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Best Practice Advisory Alerts for Heart Failure (PROMPTHF-Inova Trial)

N/A
Recruiting
Led By Mitchell Psotka, MD, PhD
Research Sponsored by Inova Health Care Services
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Left Ventricular Ejection Fraction ≤40%
Age > 18 Years
Must not have
Opted out of EHR-based research
Hospice care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether an electronic best practice advisory system, which notifies clinicians of guideline-indicated and FDA-approved heart failure medications currently not prescribed to their patients, is more effective than usual care in stimulating appropriate medication prescription for patients with heart failure and a reduced ejection fraction.

Who is the study for?
This trial is for heart failure patients over 18 years old with a left ventricular ejection fraction of 40% or less, seen by a cardiologist at Inova clinics or hospitals. It's not for those who've opted out of EHR research, had a heart transplant, are on full doses of HFrEF meds, or in hospice care.
What is being tested?
The study tests if an electronic alert system helps doctors prescribe the right FDA-approved heart failure meds versus usual care without alerts. Patients will be randomly assigned to receive either the new alert system approach or continue with standard practices.
What are the potential side effects?
Since this trial involves an electronic health record intervention rather than medication, there are no direct side effects from drugs being tested. However, changes in medication prescription patterns could indirectly affect patient outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart's pumping ability is reduced.
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have chosen not to participate in research using my electronic health records.
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I am not currently receiving hospice care.
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I am on the highest doses of all four key heart failure medications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Increased use of GDMT in patients with Heart Failure with Reduced Ejection Fraction
Secondary study objectives
All-cause hospitalization and all-cause mortality at 1 year
Perinatal death
Perinatal death
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Alert when provider is entering ordersExperimental Treatment1 Intervention
Group II: No alert, usual careActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Heart Failure CollaboratoryUNKNOWN
Inova Health Care ServicesLead Sponsor
73 Previous Clinical Trials
17,412 Total Patients Enrolled
5 Trials studying Heart Failure
511 Patients Enrolled for Heart Failure
Mitchell Psotka, MD, PhDPrincipal InvestigatorInova Health Care Services

Media Library

Best Practice Advisory using Electronic Health Record Clinical Trial Eligibility Overview. Trial Name: NCT05433220 — N/A
Heart Failure Research Study Groups: Alert when provider is entering orders, No alert, usual care
Heart Failure Clinical Trial 2023: Best Practice Advisory using Electronic Health Record Highlights & Side Effects. Trial Name: NCT05433220 — N/A
Best Practice Advisory using Electronic Health Record 2023 Treatment Timeline for Medical Study. Trial Name: NCT05433220 — N/A
~758 spots leftby Jun 2025
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