Clinical trial NCT06275191: Alternatives to Dental Opioid Prescribing After Tooth Extraction
Official title: Alternatives to Dental Opioid Prescribing After Tooth Extraction
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Analgesics, Opioid
Acute Pain
Tooth Extraction
Adolescent
Acetaminophen
Ibuprofen
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2024-02-23
Enrollment: 38159
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge cluster randomized trial
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction
timeFrame: Same calendar date as dental extraction. Electronic health records will be extracted for the duration of the 4-year study period.
Secondary outcomes:
measure: (Change in) intervention feasibility
timeFrame: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
measure: (Change in) intervention appropriateness
timeFrame: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
measure: (Change in) opioid prescribing feasibility
timeFrame: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
measure: (Change in) opioid prescribing appropriateness
timeFrame: Pre-surveys will be conducted during the calendar month preceding the transition to the intervention condition (i.e., within 60 days). Post-surveys will be conducted during the 3rd month of the intervention condition (i.e., within 120 days).
measure: Self-reported pain
timeFrame: within 10 days of tooth extraction
measure: Self-reported pain interference
timeFrame: within 10 days of tooth extraction
measure: Self-reported pain satisfaction
timeFrame: within 10 days of tooth extraction
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Douglas R Oyler, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Kentucky
name: Marcia V Rojas Ramirez, DDS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oyler DR, Rojas-Ramirez MV, Nakamura A, Quesinberry D, Miller CS. Dental opioid prescription patterns in academic and community settings. J Public Health Dent. 2023 Jun;83(2):200-206. doi: 10.1111/jphd.12568. Epub 2023 Mar 11.
citation: Oyler DR, Rojas-Ramirez MV, Nakamura A, Quesinberry D, Bernard P, Surratt H, Miller CS. Factors influencing opioid prescribing after tooth extraction. J Am Dent Assoc. 2022 Sep;153(9):868-877. doi: 10.1016/j.adaj.2022.05.001. Epub 2022 Jun 9.
citation: Oyler DR, Miller CS. Patterns of opioid prescribing in an Appalachian college of dentistry. J Am Dent Assoc. 2021 Mar;152(3):209-214. doi: 10.1016/j.adaj.2020.12.002.
citation: Oyler DR, Westgate PM, Walsh SL, Dolly Prothro J, Miller CS, Roberts MF, Freeman PR, Knudsen HK, Lang M, Dominguez-Fernandez E, Rojas-Ramirez MV. Alternatives to dental opioid prescribing after tooth extraction (ADOPT): protocol for a stepped wedge cluster randomized trial. BMC Oral Health. 2024 Apr 4;24(1):414. doi: 10.1186/s12903-024-04201-0.