Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

Not Applicable

Completed

• Conditions: Knowledge, Attitudes, Practice
• Interventions: Other: Active Comparator Control; Other: Responsible Opioid Prescriber Education (ROPES)

• Registration Number: NCT03691948
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Study Start: 2019-03-28
• Primary Completion: 2019-11-21
• Study Completion: 2019-12-05
• Results First Submitted: 2020-09-17
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-09
• Last Update Submitted: 2020-10-09
• Results First Posted: 2020-11-03
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Active Comparator Control	-
ROPEs	Responsible Opioid Prescriber Education (ROPES)	-

Primary Outcome Measures

Name	Time	Method
Methodological Feasibility: Follow-Up Completion Rates	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	Baseline completion component, approximately 90 minutes	Time participant takes to finish engaging with ROPES intervention or control intervention
Methodological Feasibility: Completion Rates	Baseline completion, approximately 2 hours	Percent of Patients Completing ROPES (or control)
Methodological Feasibility: Recruitment Rate	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 Outcome Measures

Name	Time	Method
Change at Post-test From Baseline in Knowledge Change Questionnaire Score	Single time point from pre-intervention to immediately post-intervention	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.
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)	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.

Trial Locations

Locations (1)

Jenna McCauley; 🇺🇸 Charleston, South Carolina, United States