Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06401863
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-25
Brief Title:
Shared Decision for Drug Interactions in Oral Anticoagulation
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Implementation of DDInteract A Shared-decision Making Tool for Anticoagulant Drug-Drug INTERACTions DDinteract
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
DDInteract
Brief Summary:
The purpose of this project is to implement and evaluate a shared-decision making SDM tool called DDInteract that was developed to support decision making for drug-drugs interactions while on oral anticoagulants DDInteract will be implemented in clinics at the University of Utah University of Colorado and University of Vanderbilt DDInteract will be launched from within the electronic health record EHR retrieving patient-specific risk factors will calculate the risk of harm and will allow providers and patients to dynamically explore what if scenarios to optimize treatment and minimize risk DDInteract will enable shared-decision making using individually-tailored information on the potential benefits and harms of drug interactions in anticoagulated patients
Detailed Description:
The purpose of this project are 1 Examine contextual factors and define relevant implementation strategies to facilitate integration of DDInteract within 3 university-based healthcare systems 2 Evaluate DDInteract in productionreal-world situations to identify barriers and facilitators to adoption and use of DDInteract and to develop solutions to overcome those barriers 3 Conduct a cluster randomized multi-system trial to evaluate the effectiveness of DDInteract to mitigate exposure to drug interactions involving oral anticoagulants This project will implement a SDM tool designed to inform clinicians and patients about the risk of harm from drug interactions in patients receiving oral anticoagulants An initial version of the DDInteract will be EHR-integrated and will be accessed directly in the EHR and auto-populate relevant patient-specific data including other medications that might interact with oral anticoagulants
This study will use a multi-center randomized cluster design using clinics from the above-mentioned institutions Each organization will implement DDInteract in their electronic health record system and the study will evaluate the degree to which the tool is utilized within each organization The implementation period will last 18 months This project is supported by a R18 award from Agency for Healthcare Research and Quality AHRQ
This study will use a multi-center randomized cluster design using clinics from the above-mentioned institutions Each organization will implement DDInteract in their electronic health record system and the study will evaluate the degree to which the tool is utilized within each organization The implementation period will last 18 months This project is supported by a R18 award from Agency for Healthcare Research and Quality AHRQ
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 |
|---|---|---|---|
| R18HS029300 | AHRQ | None | httpsreporternihgovquickSearchR18HS029300 |