Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
- Conditions
- Heart Failure With Reduced Ejection Fraction
- Registration Number
- NCT04514458
- Lead Sponsor
- Yale University
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1410
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Percentage of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) With an Increase in Prescribed HFrEF Therapy 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
Name Time Method Percentage of Patients on Beta Blockers Assessed from the date of randomization to 30 days post-randomization Assessed as the number of patients with prescribed beta blockers
Percentage of Patients on ACE Inhibitors Assessed from the date of randomization to 30 days post-randomization Assessed as the number of patients with a prescribed ACEi
Percentage of Patients on ARBs Assessed from the date of randomization to 30 days post-randomization Assessed as the number of patients with a prescribed ARB
Percentage of Patients on ARNIs Assessed from the date of randomization to 30 days post-randomization Assessed as the number of patients with a prescribed ARNI
Percentage of Patients on MRAs Assessed from the date of randomization to 30 days post-randomization Assessed as the number of patients with a prescribed MRA
Percentage of Patients on SGLT2 Inhibitors Assessed from the date of randomization to 30 days post-randomization Assessed as the number of patients with a prescribed SGLT2i
Rate of One-year All-cause Mortality Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization Assessed as the number of patients who expired from randomization up to one year from any cause.
Rate of 30-day Hospital Admission Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization Number of participants with a hospitalization within 30 days of randomization
Rate of 30-day All-cause Emergency Department Visits Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization Number of participants with an emergency department visit within 30 days of randomization.
Total Six-month Healthcare Costs Assessed from the date of randomization to 6 months post-randomization Assessed as total direct and indirect cost of patient care from randomization to 6 months post randomization.
Percentage of Filled Prescriptions Assessed 6 months post-randomization Proportion of prescriptions filled as assessed by SureScripts
Medication Dose of Any Prescribed Beta Blocker Assessed at 6 months post-randomization Medication Dose of Any Prescribed ACEi Assessed at 6 months post-randomization Medication Dose of Any Prescribed ARB Assessed at 6 months post-randomization Medication Dose of Any Prescribed ARNI Assessed at 6 months post-randomization Medication Dose of Any Prescribed MRA Assessed at 6 months post-randomization Medication Dose of Any Prescribed SGLT2 Inhibitor Assessed at 6 months post-randomization
Trial Locations
- Locations (1)
Yale New Haven Health System selected outpatient clinics
🇺🇸New Haven, Connecticut, United States
Yale New Haven Health System selected outpatient clinics🇺🇸New Haven, Connecticut, United States