Shared Decision for Drug Interactions in Oral Anticoagulation

NCT ID: NCT06401863

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3691 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anticoagulants Drug Interactions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Rolling implementation at the clinic level with control clinics not exposed to the tool.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

No masking due to the nature of the intervention

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Shared Decision Making Tool

Intervention Type OTHER

EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage

Standard of Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Shared Decision Making Tool

EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Shared Decision Making Tool to reduce harm from Drug Interactions

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Daniel Malone

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Daniel C Malone, PhD

Role: PRINCIPAL_INVESTIGATOR

College of Pharmacy. University of Utah

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Colorado. School of Medicine

Denver, Colorado, United States

Site Status RECRUITING

Vanderbilt University

Nashville, Tennessee, United States

Site Status RECRUITING

University of Utah

Salt Lake City, Utah, United States

Site Status ENROLLING_BY_INVITATION

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Daniel C Malone, PhD

Role: CONTACT

801 581 8054

Ainhoa Gomez Lumbreras, MD, PhD

Role: CONTACT

8015853201

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Katy E Trinkley, PharmD, PhD

Role: primary

303-724-3103

James Mitchell, PhD

Role: backup

720-694-5616

Tom J Reese, PharmD, PhD

Role: primary

(615) 936 6867

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 36260377 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34698649 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R18HS029300

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

IRB_00167936

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Medication Use and Quality of Life Among Older People
NCT05123313 ACTIVE_NOT_RECRUITING NA
Drug Interactions in Outpatients.
NCT03943524 SUSPENDED NA