Drug-Drug InteractionsDECARTNCT03581994
DDI Effectiveness and Clinical Awareness
A study testing DDI Test Report in people with Drug-Drug Interactions, run by Qure Healthcare, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Drug-Drug Interactions
- What is being tested?
- DDI Test Report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2018to 28 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- DDI Test Report
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDI Test ReportDiagnostic test
Test results of simulated patients
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: DDI Test Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug-Drug Interaction (DDI) diagnosis
Difference in difference between the control and the intervention group in their identification and effective treatment of DDls.
Measured: 3 months
Secondary outcomes (3)
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.
Measured: 3 months
DDI adoption
Rate of DDI adoption after receiving educational material on the benefits of testing in patients who are at risk.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2018
- Study start2 May 2018
- Primary completion19 Jul 2018
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug-Drug InteractionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm parallel intervention assignment using identical educational materials but different question prompt approaches. Control arm included.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qure Healthcare, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aegis Sciences Corporation
- Responsible party
- Sponsor
- Investigators
- John W Peabody, MD PhD, Principal investigator, President
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03581994
- Sponsor's protocol ID
- Pro00024720
- Acronym
- DECART
- Status last verified
- Mar 2019
- First submitted
- 18 Jun 2018
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug-Drug Interaction (DDI™) Effectiveness and Clinical Awareness Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03581994
- Acronym / sponsor ID
- DECART / Pro00024720
- Conditions
- Drug-Drug Interactions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Qure Healthcare, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Aegis Sciences Corporation
- Study start
- 2 May 2018 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 10 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 3
- Model description
- Two-arm parallel intervention assignment using identical educational materials but different question prompt approaches. Control arm included.
| Arm | Type | Receives |
|---|---|---|
| Standard Practice | No intervention | –Not receiving any intervention/educational materials on drug-drug interaction testing |
| Compulsory DDI Testing | Experimental | Diagnostic Test: DDI Test ReportReceiving educational materials on drug-drug interaction testing and a sample test report when caring for patient cases. |
| Optional DDI Testing | Experimental | Diagnostic Test: DDI Test ReportReceiving educational materials on drug-drug interaction testing and given a sample test report if ordered when caring for patient cases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DDI Test ReportTest results of simulated patients | Diagnostic test | Compulsory DDI Testing, Optional DDI Testing |
Primary outcome
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.
3 secondary outcomes
Quality of care
Time frame: 3 months
DDI adoption
Time frame: 3 months
Resource utilization
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No. No IPD will be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Peabody, MD PhD principal investigator
President
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DDI Test Report in people with Drug-Drug Interactions, run by Qure Healthcare, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug-Drug Interaction (DDI) diagnosis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.