De-Implementing Opioids for Dental Extractions

Tooth Extraction Clinical Trial

— DIODE  

Official title:

De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584789
• Other study ID #: A17-013
• Secondary ID: U01DE027441
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: May 21, 2021

Study information

• Verified date: May 2022
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overarching goal of this project is to de-implement the reliance on opioid analgesics and to implement reliance on non-opioid analgesics to manage postoperative pain following dental extractions. Using a prospective, provider-level, 3-arm cluster randomized trial design, the investigators will compare different strategies to reduce the reliance on opioids and increase the use of alternative pain management approaches utilizing information support tools aimed at both providers and their patients.

Description:

The primary objective of this project is to de-implement the use of opioid analgesics for the management of postoperative pain following dental extractions and to implement effective alternative pain management. The investigators propose a cluster-randomized trial design in which dental practitioners will be randomly assigned to 1 of 3 conditions involving different implementation strategies. The first condition, Standard Practice, will serve as a control condition. The second condition will implement a clinical decision support (CDS) tool that will extract patient history and interface with the state prescription drug monitoring program to provide personalized recommendations for analgesic prescribing and offer language for discussing optimal, evidence-based non-opioid pain management with dental extraction patients. The third condition will involve an enhanced version of the CDS (CDS-E) that will also include information regarding optimal, evidence-based, non-opioid pain management delivered directly to the patient both before and following the dental extraction visit. The investigators will examine opioid and non-opioid prescribing data from the electronic health record across study arms as well as other provider- and patient-focused outcomes using mixed methods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5722
• Est. completion date: May 21, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

PATIENTS

Inclusion Criteria:

• Have a dental extraction of a permanent teeth performed by an eligible HealthPartners provider during the intervention period

Exclusion Criteria:

• Patients who have opted out of research at HealthPartners

• Meet above age criteria

Related Conditions & MeSH terms

• Tooth Extraction

Intervention

Other:
• Clinical Decision Support
A clinical decision support system designed to assist dentists in providing optimal pain management for patients without resorting to opioids when a non-opioid alternative would suffice. It provides pertinent clinical information to the dentist, including point-of-care access to the Prescription Drug Monitoring Program.
• Patient education
Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.

Locations

Country	Name	City	State
United States	HealthPartners Dental Group	Bloomington	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
HealthPartners Institute	Friends Research Institute, Inc., National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12. — View Citation

Mitchell SG, Truitt AR, Davin LM, Rindal DB. Pain management after third molar extractions in adolescents: a qualitative study. BMC Pediatr. 2022 Apr 7;22(1):184. doi: 10.1186/s12887-022-03261-x. — View Citation

Rindal DB, Asche SE, Gryczynski J, Kane SM, Truitt AR, Shea TL, Ziegenfuss JY, Schwartz RP, Worley DC, Mitchell SG. De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial. JMIR Res Protoc. 2021 Apr 12;10(4):e24342. doi: 10.2196/24342. — View Citation

Rindal DB, Asche SE, Kane S, Truitt AR, Worley DC, Davin LM, Gryczynski J, Mitchell SG. Patient, Provider Type, and Procedure Type Factors Associated with Opioid Prescribing by Dentists in a Health Care System. J Pain Res. 2021 Oct 20;14:3309-3319. doi: 10.2147/JPR.S330598. eCollection 2021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid Prescribing at the Extraction Encounter	Number of participants prescribed an opioid.	At the extraction encounter
Secondary	Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter	Number of participants prescribed or recommended non-opioid analgesics (ibuprofen, naproxen, aspirin, or acetaminophen) and did not prescribe opioids (at the time of the extraction encounter).	At the extraction encounter
Secondary	Compare the Study Arm Differences in Shared Decision-making	The CollaboRATE scale measures shared decision making and consists of the mean of three items, each rated on a 0 ("no effort was made") to 4 ("every effort was made") scale. The possible range for the composite score is 0-4, with a higher score on the scale indicating that more shared decision-making occurred.	3-6 days after the extraction encounter
Secondary	Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain	Study arm comparison of the average patient-reported pain 3 days following the extraction encounter. (Numeric Rating Scale, 0 'no pain at all' - 10 'worst pain imaginable')	3-6 days after the extraction encounter