Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction

NCT ID: NCT06273085

Last Updated: 2024-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-02-28

Brief Summary

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The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital.

Detailed Description

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This is a randomized clinical trial assessing the possible benefit of post-discharge education on the extent of guideline directed medical treatment for heart failure with reduced ejection fraction. Patients that are admitted to medical facilities of the Medstar health, Baltimore will be screened and if consented, they will all get an initial inhouse face to face education, and upon discharge, they will be randomized to the control group and intervention group. The latter will get more educations via phone-call sessions at 1, 3 and 5 months post discharge. The educational sessions will include educating the benefits of GDMT, reviewing the components of GDMT and their possible side effects, performing Medication reconciliation, Inquiries about reasons not getting the medications and encouraging adherence to clinic visits and requesting the treating providers for GDMT optimization. There will be no formal prescription or change of medication during the educational sessions. GDMT use will be assessed in all patients after 6 months according to GDMT score by the Heart Failure Collaboratory.

Conditions

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Heart Failure Patient Acceptance of Health Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention

Intervention arm will receive initial face to face education during hospital admission and also an educational flier about GDMT. They will get 3 more sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers.

Group Type ACTIVE_COMPARATOR

Patient education

Intervention Type BEHAVIORAL

3 sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers.

Control

Control arm will receive initial face to face education during hospital admission and also an educational flier about GDMT.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Patient education

3 sessions of education over phone at 1, 3 and 5 months after discharge, each session includes an overview of benefits and side effects of GDMT, inquiries about reasons of not using optimal doses of GDMT medications, and encouraging adherence to visits with providers.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with Heart Failure reduced Ejection Fraction (EF≤40%)
* Age \>18 years
* Able to consent for enrollment.
* Hospitalized at one of the Medstar facilities (Inpatient)

Exclusion Criteria

* Pregnancy
* Patient with stage D heart failure candidates for advanced therapies or on home inotropes or receiving hospice service
* Patients with advanced organ failure (End stage cancer, Advanced dementia, MELD (Model for End-Stage Liver Disease) score \> 30, GFR (Glomerular filtration rate) \<25) in whom GDMT is Futile
* Patients with Heart failure Collaboratory Score (HFCS) of 9
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Baltimore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anup Agarwal, MD

Role: PRINCIPAL_INVESTIGATOR

MedStar Health

Locations

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Medstar Union Memorial Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Medstar Harbor Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Medstar Franklin Medical Center

Baltimore, Maryland, United States

Site Status RECRUITING

Medstar Good Samaritan Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anup Agarwal, MD

Role: CONTACT

5066207815

Sumanth Bandaru, MBBS

Role: CONTACT

6462405289

Facility Contacts

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Ahmad Amin, MD

Role: primary

401-533-0696

Sumanth Bandaru, MBBS

Role: primary

646-240-5289

Anup Agarwal, MD

Role: primary

505-620-7815

Sumanth Bandaru, MBBS

Role: primary

646-240-5289

Other Identifiers

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MOD00016877

Identifier Type: -

Identifier Source: org_study_id

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