De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial

Abstract

Background 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 postextraction pain. Nevertheless, many dentists routinely prescribe opioids after dental extractions. Objective We describe the rationale, design, and methods for a randomized trial of interventions designed to de-implement opioid prescribing by dentists while implementing effective nonopioid analgesics following dental extractions. Methods 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 2 interventions to decrease opioid prescribing following dental extractions: clinical decision support with (CDS-E) and without patient education (CDS). 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 postimplementation 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 nonopioid analgesics, patients’ perceptions of shared decision making, and patients’ pain experiences following the extraction. Results The HealthPartners Institutional Review Board 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 the National Institute of Dental and Craniofacial Research. The intervention was implemented in February 2020, with 51 dentists who were randomized to 1 of the 3 arms. Conclusions If the intervention strategies are shown to be effective, they could be implemented more broadly in dental settings with high levels of opioid prescribing. Trial Registration ClinicalTrials.gov NCT03584789, https://clinicaltrials.gov/ct2/show/NCT03584789 International Registered Report Identifier (IRRID) DERR1-10.2196/24342

De-Implementing Opioids for Dental Extractions (DIODE): a multi-clinic, cluster-randomized trial of clinical decision support strategies in dentistry

“…Figure 1 depicts the study flow. The study protocol and methodological details have been previously reported [ 19 ]. The HealthPartners Institutional Review Board approved the study.…”

Patient experience of post-extraction pain management

“…The patient education was either automatically printed when a patient checked in for a scheduled extraction or was printed by the dentist at the point of care. Further details about the trial are described elsewhere (17). The survey results presented here are an exploratory analysis in the context of this larger project.…”

De‐implementing opioid prescribing in a dental group practice: Lessons learned

“…The study was conducted in the HealthPartners Dental Group, which is embedded within a healthcare system. Further information about the design and conduct of the study is published elsewhere 10 …”

“…7,8 Despite the widespread use of opioids in dentistry, evidence shows that adequate pain relief following dental extractions can usually be achieved with non-opioid analgesics. 9 A well-designed clinical decision support (CDS) system 10,11 can support dentists in providing optimal care by pulling in relevant medical conditions and medications so the prescribing decision does not create needless side effects or drug interactions. This includes safer, evidence-based pain management for patients and not resorting to opioids when a safer alternative would provide effective pain management.…”