Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

NCT04514458 | Completed Results DMC

• 1 other identifier: 2000027014
• Study Type: interventional
• Target: 1,410
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized controlled trial to compare the efficacy of an electronic health record-based alert informing providers about evidence-based medications for HFrEF versus usual care (no alert) in outpatient clinics across a single health system.

Conditions

Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) With an Increase in Prescribed HFrEF Therapy

  Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.

  Assessed from the date of randomization to 30 days post-randomization

Secondary Outcomes (17)

• Percentage of Patients on Beta Blockers

  Assessed from the date of randomization to 30 days post-randomization

• Percentage of Patients on ACE Inhibitors

  Assessed from the date of randomization to 30 days post-randomization

• Percentage of Patients on ARBs

  Assessed from the date of randomization to 30 days post-randomization

• Percentage of Patients on ARNIs

  Assessed from the date of randomization to 30 days post-randomization

• Percentage of Patients on MRAs

  Assessed from the date of randomization to 30 days post-randomization

Study Arms (2)

EHR-based alert

EXPERIMENTAL

Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.

Other: Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)

Usual Care

NO INTERVENTION

Providers will not receive an alert and will proceed with usual care.

Interventions

Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial) OTHER

Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.

EHR-based alert

Eligibility Criteria

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

You may qualify if:

• Age 18 or over
• Seen in eligible internal medicine or cardiology clinic
• Left ventricular ejection fraction less than or equal to 40%
• Registered in the Yale Heart Failure Registry

You may not qualify if:

• Opted out of EHR-based research
• Under hospice care
• Already receiving each targeted class of evidence-based HFrEF medical therapy
• Selection of Providers:
• Practicing at an eligible internal medicine or cardiology clinic
• High frequency of visits by eligible patients based on retrospective chart review

Sponsors & Collaborators

• Yale University: lead
• AstraZeneca: collaborator

Study Sites (1)

Yale New Haven Health System selected outpatient clinics

New Haven, Connecticut, 06510, United States

Location

Related Publications (2)

• Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial. J Am Coll Cardiol. 2022 Jun 7;79(22):2203-2213. doi: 10.1016/j.jacc.2022.03.338. Epub 2022 Apr 3.

  PMID: 35385798 DERIVED

• Ghazi L, Desai NR, Simonov M, Yamamoto Y, O'Connor KD, Riello RJ, Huang J, Olufade T, McDermott J, Inzucchi SE, Velazquez EJ, Wilson FP, Ahmad T. Rationale and design of a cluster-randomized pragmatic trial aimed at improving use of guideline directed medical therapy in outpatients with heart failure: PRagmatic trial of messaging to providers about treatment of heart failure (PROMPT-HF). Am Heart J. 2022 Feb;244:107-115. doi: 10.1016/j.ahj.2021.11.010. Epub 2021 Nov 20.

  PMID: 34808104 DERIVED

Limitations and Caveats

Limitations include being conducted at a single health system, that it primarily examined an increase in medication initiation rather than up-titration of dosing, that the alert has only been created and used in the Epic EHR framework, and that the alert was tested during a time when there were coordinated and intensive efforts across the study site to improve medical therapy for heart failure, which is reflected by increases in HFrEF therapies in the usual care arm of the study.

Results Point of Contact

• Title: Tariq Ahmad
• Organization: Yale University

tariq.ahmad@yale.edu

203-843-1667

Study Officials

• Tariq Ahmad, MD MPH

  Yale University

  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: July 29, 2020
• First Posted: August 17, 2020
• Study Start: January 25, 2021
• Primary Completion: November 20, 2021
• Study Completion: October 20, 2022
• Last Updated: July 1, 2025
• Results First Posted: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Upon publication of results; indefinitely.

Locations

US (1)