What side effects are associated with this type of intervention?

Common treatments for heart failure include medications such as ACE inhibitors, beta-blockers, diuretics, and aldosterone antagonists. Side effects of these medications can include cough, elevated potassium levels, low blood pressure, dizziness, and kidney dysfunction. In the context of Mobile Integrated Health, which involves in-home evaluations and video consultations, the side effects would still be monitored and managed similarly, ensuring that patients receive timely interventions to mitigate any adverse effects.

What prior FDA approvals exist?

The FDA has approved several treatments for heart failure that align with the concept of remote monitoring and telehealth. Notably, devices like the CardioMEMS HF System, which allows for remote monitoring of pulmonary artery pressure, have been approved to help manage heart failure patients. Additionally, telehealth platforms and mobile health technologies have been increasingly integrated into heart failure management, enabling remote consultations and continuous monitoring of patients' conditions. These approaches aim to reduce hospital readmissions and improve the quality of life for heart failure patients by providing timely interventions and continuous care.

What other types of research exist?

Promising alternatives to Mobile Integrated Health for Heart Failure patients include: 1) Remote patient monitoring programs that use non-invasive digital technologies to track vital signs and symptoms, allowing for early intervention. 2) Telehealth platforms that provide continuous care and management through virtual consultations with cardiologists and other specialists. 3) Integrated care models that combine telemedicine with home-based care services, such as nurse visits and medication management. These approaches have demonstrated potential in improving patient outcomes and reducing hospital readmissions.

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Mobile Integrated Health for Heart Failure

N/A

Recruiting

Led By Ruth M Masterson Creber, PhD, MSc, RN

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receiving inpatient care at NewYork Presbyterian or Mount Sinai Health Systems

Medicare or Medicaid recipient

Must not have

Anticipated discharge to, or current residence in, skilled nursing facility or rehab center

Current candidate for and awaiting heart transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

There may be no direct 'side effects' like in drug trials but participants might experience stress due to additional follow-ups or interventions. There could also be privacy concerns when receiving home visits from healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I receive Medicare or Medicaid benefits.

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I have been diagnosed with heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am on the waiting list for a heart transplant.

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I do not speak English, Spanish, Mandarin, or French.

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I am expected to be or am currently in hospice care.

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I have been diagnosed with dementia or psychosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Number of all-cause hospital readmissions

Number of days at home

Number of preventable emergency department visits

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mobile Integrated Health (MIH)Experimental Treatment1 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 Control1 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Heart Failure with Reduced Ejection Fraction (HFrEF) include ACE inhibitors, beta-blockers, diuretics, and mineralocorticoid receptor antagonists. ACE inhibitors work by blocking the conversion of angiotensin I to angiotensin II, leading to vasodilation and reduced blood pressure, which decreases the workload on the heart. Beta-blockers reduce heart rate and myocardial oxygen demand by blocking the effects of adrenaline. Diuretics help to remove excess fluid from the body, reducing symptoms of fluid overload such as edema and shortness of breath. Mineralocorticoid receptor antagonists block the effects of aldosterone, reducing sodium and water retention. These treatments are crucial for managing symptoms and improving the quality of life for Heart Failure patients. In the context of in-home evaluations and video consultations, these mechanisms are important as they allow for real-time monitoring and adjustment of therapy, potentially preventing hospital readmissions and managing acute decompensation episodes more effectively.