Heart FailurePROMPTHF-InovaNCT05433220
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova
A study testing Best Practice Advisory using Electronic Health Record in people with Heart Failure, run by Inova Health Care Services at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Best Practice Advisory using Electronic Health Record
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2022to 25 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 Years
- Seen by a Cardiologist in an Inova clinic or Inova hospital setting
- Left Ventricular Ejection Fraction ≤40%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Inova Health System
Falls Church, Virginia, 22042
Matthew Dimond, 703-776-6248, matthew.dimond@inova.org
Bhruga Shah, 7037762828, Bhruga.shah@inova.org
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Best Practice Advisory using Electronic Health Record
- Keywords
- Heart Failure, GDMT, NYHA, HFrEF, Implementation
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best Practice Advisory using Electronic Health RecordOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Alert when provider is entering orders | Experimental | Not described Receives: Other: Best Practice Advisory using Electronic Health Record |
| No alert, usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after randomization
Secondary outcomes (4)
All-cause hospitalization and all-cause mortality at 30 days
Outcomes will be determined by review of medical, hospital, and billing records.
Measured: 30 days
All-cause hospitalization and all-cause mortality at 90 days
Outcomes will be determined by review of medical, hospital, and billing records.
Measured: 90 days
All-cause hospitalization and all-cause mortality at 180 days
Outcomes will be determined by review of medical, hospital, and billing records.
Measured: 180 days
All-cause hospitalization and all-cause mortality at 1 year
Outcomes will be determined by review of medical, hospital, and billing records.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start25 Aug 2022
- Primary completionJun 2027 (estimated)
- Study completion25 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitchell Psotka, MD, PhD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433220
- Sponsor's protocol ID
- U22-04-4736
- Acronym
- PROMPTHF-Inova
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2022
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregate participant data will be reported upon the completion of the project.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure (PROMPT-HF) at Inova
- ClinicalTrials.gov ID
- NCT05433220
- Acronym / sponsor ID
- PROMPTHF-Inova / U22-04-4736
- Conditions
- Heart Failure
- Keywords
- Heart Failure, GDMT, NYHA, HFrEF, Implementation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Inova Health Care ServicesUniversity, hospital or other
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 25 Aug 2027 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alert when provider is entering orders | Experimental | Other: Best Practice Advisory using Electronic Health Record |
| No alert, usual care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18 Years
- Seen by a Cardiologist in an Inova clinic or Inova hospital setting
- Left Ventricular Ejection Fraction ≤40%
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best Practice Advisory using Electronic Health RecordProviders 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. | Other | Alert when provider is entering orders |
Primary outcome
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.
4 secondary outcomes
All-cause hospitalization and all-cause mortality at 30 days
Time frame: 30 days
All-cause hospitalization and all-cause mortality at 90 days
Time frame: 90 days
All-cause hospitalization and all-cause mortality at 180 days
Time frame: 180 days
All-cause hospitalization and all-cause mortality at 1 year
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting (PROMPT-HF)Link provided by the sponsor.
- Individual participant dataSharing planned: No. Only aggregate participant data will be reported upon the completion of the project.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mitchell Psotka, MD, PhD principal investigator
Inova Health Care Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice Advisory using Electronic Health Record in people with Heart Failure, run by Inova Health Care Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew G Dimond, BS (7037762828, matthew.dimond@inova.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increased use of GDMT in patients with Heart Failure with Reduced Ejection Fraction (time frame: 30 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.