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

  • STATUS
    Recruiting
  • End date
    May 3, 2023
  • participants needed
    1012
  • sponsor
    Yale University
Updated on 3 September 2021
medical therapy
ejection fraction
heart failure
potassium
loop diuretic
b-type natriuretic peptide

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.

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.

Details
Condition cardiac failure, Cardiac Disease, Heart disease, Heart Failure, Heart Disease, Heart failure, Congestive Heart Failure, congestive heart disease
Treatment Best practice alert for the notification of patient HFrEF and recommended evidence-based medical therapies (NO drugs are being administered in this trial)
Clinical Study IdentifierNCT04686604
SponsorYale University
Last Modified on3 September 2021

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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