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

Opioid Prescribing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06130904
• Other study ID #: HUM00238416
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Prescribing

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	The Benter Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Percentage of participants that complete the initial academic detailing session		4 months (intervention period)
Secondary	Satisfaction with the detailing intervention as measured by a follow-up survey on a 5-point Likert scale	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).	Up to three weeks following the academic detailing
Secondary	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	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