Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT04686604
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2020-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting
Sponsor:
Yale University
Organization:
Study Overview
Official Title:
PRagmatic Trial Of Messaging to Providers About Treatment of Heart Failure in the Inpatient Setting
Status:
COMPLETED
Status Verified Date:
2024-01
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 single-blind interventional trial to test the effectiveness of an electronic medical record-based best practice alert recommending evidence-based medical therapies versus usual care in inpatient adult patients presenting with heart failure with reduced ejection fraction.
Detailed Description:
Heart failure (HF) is the major cause of healthcare expenditure, morbidity, and mortality in the United States. HF is the primary diagnosis for hospital discharge in \~1 million and a secondary diagnosis in \~2 million hospitalizations annually in the US. In fact, inpatient admissions account for more than half of HF healthcare expenditure. 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 HF reduced ejection fraction (HFrEF) are not on evidence-based therapies especially post hospital discharge and why the percentages are consistent across national registries over time. Whether the gap between clinical trial use and real-world practice is due to a lack of knowledge or providers making individualized decisions about their patients is unclear. 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.
The goal of this trial is to determine the effectiveness of a BPA alert system that informs providers about evidence-based medical therapy for the treatment of HFrEF versus usual care (no alert) in the inpatient setting.
The goal of this trial is to determine the effectiveness of a BPA alert system that informs providers about evidence-based medical therapy for the treatment of HFrEF versus usual care (no alert) in the inpatient setting.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| No NIH funding | OTHER | 10.11.23 | View |