DDI Effectiveness and Clinical Awareness (DECART)

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.

Study Overview

• Status: Completed
• Conditions: Drug-Drug Interactions
• Intervention / Treatment: Diagnostic test: DDI Test Report

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 Type: Interventional
• Enrollment (Actual): 330
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94109
      • QURE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qure Healthcare, LLC
• Collaborators: Aegis Sciences Corporation

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2018
• Primary Completion (Actual): July 19, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 18, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: Pro00024720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No