Clinical trial NCT03584789: De-Implementing Opioids for Dental Extractions
Official title: De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Keywords: Decision Support Systems, Clinical
Pain Management
Analgesics
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Friends Research Institute, Inc.
name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2018-07-12
Enrollment: 5722
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opioid Prescribing at the Extraction Encounter
timeFrame: At the extraction encounter
Secondary outcomes:
measure: Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter
timeFrame: At the extraction encounter
measure: Compare the Study Arm Differences in Shared Decision-making
timeFrame: 3-6 days after the extraction encounter
measure: Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain
timeFrame: 3-6 days after the extraction encounter
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: HealthPartners Dental Group
state: Minnesota
Study officials:
affiliation: HealthPartners Institute
name: D. Brad Rindal, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Friends Research Institute, Inc.
name: Shannon G. Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.