PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova
PROMPTHF-Inova
1 other identifier
interventional
5,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Aug 2022
Typical duration for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
June 27, 2022
CompletedStudy Start
First participant enrolled
August 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2026
August 24, 2025
August 1, 2025
3.8 years
June 21, 2022
August 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increased use of GDMT in patients with Heart Failure with Reduced Ejection Fraction
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.
30 days after randomization
Secondary Outcomes (4)
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
All-cause hospitalization and all-cause mortality at 1 year
1 year
Study Arms (2)
Alert when provider is entering orders
EXPERIMENTALNo alert, usual care
NO INTERVENTIONInterventions
Providers caring for patients randomized to the intervention arm will have a best practice alert appear for each of their eligible patients upon opening of the order entry screen in the patient's medical record. This alert informs the provider to the presence of HFrEF, notes the patient's current LVEF and current evidence-based medications, and gives access to an order set with recommended evidence- based, guideline-recommended, and FDA- approved therapies for patients with HFrEF. Providers will also have access to a link to best available guideline recommended information regarding treatment of heart failure to allow further education if desired by the provider. The alerts will also clearly state the expected monitoring and follow-up required for prescriptions of these medications.
Eligibility Criteria
You may qualify if:
- Age\>18 Years
- Seen by a Cardiologist in an Inova clinic or Inova hospital setting
- Left Ventricular Ejection Fraction ≤40%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Inova Health System
Falls Church, Virginia, 22042, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mitchell Psotka, MD, PhD
Inova Health Care Services
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2022
First Posted
June 27, 2022
Study Start
August 25, 2022
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
August 1, 2026
Last Updated
August 24, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
Only aggregate participant data will be reported upon the completion of the project.