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

Heart Failure Clinical Trial

— BETTER CARE-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05275920
• Other study ID #: 21-00644
• Status: Completed
• Phase: N/A
• Start date: April 28, 2022
• Est. completion date: October 26, 2022

Study information

• Verified date: January 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2211
• Est. completion date: October 26, 2022
• Est. primary completion date: October 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• Best Practice Alert (BPA)
A BPA will fire in the EHR reminding care providers of the best practice when prescribing medical therapies for heart failure patients.
• In-Basket Message
An In-Basket message will be sent biweekly to care providers with a reminder of the best practice when prescribing medical therapies for heart failure

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients prescribed MRA		through study completion, 1 year
Secondary	Incidence of provider engagement with each alert type	Provider engagement is reported when the provider clicks on links or buttons within each alert.	through study completion, 1 year