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Completed

NCT Number: NCT04686604

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

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.

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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 Hospital

New Haven, Connecticut, 06512, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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:
  • 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)

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

Treatment and study plan

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. The percentage increase of beta blockers for HFrEF

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

    Increase in proportion of patients on beta blockers

  2. The percentage increase of ACEi/ARB/ARNI for HFrEF

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

    Increase in proportion of patients on ACEi/ARB/ARNI

  3. The percentage increase of MRAs for HFrEF

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

    Increase in proportion of patients on MRAs

  4. The percentage increase of SGLT2i for HFrEF

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

    Increase in proportion of patients on SGLT2i

  5. 30-day hospital readmission rates

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

  6. 30-day emergency department visits

    Time frame: Assessed from the date of discharge to the date of ED/ER admission, up to 30 days post-discharge

  7. 6 months all-cause mortality

    Time frame: Assessed from the date of randomization to the date of death from any cause, up to 6 months post-randomization

  8. Percentage of evidence-based medical therapy prescriptions for HFrEF filled by patients within 30 days of discharge

    Time frame: Assessed from the date of discharge and up to 30 days post-discharge.

    Percentage of patients who filled evidence-based medical therapies. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • AstraZeneca

Registry information

Acronym: PROMPT-HF

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 29, 2020
Registry last updated
Jan 26, 2024

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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