Drug Interactions Clinical Trial
— DDInteractOfficial title:
Implementation of DDInteract A Shared-decision Making Tool for Anticoagulant Drug-Drug INTERACTions (DDinteract)
Verified date | May 2024 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 3691 |
Est. completion date | July 31, 2026 |
Est. primary completion date | February 28, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - Be at least 21 years of age or older - Receive more than one prescription of an oral anticoagulant (i.e. warfarin, apixaban, edoxaban, dabigatran, rivaroxaban) Exclusion Criteria: - Individuals not able to speak English or Spanish |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado. School of Medicine | Denver | Colorado |
United States | Vanderbilt University | Nashville | Tennessee |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | Agency for Healthcare Research and Quality (AHRQ) |
United States,
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Gastrointestinal Bleeding Episodes | Number of GI hemorrhage episodes by time period in the participation sites before and after DDInteract implementation | Through study completion, an average of 18 months, 6 months per sites (UoU, UC and VU) before and after implementation | |
Primary | 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 | Through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics |
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