PROMPTHF-Inova: PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova

Sponsor

Inova Health Care Services (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05433220

Collaborator

Heart Failure Collaboratory (Other)

5,000

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Best Practice Advisory using Electronic Health Record	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

5000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alert when provider is entering orders	Other: Best Practice Advisory using Electronic Health Record 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.
No Intervention: No alert, usual care

Arm

Intervention/Treatment

Experimental: Alert when provider is entering orders

Other: Best Practice Advisory using Electronic Health Record

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.

No Intervention: No alert, usual care

Outcome Measures

Primary Outcome Measures

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

All-cause hospitalization and all-cause mortality at 1 year [1 year]
Outcomes will be determined by review of medical, hospital, and billing records.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Inova Health Care Services
Heart Failure Collaboratory

Investigators

Principal Investigator: Mitchell Psotka, MD, PhD, Inova Health Care Services

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting (PROMPT-HF)

Publications

None provided.

Responsible Party:

Mitchell Psotka, MD, Ph.D, System Section Chief, Heart Failure and Transplant, Inova Health Care Services

ClinicalTrials.gov Identifier:

NCT05433220

Other Study ID Numbers:

U22-04-4736

First Posted:

Jun 27, 2022

Last Update Posted:

Jun 27, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mitchell Psotka, MD, Ph.D, System Section Chief, Heart Failure and Transplant, Inova Health Care Services

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Jun 27, 2022