Yale New Haven Health System selected outpatient clinics
New Haven, Connecticut, 06510, United States
NCT Number: NCT04514458
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06510, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Selection of Providers:
Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
Time frame: 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.
Time frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with prescribed beta blockers
Time frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed ACEi
Time frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed ARB
Time frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed ARNI
Time frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed MRA
Time frame: Assessed from the date of randomization to 30 days post-randomization
Assessed as the number of patients with a prescribed SGLT2i
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Assessed 6 months post-randomization
Proportion of prescriptions filled as assessed by SureScripts
Time frame: Assessed at 6 months post-randomization
Time frame: Assessed at 6 months post-randomization
Time frame: Assessed at 6 months post-randomization
Time frame: Assessed at 6 months post-randomization
Time frame: Assessed at 6 months post-randomization
Time frame: Assessed at 6 months post-randomization
Yale University
Other
Acronym: PROMPT-HF
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