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Active, Not Recruiting

NCT Number: NCT06401863

Shared Decision for Drug Interactions in Oral Anticoagulation

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anticoagulants Digestive System Diseases Drug Interactions Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado. School of Medicine, Denver, Colorado, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shared Decision Making Tool

Other

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

Primary outcomes

  1. Differences of Differences in Estimated Risk of Gastrointestinal Bleeding by DDInteract algorithm

    Time frame: Through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics

    We will compare population Gastrointestinal Bleeding risk across the randomized clinics before and after implementation of DDInteract

Other outcomes

  1. Gastrointestinal Bleeding Episodes

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

    Number of GI hemorrhage episodes by time period in the participation sites before and after DDInteract implementation

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Acronym: DDInteract

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
May 7, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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