Shared Decision for Drug Interactions in Oral Anticoagulation
NCT ID: NCT06401863
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
3691 participants
INTERVENTIONAL
2023-10-01
2026-07-31
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Exposure to DDInteract tool in anticoagulated patients
This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has been implemented. This intervention is referred to as DDInteract tool exposure in anticoagulated patients. DDInteract may be accessed by clinicians to evaluate risk of harm from drug-drug interactions for patients on anticoagulants.
Shared Decision Making Tool
EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage
Standard of Care
This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented.
No interventions assigned to this group
Interventions
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Shared Decision Making Tool
EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Receive more than one prescription of an oral anticoagulant (i.e. warfarin, apixaban, edoxaban, dabigatran, rivaroxaban)
Exclusion Criteria
21 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
University of Utah
OTHER
Responsible Party
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Daniel Malone
Professor
Principal Investigators
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Daniel C Malone, PhD
Role: PRINCIPAL_INVESTIGATOR
College of Pharmacy. University of Utah
Locations
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University of Colorado. School of Medicine
Denver, Colorado, United States
Vanderbilt University
Nashville, Tennessee, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Gomez Lumbreras A, Reese TJ, Del Fiol G, Tan MS, Butler JM, Hurwitz JT, Brown M, Kawamoto K, Thiess H, Wright M, Malone DC. Shared Decision-Making for Drug-Drug Interactions: Formative Evaluation of an Anticoagulant Drug Interaction. JMIR Form Res. 2022 Oct 19;6(10):e40018. doi: 10.2196/40018.
Reese TJ, Del Fiol G, Morgan K, Hurwitz JT, Kawamoto K, Gomez-Lumbreras A, Brown ML, Thiess H, Vazquez SR, Nelson SD, Boyce R, Malone D. A Shared Decision-making Tool for Drug Interactions Between Warfarin and Nonsteroidal Anti-inflammatory Drugs: Design and Usability Study. JMIR Hum Factors. 2021 Oct 26;8(4):e28618. doi: 10.2196/28618.
Other Identifiers
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IRB_00167936
Identifier Type: -
Identifier Source: org_study_id
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