Tooth Extraction
Conditions
Keywords
Decision Support Systems, Clinical, Pain Management, Analgesics
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.
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.
Interventions
OTHERClinical 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.
OTHERPatient education
Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.
Sponsors
Friends Research Institute, Inc.
National Institute of Dental and Craniofacial Research (NIDCR)
HealthPartners Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Prescribing at the Extraction Encounter | At the extraction encounter | Number of participants prescribed an opioid. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter | 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). |
| Compare the Study Arm Differences in Shared Decision-making | 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. |
| Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain | 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') |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Practice Standard Practice: The patients in this arm were part of usual care with their dental provider. | 1,720 |
| 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. | 2,269 |
| 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. | 1,660 |
| Total | 5,649 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | patients tied to a provider who retired | 0 | 0 | 3 |
| Overall Study | refused EHR permission | 19 | 28 | 23 |
Baseline characteristics
| Characteristic | Standard Practice | Clinical Decision Support + Education | Clinical Decision Support | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 115 Participants | 89 Participants | 151 Participants | 355 Participants |
| Age, Categorical >=65 years | 315 Participants | 435 Participants | 520 Participants | 1270 Participants |
| Age, Categorical Between 18 and 65 years | 1290 Participants | 1136 Participants | 1598 Participants | 4024 Participants |
| Age, Continuous | 45.4 years STANDARD_DEVIATION 19.4 | 49.7 years STANDARD_DEVIATION 20 | 46.6 years STANDARD_DEVIATION 20.6 | 47.2 years STANDARD_DEVIATION 20.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 91 Participants | 71 Participants | 113 Participants | 275 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1274 Participants | 1073 Participants | 1479 Participants | 3826 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 355 Participants | 516 Participants | 677 Participants | 1548 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 13 Participants | 11 Participants | 17 Participants | 41 Participants |
| Race (NIH/OMB) Asian | 142 Participants | 132 Participants | 183 Participants | 457 Participants |
| Race (NIH/OMB) Black or African American | 324 Participants | 284 Participants | 421 Participants | 1029 Participants |
| Race (NIH/OMB) More than one race | 14 Participants | 10 Participants | 29 Participants | 53 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 272 Participants | 270 Participants | 400 Participants | 942 Participants |
| Race (NIH/OMB) White | 953 Participants | 950 Participants | 1217 Participants | 3120 Participants |
| Sex: Female, Male Female | 1019 Participants | 937 Participants | 1284 Participants | 3240 Participants |
| Sex: Female, Male Male | 701 Participants | 723 Participants | 985 Participants | 2409 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,720 | 0 / 2,269 | 0 / 1,660 |
| other Total, other adverse events | 0 / 1,720 | 1 / 2,269 | 0 / 1,660 |
| serious Total, serious adverse events | 0 / 1,720 | 0 / 2,269 | 0 / 1,660 |
Outcome results
Primary
Opioid Prescribing at the Extraction Encounter
Number of participants prescribed an opioid.
Time frame: At the extraction encounter
Population: 73 participants declined use of their EHR data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Practice | Opioid Prescribing at the Extraction Encounter | 443 Participants |
| Clinical Decision Support | Opioid Prescribing at the Extraction Encounter | 643 Participants |
| Clinical Decision Support + Education | Opioid Prescribing at the Extraction Encounter | 418 Participants |
p-value: 0.0897.5% CI: [0.93, 1.8]Mixed Models Analysis
p-value: 0.1897.5% CI: [0.86, 1.79]Mixed Models Analysis
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')
Time frame: 3-6 days after the extraction encounter
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Practice | Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain | 3.8 score on a scale |
| Clinical Decision Support | Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain | 3.7 score on a scale |
| Clinical Decision Support + Education | Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain | 3.5 score on a scale |
p-value: 0.6595% CI: [-0.79, 0.5]Mixed Models Analysis
p-value: 0.4195% CI: [-0.99, 0.41]Mixed Models Analysis
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.
Time frame: 3-6 days after the extraction encounter
Population: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Practice | Compare the Study Arm Differences in Shared Decision-making | 3.3 score on a scale |
| Clinical Decision Support | Compare the Study Arm Differences in Shared Decision-making | 3.3 score on a scale |
| Clinical Decision Support + Education | Compare the Study Arm Differences in Shared Decision-making | 3.3 score on a scale |
p-value: 0.3895% CI: [-0.26, 0.12]Mixed Models Analysis
p-value: 0.795% CI: [-0.24, 0.17]Mixed Models Analysis
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).
Time frame: At the extraction encounter
Population: 73 participants declined use of their EHR data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Practice | Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter | 714 Participants |
| Clinical Decision Support | Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter | 888 Participants |
| Clinical Decision Support + Education | Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter | 566 Participants |
p-value: 0.7197.5% CI: [0.2, 9.44]Mixed Models Analysis
p-value: 0.6297.5% CI: [0.21, 11]Mixed Models Analysis