continuous, on-site care management, aiming to improve health outcomes and reduce costs for these vulnerable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Innovative Approach to Health Care Delivery for Patients with Chronic Conditions. Clarke, JL., Bourn, S., Skoufalos, A., et al.[2018]

The Johns Hopkins Community Health Partnership (J-CHiP) effectively improved care coordination for high-risk patients by implementing redesigned acute care delivery and seamless transitions of care, targeting adults discharged from hospitals and those receiving primary care in the community.

Key interventions included risk screening, multidisciplinary care planning, and collaboration with skilled nursing facilities, which collectively enhanced patient engagement and strengthened partnerships with community organizations, ultimately aiming to improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive program to improve coordination of care in an urban academic health care system. Hsiao, YL., Bass, EB., Wu, AW., et al.[2018]

Transitional care (TC) models, particularly those led by nurses and supported by a dedicated multidisciplinary team, have been identified as the most effective approach for managing heart failure (HF) and improving patient outcomes.

The integration of remote technology to monitor patient progress enhances the effectiveness of TC in HF care, addressing the challenge of limited healthcare resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transitional Care to Reduce Heart Failure Readmission Rates in South East Asia. Chan, WX., Lin, W., Wong, RCC.[2020]

Implementing a proactive telehealth follow-up system for geriatric patients at the Tennessee Valley Healthcare System led to a significant reduction in 30-day all-cause readmissions, decreasing from 21% to 13% during the intervention period.

The use of Plan, Do, Study, Act (PDSA) cycles and data sharing among care teams improved care coordination and accountability, contributing to better management of high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The GeriPACT Initiative to Prevent All-Cause 30-Day Readmission in High Risk Elderly. Powers, JS., Abraham, L., Parker, R., et al.[2021]

Transitional care services, including nurse home visits (NHVs), disease management clinics, and nurse case management, are more effective and cost-effective than standard care for older patients with heart failure, with NHVs showing the highest cost-effectiveness.

In a lifetime analysis of patients aged 75 years at hospital discharge, NHVs increased quality-adjusted life-years (QALYs) and had an incremental cost-effectiveness ratio (ICER) of $19,570 per QALY gained, suggesting that these services should be standard practice for postdischarge management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Transitional Care Services After Hospitalization With Heart Failure. Blum, MR., Øien, H., Carmichael, HL., et al.[2020]

The MIGHTy-Heart study is a large-scale trial involving 2100 heart failure patients, comparing two postdischarge interventions: mobile integrated health (MIH) with community paramedic home visits and telehealth support, and transitions of care coordinators (TOCC) with follow-up calls from registered nurses.

The primary outcomes of the study focus on reducing 30-day hospital readmissions and improving quality of life, aiming to enhance patient care during the critical transition from hospital to home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Masterson Creber, RM., Daniels, B., Munjal, K., et al.[2022]

In a study of 908 patients with heart failure, 74.7% successfully enrolled in a community paramedicine program, with higher enrollment rates for those contacted in person (81.1%) compared to those contacted through other methods (66%).

Patients receiving transitional care services also showed increased enrollment (78.9%) compared to those who did not (62.5%), highlighting the importance of in-person outreach and additional support services for improving patient engagement in community paramedicine programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors Associated With Successful Enrollment in a Community Paramedicine Program for Heart Failure. Johnson, D., Druschel, J., Wattai, B., et al.[2023]

A quality improvement project was implemented to enhance communication between hospital and outpatient care for heart failure patients, addressing the common issue of fragmented care after discharge.

The use of a communication tool was emphasized to ensure that the care plan initiated during hospitalization is effectively continued in the ambulatory setting, improving patient management and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart failure management across the continuum: a communication link. Walblay, AM.[2007]

A nurse-led care management project significantly reduced hospital admissions by 62% and length of stay by 73% for heart failure patients, based on a study involving 47 participants.

Improved interdisciplinary communication not only enhanced patient satisfaction but also led to a dramatic decrease in readmission penalties, saving the health system approximately $615,000.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Hospital Admissions for Patients with Heart Failure by Implementing the Chronic Care Management Framework: A Cost, Quality and Satisfaction Improvement Project. Koutlas, A., Jenkins, P.[2022]

Citations

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acc.org

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A program that delivered in-home visits from a trained paramedic team to people with heart failure did not significantly reduce 30-day hospital readmissions or ...

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internationaljournalofparamedicine.com

internationaljournalofparamedicine.com/index.php/ijop/article/view/3378

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Objective: Heart failure (HF) patients are at high risk for 30-day hospital readmission which is a negative predictor of patient-centered ...

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ahajournals.org

ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009142

Community Paramedic Home Care Program for Acute ...

Community paramedic (CP) mobile integrated healthcare program (MIHP) home visits for acute decompensated heart failure (HF) may ease care transitions, reduce ...

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jamanetwork.com

jamanetwork.com/journals/jamainternalmedicine/article-abstract/2838721

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This randomized clinical trial assesses the effectiveness of mobile integrated health compared with a transitions of care coordinator alone ...

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pmc.ncbi.nlm.nih.gov

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Using Mobile Integrated Health and telehealth to support ...

The coprimary study outcomes are all-cause 30-day hospital readmissions and quality of life measured with the Kansas City Cardiomyopathy ...

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jhltonline.org

jhltonline.org/article/S1053-2498(18)30801-5/fulltext

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To assess the efficacy of the Mobile Integrated Healthcare - Community Paramedicine (MIH-CP) program in the reduction of heart failure (HF) readmissions.

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Mobile Integrated Health Care and Community Paramedicine

There have been few data published on the safety, cost-effectiveness, and feasibility of mobile integrated health care and community paramedicine programs.15 ...