- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06130904
Effect of Academic Detailing on Opioid Prescribing by Dentists to Adolescents and Young Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48104
- University of Michigan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for the practioners:
- General dentist, dental subspecialist, or oral and maxillofacial surgeon practicing in the State of Michigan that accounted for at least one dispensed opioid prescription to patients aged 13-30 years during January 1, 2023 through September 30, 2023.
Exclusion Criteria for the practioners:
- Dentist is not included in the OneKey database
- Dentist has an address in OneKey that corresponds to an academic institution (thus excluding residents/fellows and attendings at academic institutions)
- Dentist did not practice in a high-population county in Southeast Michigan, such as Wayne, Oakland, Macomb, Washtenaw, Ingham, Genesee, during the pre-intervention period (April 1, 2023 through November 30, 2023).
- Dentist was not in the 85th-94th percentile of dispensed opioid prescriptions to patients aged 13-30 years during January 1, 2023 through September 30, 2023.
- Dentist's practice address cannot be confirmed
- The dentist is no longer practicing as of the day before the beginning of the intervention period (December 1, 2023).
- The study team discovers after the time of randomization that dentists are either non-English speaking or have a medical or psychiatric condition that preclude participation in this project (in the judgment of the study team).
- The study team discovers after the time of randomization that the dentist moved to a practice location different from the one had at the time of randomization at any point between the time of randomization and the end of the study period in November 30, 2024. Practice location changes will be assessed based on IQVIA OneKey data as of November 2024. Additionally, the study team will call all included practices up to 2 times during November 2024 to confirm whether the dentist is still practicing at the location.
- The study team discovers after the time of randomization that the dentist stopped practicing dentistry between the time of randomization and the end of the study period on November 30, 2024 (e.g., retirement, death, etc.). This will be assessed using IQVIA (Longitudinal Prescription Database) OneKey data as of November 2024 and by calling practices in November 2024. Additionally, the study team will use 2024 IQVIA data to assess the number of dispensed antibiotic prescriptions in the post-intervention period across all age groups. If this number is zero, this might strongly suggest that the dentist is no longer practicing, as antibiotics are one of the most commonly prescribed classes of medications by dentists.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Academic detailing intervention
|
Eligible dentists/oral surgeons will have one visit (30 minutes or less) at the dentist's office. During the initial visit, the detailers will discuss the evidence against routine opioid prescribing to adolescents and young adults for most common surgeries performed by dentists and oral surgeons, the harms of dental opioid exposure in adolescents and young adults, and the benefits and feasibility of relying on non-opioids as a first line option for routine dental procedures among adolescents and young adults. A survey will be completed to assess the satisfaction regarding the intervention. A professionally designed packet of information on reducing use of opioids for routine procedures will also be given. There may also be a second optional follow-up visit conducted virtually for any participants that wish to discuss further with the detailer. The second visit may occur any time between the initial visit and March 31, 2024. |
|
No Intervention: Control group
Control dentists will receive no intervention at all.
Only dentist's prescribing data will be analyzed.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Differential change in the number of dispensed opioid prescriptions to patients aged 13-30 years between the 8 months before and 8 months after the academic detailing intervention period ends among treatment versus control dentists
Time Frame: 20 months (8 months prior, 4 months for detailing, 8 months after detailing)
|
20 months (8 months prior, 4 months for detailing, 8 months after detailing)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differential change in total morphine milligram equivalents (MMEs) dispensed to patients aged 13-30 years the 8 months before and 8 months after the academic detailing intervention period ends among treatment versus control dentists
Time Frame: 20 months (8 months prior, 4 months for detailing, 8 months after detailing)
|
20 months (8 months prior, 4 months for detailing, 8 months after detailing)
|
|
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Differential change in the number of opioid prescriptions dispensed to patients aged 31 years or older between the 8 months before and 8 months after the academic detailing intervention period ends among treatment versus control dentists
Time Frame: 20 months (8 months prior, 4 months for detailing, 8 months after detailing)
|
20 months (8 months prior, 4 months for detailing, 8 months after detailing)
|
|
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Percentage of participants that complete the initial academic detailing session
Time Frame: 4 months (intervention period)
|
4 months (intervention period)
|
|
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Satisfaction with the detailing intervention as measured by a follow-up survey on a 5-point Likert scale
Time Frame: Up to three weeks following the academic detailing
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This is a one question survey that participants select from 5 responses: very dissatisfied (1), somewhat dissatisfied (2), neither satisfied nor dissatisfied (3), somewhat satisfied (4), satisfied (5).
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Up to three weeks following the academic detailing
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Participants willingness to change opioid prescribing practices based on the academic detailing intervention as measured by the follow-up survey on a 5-point Likert scale
Time Frame: Up to three weeks following the academic detailing
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Participants answer one question as to how likely participants will reduce opioid prescribing to adolescents and young adults.
The five responses include: very unlikely (1), unlikely (2), neither likely nor unlikely (3), likely (4), very likely (5).
|
Up to three weeks following the academic detailing
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chad Brummet, M.D., University of Michigan
- Principal Investigator: Kao-Ping Chua, MD, PhD, 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
- HUM00238416
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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