Currently submitted to: JMIR Research Protocols
Date Submitted: Sep 16, 2020
Open Peer Review Period: Sep 15, 2020 - Nov 10, 2020
(closed for review but you can still tweet)
NOTE: This is an unreviewed Preprint
Warning: This is a unreviewed preprint (What is a preprint?). Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn (a note "no longer under consideration" will appear above).
Peer-review me: Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period (in this case, a "Peer-Review Me" button to sign up as reviewer is displayed above). All preprints currently open for review are listed here. Outside of the formal open peer-review period we encourage you to tweet about the preprint.
Citation: Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).
Final version: If our system detects a final peer-reviewed "version of record" (VoR) published in any journal, a link to that VoR will appear below. Readers are then encourage to cite the VoR instead of this preprint.
Settings: If you are the author, you can login and change the preprint display settings, but the preprint URL/DOI is supposed to be stable and citable, so it should not be removed once posted.
Submit: To post your own preprint, simply submit to any JMIR journal, and choose the appropriate settings to expose your submitted version as preprint.
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
Request queued. Please wait while the file is being generated. It may take some time.
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.