DDI Effectiveness and Clinical Awareness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Drug-Drug Interaction (DDI™) Effectiveness and Clinical Awareness Randomized Controlled Trial

Conditions
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Drug-Drug Interactions

Intervention / Treatment
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* Diagnostic Test: DDI Test Report


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide consent to participate in the study Board-certified physician currently practicing in the following areas: Internal medicine Family medicine Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. Have not used Aegis DDI English-speaking Community/ non-academic based practice setting 40 patients under care weekly 15% of their patient panel on opioid pain medications Access to the internet Exclusion Criteria: Provide consent to participate in the study Board-certified physician currently practicing in the following areas: Internal medicine Family medicine Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years. Have not used Aegis DDI English-speaking Community/ non-academic based practice setting 40 patients under care weekly 15% of their patient panel on opioid pain medications Access to the internet
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two-arm parallel intervention assignment using identical educational materials but different question prompt approaches. Control arm included.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Practice<br>Not receiving any intervention/educational materials on drug-drug interaction testing | |
| Experimental: Compulsory DDI Testing<br>Receiving educational materials on drug-drug interaction testing and a sample test report when caring for patient cases. | Diagnostic Test: DDI Test Report<br>* Test results of simulated patients<br>|
| Experimental: Optional DDI Testing<br>Receiving educational materials on drug-drug interaction testing and given a sample test report if ordered when caring for patient cases. | Diagnostic Test: DDI Test Report<br>* Test results of simulated patients<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |