Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

Reducing Prescription Opioid Misuse: Dental Provider Intervention Development

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 Overview

• Status: Completed
• Conditions: Knowledge, Attitudes, Practice
• Intervention / Treatment: Other: Responsible Opioid Prescriber Education (ROPES); Other: Active Comparator Control

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Jenna McCauley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control	Other: Active Comparator Control; An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Experimental: ROPEs	Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2019
• Primary Completion (Actual): November 21, 2019
• Study Completion (Actual): December 5, 2019

Study Registration Dates

• First Submitted: September 27, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: Pro00082658

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No