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Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

Primary Purpose

Knowledge, Attitudes, Practice

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Responsible Opioid Prescriber Education (ROPES)
Active Comparator Control
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knowledge, Attitudes, Practice

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Jenna McCauley

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ROPEs

Control

Arm Description

Outcomes

Primary Outcome Measures

Methodological Feasibility: Recruitment Rate
Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.
Methodological Feasibility: Completion Rates
Percent of Patients Completing ROPES (or control)
Methodological Feasibility: Follow-Up Completion Rates
Percent of baseline participants completing the one-month follow-up assessment
Methodological Feasibility: Time to Complete Intervention
Time participant takes to finish engaging with ROPES intervention or control intervention

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 27, 2018
Last Updated
October 9, 2020
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03691948
Brief Title
Reducing Prescription Opioid Misuse: ROPEs Pilot Trial
Official Title
Reducing Prescription Opioid Misuse: Dental Provider Intervention Development
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 28, 2019 (Actual)
Primary Completion Date
November 21, 2019 (Actual)
Study Completion Date
December 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knowledge, Attitudes, Practice

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ROPEs
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Responsible Opioid Prescriber Education (ROPES)
Intervention Description
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
Intervention Name(s)
Active Comparator Control
Intervention Description
An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Primary Outcome Measure Information:
Title
Methodological Feasibility: Recruitment Rate
Description
Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.
Time Frame
Baseline completion, approximately 2 hours
Title
Methodological Feasibility: Completion Rates
Description
Percent of Patients Completing ROPES (or control)
Time Frame
Baseline completion, approximately 2 hours
Title
Methodological Feasibility: Follow-Up Completion Rates
Description
Percent of baseline participants completing the one-month follow-up assessment
Time Frame
Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
Title
Methodological Feasibility: Time to Complete Intervention
Description
Time participant takes to finish engaging with ROPES intervention or control intervention
Time Frame
Baseline completion component, approximately 90 minutes
Secondary Outcome Measure Information:
Title
Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score
Description
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.
Time Frame
Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
Title
Change at Post-test From Baseline in Knowledge Change Questionnaire Score
Description
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.
Time Frame
Single time point from pre-intervention to immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Unable to provide informed consent due to mental or physical limitations. Participation in ROPEs intervention development focus groups.
Facility Information:
Facility Name
Jenna McCauley
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

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