AnticoagulantsDDInteractNCT06401863
Shared Decision for Drug Interactions in Oral Anticoagulation
A study testing Shared Decision Making Tool in people with Anticoagulants and Drug Interactions, run by University of Utah at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Anticoagulants, Drug Interactions
- What is being tested?
- Shared Decision Making Tool
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Oct 2023to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Individuals not able to speak English or Spanish
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado. School of Medicine
Denver, Colorado, 80045
Vanderbilt University
Nashville, Tennessee, 37235
University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: 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.
Read the 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).
- Conditions
- Anticoagulants, Drug Interactions
- Being tested
- Shared Decision Making Tool
- Keywords
- Oral anticoagulants, Drug interactions, Gastrointestinal hemorrhage, Shared Decision Making
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shared Decision Making ToolOther
Also called Shared Decision Making Tool to reduce harm from Drug Interactions
EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Oct 2023
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnticoagulantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Rolling implementation at the clinic level with control clinics not exposed to the tool.
- Masking
- None (open label)
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Daniel Malone, University of Utah
- Investigators
- Daniel C Malone, PhD, Principal investigator, College of Pharmacy. University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401863
- Sponsor's protocol ID
- IRB_00167936
- Other IDs
- R18HS029300
- Acronym
- DDInteract
- Status last verified
- Oct 2026
- First submitted
- 25 Apr 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36260377Reese 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.
PubMed 34698649
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of DDInteract A Shared-decision Making Tool for Anticoagulant Drug-Drug INTERACTions (DDinteract)
- ClinicalTrials.gov ID
- NCT06401863
- Acronym / sponsor ID
- DDInteract / IRB_00167936
- Conditions
- Anticoagulants, Drug Interactions
- Keywords
- Oral anticoagulants, Drug interactions, Gastrointestinal hemorrhage, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Rolling implementation at the clinic level with control clinics not exposed to the tool.
| Arm | Type | Receives |
|---|---|---|
| Exposure to DDInteract tool in anticoagulated patients | Experimental | Other: Shared Decision Making ToolThis 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. |
| Standard of Care | No intervention | –This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Individuals not able to speak English or Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shared Decision Making ToolAlso: Shared Decision Making Tool to reduce harm from Drug InteractionsEHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage | Other | Exposure to DDInteract tool in anticoagulated patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 36260377Gomez 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.
- Background: PubMed 34698649Reese 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel C Malone, PhD principal investigator
College of Pharmacy. University of Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shared Decision Making Tool in people with Anticoagulants and Drug Interactions, run by University of Utah at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06401863, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.