Clinical trial NCT05077293: Building Electronic Tools To Enhance and Reinforce Cardiovascular Recommendations - Heart Failure
Official title: BETTER CARE-HF Pilot Study: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure, a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Keywords: Best Practice Alert
In-Basket message
Mineralocorticoid Receptor Antagonists
MRA
guideline-directed medical therapy
GDMT
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 596
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Langone cardiology outpatients

Brief summary: This is a feasibility study using a cross-over design to implement and compare a best practice alert (BPA) with an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this pilot study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention).

Detailed 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.

This is a feasibility study using cross-over design at two outpatient clinics in a large health system to implement and compare a best practice alert (BPA) and an automated in-basket message to inform providers when a patient with heart failure and reduced ejection fraction (HFrEF) is not on appropriate medical therapy. The data from this study will lead to a randomized controlled trial to compare the effectiveness of the BPA versus an automated in-basket message, versus usual care (no intervention).

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

Primary outcomes:
measure: Percentage of patients prescribed MRA
timeFrame: 14 days after alert
measure: Incidence of provider engagement with each alert type
timeFrame: 14 days after alert
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
References: