Drug-Drug Interactions Clinical Trial
Official title:
Drug-Drug Interaction (DDI™) Effectiveness and Clinical Awareness Randomized Controlled Trial
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.
- 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.
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