Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Prescription Opioid Misuse: Dental Provider Intervention Development

Conditions
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Knowledge, Attitudes, Practice

Intervention / Treatment
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* Other: Responsible Opioid Prescriber Education (ROPES)
* Other: Active Comparator Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female; any race or ethnicity; age 21-85 years. Able to comprehend English. 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). Report having ever prescribed an opioid analgesic to a patient Must have Internet access Must have a valid, usable email account Must agree to complete all study measurements. Exclusion Criteria: Unable to provide informed consent due to mental or physical limitations. Participation in ROPEs intervention development focus groups.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROPEs<br> | Other: Responsible Opioid Prescriber Education (ROPES)<br>* 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.<br>|
| Active Comparator: Control<br> | Other: Active Comparator Control<br>* An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methodological Feasibility: Recruitment Rate | Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials. | Baseline completion, approximately 2 hours | 
| Methodological Feasibility: Completion Rates | Percent of Patients Completing ROPES (or control) | Baseline completion, approximately 2 hours | 
| Methodological Feasibility: Follow-Up Completion Rates | Percent of baseline participants completing the one-month follow-up assessment | Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) | 
| Methodological Feasibility: Time to Complete Intervention | Time participant takes to finish engaging with ROPES intervention or control intervention | Baseline completion component, approximately 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) | 
| 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. | Single time point from pre-intervention to immediately post-intervention |