Heart Failure Clinical Trial

Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations – Heart Failure (BETTER CARE-HF)

Summary

Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF) is a pragmatic, cluster-randomized, three-arm intervention trial that will compare the effectiveness of two targeted clinical decision support (CDS) intervention tools (best practice alert (BPA) and automated in-basket massage) to inform providers when a patient with heart failure and reduce ejection fraction (HFrEF) is not on appropriate medical therapy, as compared to usual care.

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Full Description

An estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (HFrEF), with the majority being due to lack of mineralocorticoid receptor antagonists (MRA). Despite proven benefits in randomized trials, class I guideline recommendations, and published clinical performance measures, patients with HFrEF are often not on guideline-directed medical therapy (GDMT). While successful interventions for improvement in prescription of GDMT have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (EHR)-based interventions. Prior studies on EHR-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of MRA. The development and study of outpatient EHR-based alerts for HFrEF GDMT are needed. Two types of outpatient EHR-based interventions include best practice alerts (BPA) and automated in-basket messages. Both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. To our knowledge, there is no study that has directly compared these different types of EHR-based interventions.

BETTER CARE - HF is a pragmatic, cluster-randomized, three-arm intervention trail that will compare the effectiveness of two targeted CDS intervention tools (BPA and automated in-basket message) as compared to usual care on the primary outcome of MRA prescription at end of study period.

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Eligibility Criteria

Inclusion Criteria:

Cardiologist visit
Transthoracic echocardiogram with the most recent EF >= 40%

Exclusion Criteria:

Hypotension: SBP < 95
Hyperkalemia: most recent K > 5.1, or any K >5.5
Renal dysfunction: eGFR < 30
Ventricular assist device
Hospice care
Cardiac amyloid

Study is for people with:

Heart Failure

Estimated Enrollment:

2211

Study ID:

NCT05275920

Recruitment Status:

Completed

Sponsor:

NYU Langone Health

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There is 1 Location for this study

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NYU Langone Health
New York New York, 10016, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

2211

Study ID:

NCT05275920

Recruitment Status:

Completed

Sponsor:


NYU Langone Health

How clear is this clinincal trial information?

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