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Completed

NCT Number: NCT03584789

De-Implementing Opioids for 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.

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Key information

Conditions

Tooth Extraction Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Dental Group

Bloomington, Minnesota, 55425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical Decision Support

Other

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.

Patient Education

Other

Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.

Primary outcomes

  1. Opioid Prescribing at the Extraction Encounter

    Time frame: At the extraction encounter

    Number of participants prescribed an opioid.

Secondary outcomes

  1. Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter

    Time frame: 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).

  2. Compare the Study Arm Differences in Shared Decision-making

    Time frame: 3-6 days after the extraction encounter

    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. Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain

    Time frame: 3-6 days after the extraction encounter

    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')

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Friends Research Institute, Inc.
  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Acronym: DIODE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 12, 2018
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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