Anticoagulants, Drug Interactions
Conditions
Keywords
Oral anticoagulants, Drug interactions, Gastrointestinal hemorrhage, Shared Decision Making
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.
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).
Interventions
EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage
Sponsors
University of Utah
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No masking due to the nature of the intervention
Intervention model description
Rolling implementation at the clinic level with control clinics not exposed to the tool.
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences of Differences in Estimated Risk of Gastrointestinal Bleeding by DDInteract algorithm | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel C Malone, PhD
College of Pharmacy. University of Utah
Outcome results
None listed