search
Back to results

PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova (PROMPTHF-Inova)

Primary Purpose

Heart Failure

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice Advisory using Electronic Health Record
Sponsored by
Inova Health Care Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Heart Failure focused on measuring Heart Failure, GDMT, NYHA, HFrEF, Implementation

Eligibility Criteria

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

Inclusion Criteria:

  • Age>18 Years
  • Seen by a Cardiologist in an Inova clinic or Inova hospital setting
  • Left Ventricular Ejection Fraction ≤40%

Exclusion Criteria:

  • Opted out of EHR-based research
  • Hospice care
  • Already receiving maximally titrated doses of each of the four classes of evidence- based HFrEF medical therapy
  • Prior heart transplant

Sites / Locations

  • Inova Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alert when provider is entering orders

No alert, usual care

Arm Description

Outcomes

Primary Outcome Measures

Increased use of GDMT in patients with Heart Failure with Reduced Ejection Fraction
The primary outcome for the trial will be the proportion of patients with HFrEF who have an increase in the number of prescribed evidence-based therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i) 30 days after randomization.

Secondary Outcome Measures

All-cause hospitalization and all-cause mortality at 30 days
Outcomes will be determined by review of medical, hospital, and billing records.
All-cause hospitalization and all-cause mortality at 90 days
Outcomes will be determined by review of medical, hospital, and billing records.
All-cause hospitalization and all-cause mortality at 180 days
Outcomes will be determined by review of medical, hospital, and billing records.
All-cause hospitalization and all-cause mortality at 1 year
Outcomes will be determined by review of medical, hospital, and billing records.

Full Information

First Posted
June 21, 2022
Last Updated
October 6, 2023
Sponsor
Inova Health Care Services
search

1. Study Identification

Unique Protocol Identification Number
NCT05433220
Brief Title
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova
Acronym
PROMPTHF-Inova
Official Title
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure (PROMPT-HF) at Inova
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inova Health Care Services

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
A randomized, single-blind intervention trial to test the comparative effectiveness of an electronic health record best practice advisory system that informs clinicians of guideline-indicated and FDA-approved heart failure medications currently not prescribed to their patients with heart failure versus usual care (no alert and how things are done currently). The purpose of the alert is to stimulate appropriate medication prescription for patients with heart failure and a reduced ejection fraction. This will be done across outpatient Inova clinics and at the five Inova hospitals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, GDMT, NYHA, HFrEF, Implementation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
5000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alert when provider is entering orders
Arm Type
Experimental
Arm Title
No alert, usual care
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Best Practice Advisory using Electronic Health Record
Intervention Description
Providers caring for patients randomized to the intervention arm will have a best practice alert appear for each of their eligible patients upon opening of the order entry screen in the patient's medical record. This alert informs the provider to the presence of HFrEF, notes the patient's current LVEF and current evidence-based medications, and gives access to an order set with recommended evidence- based, guideline-recommended, and FDA- approved therapies for patients with HFrEF. Providers will also have access to a link to best available guideline recommended information regarding treatment of heart failure to allow further education if desired by the provider. The alerts will also clearly state the expected monitoring and follow-up required for prescriptions of these medications.
Primary Outcome Measure Information:
Title
Increased use of GDMT in patients with Heart Failure with Reduced Ejection Fraction
Description
The primary outcome for the trial will be the proportion of patients with HFrEF who have an increase in the number of prescribed evidence-based therapies for HFrEF (beta-blockers, ACE-I/ARB/ARNI, MRA, SGLT2i) 30 days after randomization.
Time Frame
30 days after randomization
Secondary Outcome Measure Information:
Title
All-cause hospitalization and all-cause mortality at 30 days
Description
Outcomes will be determined by review of medical, hospital, and billing records.
Time Frame
30 days
Title
All-cause hospitalization and all-cause mortality at 90 days
Description
Outcomes will be determined by review of medical, hospital, and billing records.
Time Frame
90 days
Title
All-cause hospitalization and all-cause mortality at 180 days
Description
Outcomes will be determined by review of medical, hospital, and billing records.
Time Frame
180 days
Title
All-cause hospitalization and all-cause mortality at 1 year
Description
Outcomes will be determined by review of medical, hospital, and billing records.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age>18 Years Seen by a Cardiologist in an Inova clinic or Inova hospital setting Left Ventricular Ejection Fraction ≤40% Exclusion Criteria: Opted out of EHR-based research Hospice care Already receiving maximally titrated doses of each of the four classes of evidence- based HFrEF medical therapy Prior heart transplant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew G Dimond, BS
Phone
7037762828
Email
matthew.dimond@inova.org
First Name & Middle Initial & Last Name or Official Title & Degree
Bhruga Shah, MS, BSN-RN
Phone
7037762828
Email
Bhruga.Shah@inova.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell Psotka, MD, PhD
Organizational Affiliation
Inova Health Care Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Health System
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Dimond
Phone
703-776-6248
Email
matthew.dimond@inova.org
First Name & Middle Initial & Last Name & Degree
Bhruga Shah
Phone
7037762828
Email
Bhruga.shah@inova.org

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Only aggregate participant data will be reported upon the completion of the project.
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT04686604?term=PROMPT-HF&draw=2&rank=1
Description
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting (PROMPT-HF)

Learn more about this trial

PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova

We'll reach out to this number within 24 hrs