Knowledge, Attitudes, PracticeNCT03691948

Reducing Prescription Opioid Misuse: ROPEs Pilot Trial

A study testing Responsible Opioid Prescriber Education (ROPES) in people with Knowledge, Attitudes, Practice, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Knowledge, Attitudes, Practice
What is being tested?: Responsible Opioid Prescriber Education (ROPES)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 28 Mar 2019to 5 Dec 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Jenna McCauley
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Reducing Prescription Opioid Misuse: Dental Provider Intervention Development

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.

Conditions: Knowledge, Attitudes, Practice
Being tested: Responsible Opioid Prescriber Education (ROPES), Active Comparator Control
Medical subject headings: Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Responsible Opioid Prescriber Education (ROPES)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.
Active Comparator ControlOther
An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.

Study groups in NCT03691948
Study group	Role	What they receive
ROPEs	Experimental	Not described Receives: Other: Responsible Opioid Prescriber Education (ROPES)
Control	Active comparator	Not described Receives: Other: Active Comparator Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Methodological Feasibility: Recruitment Rate
Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.
Measured: Baseline completion, approximately 2 hours
Methodological Feasibility: Completion Rates
Percent of Patients Completing ROPES (or control)
Measured: Baseline completion, approximately 2 hours
Methodological Feasibility: Follow-Up Completion Rates
Percent of baseline participants completing the one-month follow-up assessment
Measured: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
Methodological Feasibility: Time to Complete Intervention
Time participant takes to finish engaging with ROPES intervention or control intervention
Measured: Baseline completion component, approximately 90 minutes

Secondary outcomes (2)

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.
Measured: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
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.
Measured: Single time point from pre-intervention to immediately post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Mar 20195 Dec 2019

First posted2 Oct 2018
Study start28 Mar 2019
Primary completion21 Nov 2019
Study completion5 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03691948
Sponsor's protocol ID: Pro00082658
Status last verified: Oct 2020
First submitted: 27 Sep 2018
Last updated: 3 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Prescription Opioid Misuse: Dental Provider Intervention Development
ClinicalTrials.gov ID: NCT03691948
Acronym / sponsor ID: Pro00082658
Conditions: Knowledge, Attitudes, Practice
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 28 Mar 2019 (actual)
Primary completion: 21 Nov 2019 (actual)
Study completion: 5 Dec 2019 (actual)
First posted: 2 Oct 2018 (actual)
Results: Posted 3 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
ROPEs	Experimental	Other: Responsible Opioid Prescriber Education (ROPES)
Control	Active comparator	Other: Active Comparator Control

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	ROPEs
Active Comparator ControlAn online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.	Other	Control

Primary outcome

Methodological Feasibility: Recruitment Rate
Time frame: Baseline completion, approximately 2 hours
Number of participants enrolled and randomized out of the number of individuals expressing interest and receiving log-in credentials.
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

2 secondary outcomes

Change at 1-Month Follow-Up From Baseline in Knowledge Change Questionnaire Score
Time frame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up)
Change at Post-test From Baseline in Knowledge Change Questionnaire Score
Time frame: Single time point from pre-intervention to immediately post-intervention

Results and safety

Results posted to the registry on 3 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ROPEs	27	26
Control	33	30

Primary outcome: Methodological Feasibility: Recruitment Rate

Time frame: Baseline completion, approximately 2 hours. Count of participants. Unit: Participants

Measure	Overall - Intervention and Control Participants n = 76
Value	60

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

Primary outcome: Methodological Feasibility: Completion Rates

Time frame: Baseline completion, approximately 2 hours. Count of participants. Unit: Participants

Measure	ROPEs n = 27	Control n = 33
Value	26	31

Population analysed: All enrolled participants

Primary outcome: Methodological Feasibility: Follow-Up Completion Rates

Time frame: Through study completion, an average of 4-6 weeks (Baseline and one-month follow-up). Count of participants. Unit: Participants

Measure	ROPEs n = 27	Control n = 33
Value	26	30

Population analysed: All enrolled participants

Primary outcome: Methodological Feasibility: Time to Complete Intervention

Time frame: Baseline completion component, approximately 90 minutes. Mean (Standard Deviation). Unit: Minutes

Measure	ROPEs n = 26	Control n = 31
Value	108 (48.02)	21 (18.91)

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Enrollment (completion of first item on pre-test) through 1-month post-intervention follow-up completion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ROPEs	0 of 27 (0%)	0 of 27 (0%)	0 of 27
Control	0 of 33 (0%)	0 of 33 (0%)	0 of 33

Limitations and caveats (from the sponsor): This was a pilot trial intended to demonstrate methodological feasibility. Thus, the trial was not intended to be sufficiently powered to detect significant differences between the intervention and control groups.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Responsible Opioid Prescriber Education (ROPES) in people with Knowledge, Attitudes, Practice, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Methodological Feasibility: Recruitment Rate (time frame: Baseline completion, approximately 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03691948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.