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

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best practice alert for the notification of patient HFrEF and recommended evidence-based medical therapies (NO drugs are being administered in this trial)
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Electron Health Record-based Provider Alert

Usual Care

Arm Description

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.

Providers will not receive an alert and will proceed with usual care.

Outcomes

Primary Outcome Measures

Proportion of patients with HFrEF with an increase in prescribed evidence-based HFrEF medical therapy
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

The percentage increase of beta blockers for HFrEF
Increase in proportion of patients on beta blockers
The percentage increase of ACEi/ARB/ARNI for HFrEF
Increase in proportion of patients on ACEi/ARB/ARNI
The percentage increase of MRAs for HFrEF
Increase in proportion of patients on MRAs
The percentage increase of SGLT2i for HFrEF
Increase in proportion of patients on SGLT2i
30-day hospital readmission rates
30-day emergency department visits
6 months all-cause mortality
Percentage of evidence-based medical therapy prescriptions for HFrEF filled by patients within 30 days of discharge
Percentage of patients who filled evidence-based medical therapies. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.

Full Information

First Posted
December 16, 2020
Last Updated
September 29, 2022
Sponsor
Yale University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04686604
Brief Title
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting
Acronym
PROMPT-HF
Official Title
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1012 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electron Health Record-based Provider Alert
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Providers will not receive an alert and will proceed with usual care.
Intervention Type
Other
Intervention Name(s)
Best practice alert for the notification of patient HFrEF and recommended evidence-based medical therapies (NO drugs are being administered in this trial)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with HFrEF with an increase in prescribed evidence-based HFrEF medical therapy
Description
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.
Time Frame
Assessed from the date of randomization to discharge date, assessed up to 12 months.
Secondary Outcome Measure Information:
Title
The percentage increase of beta blockers for HFrEF
Description
Increase in proportion of patients on beta blockers
Time Frame
Assessed from the date of randomization to discharge date, assessed up to 12 months.
Title
The percentage increase of ACEi/ARB/ARNI for HFrEF
Description
Increase in proportion of patients on ACEi/ARB/ARNI
Time Frame
Assessed from the date of randomization to discharge date, assessed up to 12 months.
Title
The percentage increase of MRAs for HFrEF
Description
Increase in proportion of patients on MRAs
Time Frame
Assessed from the date of randomization to discharge date, assessed up to 12 months.
Title
The percentage increase of SGLT2i for HFrEF
Description
Increase in proportion of patients on SGLT2i
Time Frame
Assessed from the date of randomization to discharge date, assessed up to 12 months.
Title
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
Title
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
Title
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
Title
Percentage of evidence-based medical therapy prescriptions for HFrEF filled by patients within 30 days of discharge
Description
Percentage of patients who filled evidence-based medical therapies. Evidence-based medical therapies include: beta-blockers, ACEi/ARBs/ARNIs, MRAs, and SGLT2is.
Time Frame
Assessed from the date of discharge and up to 30 days post-discharge.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: NT-pro-BNP >500 pg/ml within 24 hours of admission On IV loop diuretic within 24 hours of admission 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tariq Ahmad, MD, MPH
Phone
203-785-7191
Email
tariq.ahmad@yale.edu
Facility Information:
Facility Name
Yale New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tariq Ahmad
Phone
203-843-1667
Email
tariq.ahmad@yale.edu
First Name & Middle Initial & Last Name & Degree
Lama Ghazi
Phone
+1 (203) 8431667
Email
lama.ghazi@yale.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Deidentified data underlying results for publication will be made available upon publication of results.
IPD Sharing Time Frame
Upon publication of results; indefinitely.
Links:
URL
https://www.theprompttrials.org/
Description
Trial Website

Learn more about this trial

PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting

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