Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

Heart Failure With Reduced Ejection Fraction Clinical Trial

— PROMPT-HF  

Official title:

Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514458
• Other study ID #: 2000027014
• Status: Completed
• Phase: N/A
• Start date: January 25, 2021
• Est. completion date: October 20, 2022

Study information

• Verified date: December 2022
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 20, 2022
• Est. primary completion date: November 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)
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.

Locations

Country	Name	City	State
United States	Yale New Haven Health System selected outpatient clinics	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with HFrEF with an increase in prescribed HFrEF therapy	Assessed as an increase in the number of prescribed targeted evidence-based therapies for HFrEF, including beta-blockers, ACEi, ARBs, ARNIs, MRAs, and SGLT2is.	Assessed from the date of randomization to 30 days post-randomization
Secondary	Percentage of patient on beta blockers	Assessed as the number of patients with prescribed beta blockers	Assessed from the date of randomization to 30 days post-randomization
Secondary	Percentage of patient on ACE inhibitors	Assessed as the number of patients with a prescribed ACEi	Assessed from the date of randomization to 30 days post-randomization
Secondary	Percentage of patient on ARBs	Assessed as the number of patients with a prescribed ARB	Assessed from the date of randomization to 30 days post-randomization
Secondary	Percentage of patient on ARNIs	Assessed as the number of patients with a prescribed ARNI	Assessed from the date of randomization to 30 days post-randomization
Secondary	Percentage of patient on MRAs	Assessed as the number of patients with a prescribed MRA	Assessed from the date of randomization to 30 days post-randomization
Secondary	Percentage of patient on SGLT2 inhibitors	Assessed as the number of patients with a prescribed SGLT2i	Assessed from the date of randomization to 30 days post-randomization
Secondary	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
Secondary	Rate of 30-day hospital admission		Assessed from the date of randomization to the date of hospital admission, up to 30 days post-randomization
Secondary	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
Secondary	Total six-month healthcare costs		Assessed from the date of randomization to 6 months post-randomization
Secondary	Percentage of filled prescriptions	Proportion of prescriptions filled as assessed by SureScripts	Assessed 6 months post-randomization
Secondary	Medication dose of any prescribed beta blocker		Assessed at 6 months post-randomization
Secondary	Medication dose of any prescribed ACEi		Assessed at 6 months post-randomization
Secondary	Medication dose of any prescribed ARB		Assessed at 6 months post-randomization
Secondary	Medication dose of any prescribed ARNI		Assessed at 6 months post-randomization
Secondary	Medication dose of any prescribed MRA		Assessed at 6 months post-randomization
Secondary	Medication dose of any prescribed SGLT2 inhibitor		Assessed at 6 months post-randomization