Alternatives to Dental Opioid Prescribing After Tooth Extraction (ADOPT)

Douglas Oyler

Status

Invitation-only

Conditions

Tooth Extraction

Ibuprofen

Acetaminophen

Analgesics, Opioid

Adolescent

Acute Pain

Treatments

Other: Usual care

Behavioral: Multicomponent intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06275191

80758

4UH3DE032621-02 (U.S. NIH Grant/Contract)

1UG3DE032621-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this clinical trial is to test a three-item intervention in oral surgeons who remove teeth. The main questions it aims to answer are:

Can the intervention reduce opioid prescriptions to adolescents and young adults after tooth removal?
Do oral surgeons' beliefs about the intervention and opioid prescribing change?
Do patients that report using opioids after tooth removal have different experiences than patients that do not?

Oral surgeon participants will:

Attend a 1-hour education session with a trained pharmacist
Receive patient instructions and blister packs of pain medicine to give to patients
Complete 2 surveys about feasibility and appropriateness

Patient participants will complete a survey about pain and medication use after having a tooth removed.

Researchers will compare the intervention to usual care to see if it reduces opioid prescribing.

Full description

Although use of nonsteroidal antiinflammatory drugs and acetaminophen is recommended first-line by the American Dental Association and American Association of Oral and Maxillofacial Surgeons, dentists and oral surgeons are leading prescribers of opioids to adolescents and young adults (AYA), who are at high risk for developing problematic opioid use after an initial exposure. This multi-site, stepped wedge cluster-randomized trial will assess whether a multicomponent behavioral intervention can influence opioid prescribing behavior among dentists and oral surgeons compared to usual practice. Across up to 12 clinical practices (clusters), up to 33 dentists and oral surgeons (provider participants) who perform tooth extractions for individuals 12-25 years old will be enrolled. After enrollment, all provider participants will receive the intervention at a time based on the sequence to which their cluster is randomized. The intervention consists of academic detailing plus provision of standardized patient post-extraction instructions and blister packs of acetaminophen (APAP) and ibuprofen for dispensing. Provider participants will dispense the blister packs and distribute the patient instructions at their discretion to AYA undergoing tooth extraction, with or without additional analgesics (e.g., opioids). The primary outcome is a binary, patient-level indicator of electronic post-extraction opioid prescription. Data for the primary outcome will be collected from the provider participant's electronic health records quarterly throughout the study. Provider participants will complete a survey before and approximately 3 months after transitioning into the intervention condition to assess implementation outcomes. AYA patients undergoing tooth extraction will be offered a survey to assess pain control and satisfaction with pain management in the week after their extraction. Primary analyses will use generalized estimating equations to compare the binary patient-level indicator of being prescribed a post-extraction opioid in the intervention condition compared to the control condition (i.e., usual practice). Analyses will adjust for patient-level factors (e.g., sex, number of teeth extracted, etc.). Secondary analyses will assess provider participants' perceptions of feasibility and appropriateness of the intervention, and patient-reported pain control and satisfaction with pain management.

Enrollment

38,159 estimated patients

Sex

All

Ages

12 to 25 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (Provider):

Actively U.S. licensed dentist or oral surgeon practicing at a participating cluster. Participating clinics were finalized prior to the beginning of the study based on the following criteria: (1) perform tooth extractions on at least 70 AYA patients during a 5-month screening period from July 1, 2022 through November 30, 2022 and (2) electronically prescribe opioids to at least 30% of AYA patients who underwent extraction during the screening period. Additionally, each participating cluster signed a data use agreement (DUA) for sharing electronic health record data, can provide the necessary electronic health record data, and agreed to comply with study procedures and be available for the duration of the study.
Provide a signed and dated informed consent form.
Willing to comply with all study procedures and be available for the duration of the study.

Inclusion Criteria (Patient):

Undergoes any tooth extraction at a participating cluster during the study (intervention condition, transition period, or control condition) between 6-10 days earlier.
Age 12-25 at the time of tooth extraction.
Reads and acknowledges survey cover letter in lieu of a full consent/assent process.
Can access the electronic survey using an internet-capable device.

Exclusion Criteria:

There are no other exclusion criteria for clusters or provider/patient participants that meet all inclusion criteria.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

38,159 participants in 2 patient groups

Intervention condition

Experimental group

Description:

1. Academic detailing (45 to 60-minute session), plus 2. Provision of standardized patient post-extraction instructions for distribution, plus 3. Provision of blister-packaged acetaminophen and ibuprofen at recommended standard doses for distribution to to adolescent/young adult patients after tooth extraction in the course of clinical practice

Treatment:

Behavioral: Multicomponent intervention

Control condition

Active Comparator group

Description:

Usual practice

Treatment:

Other: Usual care