Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure (PROMPT-HF)

December 8, 2022 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data from clinical trials suggest that pharmacological therapies prescribed at appropriate doses will lead to dramatic improvements in survival and hospitalization rates in patients with heart failure with reduced ejection fraction (HFrEF). Consequently, major cardiovascular societies assign the highest level of recommendation to use these therapies in all eligible patients. 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 HFrEF are not on evidence-based therapies, and why the percentages are consistent across national registries over time. One explanation might be that providers know the data regarding evidence-based therapies, but the therapies only benefit a narrow population. Another factor might be a lack of knowledge among providers about the appropriate management of HFrEF patients. 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.

This study will conduct a randomized controlled trial across outpatient clinics within a single health system comparing the effectiveness of an EHR-based alerting system that informs practitioners about what evidence-based medications they can prescribe for HFrEF patients versus usual care (no alert). One hundred eligible unique providers will be randomized to an intervention in which an alert will appear for all eligible patients with HFrEF, or to a control group in which no alert appears and usual care will continue, with a target patient enrollment of 1,310. The primary outcome for the trial will be the proportion of patients with HFrEF with an increase in evidence based medical therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i). Secondary outcomes will include 30-day hospital admission rates, 30-day ED visits, one year all-cause mortality, and total 6 month healthcare costs.

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Health System selected outpatient clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Patient Inclusion Criteria:

  • 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

Patient Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Providers will not receive an alert and will proceed with usual care.
Experimental: EHR-based 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 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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients with HFrEF with an increase in prescribed HFrEF therapy
Time Frame: Assessed from the date of randomization to 30 days post-randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patient on beta blockers
Time Frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with prescribed beta blockers
Assessed from the date of randomization to 30 days post-randomization
Percentage of patient on ACE inhibitors
Time Frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed ACEi
Assessed from the date of randomization to 30 days post-randomization
Percentage of patient on ARBs
Time Frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed ARB
Assessed from the date of randomization to 30 days post-randomization
Percentage of patient on ARNIs
Time Frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed ARNI
Assessed from the date of randomization to 30 days post-randomization
Percentage of patient on MRAs
Time Frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed MRA
Assessed from the date of randomization to 30 days post-randomization
Percentage of patient on SGLT2 inhibitors
Time Frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed SGLT2i
Assessed from the date of randomization to 30 days post-randomization
Rate of one-year all-cause mortality
Time Frame: Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization
Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization
Rate of 30-day hospital admission
Time Frame: Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization
Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization
Rate of 30-day all-cause emergency department visits
Time Frame: Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization
Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization
Total six-month healthcare costs
Time Frame: Assessed from the date of randomization to 6 months post-randomization
Assessed from the date of randomization to 6 months post-randomization
Percentage of filled prescriptions
Time Frame: Assessed 6 months post-randomization
Proportion of prescriptions filled as assessed by SureScripts
Assessed 6 months post-randomization
Medication dose of any prescribed beta blocker
Time Frame: Assessed at 6 months post-randomization
Assessed at 6 months post-randomization
Medication dose of any prescribed ACEi
Time Frame: Assessed at 6 months post-randomization
Assessed at 6 months post-randomization
Medication dose of any prescribed ARB
Time Frame: Assessed at 6 months post-randomization
Assessed at 6 months post-randomization
Medication dose of any prescribed ARNI
Time Frame: Assessed at 6 months post-randomization
Assessed at 6 months post-randomization
Medication dose of any prescribed MRA
Time Frame: Assessed at 6 months post-randomization
Assessed at 6 months post-randomization
Medication dose of any prescribed SGLT2 inhibitor
Time Frame: Assessed at 6 months post-randomization
Assessed at 6 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Actual)

November 20, 2021

Study Completion (Actual)

October 20, 2022

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

August 12, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Estimate)

December 9, 2022

Last Update Submitted That Met QC Criteria

December 8, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000027014

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
  • Statistical Analysis Plan (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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