Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 16, 2020
Open Peer Review Period: Sep 15, 2020 - Nov 10, 2020
(currently open for review)
De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Trial rationale, protocol, and progress to date
Overdose deaths from prescription opioid analgesics are a continuing crisis in the United States. Opioid analgesics are among the most frequently prescribed drugs by dentists. An estimated 5 million people undergo third-molar extractions in the United States each year, resulting in postoperative pain. Studies show that in most cases the combination of ibuprofen and acetaminophen is an effective alternative to commonly-prescribed opioid analgesics for the management of post-extraction pain. Nevertheless, many dentists routinely prescribe opioids after dental extractions.
We describe the rationale, design, and methods for a randomized trial of interventions designed to de-implement opioid prescribing by dentists while implementing effective non-opioid analgesics following dental extractions.
Using a prospective, 3-arm cluster randomized trial design with dentists as the unit randomized and patient-level prescribing data as the primary outcome, we 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. The study will test the efficacy of two interventions to decrease opioid prescribing following dental extractions: Clinical Decision Support (CDS), and CDS with Patient Education (CDS-E). Providers will be randomized to CDS, CDS-E, or standard practice. Patient-level outcomes will be determined via review of comprehensive electronic health records. We will compare study arms on differential change in prescribing patterns from pre- to post-implementation of the intervention. The primary outcome of interest is a binary indicator of whether or not the patient received an opioid prescription on the day of the extraction encounter. We will also examine recommendations or prescriptions for non-opioid analgesics, patients’ perception of shared decision making, and patients’ pain experiences following the extraction.
The HealthPartners Institutional Review Board has approved the study. All study materials including the CDS and patient education materials have been developed and pilot tested and the protocol has been approved by National Institute of Dental and Craniofacial Research (NIDCR). The intervention was implemented in February 2020 and data collection has begun.
If the intervention strategies are shown to be effective, they could be implemented more broadly in dental settings with high levels of opioid prescribing. Clinical Trial: ClinicalTrials.gov Identifier: NCT03584789
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