DDI Effectiveness and Clinical Awareness

Drug-Drug Interactions Clinical Trial

— DECART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03581994
• Other study ID #: Pro00024720
• Status: Completed
• Phase: N/A
• Start date: May 2, 2018
• Est. completion date: August 28, 2018

Study information

• Verified date: March 2019
• Source: Qure Healthcare, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: August 28, 2018
• Est. primary completion date: July 19, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Drug-Drug Interactions

Intervention

Diagnostic Test:
• DDI Test Report
Test results of simulated patients

Locations

Country	Name	City	State
United States	QURE Healthcare	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
Qure Healthcare, LLC	Aegis Sciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	DDI adoption	Rate of DDI adoption after receiving educational material on the benefits of testing in patients who are at risk.	3 months
Secondary	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