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| ID | Type | Description | Link |
|---|---|---|---|
| R18HS029300 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Standard of Care | No Intervention | This population will consist in outpatient clinics who treat oral anticoagulated patients where DDInteract has not yet been implemented. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shared Decision Making Tool | Other | EHR-integrated SDM for Patients on Oral Anticoagulants and other medications that might increase the risk of hemorrhage |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Through study completion, an average of 18 months for the implementation period and 12 months for the baseline period clinics |
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| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal Bleeding Episodes | Number of GI hemorrhage episodes by time period in the participation sites before and after DDInteract implementation | Through study completion, an average of 18 months, 6 months per sites (UoU, UC and VU) before and after implementation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel C Malone, PhD | College of Pharmacy. University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado. School of Medicine | Denver | Colorado | 80045 | United States | ||
| Vanderbilt University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36260377 | Background | 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. | |
| 34698649 | Background | 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. |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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Rolling implementation at the clinic level with control clinics not exposed to the tool.
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No masking due to the nature of the intervention
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| Nashville |
| Tennessee |
| 37235 |
| United States |
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |