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Completed

NCT Number: NCT04514458

Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale New Haven Health System selected outpatient clinics

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Patients With Heart Failure With Reduced Ejection Fraction (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.

Secondary outcomes

  1. Percentage of Patients 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

  2. Percentage of Patients 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

  3. Percentage of Patients 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

  4. Percentage of Patients 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

  5. Percentage of Patients 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

  6. Percentage of Patients 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

  7. 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 as the number of patients who expired from randomization up to one year from any cause.

  8. 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

    Number of participants with a hospitalization within 30 days of randomization

  9. 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

    Number of participants with an emergency department visit within 30 days of randomization.

  10. Total Six-month Healthcare Costs

    Time frame: Assessed from the date of randomization to 6 months post-randomization

    Assessed as total direct and indirect cost of patient care from randomization to 6 months post randomization.

  11. Percentage of Filled Prescriptions

    Time frame: Assessed 6 months post-randomization

    Proportion of prescriptions filled as assessed by SureScripts

  12. Medication Dose of Any Prescribed Beta Blocker

    Time frame: Assessed at 6 months post-randomization

  13. Medication Dose of Any Prescribed ACEi

    Time frame: Assessed at 6 months post-randomization

  14. Medication Dose of Any Prescribed ARB

    Time frame: Assessed at 6 months post-randomization

  15. Medication Dose of Any Prescribed ARNI

    Time frame: Assessed at 6 months post-randomization

  16. Medication Dose of Any Prescribed MRA

    Time frame: Assessed at 6 months post-randomization

  17. Medication Dose of Any Prescribed SGLT2 Inhibitor

    Time frame: Assessed at 6 months post-randomization

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • AstraZeneca

Registry information

Acronym: PROMPT-HF

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Aug 17, 2020
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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