Drug-Drug Interactions
Conditions
Brief summary
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.
Detailed description
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. * Round 1 (Baseline Assessment): Providers in both the control and intervention groups will care for 3 CPV simulated patients using their standard practice approach, to evaluate their awareness of DDI interactions and associated variability in caring for patients at risk for DDIs. * Intervention/DD! Education: Approximately 3 weeks after CPV Round 1 is complete, the intervention arms will receive Aegis test education materials, consisting of: 1) on-demand, online video on the Aegis DDI test, 2) example test results, 3) example case study, 4) clinical care reference guide, and 5) test overview. * Round 2 (Post-Educational Intervention Assessment): Approximately 3 weeks after the intervention, all providers in the control and intervention arms will receive another 3 simulated patients to care for to determine if their awareness has changed and if their practice has improved. In the post--educational assessment, one-half of intervention participants will have access to Aegis DDI test results for their patients to help guide their decision making. The other half will have the option of receiving test results if ordered. Control physicians will continue to their standard practice approach.
Interventions
DIAGNOSTIC_TESTDDI Test Report
Test results of simulated patients
Sponsors
Aegis Sciences Corporation
Qure Healthcare, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Caregiver)
Masking description
Single-blind masking
Intervention model description
Two-arm parallel intervention assignment using identical educational materials but different question prompt approaches. Control arm included.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
1. Provide consent to participate in the study 2. Board-certified physician currently practicing in the following areas: 3. Internal medicine 4. Family medicine 5. Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. 6. Have not used Aegis DDI 7. English-speaking 8. Community/ non-academic based practice setting 9. 40 patients under care weekly 10. 15% of their patient panel on opioid pain medications 11. Access to the internet
Exclusion criteria
1. Provide consent to participate in the study 2. Board-certified physician currently practicing in the following areas: 3. Internal medicine 4. Family medicine 5. Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. 6. Have not used Aegis DDI 7. English-speaking 8. Community/ non-academic based practice setting 9. 40 patients under care weekly 10. 15% of their patient panel on opioid pain medications 11. Access to the internet
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Drug-Drug Interaction (DDI) diagnosis | 3 months | Difference in difference between the control and the intervention group in their identification and effective treatment of DDls. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of care | 3 months | 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. |
| DDI adoption | 3 months | Rate of DDI adoption after receiving educational material on the benefits of testing in patients who are at risk. |
| Resource utilization | 3 months | Difference in health care utilization and/or costs in patients tested with DDI versus the control group in aggregate and by case type. |
Countries
United States
Outcome results
None listed