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

NCT05275920 | Completed Results

• 1 other identifier: 21-00644
• Study Type: interventional
• Target: 2,211
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants Prescribed Mineralocorticoid Receptor Antagonists (MRA) During Study

  Through study completion, an average of 6 months

Secondary Outcomes (1)

• 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

Study Arms (3)

Best Practice Alert group

EXPERIMENTAL

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)

In-Basket Message group

EXPERIMENTAL

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

Control group

NO INTERVENTION

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

Interventions

Best Practice Alert (BPA) OTHER

A BPA will fire in the EHR reminding care providers of the best practice when prescribing medical therapies for heart failure patients.

Best Practice Alert group

In-Basket Message 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

In-Basket Message group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cardiologist visit
• Transthoracic echocardiogram with the most recent EF \>= 40%

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

Related Publications (3)

• 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.

  PMID: 38043045 DERIVED

• 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.

  PMID: 36882134 DERIVED

• 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.

  PMID: 36640860 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Amrita Mukhopadhyay, MD
• Organization: NYU Langone Health

amrita.mukhopadhyay@nyulangone.org

212-263-7751

Study Officials

• Amrita Mukhopadhyay, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: March 11, 2022
• Study Start: April 28, 2022
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Locations

US (1)