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Completed

NCT Number: NCT03581994

DDI Effectiveness and Clinical Awareness

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

QURE Healthcare

San Francisco, California, 94109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 40 patients under care weekly
  • 15% of their patient panel on opioid pain medications
  • Access to the internet

Exclusion criteria

  • 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
  • 40 patients under care weekly
  • 15% of their patient panel on opioid pain medications
  • Access to the internet

Treatment and study plan

DDI Test Report

Diagnostic Test

Test results of simulated patients

Primary outcomes

  1. Drug-Drug Interaction (DDI) diagnosis

    Time frame: 3 months

    Difference in difference between the control and the intervention group in their identification and effective treatment of DDls.

Secondary outcomes

  1. Quality of care

    Time frame: 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.

  2. DDI adoption

    Time frame: 3 months

    Rate of DDI adoption after receiving educational material on the benefits of testing in patients who are at risk.

  3. Resource utilization

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Qure Healthcare, LLC

Industry

Collaborators

  • Aegis Sciences Corporation

Registry information

Official study title

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

Acronym: DECART

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 10, 2018
Registry last updated
Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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