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

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ClinicalTrials.gov Identifier: NCT04686604
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : August 27, 2021
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
A randomized single-blind interventional trial to test the effectiveness of an electronic medical record-based best practice alert recommending evidence-based medical therapies versus usual care in inpatient adult patients presenting with heart failure with reduced ejection fraction.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Best practice alert for the notification of patient HFrEF and recommended evidence-based medical therapies (NO drugs are being administered in this trial) Not Applicable

Detailed Description:

Heart failure (HF) is the major cause of healthcare expenditure, morbidity, and mortality in the United States. HF is the primary diagnosis for hospital discharge in ~1 million and a secondary diagnosis in ~2 million hospitalizations annually in the US. In fact, inpatient admissions account for more than half of HF healthcare expenditure. 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 HF reduced ejection fraction (HFrEF) are not on evidence-based therapies especially post hospital discharge and why the percentages are consistent across national registries over time. Whether the gap between clinical trial use and real-world practice is due to a lack of knowledge or providers making individualized decisions about their patients is unclear. 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.

The goal of this trial is to determine the effectiveness of a BPA alert system that informs providers about evidence-based medical therapy for the treatment of HFrEF versus usual care (no alert) in the inpatient setting.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1012 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting
Actual Study Start Date : July 7, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Electron Health Record-based Provider Alert
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, most recent blood pressure and heart rate, most recent potassium and estimated glomerular filtration rate, 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: Best practice alert for the notification of patient HFrEF and recommended evidence-based medical 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, most recent blood pressure and heart rate, most recent potassium and estimated glomerular filtration rate, 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.
No Intervention: Usual Care
Providers will not receive an alert and will proceed with usual care.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with HFrEF with an increase in prescribed evidence-based HFrEF medical therapy [ Time Frame: Assessed from the date of randomization to discharge date, assessed up to 12 months. ]
    Assessed as an increase in the number of prescribed targeted evidence-based medical therapies for HFrEF. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.


Secondary Outcome Measures :
  1. The percentage increase of beta blockers for HFrEF [ Time Frame: Assessed from the date of randomization to discharge date, assessed up to 12 months. ]
    Increase in proportion of patients on beta blockers

  2. The percentage increase of ACEi/ARB/ARNI for HFrEF [ Time Frame: Assessed from the date of randomization to discharge date, assessed up to 12 months. ]
    Increase in proportion of patients on ACEi/ARB/ARNI

  3. The percentage increase of MRAs for HFrEF [ Time Frame: Assessed from the date of randomization to discharge date, assessed up to 12 months. ]
    Increase in proportion of patients on MRAs

  4. The percentage increase of SGLT2i for HFrEF [ Time Frame: Assessed from the date of randomization to discharge date, assessed up to 12 months. ]
    Increase in proportion of patients on SGLT2i

  5. 30-day hospital readmission rates [ Time Frame: Assessed from the date of discharge to the date of hospital readmission, up to 30 days post-discharge ]
  6. 30-day emergency department visits [ Time Frame: Assessed from the date of discharge to the date of ED/ER admission, up to 30 days post-discharge ]
  7. 6 months all-cause mortality [ Time Frame: Assessed from the date of randomization to the date of death from any cause, up to 6 months post-randomization ]
  8. Percentage of evidence-based medical therapy prescriptions for HFrEF filled by patients within 30 days of discharge [ Time Frame: Assessed from the date of discharge and up to 30 days post-discharge. ]
    Percentage of patients who filled evidence-based medical therapies. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥18 years admitted to a hospital within the Yale New Haven Hospital system (either Yale New Haven Hospital, St. Raphael's Campus, Greenwich Hospital, or Bridgeport Hospital).

  • Have HFrEF defined as:

    1. NT-pro-BNP >500 pg/ml within 24 hours of admission
    2. On IV loop diuretic within 24 hours of admission
    3. Left ventricular ejection fraction ≤40% (most recent)

Exclusion Criteria:

  • Patients within 48 hours of admission
  • Patients in the intensive care unit
  • Patients on hospice service
  • Patients receiving intravenous milrinone
  • Patient on NPO (nothing by mouth) order
  • Patients on all evidence based medical therapy for HFrEF (on all 4 classes of evidence based medical therapy: beta-blockers, ACEi/ARB/ARNI, MRA, SGLT2i)
  • Opted out of medical record research
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686604


Contacts
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Contact: Tariq Ahmad, MD, MPH 203-785-7191 tariq.ahmad@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06512
Contact: Tariq Ahmad    203-843-1667    tariq.ahmad@yale.edu   
Contact: Lama Ghazi    +1 (203) 8431667    lama.ghazi@yale.edu   
Sponsors and Collaborators
Yale University
AstraZeneca
More Information
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Additional Information:

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04686604    
Other Study ID Numbers: 2000029438
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data underlying results for publication will be made available upon publication of results.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Upon publication of results; indefinitely.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases