Trial Outcomes & Findings for Reducing Prescription Opioid Misuse: ROPEs Pilot Trial (NCT NCT03691948)

NCT ID: NCT03691948

Last Updated: 2020-11-03

Results Overview

Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Baseline completion, approximately 2 hours
• Results posted on: 2020-11-03

Participant Flow

No significant pre-assignment study events occurred.

Participant milestones

Measure	ROPEs 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.	Control Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Overall Study STARTED	27	33
Overall Study COMPLETED	26	30
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Measure	ROPEs 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.	Control Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Overall Study Lost to Follow-up	1	3

Baseline Characteristics

Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

Baseline characteristics by cohort

Measure	ROPEs n=27 Participants 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.	Control n=33 Participants Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.	Total n=60 Participants Total of all reporting groups
Age, Continuous	35.85 years STANDARD_DEVIATION 10.63 • n=5 Participants	39.91 years STANDARD_DEVIATION 12.78 • n=7 Participants	38.08 years STANDARD_DEVIATION 11.94 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants	23 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	31 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	25 Participants n=7 Participants	45 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	33 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline completion, approximately 2 hours

Population: 76 individuals received log-in credentials for this study.

Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.

Outcome measures

Measure	Overall - Intervention and Control Participants n=76 Participants This measure of recruitment is reported for the overall study and includes participants randomized to both intervention (ROPEs) and control arms of the study.	Control Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Methodological Feasibility: Recruitment Rate	60 Participants	—

PRIMARY outcome

Timeframe: Baseline completion, approximately 2 hours

Population: All enrolled participants

Percent of Patients Completing ROPES (or control)

Outcome measures

Measure	Overall - Intervention and Control Participants n=27 Participants This measure of recruitment is reported for the overall study and includes participants randomized to both intervention (ROPEs) and control arms of the study.	Control n=33 Participants Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Methodological Feasibility: Completion Rates	26 Participants	31 Participants

PRIMARY outcome

Timeframe: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)

Population: All enrolled participants

Percent of baseline participants completing the one-month follow-up assessment

Outcome measures

Measure	Overall - Intervention and Control Participants n=27 Participants This measure of recruitment is reported for the overall study and includes participants randomized to both intervention (ROPEs) and control arms of the study.	Control n=33 Participants Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Methodological Feasibility: Follow-Up Completion Rates	26 Participants	30 Participants

PRIMARY outcome

Timeframe: Baseline completion component, approximately 90 minutes

Population: All enrolled participants who completed the intervention. Note that 1 ROPEs participant and 1 Control participant did not start/complete the intervention, thus no data was available regarding their time to completion.

Time participant takes to finish engaging with ROPES intervention or control intervention

Outcome measures

Measure	Overall - Intervention and Control Participants n=26 Participants This measure of recruitment is reported for the overall study and includes participants randomized to both intervention (ROPEs) and control arms of the study.	Control n=31 Participants Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Methodological Feasibility: Time to Complete Intervention	108 Minutes Standard Deviation 48.02	21 Minutes Standard Deviation 18.91

SECONDARY outcome

Timeframe: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)

Population: All participants completing the pre-test and the 1-month follow-up. Note that 1 ROPEs participant was lost to follow-up and 3 Control participants were lost to 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.

Outcome measures

Measure	Overall - Intervention and Control Participants n=26 Participants This measure of recruitment is reported for the overall study and includes participants randomized to both intervention (ROPEs) and control arms of the study.	Control n=30 Participants Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score	-.19 Change in score on a scale Standard Deviation 1.17	.00 Change in score on a scale Standard Deviation 1.11

SECONDARY outcome

Timeframe: Single time point from pre-intervention to immediately post-intervention

Population: All participants completing the pre-test and the post-test. Note that 1 ROPEs participant was lost to follow-up and 2 Control participants were lost to 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 post-test) in knowledge regarding best practices in dental opioid prescribing.

Outcome measures

Measure	Overall - Intervention and Control Participants n=26 Participants This measure of recruitment is reported for the overall study and includes participants randomized to both intervention (ROPEs) and control arms of the study.	Control n=31 Participants Active Comparator Control: An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
Change at Post-test From Baseline in Knowledge Change Questionnaire Score	0.42 change in score on a scale Standard Deviation 1.10	-0.03 change in score on a scale Standard Deviation 0.80

Adverse Events

ROPEs

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jenna L. McCauley, PhD, Assistant Professor of Psychiatry

Medical University of South Carolina

Phone: 8437923922

Email: mccaule@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place