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Clinical Trials/NCT03691948
NCT03691948CompletedNot Applicable

Reducing Prescription Opioid Misuse: Dental Provider Intervention Development

Medical University of South Carolina2 sites in 1 country60 target enrollmentStarted: March 28, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Methodological Feasibility: Follow-Up Completion Rates

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Methodological Feasibility: Follow-Up Completion Rates

Time Frame: 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

Time Frame: Baseline completion component, approximately 90 minutes

Time participant takes to finish engaging with ROPES intervention or control intervention

Methodological Feasibility: Completion Rates

Time Frame: Baseline completion, approximately 2 hours

Percent of Patients Completing ROPES (or control)

Methodological Feasibility: Recruitment Rate

Time Frame: Baseline completion, approximately 2 hours

Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.

Secondary Outcomes

  • Change at Post-test From Baseline in Knowledge Change Questionnaire Score(Single time point from pre-intervention to immediately post-intervention)
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jenna McCauley

Assistant Professor

Medical University of South Carolina

Study Sites (2)

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