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Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

NCT ID: NCT03691948

Last Updated: 2020-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2019-12-05

Brief Summary

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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

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Conditions

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Knowledge, Attitudes, Practice

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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ROPEs

Group Type EXPERIMENTAL

Responsible Opioid Prescriber Education (ROPES)

Intervention Type 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.

Control

Group Type ACTIVE_COMPARATOR

Active Comparator Control

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Active Comparator Control

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Jenna McCauley

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Jenna McCauley

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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Pro00082658

Identifier Type: -

Identifier Source: org_study_id