Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Jenna McCauley，Medical University of South Carolina

Tracking Information

First Submitted Date ^ICMJE

September 27, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

January 2019

Estimated Primary Completion Date

August 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Methodological Feasibility: Recruitment Rate[ Time Frame: Baseline completion, approximately 2 hours ]

Number of Participants Recruited

Methodological Feasibility: Completion Rates[ Time Frame: Baseline completion, approximately 2 hours ]

Percent of Patients Completing ROPES (or control)

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

ROPEs Knowledge Change Questionnaire[ Time Frame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up) ]
Change in dentists' knowledge regarding opioid misuse, acute pain management recommendations, and risk mitigation strategies will be assessed by a questionnaire developed for this study and administered immediately prior and immediately subsequent to intervention (or control) completion and at 1-month follow-up. Knowledge scale contains 5 items. 1 point is awarded for each item correctly answered. 0 points are awarded for incorrect responses. Scale ranges from 0 (least accurate knowledge) to 5 (most accurate knowledge)

Descriptive Information

Brief Title ^ICMJE

Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

Official Title ^ICMJE

Reducing Prescription Opioid Misuse: Dental Provider Intervention Development

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Other

Condition ^ICMJE

Intervention ^ICMJE

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

Study Arms

Experimental: ROPEs
Active Comparator: Control

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 2019

Estimated Primary Completion Date

August 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Jenna McCauley，Medical University of South Carolina

Study Sponsor ^ICMJE

Medical University of South Carolina

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Medical University of South Carolina

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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