Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04514458
Status:
COMPLETED
Last Update Posted:
2022-12-09
First Post:
2020-07-29
Brief Title:
Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Pragmatic Trial of Messaging to Providers About Treatment of Heart Failure
Status:
COMPLETED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROMPT-HF
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 1310 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-IARBARNI 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
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 1310 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-IARBARNI 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None