Heart Failure Clinical Trial

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

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.

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Full 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.

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Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

1012

Study ID:

NCT04686604

Recruitment Status:

Completed

Sponsor:

Yale University

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There is 1 Location for this study

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

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Study is for people with:

Heart Failure

Estimated Enrollment:

1012

Study ID:

NCT04686604

Recruitment Status:

Completed

Sponsor:


Yale University

How clear is this clinincal trial information?

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