PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting

NCT04686604 | Completed DMC

• 2 other identifiers: 2000029438No NIH funding
• Study Type: interventional
• Target: 1,012
• Locations: 1 country
• Sites: 1

Brief Summary

A randomized single-blind interventional trial to test the effectiveness of an electronic medical record-based best practice alert recommending evidence-based medical therapies versus usual care in inpatient adult patients presenting with heart failure with reduced ejection fraction.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with HFrEF with an increase in prescribed evidence-based HFrEF medical therapy

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

  Assessed from the date of randomization to discharge date, assessed up to 12 months.

Secondary Outcomes (8)

• The percentage increase of beta blockers for HFrEF

  Assessed from the date of randomization to discharge date, assessed up to 12 months.

• The percentage increase of ACEi/ARB/ARNI for HFrEF

  Assessed from the date of randomization to discharge date, assessed up to 12 months.

• The percentage increase of MRAs for HFrEF

  Assessed from the date of randomization to discharge date, assessed up to 12 months.

• The percentage increase of SGLT2i for HFrEF

  Assessed from the date of randomization to discharge date, assessed up to 12 months.

• 30-day hospital readmission rates

  Assessed from the date of discharge to the date of hospital readmission, up to 30 days post-discharge

Study Arms (2)

Electron Health Record-based Provider 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, most recent blood pressure and heart rate, most recent potassium and estimated glomerular filtration rate, 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 medical 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 medical 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, most recent blood pressure and heart rate, most recent potassium and estimated glomerular filtration rate, 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.

Electron Health Record-based Provider Alert

Eligibility Criteria

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

You may qualify if:

• Adults ≥18 years admitted to a hospital within the Yale New Haven Hospital system (either Yale New Haven Hospital, St. Raphael's Campus, Greenwich Hospital, or Bridgeport Hospital).
• Have HFrEF defined as:
• NT-pro-BNP \>500 pg/ml within 24 hours of admission
• On IV loop diuretic within 24 hours of admission
• Left ventricular ejection fraction ≤40% (most recent)

You may not qualify if:

• Patients within 48 hours of admission
• Patients in the intensive care unit
• Patients on hospice service
• Patients receiving intravenous milrinone
• Patient on NPO (nothing by mouth) order
• Patients on all evidence based medical therapy for HFrEF (on all 4 classes of evidence based medical therapy: beta-blockers, ACEi/ARB/ARNI, MRA, SGLT2i)
• Opted out of medical record research

Sponsors & Collaborators

• Yale University: lead
• AstraZeneca: collaborator

Study Sites (1)

Yale New Haven Hospital

New Haven, Connecticut, 06512, United States

Location

Related Publications (1)

• Ghazi L, O'Connor K, Yamamoto Y, Fuery M, Sen S, Samsky M, Riello RJ 3rd, Huang J, Olufade T, McDermott J, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Pragmatic trial of messaging to providers about treatment of acute heart failure: The PROMPT-AHF trial. Am Heart J. 2023 Mar;257:111-119. doi: 10.1016/j.ahj.2022.12.002. Epub 2022 Dec 6.

  PMID: 36493842 DERIVED

Related Links

• Trial Website

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Tariq Ahmad, MD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

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: December 16, 2020
• First Posted: December 29, 2020
• Study Start: July 7, 2021
• Primary Completion: December 14, 2022
• Study Completion: June 30, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

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

Locations

US (1)