Clinical trial NCT05275920: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
Official title: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Keywords: Best Practice Alert [BPA]
In-Basket message
Mineralocorticoid Receptor Antagonists [MRA]
guideline-directed medical therapy [GDMT]
Clinical decision support
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 2211
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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.

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

Primary outcomes:
measure: Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Number of Participants Prescribed to Beta-blocker (BB), Angiotensin Converting Enzyme (ACE) Inhibitor, Angiotensin Receptor Blocker (ARB), or Angiotensin Receptor/Neprilysin Inhibitor (ARNI) During Study
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Amrita Mukhopadhyay, MD
role: PRINCIPAL_INVESTIGATOR
References: