Ignite Creation Date:
2024-05-06 @ 6:10 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05563714
Status:
COMPLETED
Last Update Posted:
2024-04-30
First Post:
2022-09-28
Brief Title:
Anticoagulation With Enhanced Gastrointestinal Safety
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Anticoagulation With Enhanced Gastrointestinal Safety AEGIS A Pragmatic Randomized Trial to Evaluate Clinician Outreach to Reduce Upper Gastrointestinal Bleeding Risk in Patients Taking Warfarin and Antiplatelet Therapy
Status:
COMPLETED
Status Verified Date:
2024-04
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:
AEGIS
Brief Summary:
This study is a pragmatic cluster randomized controlled trial to evaluate the effectiveness of a clinician-facing implementation strategy on the use of medication optimization defined as either discontinuation of all antiplatelet therapy or initiation of and adherence to a proton pump inhibitor PPI to reduce upper GI bleeding risk in patients prescribed anticoagulant-antiplatelet therapy AAT relative to usual care
Detailed Description:
This is a pragmatic single-center cluster randomized controlled trial to evaluate a clinician-facing implementation strategy to increase the use of evidence-based practices EBPs to reduce bleeding in patients who are using AAT and who are managed by the Michigan Medicine anticoagulation monitoring service The active intervention is clinician notification with nurse facilitation CNNF which consists of an anticoagulation clinic nurse sending an electronic health record message that identifies the patient as high risk for upper GI bleeding and recommends either discontinuing the antiplatelet agent or initiating a PPI the nurse also pends medication orders for PPIs and provides patient education upon request Clinicians will be cluster randomized such that up to 4 patients cared for by each clinician will receive the same clinician-level notification
This study will use a wait-listed design in which patients will be randomized to either have their clinicians receive CNNF or be included in a wait-list control group At the completion of the study the patients who were randomized to the wait-list control group will receive the intervention
This study will use a wait-listed design in which patients will be randomized to either have their clinicians receive CNNF or be included in a wait-list control group At the completion of the study the patients who were randomized to the wait-list control group will receive the intervention
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23DK118179 | NIH | None | httpsreporternihgovquickSearchK23DK118179 |