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

Heart Failure Clinical Trial

— PROMPTHF-Inova  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05433220
• Other study ID #: U22-04-4736
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: Inova Health Care Services
• Contact: Matthew G Dimond, BS
• Phone: 7037762828
• Email: matthew.dimond[@]inova.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Inova Health System	Falls Church	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause hospitalization and all-cause mortality at 30 days	Outcomes will be determined by review of medical, hospital, and billing records.	30 days
Secondary	All-cause hospitalization and all-cause mortality at 90 days	Outcomes will be determined by review of medical, hospital, and billing records.	90 days
Secondary	All-cause hospitalization and all-cause mortality at 180 days	Outcomes will be determined by review of medical, hospital, and billing records.	180 days
Secondary	All-cause hospitalization and all-cause mortality at 1 year	Outcomes will be determined by review of medical, hospital, and billing records.	1 year

External Links

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