Shared Decision for Drug Interactions in Oral Anticoagulation

NCT06401863 | Recruiting

• 2 other identifiers: IRB_00167936R18HS029300
• Study Type: interventional
• Target: 3,691
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Anticoagulants; Drug Interactions

Keywords

Oral anticoagulants; Drug interactions; Gastrointestinal hemorrhage; Shared Decision Making

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Gastrointestinal Bleeding Episodes

  Through study completion, an average of 18 months, 6 months per sites (UoU, UC and VU) before and after implementation

Study Arms (2)

Exposure to DDInteract tool in anticoagulated patients

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented.

Interventions

Shared Decision Making Tool OTHER

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

Exposure to DDInteract tool in anticoagulated patients

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Individuals not able to speak English or Spanish

Sponsors & Collaborators

• University of Utah: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (3)

University of Colorado. School of Medicine

Denver, Colorado, 80045, United States

RECRUITING

Vanderbilt University

Nashville, Tennessee, 37235, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84112, United States

ENROLLING BY INVITATION

Related 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.

  PMID: 36260377 BACKGROUND

• 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.

  PMID: 34698649 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Daniel C Malone, PhD

  College of Pharmacy. University of Utah

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniel C Malone, PhD

CONTACT

801 581 8054; dan.malone@utah.edu

Ainhoa Gomez Lumbreras, MD, PhD

CONTACT

8015853201; Ainhoa.Gomez-Lumbreras@pharm.utah.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking due to the nature of the intervention
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Rolling implementation at the clinic level with control clinics not exposed to the tool.

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 7, 2024
• Study Start: October 1, 2023
• Primary Completion: February 28, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

US (3)