DDI Effectiveness and Clinical Awareness

NCT03581994 | Completed

• 1 other identifier: Pro00024720
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug-Drug Interactions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Quality of care

  3 months

• DDI adoption

  3 months

• Resource utilization

  3 months

Study Arms (3)

Standard Practice

NO INTERVENTION

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

Compulsory DDI Testing

EXPERIMENTAL

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

Diagnostic Test: DDI Test Report

Optional DDI Testing

EXPERIMENTAL

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

Interventions

DDI Test Report DIAGNOSTIC_TEST

Test results of simulated patients

Compulsory DDI Testing; Optional DDI Testing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide consent to participate in the study
• Board-certified physician currently practicing in the following areas:
• Internal medicine
• Family medicine
• Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years.
• Have not used Aegis DDI
• English-speaking
• Community/ non-academic based practice setting
• patients under care weekly
• % of their patient panel on opioid pain medications
• Access to the internet

You may not qualify if:

• Provide consent to participate in the study
• Board-certified physician currently practicing in the following areas:
• Internal medicine
• Family medicine
• Have practiced as a board-certified physician in internal or family medicine for greater than 2 but less than 30 years.
• Have not used Aegis DDI
• English-speaking
• Community/ non-academic based practice setting
• patients under care weekly
• % of their patient panel on opioid pain medications
• Access to the internet

Sponsors & Collaborators

• Qure Healthcare, LLC: lead
• Aegis Sciences Corporation: collaborator

Study Sites (1)

QURE Healthcare

San Francisco, California, 94109, United States

Location

Study Officials

• John W Peabody, MD PhD

  President

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Single-blind masking
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two-arm parallel intervention assignment using identical educational materials but different question prompt approaches. Control arm included.

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 10, 2018
• Study Start: May 2, 2018
• Primary Completion: July 19, 2018
• Study Completion: August 28, 2018
• Last Updated: March 20, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)