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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medstar Health Baltimore
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- Change in GDMT score
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief 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.
Detailed 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in GDMT score
Time Frame: 6 months
Changes in GDMT score defined by the Heart Failure Collaboratory (Vericiguat and Ivabradine score will not be included in this study)
Secondary Outcomes
- Number of GDMT classes of medications in use(6 months)
- cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant(6 months)
- Heart Failure hospitalization(6 months)