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Clinical Trials/NCT06275191
NCT06275191
Enrolling By Invitation
Not Applicable

Alternatives to Dental Opioid Prescribing After Tooth Extraction

Douglas Oyler1 site in 1 country38,159 target enrollmentApril 16, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesics, Opioid
Sponsor
Douglas Oyler
Enrollment
38159
Locations
1
Primary Endpoint
Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction
Status
Enrolling By Invitation
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 16, 2024
End Date
December 1, 2028
Last Updated
10 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor Investigator
Principal Investigator

Douglas Oyler

Assistant Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction

Time Frame: Same calendar date as dental extraction. Electronic health records will be extracted for the duration of the 4-year study period.

The primary outcome is a patient-level binary indicator for being prescribed an opioid. The value for this outcome variable is equal to 1 if the patient is prescribed an opioid, whereas this variable takes on a value of 0 if this patient is not prescribed an opioid. Opioid prescription will be defined as an electronic order (from the electronic health record) for an opioid analgesic (e.g., hydrocodone, oxycodone, tramadol, morphine, fentanyl, etc.) on the same calendar date as the tooth extraction appointment.

Secondary Outcomes

  • (Change in) intervention appropriateness(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).)
  • Self-reported pain interference(within 10 days of tooth extraction)
  • Self-reported pain satisfaction(within 10 days of tooth extraction)
  • (Change in) intervention feasibility(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).)
  • (Change in) opioid prescribing feasibility(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).)
  • Self-reported pain(within 10 days of tooth extraction)
  • (Change in) opioid prescribing appropriateness(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).)

Study Sites (1)

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