Shared Decision for Drug Interactions in Oral Anticoagulation

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Utah
Study ID
NCT06401863
Status
Recruiting
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Conditions

  • Anticoagulants
  • Drug Interactions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Shared Decision Making Tool — OTHER
    EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage

Study Details

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.

Key Dates

Start date
Oct 1, 2023
Status verified
May 2025
Primary completion
Feb 28, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
3,691 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Experimental: 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.
  • No Intervention: Standard of Care
    This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented.

Primary Outcome Measure

Differences of Differences in Estimated Risk of Gastrointestinal Bleeding by DDInteract algorithm [ Time Frame: Through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Colorado. School of MedicineDenverColorado80045
Katy E Trinkley, PharmD, PhD
[email protected]
303-724-3103
James Mitchell, PhD
[email protected]
720-694-5616
Katy Trinkley (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37235
Tom J Reese, PharmD, PhD
[email protected]
(615) 936 6867
University of UtahSalt Lake CityUtah84112-

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By research site
University of Colorado. School of Medicine· Denver, COVanderbilt University· Nashville, TNUniversity of Utah· Salt Lake City, UT

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