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Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF) (BETTER CARE-HF)

Primary Purpose

Heart Failure, Heart Failure With Reduced Ejection Fraction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice Alert (BPA)
In-Basket Message
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Best Practice Alert [BPA], In-Basket message, Mineralocorticoid Receptor Antagonists [MRA], guideline-directed medical therapy [GDMT], Clinical decision support

Eligibility Criteria

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

Inclusion Criteria:

  • Cardiologist visit
  • Transthoracic echocardiogram with the most recent EF >= 40%

Exclusion Criteria:

  • Hypotension: SBP < 95
  • Hyperkalemia: most recent K > 5.1, or any K >5.5
  • Renal dysfunction: eGFR < 30
  • Ventricular assist device
  • Hospice care
  • Cardiac amyloid

Sites / Locations

  • NYU Langone Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Best Practice Alert group

In-Basket Message group

Control group

Arm Description

Providers will receive a BPA at the time of visit for patients with HFrEF who are not on MRA (and who do not have contraindication to MRA). This alert will display the patient's current HFrEF therapies, EF, blood pressure, potassium, and glomerular filtration rate. The alert will give access to an outpatient heart failure order set, and also provide links to the most recent guidelines.

Providers will receive a monthly in-basket messages linking to a list of patients who have been seen in the past 2 months or will be seen in the upcoming month with HFrEF who are not on MRA (and who do not have contraindication to MRA). This list will display each patient's current hFrEF therapies, EF, blood pressure, potassium, glomerular filtration rate, date of last visit, and date of next visit. From the list, providers can access the patient's chart, order medications, and document communication with the patient.

Patients who will receive the current standard practice of care (no BPA or in-basket message)

Outcomes

Primary Outcome Measures

Percentage of patients prescribed MRA

Secondary Outcome Measures

Incidence of provider engagement with each alert type
Provider engagement is reported when the provider clicks on links or buttons within each alert.

Full Information

First Posted
February 9, 2022
Last Updated
January 12, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05275920
Brief Title
Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
Acronym
BETTER CARE-HF
Official Title
Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
October 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

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

5. Study Description

Brief Summary
Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF) is a pragmatic, cluster-randomized, three-arm intervention trial that will compare the effectiveness of two targeted clinical decision support (CDS) intervention tools (best practice alert (BPA) and automated in-basket massage) to inform providers when a patient with heart failure and reduce ejection fraction (HFrEF) is not on appropriate medical therapy, as compared to usual care.
Detailed Description
An estimated 68,000 deaths per year nationwide can be attributed to gaps in care for patients with heart failure and reduced ejection fraction (HFrEF), with the majority being due to lack of mineralocorticoid receptor antagonists (MRA). Despite proven benefits in randomized trials, class I guideline recommendations, and published clinical performance measures, patients with HFrEF are often not on guideline-directed medical therapy (GDMT). While successful interventions for improvement in prescription of GDMT have often included multidisciplinary approaches with dedicated staff, the relatively high cost of hiring additional personnel has led to an interest in electronic health record (EHR)-based interventions. Prior studies on EHR-based interventions in this arena have mainly been conducted in the inpatient setting, which is limited to one encounter during acute hospitalization, a setting often complicated by renal dysfunction or hypotension that can limit prescription of MRA. The development and study of outpatient EHR-based alerts for HFrEF GDMT are needed. Two types of outpatient EHR-based interventions include best practice alerts (BPA) and automated in-basket messages. Both of these methods have limited data, with some studies showing benefit and others demonstrating provider fatigue and burnout. To our knowledge, there is no study that has directly compared these different types of EHR-based interventions. BETTER CARE - HF is a pragmatic, cluster-randomized, three-arm intervention trail that will compare the effectiveness of two targeted CDS intervention tools (BPA and automated in-basket message) as compared to usual care on the primary outcome of MRA prescription at end of study period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure With Reduced Ejection Fraction
Keywords
Best Practice Alert [BPA], In-Basket message, Mineralocorticoid Receptor Antagonists [MRA], guideline-directed medical therapy [GDMT], Clinical decision support

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Best Practice Alert group
Arm Type
Experimental
Arm Description
Providers will receive a BPA at the time of visit for patients with HFrEF who are not on MRA (and who do not have contraindication to MRA). This alert will display the patient's current HFrEF therapies, EF, blood pressure, potassium, and glomerular filtration rate. The alert will give access to an outpatient heart failure order set, and also provide links to the most recent guidelines.
Arm Title
In-Basket Message group
Arm Type
Experimental
Arm Description
Providers will receive a monthly in-basket messages linking to a list of patients who have been seen in the past 2 months or will be seen in the upcoming month with HFrEF who are not on MRA (and who do not have contraindication to MRA). This list will display each patient's current hFrEF therapies, EF, blood pressure, potassium, glomerular filtration rate, date of last visit, and date of next visit. From the list, providers can access the patient's chart, order medications, and document communication with the patient.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients who will receive the current standard practice of care (no BPA or in-basket message)
Intervention Type
Other
Intervention Name(s)
Best Practice Alert (BPA)
Intervention Description
A BPA will fire in the EHR reminding care providers of the best practice when prescribing medical therapies for heart failure patients.
Intervention Type
Other
Intervention Name(s)
In-Basket Message
Intervention Description
An In-Basket message will be sent biweekly to care providers with a reminder of the best practice when prescribing medical therapies for heart failure
Primary Outcome Measure Information:
Title
Percentage of patients prescribed MRA
Time Frame
through study completion, 1 year
Secondary Outcome Measure Information:
Title
Incidence of provider engagement with each alert type
Description
Provider engagement is reported when the provider clicks on links or buttons within each alert.
Time Frame
through study completion, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiologist visit Transthoracic echocardiogram with the most recent EF >= 40% Exclusion Criteria: Hypotension: SBP < 95 Hyperkalemia: most recent K > 5.1, or any K >5.5 Renal dysfunction: eGFR < 30 Ventricular assist device Hospice care Cardiac amyloid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amrita Mukhopadhyay, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Building Electronic Tools To Enhance and Reinforce CArdiovascular REcommendations - Heart Failure (BETTER CARE-HF)

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