An interventional study of Shared Decision Making Tool in Anticoagulants and Drug Interactions, sponsored by University of Utah. Active, not recruiting at 3 sites in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University of Utah · Not applicable, Interventional, and Prevention
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.
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 production/real-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).
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's planned enrollment of 3,691 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
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Of its 107 completed or terminated interventional studies of FDA-regulated products, 62 (58%) have results posted.
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Exclusion Criteria:
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.
Other: Shared Decision Making Tool
This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented.
EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage
Also known as: Shared Decision Making Tool to reduce harm from Drug Interactions
Differences of Differences in Estimated Risk of Gastrointestinal Bleeding by DDInteract algorithm
We will compare population Gastrointestinal Bleeding risk across the randomized clinics before and after implementation of DDInteract
Time frame: Through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics
Gastrointestinal Bleeding Episodes
Number of GI hemorrhage episodes by time period in the participation sites before and after DDInteract implementation
Time frame: Through study completion, an average of 18 months, 6 months per sites (UoU, UC and VU) before and after implementation
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Utah