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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Active Comparator | 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. |
|
| Control | No Intervention | Control arm will receive initial face to face education during hospital admission and also an educational flier about GDMT. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient education | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Failure hospitalization | Proportion of Heart failure hospitalization | 6 months |
| cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant | Proportion of cardiovascular death/Left Ventricular Assist Device implantation/Cardiac Transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anup Agarwal, MD | Contact | 5066207815 | anup.agarwal@medstar.net | |
| Sumanth Bandaru, MBBS | Contact | 6462405289 | sumanthkumar.bandaru@medstar.net |
| Name | Affiliation | Role |
|---|---|---|
| Anup Agarwal, MD | MedStar Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Union Memorial Hospital | Recruiting | Baltimore | Maryland | 21218 | United States |
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|
| 6 months |
| Number of GDMT classes of medications in use | Number of GDMT classes of medications in use | 6 months |
| Medstar Harbor Hospital | Recruiting | Baltimore | Maryland | 21225 | United States |
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| Medstar Franklin Medical Center | Recruiting | Baltimore | Maryland | 21237 | United States |
|
| Medstar Good Samaritan Hospital | Recruiting | Baltimore | Maryland | 21239 | United States |
|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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