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De-Implementing Opioids for Dental Extractions (DIODE)

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ClinicalTrials.gov Identifier: NCT03584789
Recruitment Status : Not yet recruiting
First Posted : July 12, 2018
Last Update Posted : July 9, 2019
Sponsor:
Collaborators:
Friends Research Institute, Inc.
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
HealthPartners Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tooth Extraction Other: Clinical Decision Support Other: Patient education Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7958 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions
Estimated Study Start Date : February 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Standard Practice
Experimental: Clinical Decision Support 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 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.




Primary Outcome Measures :
  1. Decrease opioid prescribing for dental extractions [ Time Frame: through study completion, an average of 2 years ]
    Differential pre- to post-intervention change by study arm in the percentage of extraction encounters with an opioid prescribed (during the day of the extraction encounter).


Secondary Outcome Measures :
  1. Increase exclusive non-opioid pain management for dental extractions [ Time Frame: through study completion, an average of 2 years ]
    Differential pre- to post-intervention change by study arm in the percentage of extraction encounters at which a provider 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: through study completion, an average of 1 year ]
    Study arm comparison of the mean of the patient-reported shared decision-making composite score (composite of 3 components concerning management of post-extraction pain options: effort to explain, to listen, and to personalize 3-6 days after the extraction encounter)

  3. Compare the study arm differences in patient experiences of post-extraction pain [ Time Frame: through study completion, an average of 1 year ]
    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')



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

PROVIDERS

Inclusion Criteria:

  • Have a current Drug Enforcement Administration (DEA) number allowing them to write prescriptions for controlled substances, including opioids, during the baseline period
  • Perform dental extractions of permanent molars on a regular basis (a minimum of 6 extraction encounters during the baseline period)

PATIENTS

Inclusion Criteria:

  • Have a dental extraction of a permanent molar 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584789


Contacts
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Contact: Anjali Truitt, PhD, MPH 952-967-5002 Anjali.R.Truitt@HealthPartners.com
Contact: Tracy Shea, RDH, BS 952-967-7032 Tracy.L.Shea@HealthPartners.com

Sponsors and Collaborators
HealthPartners Institute
Friends Research Institute, Inc.
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: D. Brad Rindal, DDS HealthPartners Institute
Principal Investigator: Shannon G. Mitchell, PhD Friends Research Institute, Inc.

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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT03584789     History of Changes
Other Study ID Numbers: A17-013
U01DE027441 ( U.S. NIH Grant/Contract )
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by HealthPartners Institute:
Decision Support Systems, Clinical
Pain Management
Analgesics