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NCT Number: NCT05433220

PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure 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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice Advisory using Electronic Health Record

Other

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.

Primary outcomes

  1. 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

  1. All-cause hospitalization and all-cause mortality at 30 days

    Time frame: 30 days

    Outcomes will be determined by review of medical, hospital, and billing records.

  2. All-cause hospitalization and all-cause mortality at 90 days

    Time frame: 90 days

    Outcomes will be determined by review of medical, hospital, and billing records.

  3. All-cause hospitalization and all-cause mortality at 180 days

    Time frame: 180 days

    Outcomes will be determined by review of medical, hospital, and billing records.

  4. All-cause hospitalization and all-cause mortality at 1 year

    Time frame: 1 year

    Outcomes will be determined by review of medical, hospital, and billing records.

Study contacts

Contact information is provided by the study sponsor or research team.

Bhruga Shah, MS, BSN-RN

CONTACT

[email protected]

7037762828

Matthew G Dimond, BS

CONTACT

[email protected]

7037762828

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Registry information

Official study title

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

Acronym: PROMPTHF-Inova

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jun 27, 2022
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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