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Mobile Integrated Health (MIH) 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is comparing two different types of care to see which one is better at reducing hospital readmissions and symptom burden.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Number of all-cause hospital readmissions

Number of days at home

Number of preventable emergency department visits

+4 more

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,433 Previous Clinical Trials

2,445,159 Total Patients Enrolled

20 Trials studying Heart Failure

4,169 Patients Enrolled for Heart Failure

Weill Medical College of Cornell UniversityLead Sponsor

1,055 Previous Clinical Trials

1,314,195 Total Patients Enrolled

9 Trials studying Heart Failure

220,761 Patients Enrolled for Heart Failure

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,995,358 Total Patients Enrolled

15 Trials studying Heart Failure

232,829 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to join the current clinical trial?

"Per available clinicaltrials.gov data, this clinical trial is still recruiting patients. It was initially posted on April 1st 2021 and the most recent amendment made to it was on May 25th 2022."

Answered by AI

What is the recruitment status of this research study?

"Affirmative. The information on clinicaltrials.gov states that this trial is actively recruiting, commencing from April 1st 2021 and most recently updated on May 25th 2022. It seeks to enrole 2100 participants between two different medical centres."

Answered by AI

Recent research and studies

BMJ OpenJournal

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, Ruth M., Brock Daniels, Kevin Munjal, Meghan Reading Turchioe, Leah Shafran Topaz, Crispin Goytia, Iván Díaz, et al.. 2022. “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. BMJ. doi:10.1136/bmjopen-2021-054956.

clinicaltrials.govStudy

Mobile Integrated Health in Heart Failure

Ruth Masterson Creber 2021. "Mobile Integrated Health in Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04662541.

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