Effect of Academic Detailing on Opioid Prescribing by Dentists to Adolescents and Young Adults

NCT ID: NCT06130904

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Using 2023 IQVIA Longitudinal Prescription Database, the study team will identify dentists in the 85th-94th percentile of dispensed opioid prescriptions to patients aged 13-30 years from January 1, 2023 through September 30, 2023 and practice in high-population counties in Southeast Michigan. The study team will randomize these dentists into two study arms. Dentists in the intervention arm will receive an academic detailing session focused on evidence-based pain management education. Dentists in the control will not receive any intervention and will not be contacted. Prescribing will be evaluated using IQVIA data for differential change in the number of dispensed opioid prescriptions to patients aged 13-30 years between the 8 months before and the 8 months after the academic detailing intervention period among intervention versus control dentists.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Opioid Prescribing

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dentist Oral and maxillofacial surgeon

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors
The analysts will be blinded using codes to prevent bias in analysis.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Academic detailing intervention

Group Type EXPERIMENTAL

Academic detailing

Intervention Type BEHAVIORAL

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.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Academic detailing

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Benter Foundation

UNKNOWN

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chad Brummett

Professor of Anesthesiology Research, Senior Associate Chair for Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Chad Brummet, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Kao-Ping Chua, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HUM00238416

Identifier Type: -

Identifier Source: org_study_id