DDI Effectiveness and Clinical Awareness

Not Applicable

Completed

• Conditions: Drug-Drug Interactions
• Interventions: Diagnostic Test: DDI Test Report

• Registration Number: NCT03581994
• Lead Sponsor: Qure Healthcare, LLC

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.

Study Timeline

• Study Start: 2018-05-02
• Study First Submitted: 2018-06-18
• Study First Submitted QC: 2018-07-03
• Study First Posted: 2018-07-10
• Primary Completion: 2018-07-19
• Study Completion: 2018-08-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-18
• Last Update Posted: 2019-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 330

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optional DDI Testing	DDI Test Report	Receiving educational materials on drug-drug interaction testing and given a sample test report if ordered when caring for patient cases.
Compulsory DDI Testing	DDI Test Report	Receiving educational materials on drug-drug interaction testing and a sample test report when caring for patient cases.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

QURE Healthcare; 🇺🇸 San Francisco, California, United States