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Clinical Trials/NCT05077293
NCT05077293
Completed
Not Applicable

BETTER CARE-HF Pilot Study: Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure, a Pilot Study

NYU Langone Health1 site in 1 country596 target enrollmentSeptember 9, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
NYU Langone Health
Enrollment
596
Locations
1
Primary Endpoint
Incidence of provider engagement with each alert type
Status
Completed
Last Updated
3 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 9, 2021
End Date
January 1, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Incidence of provider engagement with each alert type

Time Frame: 14 days after alert

Provider engagement is reported when the provider clicks on links or buttons within each alert.

Percentage of patients prescribed MRA

Time Frame: 14 days after alert

Study Sites (1)

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