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| ID | Type | Description | Link |
|---|---|---|---|
| U01DE027441 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Friends Research Institute, Inc. | OTHER |
| National Institute of Dental and Craniofacial Research (NIDCR) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Practice | No Intervention | The patients in this arm were part of usual care with their dental provider. | |
| Clinical Decision Support | Experimental | 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. |
|
| Clinical Decision Support + Education | Experimental | Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Prescribing at the Extraction Encounter | Number of participants prescribed an opioid. | At the extraction encounter |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At the extraction encounter |
| Compare the Study Arm Differences in Shared Decision-making |
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PATIENTS
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D. Brad Rindal, DDS | HealthPartners Institute | Principal Investigator |
| Shannon G. Mitchell, PhD | Friends Research Institute, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HealthPartners Dental Group | Bloomington | Minnesota | 55425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33843594 | Background | 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. | |
| 35392856 | Background | 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. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Data outputs: patient survey data, Electronic Health Record (EHR) study data
Release of de-identified datasets and accompanying technical resources used for specific publications will occur within 6 months of the online publication date.
Data will be stored at HealthPartners Institute by the project co-principal investigator/site lead and statistician. Study publications will note the method for requesting the study data and technical materials. The study statistician will provide data and accompanying files in an archived zip format to requesters via email. Data will not be stored in a public repository.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Practice | Standard Practice: The patients in this arm were part of usual care with their dental provider. |
| FG001 | Clinical Decision Support | 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. |
| FG002 | Clinical Decision Support + Education | 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. Patient education: Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
73 participants declined use of their EHR data
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Practice | Standard Practice: The patients in this arm were part of usual care with their dental provider. |
| BG001 | Clinical Decision Support | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Prescribing at the Extraction Encounter | Number of participants prescribed an opioid. | 73 participants declined use of their EHR data | Posted | Count of Participants | Participants | At the extraction encounter |
|
Through 7 days following the extraction encounter.
We are following the standard definition. In addition, potential Adverse Events included subsequent opioid prescribing assessed through Electronic Health Record (EHR) data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Practice | The patients in this arm were part of usual care with their dental provider. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain at site | Surgical and medical procedures | Non-systematic Assessment | No opioid prescribed at extraction visit, same day call to care line resulted in prescription. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| D. Brad Rindal, DDS, Associate Dental Director Research | HealthPartners Institute | 952-967-5026 | donald.b.rindal@healthpartners.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 28, 2020 | Apr 25, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| Patient education | Other | Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies. |
|
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. |
| 3-6 days after the extraction encounter |
| 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') | 3-6 days after the extraction encounter |
| 34707399 | Background | 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. |
| 23768763 | Background | 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. |
| 39931509 | Derived | 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. |
| 37934572 | Derived | 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. |
| 36765414 | Derived | 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. |
| 36753410 | Derived | 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. |
| BG002 | Clinical Decision Support + Education | 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. Patient education: Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | Clinical Decision Support + Education | 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. Patient education: Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies. |
|
|
|
| Secondary | 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). | 73 participants declined use of their EHR data | Posted | Count of Participants | Participants | At the extraction encounter |
|
|
|
|
| Secondary | 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. | The information for this endpoint is based on a survey of patients and was offered to a sample of patients among the 5722 in the larger study. | Posted | Mean | 95% Confidence Interval | score on a scale | 3-6 days after the extraction encounter |
|
|
|
|
| Secondary | 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') | The information for this endpoint is based on a survey of patients and was offered to a sample of patients among the 5722 in the larger study. | Posted | Mean | 95% Confidence Interval | score on a scale | 3-6 days after the extraction encounter |
|
|
|
|
| 0 |
| 1,720 |
| 0 |
| 1,720 |
| 0 |
| 1,720 |
| EG001 | Clinical Decision Support | 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. | 0 | 2,269 | 0 | 2,269 | 1 | 2,269 |
| EG002 | Clinical Decision Support + Education | 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. Patient education: Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies. | 0 | 1,660 | 0 | 1,660 | 0 | 1,660 |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Odds Ratio (OR) |
| 1.53 |
| 2-Sided |
| 97.5 |
| .21 |
| 11.00 |
| Superiority |
| Median Difference (Net) |
| -0.03 |
| 2-Sided |
| 95 |
| -0.24 |
| .17 |
| Superiority |
| Mean Difference (Net) |
| -0.29 |
| 2-Sided |
| 95 |
| -0.99 |
| .41 |
| Superiority |