Shared Decision for Drug Interactions in Oral Anticoagulation (DDInteract)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anticoagulants; Drug Interactions
• Intervention / Treatment: Other: Shared Decision Making Tool

Detailed 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).

• Study Type: Interventional
• Enrollment (Estimated): 3691
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniel C Malone, PhD; Phone Number: 801 581 8054; Email: dan.malone@utah.edu
• Study Contact Backup: Name: Ainhoa Gomez Lumbreras, MD, PhD; Phone Number: 8015853201; Email: Ainhoa.Gomez-Lumbreras@pharm.utah.edu

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • Recruiting
      • University of Colorado. School of Medicine
      • Contact: Katy E Trinkley, PharmD, PhD; Phone Number: 303-724-3103; Email: katy.trinkley@cuanschutz.edu
      • Contact: James Mitchell, PhD; Phone Number: 720-694-5616; Email: james.2.mitchell@cuanschutz.edu
      • Principal Investigator: Katy Trinkley
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Recruiting
      • Vanderbilt University
      • Contact: Tom J Reese, PharmD, PhD; Phone Number: (615) 936 6867; Email: Thomeas.Reese@vumv.org
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Enrolling by invitation
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Shared Decision Making Tool; EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage; Other Names: Shared Decision Making Tool to reduce harm from Drug Interactions
No Intervention: Standard of Care; This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Daniel C Malone, PhD, College of Pharmacy. University of Utah

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: May 5, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Shared Decision Making; Oral anticoagulants; Drug interactions; Gastrointestinal hemorrhage
• Other Study ID Numbers: IRB_00167936; R18HS029300 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No