Heart Failure With Reduced Ejection FractionPROMPT-HFNCT04514458
Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
A study testing Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial) in people with Heart Failure With Reduced Ejection Fraction, run by Yale University at 1 site in United States.
Trial summary
A randomized controlled trial to compare the efficacy of an electronic health record-based alert informing providers about evidence-based medications for HFrEF versus usual care (no alert) in outpatient clinics across a single health system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,410 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2021to 20 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Patient Inclusion Criteria:
- Age 18 or over
- Seen in eligible internal medicine or cardiology clinic
- Left ventricular ejection fraction less than or equal to 40%
- Registered in the Yale Heart Failure Registry
Patient Exclusion Criteria:
- Opted out of EHR-based research
- Under hospice care
- Already receiving each targeted class of evidence-based HFrEF medical therapy
Selection of Providers:
- Practicing at an eligible internal medicine or cardiology clinic
- High frequency of visits by eligible patients based on retrospective chart review
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale New Haven Health System selected outpatient clinics
New Haven, Connecticut, 06510
About this study
A randomized controlled trial to compare the efficacy of an electronic health record-based alert informing providers about evidence-based medications for HFrEF versus usual care (no alert) in outpatient clinics across a single health system.
Read the detailed description
Data from clinical trials suggest that pharmacological therapies prescribed at appropriate doses will lead to dramatic improvements in survival and hospitalization rates in patients with heart failure with reduced ejection fraction (HFrEF). Consequently, major cardiovascular societies assign the highest level of recommendation to use these therapies in all eligible patients. However, data from several registries over the last three decades has failed to see use of these evidence based therapies at levels noted in clinical trials, despite aggressive guideline recommendations and promotion by thought leaders in the field.
It remains unclear as to why many patients with HFrEF are not on evidence-based therapies, and why the percentages are consistent across national registries over time. One explanation might be that providers know the data regarding evidence-based therapies, but the therapies only benefit a narrow population. Another factor might be a lack of knowledge among providers about the appropriate management of HFrEF patients. A simple way to test this hypothesis is to examine whether electronic health record (EHR) based "best practice advisories" (BPAs) can increase use of evidence based therapies. If found to be effective, these low cost interventions can be rapidly applied across large healthcare systems.
This study will conduct a randomized controlled trial across outpatient clinics within a single health system comparing the effectiveness of an EHR-based alerting system that informs practitioners about what evidence-based medications they can prescribe for HFrEF patients versus usual care (no alert). One hundred eligible unique providers will be randomized to an intervention in which an alert will appear for all eligible patients with HFrEF, or to a control group in which no alert appears and usual care will continue, with a target patient enrollment of 1,310. The primary outcome for the trial will be the proportion of patients with HFrEF with an increase in evidence based medical therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i). Secondary outcomes will include 30-day hospital admission rates, 30-day ED visits, one year all-cause mortality, and total 6 month healthcare costs.
- Being tested
- Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)Other
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
| Study group | Role | What they receive |
|---|---|---|
| EHR-based alert | Experimental | Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. Receives: Other: Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial) |
| Usual Care | No intervention | Providers will not receive an alert and will proceed with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) With an Increase in Prescribed HFrEF Therapy
Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.
Measured: Assessed from the date of randomization to 30 days post-randomization
Secondary outcomes (17)
Percentage of Patients on Beta Blockers
Assessed as the number of patients with prescribed beta blockers
Measured: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on ACE Inhibitors
Assessed as the number of patients with a prescribed ACEi
Measured: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on ARBs
Assessed as the number of patients with a prescribed ARB
Measured: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on ARNIs
Assessed as the number of patients with a prescribed ARNI
Measured: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on MRAs
Assessed as the number of patients with a prescribed MRA
Measured: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on SGLT2 Inhibitors
Assessed as the number of patients with a prescribed SGLT2i
Measured: Assessed from the date of randomization to 30 days post-randomization
Rate of One-year All-cause Mortality
Assessed as the number of patients who expired from randomization up to one year from any cause.
Measured: Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization
Rate of 30-day Hospital Admission
Number of participants with a hospitalization within 30 days of randomization
Measured: Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization
Rate of 30-day All-cause Emergency Department Visits
Number of participants with an emergency department visit within 30 days of randomization.
Measured: Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization
Total Six-month Healthcare Costs
Assessed as total direct and indirect cost of patient care from randomization to 6 months post randomization.
Measured: Assessed from the date of randomization to 6 months post-randomization
Percentage of Filled Prescriptions
Proportion of prescriptions filled as assessed by SureScripts
Measured: Assessed 6 months post-randomization
Medication Dose of Any Prescribed Beta Blocker
Measured: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed ACEi
Measured: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed ARB
Measured: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed ARNI
Measured: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed MRA
Measured: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed SGLT2 Inhibitor
Measured: Assessed at 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2020
- Study start25 Jan 2021
- Primary completion20 Nov 2021
- Study completion20 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Tariq Ahmad, MD MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514458
- Sponsor's protocol ID
- 2000027014
- Acronym
- PROMPT-HF
- Status last verified
- Jun 2025
- First submitted
- 29 Jul 2020
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data underlying results for publication will be made available upon publication of results.
Publications
Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial. J Am Coll Cardiol. 2022 Jun 7;79(22):2203-2213. doi: 10.1016/j.jacc.2022.03.338. Epub 2022 Apr 3.
PubMed 35385798Ghazi L, Desai NR, Simonov M, Yamamoto Y, O'Connor KD, Riello RJ, Huang J, Olufade T, McDermott J, Inzucchi SE, Velazquez EJ, Wilson FP, Ahmad T. Rationale and design of a cluster-randomized pragmatic trial aimed at improving use of guideline directed medical therapy in outpatients with heart failure: PRagmatic trial of messaging to providers about treatment of heart failure (PROMPT-HF). Am Heart J. 2022 Feb;244:107-115. doi: 10.1016/j.ahj.2021.11.010. Epub 2021 Nov 20.
PubMed 34808104
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. 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
- ClinicalTrials.gov ID
- NCT04514458
- Acronym / sponsor ID
- PROMPT-HF / 2000027014
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,410 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 20 Nov 2021 (actual)
- Study completion
- 20 Oct 2022 (actual)
- First posted
- 17 Aug 2020 (actual)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized controlled trial to compare the efficacy of an electronic health record-based alert informing providers about evidence-based medications for HFrEF versus usual care (no alert) in outpatient clinics across a single health system.
Detailed description
Data from clinical trials suggest that pharmacological therapies prescribed at appropriate doses will lead to dramatic improvements in survival and hospitalization rates in patients with heart failure with reduced ejection fraction (HFrEF). Consequently, major cardiovascular societies assign the highest level of recommendation to use these therapies in all eligible patients. However, data from several registries over the last three decades has failed to see use of these evidence based therapies at levels noted in clinical trials, despite aggressive guideline recommendations and promotion by thought leaders in the field.
It remains unclear as to why many patients with HFrEF are not on evidence-based therapies, and why the percentages are consistent across national registries over time. One explanation might be that providers know the data regarding evidence-based therapies, but the therapies only benefit a narrow population. Another factor might be a lack of knowledge among providers about the appropriate management of HFrEF patients. A simple way to test this hypothesis is to examine whether electronic health record (EHR) based "best practice advisories" (BPAs) can increase use of evidence based therapies. If found to be effective, these low cost interventions can be rapidly applied across large healthcare systems.
This study will conduct a randomized controlled trial across outpatient clinics within a single health system comparing the effectiveness of an EHR-based alerting system that informs practitioners about what evidence-based medications they can prescribe for HFrEF patients versus usual care (no alert). One hundred eligible unique providers will be randomized to an intervention in which an alert will appear for all eligible patients with HFrEF, or to a control group in which no alert appears and usual care will continue, with a target patient enrollment of 1,310. The primary outcome for the trial will be the proportion of patients with HFrEF with an increase in evidence based medical therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i). Secondary outcomes will include 30-day hospital admission rates, 30-day ED visits, one year all-cause mortality, and total 6 month healthcare costs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EHR-based alert | Experimental | Other: Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. |
| Usual Care | No intervention | –Providers will not receive an alert and will proceed with usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure. | Other | EHR-based alert |
Primary outcome
Percentage of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) With an Increase in Prescribed HFrEF Therapy
Time frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.
17 secondary outcomes
Percentage of Patients on Beta Blockers
Time frame: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on ACE Inhibitors
Time frame: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on ARBs
Time frame: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on ARNIs
Time frame: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on MRAs
Time frame: Assessed from the date of randomization to 30 days post-randomization
Percentage of Patients on SGLT2 Inhibitors
Time frame: Assessed from the date of randomization to 30 days post-randomization
Rate of One-year All-cause Mortality
Time frame: Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization
Rate of 30-day Hospital Admission
Time frame: Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization
Rate of 30-day All-cause Emergency Department Visits
Time frame: Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization
Total Six-month Healthcare Costs
Time frame: Assessed from the date of randomization to 6 months post-randomization
Percentage of Filled Prescriptions
Time frame: Assessed 6 months post-randomization
Medication Dose of Any Prescribed Beta Blocker
Time frame: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed ACEi
Time frame: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed ARB
Time frame: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed ARNI
Time frame: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed MRA
Time frame: Assessed at 6 months post-randomization
Medication Dose of Any Prescribed SGLT2 Inhibitor
Time frame: Assessed at 6 months post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35385798Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial. J Am Coll Cardiol. 2022 Jun 7;79(22):2203-2213. doi: 10.1016/j.jacc.2022.03.338. Epub 2022 Apr 3.
- Derived from this study: PubMed 34808104Ghazi L, Desai NR, Simonov M, Yamamoto Y, O'Connor KD, Riello RJ, Huang J, Olufade T, McDermott J, Inzucchi SE, Velazquez EJ, Wilson FP, Ahmad T. Rationale and design of a cluster-randomized pragmatic trial aimed at improving use of guideline directed medical therapy in outpatients with heart failure: PRagmatic trial of messaging to providers about treatment of heart failure (PROMPT-HF). Am Heart J. 2022 Feb;244:107-115. doi: 10.1016/j.ahj.2021.11.010. Epub 2021 Nov 20.
- Individual participant dataSharing planned: Yes. Deidentified data underlying results for publication will be made available upon publication of results.
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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. This study is not recruiting at the moment.
Tariq Ahmad, MD MPH principal investigator
Yale University
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 alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial) in people with Heart Failure With Reduced Ejection Fraction, run by Yale University 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?
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: finished, as of the sponsor's last update on 1 Jul 2025. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) With an Increase in Prescribed HFrEF Therapy (time frame: Assessed from the date of randomization to 30 days post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04514458, which also lists 2 linked publications.
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 1 Jul 2025.