DDI Effectiveness and Clinical Awareness

NCT ID: NCT03581994

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-02
• Study Completion Date: 2018-08-28

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.

Conditions

Drug-Drug Interactions

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Standard Practice

Not receiving any intervention/educational materials on drug-drug interaction testing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Compulsory DDI Testing

Receiving educational materials on drug-drug interaction testing and a sample test report when caring for patient cases.

Group Type: EXPERIMENTAL

DDI Test Report

Intervention Type: DIAGNOSTIC_TEST

Test results of simulated patients

Optional DDI Testing

Receiving educational materials on drug-drug interaction testing and given a sample test report if ordered when caring for patient cases.

Group Type: EXPERIMENTAL

DDI Test Report

Intervention Type: DIAGNOSTIC_TEST

Test results of simulated patients

Interventions

DDI Test Report

Test results of simulated patients

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aegis Sciences Corporation

INDUSTRY

Sponsor Role: collaborator

Qure Healthcare, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John W Peabody, MD PhD

Role: PRINCIPAL_INVESTIGATOR

President

Locations

QURE Healthcare

San Francisco, California, United States

Countries

United States

Other Identifiers

Pro00024720

Identifier Type: -

Identifier Source: org_study_id