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Tooth ExtractionDIODENCT03584789

De-Implementing Opioids for Dental Extractions

A study testing Clinical Decision Support and Patient education in people with Tooth Extraction, run by HealthPartners Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Tooth Extraction
What is being tested?
Clinical Decision Support and Patient education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,722 participants
Where
1 siteUnited States
Study dates
17 Feb 2020to 21 May 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Have a dental extraction of a permanent teeth performed by an eligible HealthPartners provider during the intervention period

Who cannot join

  • Patients who have opted out of research at HealthPartners
  • Meet above age criteria

Trial locations and contacts

1 site in 1 country.

United States1 site

  • HealthPartners Dental Group

    Bloomington, Minnesota, 55425

Other trials in United States

About this study

Official title: De-Implementing Opioid Use and Implementing Optimal Pain Management Following 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.

Read the 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.

Being tested
Clinical Decision Support, Patient education
Keywords
Decision Support Systems, Clinical, Pain Management, Analgesics
Medical subject headings
Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinical Decision SupportOther

    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 educationOther

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

Study groups in NCT03584789
Study groupRoleWhat they receive
Standard PracticeNo interventionThe patients in this arm were part of usual care with their dental provider.
Clinical Decision SupportExperimentalA 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.
Receives: Other: Clinical Decision Support
Clinical Decision Support + EducationExperimentalPatient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.
Receives: Other: Clinical Decision Support; Other: Patient education

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Opioid Prescribing at the Extraction Encounter

    Number of participants prescribed an opioid.

    Measured: At the extraction encounter

Secondary outcomes (3)

  1. Exclusive Non-opioid Prescribing or Recommendations 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).

    Measured: At the extraction encounter

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

    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.

    Measured: 3-6 days after the extraction encounter

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

    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')

    Measured: 3-6 days after the extraction encounter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2018
  2. Study start17 Feb 2020
  3. Primary completion14 May 2021
  4. Study completion21 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,722 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03584789
Sponsor's protocol ID
A17-013
Other IDs
U01DE027441
Acronym
DIODE
Status last verified
May 2022
First submitted
8 Jun 2018
Last updated
30 Aug 2022
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data outputs: patient survey data, Electronic Health Record (EHR) study data

Publications

  • Rindal DB, Asche SE, Gryczynski J, Kane SM, Truitt AR, Shea TL, Ziegenfuss JY, Schwartz RP, Worley DC, Mitchell SG. De-Implementing Opioid Use and Implementing Optimal Pain Management Following Dental Extractions (DIODE): Protocol for a Cluster Randomized Trial. JMIR Res Protoc. 2021 Apr 12;10(4):e24342. doi: 10.2196/24342.

    PubMed 33843594

  • Mitchell SG, Truitt AR, Davin LM, Rindal DB. Pain management after third molar extractions in adolescents: a qualitative study. BMC Pediatr. 2022 Apr 7;22(1):184. doi: 10.1186/s12887-022-03261-x.

    PubMed 35392856

  • Rindal DB, Asche SE, Kane S, Truitt AR, Worley DC, Davin LM, Gryczynski J, Mitchell SG. Patient, Provider Type, and Procedure Type Factors Associated with Opioid Prescribing by Dentists in a Health Care System. J Pain Res. 2021 Oct 20;14:3309-3319. doi: 10.2147/JPR.S330598. eCollection 2021.

    PubMed 34707399

  • Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.

    PubMed 23768763

  • Mitchell SG, Gryczynski J, Worley DC, Asche SE, Truitt AR, Rindal DB. Barriers to dental providers' use of a clinical decision support tool for pain management following tooth extractions. Implement Res Pract. 2025 Feb 9;6:26334895251319810. doi: 10.1177/26334895251319810. eCollection 2025 Jan-Dec.

    PubMed 39931509

  • Rindal DB, Pasumarthi DP, Thirumalai V, Truitt AR, Asche SE, Worley DC, Kane SM, Gryczynski J, Mitchell SG. Clinical Decision Support to Reduce Opioid Prescriptions for Dental Extractions using SMART on FHIR: Implementation Report. JMIR Med Inform. 2023 Nov 7;11:e45636. doi: 10.2196/45636.

    PubMed 37934572

  • Gryczynski J, Mitchell SG, Asche SE, Truitt AR, Worley DC, Rindal DB. De-Implementing Opioids for Dental Extractions (DIODE): a multi-clinic, cluster-randomized trial of clinical decision support strategies in dentistry. Implement Sci. 2023 Feb 10;18(1):5. doi: 10.1186/s13012-023-01262-7.

    PubMed 36765414

  • Rindal DB, Gryczynski J, Asche SE, Truitt AR, Kane SM, Worley DC, Mitchell SG. De-implementing opioid prescribing in a dental group practice: Lessons learned. Community Dent Oral Epidemiol. 2023 Feb;51(1):139-142. doi: 10.1111/cdoe.12820. Epub 2023 Feb 8.

    PubMed 36753410

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Decision Support and Patient education in people with Tooth Extraction, run by HealthPartners Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Opioid Prescribing at the Extraction Encounter (time frame: At the extraction encounter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03584789, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2022.

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