Clinical trial NCT03691948: Reducing Prescription Opioid Misuse: ROPEs Pilot Trial
Official title: Reducing Prescription Opioid Misuse: Dental Provider Intervention Development
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Methodological Feasibility: Recruitment Rate
timeFrame: Baseline completion, approximately 2 hours
measure: Methodological Feasibility: Completion Rates
timeFrame: Baseline completion, approximately 2 hours
measure: Methodological Feasibility: Follow-Up Completion Rates
timeFrame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
measure: Methodological Feasibility: Time to Complete Intervention
timeFrame: Baseline completion component, approximately 90 minutes
Secondary outcomes:
measure: Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score
timeFrame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
measure: Change at Post-test From Baseline in Knowledge Change Questionnaire Score
timeFrame: Single time point from pre-intervention to immediately post-intervention
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Jenna McCauley
state: South Carolina
Study officials:
References: