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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273085
• Other study ID #: MOD00016877
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: February 2025

Study information

• Verified date: February 2024
• Source: Medstar Health Baltimore
• Contact: Anup Agarwal, MD
• Phone: 5066207815
• Email: anup.agarwal[@]medstar.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Patient Acceptance of Health Care

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Medstar Franklin Medical Center	Baltimore	Maryland
United States	Medstar Good Samaritan Hospital	Baltimore	Maryland
United States	Medstar Harbor Hospital	Baltimore	Maryland
United States	Medstar Union Memorial Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Baltimore

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in GDMT score	Changes in GDMT score defined by the Heart Failure Collaboratory (Vericiguat and Ivabradine score will not be included in this study)	6 months
Secondary	Heart Failure hospitalization	Proportion of Heart failure hospitalization	6 months
Secondary	cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant	Proportion of cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant	6 months
Secondary	Number of GDMT classes of medications in use	Number of GDMT classes of medications in use	6 months