De-Implementing Opioids for Dental Extractions (DIODE)

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

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.

Study Overview

• Status: Completed
• Conditions: Tooth Extraction
• Intervention / Treatment: Other: Clinical Decision Support; Other: Patient education

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.

• Study Type: Interventional
• Enrollment (Actual): 5722
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55425
      • HealthPartners Dental Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Standard Practice; The patients in this arm were part of usual care with their dental provider.
EXPERIMENTAL: 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.	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.
EXPERIMENTAL: Clinical Decision Support + Education; Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.	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.; Other: Patient education; Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Prescribing at the Extraction Encounter	Number of participants prescribed an opioid.	At the extraction encounter

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR); Friends Research Institute, Inc.
• Investigators: Principal Investigator: Shannon G. Mitchell, PhD, Friends Research Institute, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2020
• Primary Completion (ACTUAL): May 14, 2021
• Study Completion (ACTUAL): May 21, 2021

Study Registration Dates

• First Submitted: June 8, 2018
• First Submitted That Met QC Criteria: June 29, 2018
• First Posted (ACTUAL): July 12, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Pain Management; Analgesics; Decision Support Systems, Clinical
• Other Study ID Numbers: A17-013; U01DE027441 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data outputs: patient survey data, Electronic Health Record (EHR) study data
• IPD Sharing Time Frame: Release of de-identified datasets and accompanying technical resources used for specific publications will occur within 6 months of the online publication date.
• IPD Sharing Access Criteria: Data will be stored at HealthPartners Institute by the project co-principal investigator/site lead and statistician. Study publications will note the method for requesting the study data and technical materials. The study statistician will provide data and accompanying files in an archived zip format to requesters via email. Data will not be stored in a public repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Study Data/Documents

1. Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No