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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Heart Failure With Reduced Ejection Fraction
• Intervention / Treatment: Other: Best Practice Alert (BPA); Other: In-Basket Message

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.

• Study Type: Interventional
• Enrollment (Actual): 2211
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Best Practice Alert group; Providers will receive a BPA at the time of visit for patients with HFrEF who are not on MRA (and who do not have contraindication to MRA). This alert will display the patient's current HFrEF therapies, EF, blood pressure, potassium, and glomerular filtration rate. The alert will give access to an outpatient heart failure order set, and also provide links to the most recent guidelines.	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.
Experimental: In-Basket Message group; Providers will receive a monthly in-basket messages linking to a list of patients who have been seen in the past 2 months or will be seen in the upcoming month with HFrEF who are not on MRA (and who do not have contraindication to MRA). This list will display each patient's current hFrEF therapies, EF, blood pressure, potassium, glomerular filtration rate, date of last visit, and date of next visit. From the list, providers can access the patient's chart, order medications, and document communication with the patient.	Other: 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
No Intervention: Control group; Patients who will receive the current standard practice of care (no BPA or in-basket message)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study	Through study completion, an average of 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Through study completion, an average of 6 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Amrita Mukhopadhyay, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2022
• Primary Completion (Actual): October 26, 2022
• Study Completion (Actual): October 26, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: In-Basket message; Best Practice Alert [BPA]; Mineralocorticoid Receptor Antagonists [MRA]; guideline-directed medical therapy [GDMT]; Clinical decision support
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 21-00644

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No