Trial Outcomes & Findings for De-Implementing Opioids for Dental Extractions (NCT NCT03584789)
NCT ID: NCT03584789
Last Updated: 2022-08-30
Results Overview
Number of participants prescribed an opioid.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5722 participants
Primary outcome timeframe
At the extraction encounter
Results posted on
2022-08-30
Participant Flow
Unit of analysis: Dentists
Participant milestones
| Measure |
Standard Practice
Standard Practice: The patients in this arm were part of usual care with their dental provider.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
1739 17
|
2297 16
|
1686 17
|
|
Overall Study
COMPLETED
|
1720 16
|
2269 14
|
1660 13
|
|
Overall Study
NOT COMPLETED
|
19 1
|
28 2
|
26 4
|
Reasons for withdrawal
| Measure |
Standard Practice
Standard Practice: The patients in this arm were part of usual care with their dental provider.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
refused EHR permission
|
19
|
28
|
23
|
|
Overall Study
patients tied to a provider who retired
|
0
|
0
|
3
|
Baseline Characteristics
De-Implementing Opioids for Dental Extractions
Baseline characteristics by cohort
| Measure |
Clinical Decision Support
n=2269 Participants
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.
|
Clinical Decision Support + Education
n=1660 Participants
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.
|
Total
n=5649 Participants
Total of all reporting groups
|
Standard Practice
n=1720 Participants
Standard Practice: The patients in this arm were part of usual care with their dental provider.
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
151 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
355 Participants
n=7 Participants
|
115 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1598 Participants
n=107 Participants
|
1136 Participants
n=206 Participants
|
4024 Participants
n=7 Participants
|
1290 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
520 Participants
n=107 Participants
|
435 Participants
n=206 Participants
|
1270 Participants
n=7 Participants
|
315 Participants
n=99 Participants
|
|
Age, Continuous
|
46.6 years
STANDARD_DEVIATION 20.6 • n=107 Participants
|
49.7 years
STANDARD_DEVIATION 20.0 • n=206 Participants
|
47.2 years
STANDARD_DEVIATION 20.1 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 19.4 • n=99 Participants
|
|
Sex: Female, Male
Female
|
1284 Participants
n=107 Participants
|
937 Participants
n=206 Participants
|
3240 Participants
n=7 Participants
|
1019 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
985 Participants
n=107 Participants
|
723 Participants
n=206 Participants
|
2409 Participants
n=7 Participants
|
701 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
113 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
275 Participants
n=7 Participants
|
91 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1479 Participants
n=107 Participants
|
1073 Participants
n=206 Participants
|
3826 Participants
n=7 Participants
|
1274 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
677 Participants
n=107 Participants
|
516 Participants
n=206 Participants
|
1548 Participants
n=7 Participants
|
355 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
17 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
183 Participants
n=107 Participants
|
132 Participants
n=206 Participants
|
457 Participants
n=7 Participants
|
142 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
421 Participants
n=107 Participants
|
284 Participants
n=206 Participants
|
1029 Participants
n=7 Participants
|
324 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
1217 Participants
n=107 Participants
|
950 Participants
n=206 Participants
|
3120 Participants
n=7 Participants
|
953 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
29 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
400 Participants
n=107 Participants
|
270 Participants
n=206 Participants
|
942 Participants
n=7 Participants
|
272 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: At the extraction encounterPopulation: 73 participants declined use of their EHR data
Number of participants prescribed an opioid.
Outcome measures
| Measure |
Standard Practice
n=1720 Participants
Standard Practice: The patients in this arm were part of usual care with their dental provider.
|
Clinical Decision Support
n=2269 Participants
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.
|
Clinical Decision Support + Education
n=1660 Participants
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.
|
|---|---|---|---|
|
Opioid Prescribing at the Extraction Encounter
|
443 Participants
|
643 Participants
|
418 Participants
|
SECONDARY outcome
Timeframe: At the extraction encounterPopulation: 73 participants declined use of their EHR data
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).
Outcome measures
| Measure |
Standard Practice
n=1720 Participants
Standard Practice: The patients in this arm were part of usual care with their dental provider.
|
Clinical Decision Support
n=2269 Participants
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.
|
Clinical Decision Support + Education
n=1660 Participants
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.
|
|---|---|---|---|
|
Exclusive Non-opioid Prescribing or Recommendations at the Extraction Encounter
|
714 Participants
|
888 Participants
|
566 Participants
|
SECONDARY outcome
Timeframe: 3-6 days after the extraction encounterPopulation: 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.
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.
Outcome measures
| Measure |
Standard Practice
n=157 Participants
Standard Practice: The patients in this arm were part of usual care with their dental provider.
|
Clinical Decision Support
n=199 Participants
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.
|
Clinical Decision Support + Education
n=136 Participants
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.
|
|---|---|---|---|
|
Compare the Study Arm Differences in Shared Decision-making
|
3.3 score on a scale
Interval 3.2 to 3.5
|
3.3 score on a scale
Interval 3.2 to 3.4
|
3.3 score on a scale
Interval 3.2 to 3.4
|
SECONDARY outcome
Timeframe: 3-6 days after the extraction encounterPopulation: 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.
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')
Outcome measures
| Measure |
Standard Practice
n=157 Participants
Standard Practice: The patients in this arm were part of usual care with their dental provider.
|
Clinical Decision Support
n=199 Participants
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.
|
Clinical Decision Support + Education
n=136 Participants
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.
|
|---|---|---|---|
|
Compare the Study Arm Differences in Patient Experiences of Post-extraction Pain
|
3.8 score on a scale
Interval 3.3 to 4.3
|
3.7 score on a scale
Interval 3.2 to 4.1
|
3.5 score on a scale
Interval 3.0 to 4.0
|
Adverse Events
Standard Practice
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinical Decision Support
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Clinical Decision Support + Education
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Standard Practice
n=1720 participants at risk
The patients in this arm were part of usual care with their dental provider.
|
Clinical Decision Support
n=2269 participants at risk
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.
|
Clinical Decision Support + Education
n=1660 participants at risk
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.
|
|---|---|---|---|
|
Surgical and medical procedures
Pain at site
|
0.00%
0/1720 • 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.
|
0.04%
1/2269 • Number of events 1 • 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.
|
0.00%
0/1660 • 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.
|
Additional Information
D. Brad Rindal, DDS, Associate Dental Director Research
HealthPartners Institute
Phone: 952-967-5026
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place