Clinical trial NCT06273085: Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Patient Acceptance of Health Care
Keywords: heart failure with reduced ejection fraction
patient education
Lead sponsor: Medstar Health Baltimore
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in GDMT score
timeFrame: 6 months
Secondary outcomes:
measure: Heart Failure hospitalization
timeFrame: 6 months
measure: cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant
timeFrame: 6 months
measure: Number of GDMT classes of medications in use
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Medstar Union Memorial Hospital
state: Maryland
city: Baltimore
country: United States
facility: Medstar Harbor Hospital
state: Maryland
city: Baltimore
country: United States
facility: Medstar Franklin Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Medstar Good Samaritan Hospital
state: Maryland
Study officials:
affiliation: MedStar Health
name: Anup Agarwal, MD
role: PRINCIPAL_INVESTIGATOR
References: