Shared Decision for Drug Interactions in Oral Anticoagulation

Drug Interactions Clinical Trial

— DDInteract  

Official title:

Implementation of DDInteract A Shared-decision Making Tool for Anticoagulant Drug-Drug INTERACTions (DDinteract)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06401863
• Other study ID #: IRB_00167936
• Secondary ID: R18HS029300
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2024
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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).

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Anticoagulants
• Drug Interactions

Intervention

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

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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

Outcome

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