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Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure (PROMPT-HF)

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best practice alert for the notification of patient HFrEF and recommended evidence-based 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 With Reduced Ejection Fraction

Eligibility Criteria

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

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

Sites / Locations

  • Yale New Haven Health System selected outpatient clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EHR-based 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 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 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.

Secondary Outcome Measures

Percentage of patient on beta blockers
Assessed as the number of patients with prescribed beta blockers
Percentage of patient on ACE inhibitors
Assessed as the number of patients with a prescribed ACEi
Percentage of patient on ARBs
Assessed as the number of patients with a prescribed ARB
Percentage of patient on ARNIs
Assessed as the number of patients with a prescribed ARNI
Percentage of patient on MRAs
Assessed as the number of patients with a prescribed MRA
Percentage of patient on SGLT2 inhibitors
Assessed as the number of patients with a prescribed SGLT2i
Rate of one-year all-cause mortality
Rate of 30-day hospital admission
Rate of 30-day all-cause emergency department visits
Total six-month healthcare costs
Percentage of filled prescriptions
Proportion of prescriptions filled as assessed by SureScripts
Medication dose of any prescribed beta blocker
Medication dose of any prescribed ACEi
Medication dose of any prescribed ARB
Medication dose of any prescribed ARNI
Medication dose of any prescribed MRA
Medication dose of any prescribed SGLT2 inhibitor

Full Information

First Posted
July 29, 2020
Last Updated
December 8, 2022
Sponsor
Yale University
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04514458
Brief Title
Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
Acronym
PROMPT-HF
Official Title
Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
January 25, 2021 (Actual)
Primary Completion Date
November 20, 2021 (Actual)
Study Completion Date
October 20, 2022 (Actual)

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
EHR-based 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 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 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 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 HFrEF therapy
Description
Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.
Time Frame
Assessed from the date of randomization to 30 days post-randomization
Secondary Outcome Measure Information:
Title
Percentage of patient on beta blockers
Description
Assessed as the number of patients with prescribed beta blockers
Time Frame
Assessed from the date of randomization to 30 days post-randomization
Title
Percentage of patient on ACE inhibitors
Description
Assessed as the number of patients with a prescribed ACEi
Time Frame
Assessed from the date of randomization to 30 days post-randomization
Title
Percentage of patient on ARBs
Description
Assessed as the number of patients with a prescribed ARB
Time Frame
Assessed from the date of randomization to 30 days post-randomization
Title
Percentage of patient on ARNIs
Description
Assessed as the number of patients with a prescribed ARNI
Time Frame
Assessed from the date of randomization to 30 days post-randomization
Title
Percentage of patient on MRAs
Description
Assessed as the number of patients with a prescribed MRA
Time Frame
Assessed from the date of randomization to 30 days post-randomization
Title
Percentage of patient on SGLT2 inhibitors
Description
Assessed as the number of patients with a prescribed SGLT2i
Time Frame
Assessed from the date of randomization to 30 days post-randomization
Title
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
Title
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
Title
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
Title
Total six-month healthcare costs
Time Frame
Assessed from the date of randomization to 6 months post-randomization
Title
Percentage of filled prescriptions
Description
Proportion of prescriptions filled as assessed by SureScripts
Time Frame
Assessed 6 months post-randomization
Title
Medication dose of any prescribed beta blocker
Time Frame
Assessed at 6 months post-randomization
Title
Medication dose of any prescribed ACEi
Time Frame
Assessed at 6 months post-randomization
Title
Medication dose of any prescribed ARB
Time Frame
Assessed at 6 months post-randomization
Title
Medication dose of any prescribed ARNI
Time Frame
Assessed at 6 months post-randomization
Title
Medication dose of any prescribed MRA
Time Frame
Assessed at 6 months post-randomization
Title
Medication dose of any prescribed SGLT2 inhibitor
Time Frame
Assessed at 6 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tariq Ahmad, MD MPH
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Health System selected outpatient clinics
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States

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.
Citations:
PubMed Identifier
35385798
Citation
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.
Results Reference
derived
PubMed Identifier
34808104
Citation
Ghazi 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.
Results Reference
derived

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Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

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