Alternatives to Dental Opioid Prescribing After Tooth Extraction

Acute Pain Clinical Trial

— ADOPT  

Official title:

Alternatives to Dental Opioid Prescribing After Tooth Extraction

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06275191
• Other study ID #: 80758
• Secondary ID: 1UG3DE032621-014
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 16, 2024
• Est. completion date: December 2028

Study information

• Verified date: June 2024
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 38159
• Est. completion date: December 2028
• Est. primary completion date: January 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acetaminophen
• Acute Pain
• Adolescent
• Analgesics, Opioid
• Ibuprofen
• Tooth Extraction

Intervention

Behavioral:
• Multicomponent intervention
The multicomponent intervention consists of (1) a single 45-60-minute academic detailing session with provider participants, plus (2) provision of patient post-extraction instruction materials and (3) provision of blister-packaged acetaminophen and ibuprofen for distribution to adolescent/young adult patients after tooth extraction in the course of clinical practice

Other:
• Usual care
No intervention.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Douglas Oyler	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Odds of post-extraction opioid prescription to adolescent/young adults after tooth extraction	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.	Same calendar date as dental extraction. Electronic health records will be extracted for the duration of the 4-year study period.
Secondary	(Change in) intervention feasibility	Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding feasibility of distributing blister packs and patient post-extraction materials. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.	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).
Secondary	(Change in) intervention appropriateness	Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding appropriateness of distributing blister packs and patient post-extraction materials. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.	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).
Secondary	(Change in) opioid prescribing feasibility	Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding feasibility of reducing opioid prescription. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.	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).
Secondary	(Change in) opioid prescribing appropriateness	Survey response. 5-point Likert-type questions (from 1-completely disagree to 5-completely agree) regarding appropriateness of reducing opioid prescription. Selection of the top 2 choices (completely agree or agree) from the scale is considered as agreement with the statement.	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).
Secondary	Self-reported pain	Patient survey, 3 items from Brief Pain Inventory (worst, least, average pain) based on self-reported opioid use. Each item uses an 11-point Visual Rating Scale from 0-no pain to 10-worst possible pain.	within 10 days of tooth extraction
Secondary	Self-reported pain interference	Patient survey, NIH PROMIS Pediatric Short Form v1.0-Pain Interference 8a (age < 18) or NIH PROMIS Adult Short Form v1.0-Pain Interference 6b (18+) based on self-reported opioid use. NIH PROMIS Pediatric Short Form t-scores range from 34.0 to 78.0, with higher scores indicating greater interference. NIH PROMIS Adult Short Form t scores range from 41.0 to 78.3, with higher scores indicating greater interference.	within 10 days of tooth extraction
Secondary	Self-reported pain satisfaction	Patient survey, 5-point Likert-type question (from 1-very unhappy to 5-very happy) regarding overall satisfaction with pain management based on self-reported opioid use. Selection of the top 2 choices (very happy or happy) from the scale is considered as satisfaction with overall pain management.	within 10 days of tooth extraction