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

Heart Failure Clinical Trial

— PROMPT-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04686604
• Other study ID #: 2000029438
• Secondary ID: No NIH funding
• Status: Completed
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: January 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1012
• Est. completion date: June 30, 2023
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

1. NT-pro-BNP >500 pg/ml within 24 hours of admission

2. On IV loop diuretic within 24 hours of admission

3. 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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Best practice alert for the notification of patient HFrEF and recommended evidence-based medical 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, 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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with HFrEF with an increase in prescribed evidence-based HFrEF medical therapy	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.	Assessed from the date of randomization to discharge date, assessed up to 12 months.
Secondary	The percentage increase of beta blockers for HFrEF	Increase in proportion of patients on beta blockers	Assessed from the date of randomization to discharge date, assessed up to 12 months.
Secondary	The percentage increase of ACEi/ARB/ARNI for HFrEF	Increase in proportion of patients on ACEi/ARB/ARNI	Assessed from the date of randomization to discharge date, assessed up to 12 months.
Secondary	The percentage increase of MRAs for HFrEF	Increase in proportion of patients on MRAs	Assessed from the date of randomization to discharge date, assessed up to 12 months.
Secondary	The percentage increase of SGLT2i for HFrEF	Increase in proportion of patients on SGLT2i	Assessed from the date of randomization to discharge date, assessed up to 12 months.
Secondary	30-day hospital readmission rates		Assessed from the date of discharge to the date of hospital readmission, up to 30 days post-discharge
Secondary	30-day emergency department visits		Assessed from the date of discharge to the date of ED/ER admission, up to 30 days post-discharge
Secondary	6 months all-cause mortality		Assessed from the date of randomization to the date of death from any cause, up to 6 months post-randomization
Secondary	Percentage of evidence-based medical therapy prescriptions for HFrEF filled by patients within 30 days of discharge	Percentage of patients who filled evidence-based medical therapies. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.	Assessed from the date of discharge and up to 30 days post-discharge.

External Links

•   Trial Website