Knowledge, Attitudes, Practice
Conditions
Brief summary
This is a randomized controlled pilot trial to establish methodological feasibility and determine whether a web-based, continuing dental education intervention regarding opioid prescribing risk mitigation strategies - consistent with ADA guidelines - produces pre-to-post changes in knowledge, motivation, and behavioral skills pertaining to the use of risk mitigation strategies when prescribing opioids in dental practice. The current study involves completion of a self-report pre-test (dentists), randomization to complete ROPEs or attention control intervention, completion of a self-report post-test (immediately following intervention/control completion), and completion of 1-month self-report follow-up assessment.
Interventions
OTHERResponsible Opioid Prescriber Education (ROPES)
The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources.
An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male or female; any race or ethnicity; age 21-85 years. 2. Able to comprehend English. 3. Be either a licensed dental practitioner currently practicing or a Resident enrolled in the College of Dental Medicine at the Medical University of South Carolina or a practicing dentist in the Charleston-county area or a licensed dental practitioner currently participating in the National Dental Practice Based Research Network (NDPBRN). 4. Report having ever prescribed an opioid analgesic to a patient 5. Must have Internet access 6. Must have a valid, usable email account 7. Must agree to complete all study measurements.
Exclusion criteria
1. Unable to provide informed consent due to mental or physical limitations. 2. Participation in ROPEs intervention development focus groups.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methodological Feasibility: Recruitment Rate | Baseline completion, approximately 2 hours | Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials. |
| Methodological Feasibility: Completion Rates | Baseline completion, approximately 2 hours | Percent of Patients Completing ROPES (or control) |
| Methodological Feasibility: Follow-Up Completion Rates | Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) | Percent of baseline participants completing the one-month follow-up assessment |
| Methodological Feasibility: Time to Complete Intervention | Baseline completion component, approximately 90 minutes | Time participant takes to finish engaging with ROPES intervention or control intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score | Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) | The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge). This outcome will assess mean differences between groups in their change (from pre-test to one-month follow-up) in knowledge regarding best practices in dental opioid prescribing. |
| Change at Post-test From Baseline in Knowledge Change Questionnaire Score | Single time point from pre-intervention to immediately post-intervention | The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge). This outcome will assess mean differences between groups in their change (from pre-test to post-test) in knowledge regarding best practices in dental opioid prescribing. |
Countries
United States
Participant flow
Pre-assignment details
No significant pre-assignment study events occurred.
Participants by arm
| Arm | Count |
|---|---|
| ROPEs Responsible Opioid Prescriber Education (ROPES): The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources. | 27 |
| Control Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain. | 33 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 3 |
Baseline characteristics
| Characteristic | ROPEs | Total | Control |
|---|---|---|---|
| Age, Continuous | 35.85 years STANDARD_DEVIATION 10.63 | 38.08 years STANDARD_DEVIATION 11.94 | 39.91 years STANDARD_DEVIATION 12.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 58 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 20 Participants | 45 Participants | 25 Participants |
| Region of Enrollment United States | 27 participants | 60 participants | 33 participants |
| Sex: Female, Male Female | 10 Participants | 20 Participants | 10 Participants |
| Sex: Female, Male Male | 17 Participants | 40 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 27 | 0 / 33 |
| other Total, other adverse events | 0 / 27 | 0 / 33 |
| serious Total, serious adverse events | 0 / 27 | 0 / 33 |
Outcome results
Primary
Methodological Feasibility: Completion Rates
Percent of Patients Completing ROPES (or control)
Time frame: Baseline completion, approximately 2 hours
Population: All enrolled participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall - Intervention and Control Participants | Methodological Feasibility: Completion Rates | 26 Participants |
| Control | Methodological Feasibility: Completion Rates | 31 Participants |
Primary
Methodological Feasibility: Follow-Up Completion Rates
Percent of baseline participants completing the one-month follow-up assessment
Time frame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
Population: All enrolled participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall - Intervention and Control Participants | Methodological Feasibility: Follow-Up Completion Rates | 26 Participants |
| Control | Methodological Feasibility: Follow-Up Completion Rates | 30 Participants |
Primary
Methodological Feasibility: Recruitment Rate
Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.
Time frame: Baseline completion, approximately 2 hours
Population: 76 individuals received log-in credentials for this study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall - Intervention and Control Participants | Methodological Feasibility: Recruitment Rate | 60 Participants |
Primary
Methodological Feasibility: Time to Complete Intervention
Time participant takes to finish engaging with ROPES intervention or control intervention
Time frame: Baseline completion component, approximately 90 minutes
Population: All enrolled participants who completed the intervention. Note that 1 ROPEs participant and 1 Control participant did not start/complete the intervention, thus no data was available regarding their time to completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall - Intervention and Control Participants | Methodological Feasibility: Time to Complete Intervention | 108 Minutes | Standard Deviation 48.02 |
| Control | Methodological Feasibility: Time to Complete Intervention | 21 Minutes | Standard Deviation 18.91 |
Secondary
Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score
The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge). This outcome will assess mean differences between groups in their change (from pre-test to one-month follow-up) in knowledge regarding best practices in dental opioid prescribing.
Time frame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
Population: All participants completing the pre-test and the 1-month follow-up. Note that 1 ROPEs participant was lost to follow-up and 3 Control participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall - Intervention and Control Participants | Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score | -.19 Change in score on a scale | Standard Deviation 1.17 |
| Control | Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score | .00 Change in score on a scale | Standard Deviation 1.11 |
p-value: 0.531ANOVA
Secondary
Change at Post-test From Baseline in Knowledge Change Questionnaire Score
The Knowledge Change Questionnaire was developed specifically for this study and contains five items that assess dentists' knowledge regarding: (1) dentists' role in curbing prescription opioid misuse, initiation to abuse, and diversion; (2) recent released guideline recommendations for standard pain management in dental practices; and, (3) risk mitigation strategies, such as prescription opioid misuse screening and use of their state's PDMP. One point is awarded for each correct response to items on the questionnaire. The questionnaire scale ranges from 0 (no correct items, least knowledge) to 5 (all correct items, most knowledge). This outcome will assess mean differences between groups in their change (from pre-test to post-test) in knowledge regarding best practices in dental opioid prescribing.
Time frame: Single time point from pre-intervention to immediately post-intervention
Population: All participants completing the pre-test and the post-test. Note that 1 ROPEs participant was lost to follow-up and 2 Control participants were lost to follow-up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall - Intervention and Control Participants | Change at Post-test From Baseline in Knowledge Change Questionnaire Score | 0.42 change in score on a scale | Standard Deviation 1.1 |
| Control | Change at Post-test From Baseline in Knowledge Change Questionnaire Score | -0.03 change in score on a scale | Standard Deviation 0.8 |
p-value: 0.076ANOVA