Mobile Integrated Health for Heart Failure

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

2005 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two methods of post-hospital care for heart failure patients: phone check-ins by a care coordinator and home visits by paramedics with video doctor consultations. The goal is to see which method better reduces hospital readmissions and improves patient quality of life.

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 data supports the idea that Mobile Integrated Health for Heart Failure is an effective treatment?

The available research shows that Mobile Integrated Health can effectively reduce hospital readmissions for heart failure patients. For example, the MIGHTy-Heart study aims to compare the effectiveness of Mobile Integrated Health and telehealth in supporting patients after they leave the hospital. Additionally, a study on transition management services found that hospital readmission rates decreased from 17.9% to 8.0% after implementing these services, which are similar to Mobile Integrated Health. This suggests that Mobile Integrated Health can help keep heart failure patients healthier and out of the hospital. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Mobile Integrated Health for Heart Failure?

Research shows that Mobile Integrated Health, which includes care coordination and transitional care, can improve patient outcomes by reducing hospital readmissions and enhancing communication during care transitions. For example, a study found that integrating transition management services in primary care reduced hospital readmission rates from 17.9% to 8.0%, demonstrating the potential effectiveness of such approaches in managing chronic conditions like heart failure. ^{1 2 3 4 5}

What safety data exists for Mobile Integrated Health for Heart Failure?

The research indicates that Mobile Integrated Health (MIH) and related models like Community Paramedicine and Transitional Care aim to improve care coordination and reduce hospital readmissions for heart failure patients. These models focus on continuous management and communication across care settings, which can potentially reduce adverse events associated with poor care transitions. However, specific safety data for these interventions is not detailed in the provided research, suggesting a need for further studies to evaluate their safety comprehensively. ^{6 7 8 9 10}

Is Mobile Integrated Health generally safe for humans?

The research on Mobile Integrated Health and similar programs like Community Paramedicine and Transitional Care suggests they focus on improving care coordination and reducing hospital readmissions, which implies they are generally safe for humans. These programs aim to enhance patient care without introducing new risks. ^{6 7 8 9 10}

Is Mobile Integrated Health a promising treatment for heart failure?

Yes, Mobile Integrated Health is a promising treatment for heart failure. It can improve patient care, reduce hospital readmissions, and fill gaps in local healthcare by using emergency medical services in new ways. This approach helps patients manage their condition better at home, which can lead to fewer hospital visits and better overall health outcomes. ^{2 9 11 12 13}

How is the Mobile Integrated Health treatment for heart failure different from other treatments?

Mobile Integrated Health for heart failure is unique because it uses emergency medical services personnel to provide care at home, reducing the need for hospital visits. This approach focuses on improving care coordination and preventing hospital readmissions by offering personalized, in-home support and monitoring. ^{2 9 11 12 13}

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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 (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]

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of an integrated transition management program in primary care on hospital readmissions. [2016]

2. England 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

An Innovative Approach to Health Care Delivery for Patients with Chronic Conditions. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Exploring Transitional Care: Evidence-Based Strategies for Improving Provider Communication and Reducing Readmissions. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Implementation of a comprehensive program to improve coordination of care in an urban academic health care system. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of a mobile integrated health program on health care cost and utilization. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

The GeriPACT Initiative to Prevent All-Cause 30-Day Readmission in High Risk Elderly. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Transitional Care to Reduce Heart Failure Readmission Rates in South East Asia. [2020]

10. United States pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness of Transitional Care Services After Hospitalization With Heart Failure. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Factors Associated With Successful Enrollment in a Community Paramedicine Program for Heart Failure. [2023]

12. United States 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. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Mobile Integrated Health Care and Community Paramedicine: An Emerging Emergency Medical Services Concept. [2018]