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| Name | Class |
|---|---|
| Aegis Sciences Corporation | INDUSTRY |
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The DECART study will determine if primary care physicians, including internists and family physicians, are able to identify and address drug-drug interactions among simulated patients and whether those physicians, when given access to Aegis Drug-Drug Interaction test results, improve patient management, take steps to reduce DDI risk, and optimize unnecessary resource utilization.
The DECART study is a pre-post, two round, randomized controlled study of a nationally representative sample of 330 primary care physicians randomly assigned to a control or one of two intervention arms. Once eligibility is determined and providers are enrolled in the study, they will be asked to complete a questionnaire describing their practice and professional background. They will then care for a total of 6 CPV® simulated patients. The simulated patients will be adults aged 30-75 and present with various clinical conditions and potential drug interactions. The design and intervention consists of two rounds with an intervention among two thirds of the participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Practice | No Intervention | Not receiving any intervention/educational materials on drug-drug interaction testing | |
| Compulsory DDI Testing | Experimental | Receiving educational materials on drug-drug interaction testing and a sample test report when caring for patient cases. |
|
| Optional DDI Testing | Experimental | Receiving educational materials on drug-drug interaction testing and given a sample test report if ordered when caring for patient cases. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDI Test Report | Diagnostic Test | Test results of simulated patients |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug-Drug Interaction (DDI) diagnosis | Difference in difference between the control and the intervention group in their identification and effective treatment of DDls. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of care | Difference in difference between the control and the intervention groups in the overall quality of care as measured by their combined domain and individual item CPV scores (ranging from 0% to 100%) for the 9 patient types in aggregate and by case type. | 3 months |
| DDI adoption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Peabody, MD PhD | President | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QURE Healthcare | San Francisco | California | 94109 | United States |
No IPD will be shared
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Two-arm parallel intervention assignment using identical educational materials but different question prompt approaches. Control arm included.
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Single-blind masking
Rate of DDI adoption after receiving educational material on the benefits of testing in patients who are at risk. |
| 3 months |
| Resource utilization | Difference in health care utilization and/or costs in patients tested with DDI versus the control group in aggregate and by case type. | 3 months |