PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting (PROMPT-HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Best practice alert for the notification of patient HFrEF and recommended evidence-based medical therapies (NO drugs are being administered in this trial)

Detailed Description

Heart failure (HF) is the major cause of healthcare expenditure, morbidity, and mortality in the United States. HF is the primary diagnosis for hospital discharge in ~1 million and a secondary diagnosis in ~2 million hospitalizations annually in the US. In fact, inpatient admissions account for more than half of HF healthcare expenditure. However, data from several registries over the last three decades has failed to see use of these evidence- based therapies at levels noted in clinical trials, despite aggressive guideline recommendations and promotion by thought leaders in the field. It remains unclear as to why many patients with HF reduced ejection fraction (HFrEF) are not on evidence-based therapies especially post hospital discharge and why the percentages are consistent across national registries over time. Whether the gap between clinical trial use and real-world practice is due to a lack of knowledge or providers making individualized decisions about their patients is unclear. A simple way to test this hypothesis is to examine whether electronic health record (EHR) based "best practice advisories" (BPAs) can increase use of evidence based therapies. If found to be effective, these low cost interventions can be rapidly applied across large healthcare systems.

The goal of this trial is to determine the effectiveness of a BPA alert system that informs providers about evidence-based medical therapy for the treatment of HFrEF versus usual care (no alert) in the inpatient setting.

• Study Type: Interventional
• Enrollment (Actual): 1012
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06512
      • Yale New Haven Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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:

  1. NT-pro-BNP >500 pg/ml within 24 hours of admission
  2. On IV loop diuretic within 24 hours of admission
  3. Left ventricular ejection fraction ≤40% (most recent)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Electron Health Record-based Provider Alert; 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); 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.
No Intervention: Usual Care; Providers will not receive an alert and will proceed with usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage increase of beta blockers for HFrEF	Increase in proportion of patients on beta blockers	Assessed from the date of randomization to discharge date, assessed up to 12 months.
The percentage increase of ACEi/ARB/ARNI for HFrEF	Increase in proportion of patients on ACEi/ARB/ARNI	Assessed from the date of randomization to discharge date, assessed up to 12 months.
The percentage increase of MRAs for HFrEF	Increase in proportion of patients on MRAs	Assessed from the date of randomization to discharge date, assessed up to 12 months.
The percentage increase of SGLT2i for HFrEF	Increase in proportion of patients on SGLT2i	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
30-day emergency department visits		Assessed from the date of discharge to the date of ED/ER admission, up to 30 days post-discharge
6 months all-cause mortality		Assessed from the date of randomization to the date of death from any cause, up to 6 months post-randomization
Percentage of evidence-based medical therapy prescriptions for HFrEF filled by patients within 30 days of discharge	Percentage of patients who filled evidence-based medical therapies. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.	Assessed from the date of discharge and up to 30 days post-discharge.

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Tariq Ahmad, MD, MPH, Yale University

Publications and helpful links

Helpful Links

• Trial Website

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2021
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Estimated): January 26, 2024
• Last Update Submitted That Met QC Criteria: January 24, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2000029438; No NIH funding (Other Identifier: 11.09.23)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data underlying results for publication will be made available upon publication of results.
• IPD Sharing Time Frame: Upon publication of results; indefinitely.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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