Clinical trial NCT04514458: Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
Official title: Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2020-08-17
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Patient Inclusion Criteria:

* 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 Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients with HFrEF with an increase in prescribed HFrEF therapy
timeFrame: Assessed from the date of randomization to 30 days post-randomization
Secondary outcomes:
measure: Percentage of patient on beta blockers
timeFrame: Assessed from the date of randomization to 30 days post-randomization
measure: Percentage of patient on ACE inhibitors
timeFrame: Assessed from the date of randomization to 30 days post-randomization
measure: Percentage of patient on ARBs
timeFrame: Assessed from the date of randomization to 30 days post-randomization
measure: Percentage of patient on ARNIs
timeFrame: Assessed from the date of randomization to 30 days post-randomization
measure: Percentage of patient on MRAs
timeFrame: Assessed from the date of randomization to 30 days post-randomization
measure: Percentage of patient on SGLT2 inhibitors
timeFrame: Assessed from the date of randomization to 30 days post-randomization
measure: Rate of one-year all-cause mortality
timeFrame: Assessed from the date of randomization to the date of death from any cause, up to 365 days post-randomization
measure: Rate of 30-day hospital admission
timeFrame: Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization
measure: Rate of 30-day all-cause emergency department visits
timeFrame: Assessed from the date of randomization to the date of ED/ER admission, up to 30 days post-randomization
measure: Total six-month healthcare costs
timeFrame: Assessed from the date of randomization to 6 months post-randomization
measure: Percentage of filled prescriptions
timeFrame: Assessed 6 months post-randomization
measure: Medication dose of any prescribed beta blocker
timeFrame: Assessed at 6 months post-randomization
measure: Medication dose of any prescribed ACEi
timeFrame: Assessed at 6 months post-randomization
measure: Medication dose of any prescribed ARB
timeFrame: Assessed at 6 months post-randomization
measure: Medication dose of any prescribed ARNI
timeFrame: Assessed at 6 months post-randomization
measure: Medication dose of any prescribed MRA
timeFrame: Assessed at 6 months post-randomization
measure: Medication dose of any prescribed SGLT2 inhibitor
timeFrame: Assessed at 6 months post-randomization
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Health System selected outpatient clinics
state: Connecticut
Study officials:
affiliation: Yale University
name: Tariq Ahmad, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ghazi L, Yamamoto Y, Riello RJ, Coronel-Moreno C, Martin M, O'Connor KD, Simonov M, Huang J, Olufade T, McDermott J, Dhar R, Inzucchi SE, Velazquez EJ, Wilson FP, Desai NR, Ahmad T. Electronic Alerts to Improve Heart Failure Therapy in Outpatient Practice: A Cluster Randomized Trial. J Am Coll Cardiol. 2022 Jun 7;79(22):2203-2213. doi: 10.1016/j.jacc.2022.03.338. Epub 2022 Apr 3.
citation: Ghazi L, Desai NR, Simonov M, Yamamoto Y, O'Connor KD, Riello RJ, Huang J, Olufade T, McDermott J, Inzucchi SE, Velazquez EJ, Wilson FP, Ahmad T. Rationale and design of a cluster-randomized pragmatic trial aimed at improving use of guideline directed medical therapy in outpatients with heart failure: PRagmatic trial of messaging to providers about treatment of heart failure (PROMPT-HF). Am Heart J. 2022 Feb;244:107-115. doi: 10.1016/j.ahj.2021.11.010. Epub 2021 Nov 20.