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

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

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 Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Other: Best Practice Advisory using Electronic Health Record

• Study Type: Interventional
• Enrollment (Estimated): 5000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Matthew G Dimond, BS; Phone Number: 7037762828; Email: matthew.dimond@inova.org
• Study Contact Backup: Name: Bhruga Shah, MS, BSN-RN; Phone Number: 7037762828; Email: Bhruga.Shah@inova.org

Study Locations

• United States
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Recruiting
      • Inova Health System
      • Contact: Matthew Dimond; Phone Number: 703-776-6248; Email: matthew.dimond@inova.org
      • Contact: Bhruga Shah; Phone Number: 7037762828; Email: Bhruga.shah@inova.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause hospitalization and all-cause mortality at 30 days	Outcomes will be determined by review of medical, hospital, and billing records.	30 days
All-cause hospitalization and all-cause mortality at 90 days	Outcomes will be determined by review of medical, hospital, and billing records.	90 days
All-cause hospitalization and all-cause mortality at 180 days	Outcomes will be determined by review of medical, hospital, and billing records.	180 days
All-cause hospitalization and all-cause mortality at 1 year	Outcomes will be determined by review of medical, hospital, and billing records.	1 year

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 21, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Heart Failure; Implementation; HFrEF; GDMT; NYHA
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: U22-04-4736

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only aggregate participant data will be reported upon the completion of the project.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No