Clinical trial NCT03581994: DDI Effectiveness and Clinical Awareness
Official title: Drug-Drug Interaction (DDI™) Effectiveness and Clinical Awareness Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug-Drug Interactions
Lead sponsor: Qure Healthcare, LLC
Sponsor class: INDUSTRY
Collaborators: name: Aegis Sciences Corporation
First posted: 2018-07-10
Enrollment: 330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm parallel intervention assignment using identical educational materials but different question prompt approaches. Control arm included.
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Drug-Drug Interaction (DDI) diagnosis
timeFrame: 3 months
Secondary outcomes:
measure: Quality of care
timeFrame: 3 months
measure: DDI adoption
timeFrame: 3 months
measure: Resource utilization
timeFrame: 3 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: QURE Healthcare
state: California
Study officials:
affiliation: President
name: John W Peabody, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: