PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure at Inova
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorInova Health Care Services
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age>18 Years
Seen by a Cardiologist in an Inova clinic or Inova hospital setting
Left Ventricular Ejection Fraction ≤40%
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Best Practice Advisory using Electronic Health Record
Other interventionProviders 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.
Treatment groups
5,000 Participants
are divided into 2 treatment groupsGroup A: Alert when provider is entering ordersExperimental treatment 1 intervention
Group B: No alert, usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
30 days after randomizationSecondary outcomes
1
All-cause hospitalization and all-cause mortality at 30 days
Outcomes will be determined by review of medical, hospital, and billing records.
Time frame
30 days2
All-cause hospitalization and all-cause mortality at 90 days
Outcomes will be determined by review of medical, hospital, and billing records.
Time frame
90 days3
All-cause hospitalization and all-cause mortality at 180 days
Outcomes will be determined by review of medical, hospital, and billing records.
Time frame
180 days4
All-cause hospitalization and all-cause mortality at 1 year
Outcomes will be determined by review of medical, hospital, and billing records.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov