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Behavioural Intervention

Decision-Making Tool for Blood Thinners (DDInteract Trial)

N/A

Waitlist Available

Led By Daniel C Malone, PhD

Research Sponsored by University of Utah

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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)

Must not have

Individuals not able to speak English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a tool called DDInteract that helps patients and doctors make decisions about drug interactions while taking oral anticoagulants. The tool will be used in clinics at three universities

Who is the study for?

This trial is for adults over 21 who are prescribed oral anticoagulants like warfarin or apixaban and take more than one medication. It's not suitable for those who can't communicate in English or Spanish.

What is being tested?

The study tests a shared-decision making tool, DDInteract, designed to manage drug interactions in patients taking blood thinners. It integrates with electronic health records to assess risks and help doctors and patients make informed decisions together.

What are the potential side effects?

Since this trial involves a decision-making tool rather than a medical treatment, there are no direct side effects related to medications. However, the outcomes of decisions made using the tool could indirectly affect patient health.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

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I am taking a prescribed oral blood thinner.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot speak English or Spanish.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Other study objectives

Gastrointestinal Bleeding Episodes

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Exposure to DDInteract tool in anticoagulated patientsExperimental Treatment1 Intervention

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 II: Standard of CareActive Control1 Intervention

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

0 / 3Eligibility criteria met