- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04425668
Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry
Effect of Academic Detailing to Reduce Opioid Prescribing in Dentistry: a Randomized Quality Improvement Effort
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48104
- Chad Brummett
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Dentists in the state of Michigan with an active drug enforcement agency (DEA) license.
Exclusion Criteria:
- All oral Surgeons in Michigan. Michigan dentists who have a significant (>5%) population living outside of Michigan (self-reported), as the prescription drug monitoring program (PDMP) data we will obtain from Michigan Automated Prescription Service (MAPS) will only cover those prescriptions filled in the state of Michigan.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
|
Dentists enrolled in the CE program will serve as the control group. They will have access to the 3 hours of CE content online similar to the AD group; however, they will not receive academic detailing or the opportunity to connect via phone with Dr. Nalliah. In this group, if the dentists have content-specific questions after participating in the CE program, they may contact MichiganOPENdental@umich.edu for responses appropriately directed to Dr. Nalliah. |
|
Experimental: Academic detailing intervention
|
In addition to continuing educational (CE) videos this group will receive up to two personalized, one-on-one, education sessions from an academic detailer.
The sessions will last between 15-30 minutes.
Each AD visit will consist of: an introduction, a brief needs assessment, key educational messages, a discussion of challenges the provider faces, and giving the provider leave-behind educational materials.
The AD visit key educational messages are specific recommendations for opioid-prescribing practice change.
When appropriate the detailer will suggest a phone call with Dr. Romesh Nalliah to discuss specific dentistry questions.
There may also be a second AD visit if agreed upon by the dentist.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the amount of opioid prescribed measured in the total oral morphine equivalents
Time Frame: baseline, up to 3 months
|
Opioid data from the Michigan Automated Prescription Service (MAPS), state prescription drug monitoring program (PDMP) will be used.
These periods yield 63 working weekdays in each period.
|
baseline, up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in the number of opioid prescriptions
Time Frame: baseline, up to 3 months
|
Number of opioid prescription details through PDMP data pulled from MAPS.
|
baseline, up to 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chad Brummett, M.D., University of Michigan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HUM00175142
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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