An interventional study of Clinical Decision Support and Patient education in Tooth Extraction, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2022-08-30.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Health services research
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.
HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
Counted across the registry records on this site, refreshed daily.
PATIENTS
Inclusion Criteria:
Exclusion Criteria:
The patients in this arm were part of usual care with their dental provider.
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: Clinical Decision Support
Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.
Other: Clinical Decision Support · Other: Patient education
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 regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.
Opioid Prescribing at the Extraction Encounter
Number of participants prescribed an opioid.
Time frame: At the extraction encounter
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).
Time frame: At the extraction encounter
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.
Time frame: 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')
Time frame: 3-6 days after the extraction encounter
| Milestone | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education |
|---|---|---|---|
| Started | 1739 | 2297 | 1686 |
| Completed | 1720 | 2269 | 1660 |
| Not completed | 19 | 28 | 26 |
| Withdrew: Refused ehr permission | 19 | 28 | 23 |
| Withdrew: Patients tied to a provider who retired | 0 | 0 | 3 |
Number of participants prescribed an opioid.
| Participants | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education |
|---|---|---|---|
| Opioid Prescribing at the Extraction Encounter | 443 | 643 | 418 |
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).
| Participants | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education |
|---|---|---|---|
| Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter | 714 | 888 | 566 |
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.
| score on a scale | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education |
|---|---|---|---|
| Compare the Study Arm Differences in Shared Decision-making | 3.3 (3.2 to 3.5) | 3.3 (3.2 to 3.4) | 3.3 (3.2 to 3.4) |
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')
| score on a scale | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education |
|---|---|---|---|
| Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain | 3.8 (3.3 to 4.3) | 3.7 (3.2 to 4.1) | 3.5 (3.0 to 4.0) |
Collected over Through 7 days following the extraction encounter.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Practice | 0/1,720 (0%) | 0/1,720 (0%) | 0/1,720 (0%) |
| Clinical Decision Support | 0/2,269 (0%) | 0/2,269 (0%) | 1/2,269 (0%) |
| Clinical Decision Support + Education | 0/1,660 (0%) | 0/1,660 (0%) | 0/1,660 (0%) |
| Event | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education |
|---|---|---|---|
| Pain at siteSurgical and medical procedures | 0/1720 | 1/2269 | 0/1660 |
73 participants declined use of their EHR data
| Age, Categorical(Participants) | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education | Total |
|---|---|---|---|---|
| <=18 years | 115 | 151 | 89 | 355 |
| Between 18 and 65 years | 1290 | 1598 | 1136 | 4024 |
| >=65 years | 315 | 520 | 435 | 1270 |
| Age, Continuous(years) | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education | Total |
|---|---|---|---|---|
| Mean | 45.4 ± 19.4 | 46.6 ± 20.6 | 49.7 ± 20.0 | 47.2 ± 20.1 |
| Sex: Female, Male(Participants) | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education | Total |
|---|---|---|---|---|
| Female | 1019 | 1284 | 937 | 3240 |
| Male | 701 | 985 | 723 | 2409 |
| Ethnicity (NIH/OMB)(Participants) | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education | Total |
|---|---|---|---|---|
| Hispanic or Latino | 91 | 113 | 71 | 275 |
| Not Hispanic or Latino | 1274 | 1479 | 1073 | 3826 |
| Unknown or Not Reported | 355 | 677 | 516 | 1548 |
| Race (NIH/OMB)(Participants) | Standard Practice | Clinical Decision Support | Clinical Decision Support + Education | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 13 | 17 | 11 | 41 |
| Asian | 142 | 183 | 132 | 457 |
| Native Hawaiian or Other Pacific Islander | 2 | 2 | 3 | 7 |
| Black or African American | 324 | 421 | 284 | 1029 |
| White | 953 | 1217 | 950 | 3120 |
| More than one race | 14 | 29 | 10 | 53 |
| Unknown or Not Reported | 272 | 400 | 270 | 942 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data outputs: patient survey data, Electronic Health Record (EHR) study data
Supporting information: Study protocol, Sap, Analytic code
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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