Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

NCT03691948 | Completed Results

• 1 other identifier: Pro00082658
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knowledge, Attitudes, Practice

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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)

• Change at Post-test From Baseline in Knowledge Change Questionnaire Score

  Single time point from pre-intervention to immediately post-intervention

Study Arms (2)

ROPEs

EXPERIMENTAL

Other: Responsible Opioid Prescriber Education (ROPES)

Control

ACTIVE COMPARATOR

Other: Active Comparator Control

Interventions

Responsible Opioid Prescriber Education (ROPES) OTHER

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.

ROPEs

Active Comparator Control OTHER

An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.

Control

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unable to provide informed consent due to mental or physical limitations.
• Participation in ROPEs intervention development focus groups.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Jenna McCauley

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Behavior

Limitations and Caveats

This was a pilot trial intended to demonstrate methodological feasibility. Thus, the trial was not intended to be sufficiently powered to detect significant differences between the intervention and control groups.

Results Point of Contact

• Title: Jenna L. McCauley, PhD, Assistant Professor of Psychiatry
• Organization: Medical University of South Carolina

mccaule@musc.edu

8437923922

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 2, 2018
• Study Start: March 28, 2019
• Primary Completion: November 21, 2019
• Study Completion: December 5, 2019
• Last Updated: November 3, 2020
• Results First Posted: November 3, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)