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

NCT ID: NCT05275920

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2211 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-28
• Study Completion Date: 2022-10-26

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.

Conditions

Heart Failure; Heart Failure With Reduced Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Best Practice Alert (BPA)

Intervention Type: OTHER

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 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.

Group Type: EXPERIMENTAL

In-Basket Message

Intervention Type: OTHER

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

Control group

Patients who will receive the current standard practice of care (no BPA or in-basket message)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amrita Mukhopadhyay, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

References

Mukhopadhyay A, Reynolds HR, King WC, Phillips LM, Nagler AR, Szerencsy A, Saxena A, Klapheke N, Katz SD, Horwitz LI, Blecker S. Impact of Visit Volume on the Effectiveness of Electronic Tools to Improve Heart Failure Care. JACC Heart Fail. 2024 Apr;12(4):665-674. doi: 10.1016/j.jchf.2023.11.002. Epub 2023 Nov 15.

Reference Type: DERIVED

PMID: 38043045 (View on PubMed)

Mukhopadhyay A, Reynolds HR, Phillips LM, Nagler AR, King WC, Szerencsy A, Saxena A, Aminian R, Klapheke N, Horwitz LI, Katz SD, Blecker S. Cluster-Randomized Trial Comparing Ambulatory Decision Support Tools to Improve Heart Failure Care. J Am Coll Cardiol. 2023 Apr 11;81(14):1303-1316. doi: 10.1016/j.jacc.2023.02.005. Epub 2023 Mar 5.

Reference Type: DERIVED

PMID: 36882134 (View on PubMed)

Mukhopadhyay A, Reynolds HR, Xia Y, Phillips LM, Aminian R, Diah RA, Nagler AR, Szerencsy A, Saxena A, Horwitz LI, Katz SD, Blecker S. Design and pilot implementation for the BETTER CARE-HF trial: A pragmatic cluster-randomized controlled trial comparing two targeted approaches to ambulatory clinical decision support for cardiologists. Am Heart J. 2023 Apr;258:38-48. doi: 10.1016/j.ahj.2022.12.016. Epub 2023 Jan 11.

Reference Type: DERIVED

PMID: 36640860 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21-00644

Identifier Type: -

Identifier Source: org_study_id