NCT06130904

Brief Summary

This randomized controlled trial will test whether an academic detailing educational outreach intervention (referred to as "academic detailing" throughout) decreases opioid prescribing to patients aged 13-30 years among high-prescribing dentists in Southeast Michigan. The primary objective is to evaluate whether an academic detailing intervention reduces the number of dispensed opioid prescriptions to patients aged 13-30 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 14, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

March 25, 2026

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

November 8, 2023

Last Update Submit

March 23, 2026

Conditions

Keywords

DentistOral and maxillofacial surgeon

Outcome Measures

Primary Outcomes (1)

  • 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

    20 months (8 months prior, 4 months for detailing, 8 months after detailing)

Secondary Outcomes (5)

  • 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

    20 months (8 months prior, 4 months for detailing, 8 months after detailing)

  • 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

    20 months (8 months prior, 4 months for detailing, 8 months after detailing)

  • Percentage of participants that complete the initial academic detailing session

    4 months (intervention period)

  • Satisfaction with the detailing intervention as measured by a follow-up survey on a 5-point Likert scale

    Up to three weeks following the academic detailing

  • 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

    Up to three weeks following the academic detailing

Study Arms (2)

Academic detailing intervention

EXPERIMENTAL
Behavioral: Academic detailing

Control group

NO INTERVENTION

Control dentists will receive no intervention at all. Only dentist's prescribing data will be analyzed.

Interventions

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.

Academic detailing intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48104, United States

Location

Study Officials

  • Chad Brummet, M.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Kao-Ping Chua, MD, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The analysts will be blinded using codes to prevent bias in analysis.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology Research, Senior Associate Chair for Research

Study Record Dates

First Submitted

November 8, 2023

First Posted

November 14, 2023

Study Start

December 1, 2023

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

March 25, 2026

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations