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Clinical Trials/NCT05433220
NCT05433220RecruitingNot Applicable

PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure (PROMPT-HF) at Inova

Inova Health Care Services1 site in 1 country5,000 target enrollmentStarted: August 25, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
5,000
Locations
1
Primary Endpoint
Increased use of GDMT in patients with Heart Failure with Reduced Ejection Fraction

Study Overview

Brief Summary

A randomized, single-blind intervention trial to test the comparative effectiveness of an electronic health record best practice advisory system that informs clinicians of guideline-indicated and FDA-approved heart failure medications currently not prescribed to their patients with heart failure versus usual care (no alert and how things are done currently). The purpose of the alert is to stimulate appropriate medication prescription for patients with heart failure and a reduced ejection fraction. This will be done across outpatient Inova clinics and at the five Inova hospitals.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age>18 Years
  • •Seen by a Cardiologist in an Inova clinic or Inova hospital setting
  • •Left Ventricular Ejection Fraction ≤40%

Exclusion Criteria

  • •Opted out of EHR-based research
  • •Hospice care
  • •Already receiving maximally titrated doses of each of the four classes of evidence- based HFrEF medical therapy
  • •Prior heart transplant

Arms & Interventions

Alert when provider is entering orders

Experimental

Intervention: Best Practice Advisory using Electronic Health Record (Other)

No alert, usual care

No Intervention

Outcomes

Primary Outcomes

Increased use of GDMT in patients with Heart Failure with Reduced Ejection Fraction

Time Frame: 30 days after randomization

The primary outcome for the trial will be the proportion of patients with HFrEF who have an increase in the number of prescribed evidence-based therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i) 30 days after randomization.

Secondary Outcomes

  • All-cause hospitalization and all-cause mortality at 1 year(1 year)
  • All-cause hospitalization and all-cause mortality at 30 days(30 days)
  • All-cause hospitalization and all-cause mortality at 90 days(90 days)
  • All-cause hospitalization and all-cause mortality at 180 days(180 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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