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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04514458
Recruitment Status : Active, not recruiting
First Posted : August 17, 2020
Last Update Posted : May 17, 2022
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Yale University

Study Description
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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.

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

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1310 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
Actual Study Start Date : January 25, 2021
Actual Primary Completion Date : October 20, 2021
Estimated Study Completion Date : July 20, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EHR-based 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 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 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.
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 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.


Secondary Outcome Measures :
  1. Percentage of patient on beta blockers [ Time Frame: Assessed from the date of randomization to 30 days post-randomization ]
    Assessed as the number of patients with prescribed beta blockers

  2. Percentage of patient on ACE inhibitors [ Time Frame: Assessed from the date of randomization to 30 days post-randomization ]
    Assessed as the number of patients with a prescribed ACEi

  3. Percentage of patient on ARBs [ Time Frame: Assessed from the date of randomization to 30 days post-randomization ]
    Assessed as the number of patients with a prescribed ARB

  4. Percentage of patient on ARNIs [ Time Frame: Assessed from the date of randomization to 30 days post-randomization ]
    Assessed as the number of patients with a prescribed ARNI

  5. Percentage of patient on MRAs [ Time Frame: Assessed from the date of randomization to 30 days post-randomization ]
    Assessed as the number of patients with a prescribed MRA

  6. Percentage of patient on SGLT2 inhibitors [ Time Frame: Assessed from the date of randomization to 30 days post-randomization ]
    Assessed as the number of patients with a prescribed SGLT2i

  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Total six-month healthcare costs [ Time Frame: Assessed from the date of randomization to 6 months post-randomization ]
  11. Percentage of filled prescriptions [ Time Frame: Assessed 6 months post-randomization ]
    Proportion of prescriptions filled as assessed by SureScripts

  12. Medication dose of any prescribed beta blocker [ Time Frame: Assessed at 6 months post-randomization ]
  13. Medication dose of any prescribed ACEi [ Time Frame: Assessed at 6 months post-randomization ]
  14. Medication dose of any prescribed ARB [ Time Frame: Assessed at 6 months post-randomization ]
  15. Medication dose of any prescribed ARNI [ Time Frame: Assessed at 6 months post-randomization ]
  16. Medication dose of any prescribed MRA [ Time Frame: Assessed at 6 months post-randomization ]
  17. Medication dose of any prescribed SGLT2 inhibitor [ Time Frame: Assessed at 6 months post-randomization ]

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

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
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): NCT04514458


Locations
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United States, Connecticut
Yale New Haven Health System selected outpatient clinics
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
AstraZeneca
Investigators
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Principal Investigator: Tariq Ahmad, MD MPH Yale University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04514458    
Other Study ID Numbers: 2000027014
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: May 17, 2022
Last Verified: May 2022
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