Reducing Prescription Opioid Misuse: Dental Provider Intervention Development
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Sponsor: Medical University of South Carolina

TITLE OF RESEARCH: Reducing Prescription Opioid Misuse: ROPEs Pilot Trial 
 
 
NCT NUMBER: NCT03691948 
 
 
DOCUMENT DATE: September 20, 2018 
 
 
DATE UPLOADED: September 17, 2020 

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PROTOCOL TITLE: 
Reducing Prescription Opioid Misuse: ROPEs Pilot Trial 
 
PRINCIPAL INVESTIGATOR: 
• 
Jenna L, McCauley, PhD 
 
 
 

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1.0 
Objectives / Specific Aims 
The objective of this study is to conduct a small-scale pilot randomized controlled trial comparing a newly 
developed web-based continuing dental education (CDE) intervention - Responsible Opioid Prescriber 
Education (ROPEs) - targeting increased prescription opioid (PO) misuse screening, use of existing 
prescription drug monitoring programs, and provision of patient-education to attention control condition.  
 
The pilot trial aims to: (1) establish the feasibility of ROPEs delivery; (2) identify and address potential 
issues with subject recruitment and retention; (3) develop and validate assessment instruments and 
procedures; (4) collect preliminary data regarding pre-to-post changes in knowledge, motivation, and 
behavioral skills pertaining to the use of risk mitigation strategies when prescribing opioids in dental 
practice; and (4) collect preliminary data regarding the sustainability of changes at one-month follow-up 
assessment.  
 
2.0 
Background 
Many individuals who go on to develop opioid use disorders, including those individuals who ultimately 
transition to heroin use, report that early exposure to opioids was through a legitimate prescription or 
prescription shared from family or friends (Canfield et al., 2010; Butler et al., 2016). Research suggests that 
lifetime non-medical use of prescription opioids is highly correlated with, and most often preceded by, 
medical use of prescription opioids (McCabe et al., 2016). This risk is particularly highlighted among 
adolescents and young adults (McCabe et al., 2016).  
 
Dental prescribing has played a role in the ready availability of immediate release opioids - like 
hydrocodone - throughout previous decades (Gupta et al., 2018; Janakirim et al., 2018; Levy et al., 2015; 
McCauley et al., 2016a; McCauley et al., 2016b). Opioids account for a nearly one-third of prescriptions 
issued by dentists (Levy et al., 2015). Due in large part to the commonality of third molar extraction 
procedures, dental opioid prescribing is particularly frequent for adolescent patients, a group at increased 
risk for misuse (Denisco et al., 2011; Gupta et al., 2018; Mutlu et al., 2013). Patients often report having 
unused medication leftover from their post-procedural prescription (Maughan et al, 2016), and a notable 
segment of dental patients report at least some nonmedical use of pain medications (Ashrafloun et al., 2014) 
and approximately one-in-five dental patients report recent substance abuse, including problematic alcohol 
use or illicit drug use (Ilgen et al., 2012). 
 
Despite dentists’ regular experience with opioid prescribing and the risks such prescribing confers, research 
suggests that dentists do not regularly implement recommended risk mitigation strategies - including 
screening for prescription drug abuse/misuse, querying a prescription drug monitoring program (PDMP; 
enacted in all US states except Missouri), and providing thorough patient education regarding safe use, 
storage, and disposal when prescribing opioid medications for pain management (Herman, 2011; McCauley 
et al., 2016a; McCauley et al., 2018a). The leading reasons cited by dental prescribers for not accessing 
their PDMP include lack of awareness of the existence and lack of knowledge regarding how to register for 
and/or use their state’s PDMP (McCauley et al., 2016b).  Further, growing evidence and recent guidelines 
support the use of ibuprofen and/or acetaminophen as first-line analgesic options for managing acute dental 
pain (ADA, 2018; Moore et al., 2018). 
 
Recently, our group conducted a large-scale survey of dentist members of the National Dental Practice-
Based Research Network regarding their prescribing behavior, risk mitigation implementation, and training 
relevant to opioid analgesics entitled, Reducing Prescription Opioid Misuse: Dental Provider Intervention 
Development Survey (McCauley et al., 2018a; McCauley et al., 2018b). Briefly, results demonstrate that a 
minority of network dentists reported prescribing opioids only (11%) or opioids in combination with 

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recommendation for NSAIDs/Acetaminophen (18%) to half or more of their patients needing management 
of acute pain. Higher opioid prescribing was significantly associated with less-consistent implementation 
of PDMP use and patient education. A majority of dentists reported infrequent PDMP use and inconsistent 
counseling of patients regarding risks, storage, and disposal of opioids. Higher frequency of opioid 
prescribing was associated with less-consistent risk mitigation implementation. Nearly half (n=388) of 
respondents reported that they had never accessed their state PDMP. The most often reported reasons for 
not accessing were lack of knowledge of the program’s existence (58% of non-users) and lack of knowledge 
regarding how to register and access the program (25% of non-users). The majority of PDMP users reported 
use to be very helpful (58%) or somewhat helpful (32%), whereas only 6% reported program use as not 
very helpful or not helpful at all. Dentists reported that PDMP use most often did not change their intended 
prescribing behavior (40% of users), led them to not prescribe an opioid (34% of users), or led them to 
prescribe fewer doses of an opioid for pain management (26% of users). Dentists practicing in states with 
mandated PDMP use policies (compared to those living in states without such a policy) reported more-
frequent use of their PDMP prior to prescribing to new patients, high-risk patients, prior to issuing refills, 
and prior to any opioid prescribing for pain management. 
 
Training and education in opioid prescribing and prescription drug abuse is recommended by leading 
practice organizations, including the American Dental Association (ADA, 2018; Dana et al., 2018). Data 
from the network survey demonstrate that training relevant to prescription drug abuse is associated with 
safer opioid prescribing practices; however, fewer than half of dentists have training specific to 
identification and assessment of drug abuse/addiction and only one-quarter of dentists reported training in 
identification of prescription drug diversion (McCauley et al., 2018a). Importantly, nearly all respondents 
(96%) identified continuing dental education as being somewhat or very valuable practice resource 
regarding controlled substance prescribing. 
 
As the culmination of our team’s prior mixed methods research regarding dental opioid prescribing 
practices and training preferences, we developed the Responsible Opioid Prescriber Education (ROPEs) 
course. ROPEs is designed as a self-directed, web-based continuing dental education intervention targeting: 
(1) more-conservative reliance on opioid analgesics for post-procedural, acute dental pain management; (2) 
more-consistent use of PDMP data prior to prescribing opioids; and (3) more-consistent provision of 
comprehensive patient education regarding the risks associated with opioid use and misuse, as well as the 
appropriate way to store and dispose of medication. This intervention was iteratively developed with 
frequent consultation of a dental advisory group, has been alpha and beta tested in dentist-comprised focus 
groups, and the current protocol is for a pilot evaluation of this online continuing dental education 
intervention.  
 
3.0 
Intervention to be studied  
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 a video-based platform and includes a range 
of downloadable practice aides (e.g., patient education handouts) and resources (e.g., ADA 
recommendations, brief substance abuse screening instruments, etc.). Active ROPEs content (excluding 
pre-test and post-test) can be completed in 60-80 minutes. While dentists will be encouraged to complete 
the ROPEs intervention in one sitting (and required to complete the intervention within 2 weeks), all 
participants will have their unique log-in credentials that will enable them to complete ROPEs (or attention 
control) in multiple sessions, as well as return to the content at any time subsequent to completion (e.g., to 

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print patient resources, review materials). The attention control condition will be a web-based version of 
the Centers for Disease Control Guideline for Prescribing Opioids for Chronic Pain. 
 
4.0 
Study Endpoints  
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. 
 
Primary outcomes are intended to establish methodological feasibility and include: (1) recruitment rates; 
(2) time to complete ROPEs and completion rates; and (3) follow-up assessment completion rates. Web 
analytic metrics will include average time spent on the site for both intervention and control participants.  
 
Secondary outcomes will include: (1) changes in dentists’ knowledge regarding the dentists’ role in curbing 
PO misuse, initiation to abuse, and diversion; (2) changes in knowledge regarding recent released guideline 
recommendations for standard pain management in dental practices; and (3) changes in knowledge of risk 
mitigation strategies, such as PO misuse screening and use of their state’s PDMP.  
 
5.0 
Inclusion and Exclusion Criteria/ Study Population 
Participants will be licensed dentists and dental residents (N=60) recruited from MUSC, the state of South 
Carolina Dental Association, the local (Charleston-area) community, and the National Dental Practice 
Based Research Network. Vulnerable populations (e.g., minors, underrepresented minorities) will not be 
targeted for recruitment; minors will not be recruited and racial/ethnic representation will result from 
random sampling.   
 
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. 
 
6.0 
Number of Subjects 
A total of 60 participants (30 per condition) will be recruited for the current study. 
 
7.0 
Setting 

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All assessment and intervention/control condition completion will take place via either secure web-based 
platform (pre-test, intervention/control, post-test) or REDCap (1-month follow-up) platform. Participating 
dentists will enter data/responses directly into the web-based platform. Data will be housed on a secure 
MUSC server using Secure Sockets Layer 128-bit encryption. Prior to analysis, data will be downloaded 
from the secure platform in comma separated values (csv) file format and imported in a statistical software 
program for analysis. 
 
8.0 
Recruitment Methods 
The study will be managed from the Department of Psychiatry and Behavioral Sciences at the Medical 
University of South Carolina. Data will be collected via online response and housed on secure servers at 
the Medical University of South Carolina. Participants for the proposed research will be recruited from the 
South Carolina Dental Association, dental practices participating in the NDPBRN, dental practices located 
in the Charleston-area community and broader state of South Carolina, and from the MUSC College of 
Dental Medicine through use of the following recruitment approaches: (1) Listserv announcements, 
advertisements, and emails through the NDPBRN, South Carolina Dental Association, the MUSC College 
of Dental Medicine, and the MUSC College of Dental Medicine Alumni Association; (2) mailed invitations 
to existing dental practices; (3) flyers posted in College of Dental Medicine; and (4) personal contact and/or 
professional networking/direct emails through mentorship team (e.g., Dr. Leite). Individuals interested in 
participating in the study will be asked to email the study PI (at ropesadmin@musc.edu) expressing interest. 
At that time, eligibility criteria will be confirmed and interested individuals will be engaged in the consent 
process described below. 
 
9.0 
Consent Process 
Participants will be a total of 60 licensed dentists and dental residents recruited from the state of South 
Carolina and the National Dental Practice Based Research Network. Interested individuals (those emailing 
the study PI) will receive an email response that reiterates eligibility criteria, provides information 
commensurate with informed consent for participation in the study, and asks individuals to confirm their 
eligibility and interest in participation via email response. Following confirmation of eligibility and interest 
in participation, participants will be emailed a hard copy of the study information sheet (attachment) and 
log-in credentials for participation.  
 
A waiver of written consent is requested for the current study. The main risk associated with participation 
in this study is loss of confidentiality and waiver of written consent is one step to diminish this risk. Whereas 
login credential will be contained in email (a non-secure form of communication), this log-in information 
will not be linkable to participant USERID credentials (used for data storage) without access to the linkage 
key document. Only IRB-approved study personnel will have access to this linkage document. 
 
10.0 Study Design / Methods 
Consenting participants will be emailed log-in credentials and instructions for accessing the ROPEs/control 
intervention site. Participants will be randomized at the time of log-in to receive either the ROPEs 
intervention or a web-based attention control condition. The attention control condition will consist of a 
website containing printed content of most recent best practice guidelines provided by the Centers for 
Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain. It is anticipated that 
the web-based intervention will take approximately 60-80 minutes to complete, excluding pre-test and post-
test completion. Outcomes will be assessed at three time-points: (1) pre-intervention; (2) post-intervention; 
and, (3) one-month post-intervention. Assessment inventories will take approximately 15 minutes each to 
complete. Pre- and post-intervention assessments will be embedded into the intervention/control website. 
Participants will be re-contacted (via email) at one-month post intervention, and asked to complete the one-
month follow-up assessment on the secure REDCap platform. Participants will receive $50 for their time 

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completing pre-intervention assessments, $50 for their time in completing post-intervention assessments, 
and $100 for their time in completing one-month post-intervention follow-up assessments. Remuneration 
will be provided via email in the form of an Amazon gift code link. 
 
11.0 Specimen Collection and Banking  
Not Applicable to the current study. 
 
12.0 Data Management  
Data for the pilot trial phase of this study will be obtained from online self-report measures and web-analytic 
metrics. Data will include: (1) recruitment rates; (2) time to complete ROPEs intervention and completion 
rates; and (3) follow-up assessment rates; as well as changes in dentists’ knowledge regarding: (1) role in 
curbing PO 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 PO misuse 
screening and use of their state’s PDMP. Web analytic metrics will include time spent on the site, number 
of log-ins, and activity completion. The participant will directly enter data into the web-based platform 
during completion of ROPEs (or attention control). Data will be housed on a secure MUSC server using 
Secure Sockets Layer 128-bit encryption. Further, assessment (pre-intervention, post-intervention, one-
month follow-up) data for this study will be stored electronically in de-identified manner using participant 
identification numbers (USERID). Only members of the study team will have access to the linkage 
document associating USERID with identifying and contact information. Identifying information will be 
used only for the purposes of participant reimbursement and contact for follow-up. Participants’ identifying 
information and linkage to data USERID will be stored on a secure MUSC server in a password protected 
file and will be destroyed at the conclusion of the study.  
 
Outcomes will be assessed at three time-points: (1) pre-intervention; (2) post-intervention; and, (3) one-
month post-intervention. Key outcomes include enhanced knowledge regarding: (1) dentists’ role in curbing 
PO 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 PO misuse screening and 
use of their state’s PDMP. It is important to reiterate that the primary aim of the pilot RCT is to demonstrate 
the feasibility of methodology. We do not anticipate the pilot to be adequately powered to produce 
meaningful between-group effect sizes. Nonetheless, we do anticipate that ROPEs will result in significant 
within group increases in knowledge. We will also make a direct comparison of the efficacy of the ROPEs 
intervention versus the attention control in increasing knowledge of risk mitigation strategies. The main 
predictor will be intervention assignment. We hypothesize that ROPEs will result in significantly improved 
knowledge regarding recommended risk mitigation strategies measured via provider self-report at 
immediately post-intervention and one-month follow-up time-points. 
 
Handling of Missing Data. Given that the majority of analyses will be descriptive in nature (rather than 
hypothesis testing), the extent of missing data will be reported for each query of interest. With respect to 
hypothesis driven analyses, there are multiple techniques available for managing missing data in a sample 
of this nature. In brief, if the pattern of missing data is independent of values of other observed variables, 
then it is considered missing completely at random (MCAR). Participants with missing data patterns that 
are MCAR are thought of as a random subsample of the original sample. If the missing mechanism is 
MCAR, we can exclude participants with missing responses without being concerned about bias. If the 
missing mechanism is differential (common with longitudinal designs), we will consider data imputation 
techniques including introducing dummy variables for the missing variables, as well as the mean, mode, or 
median substitutions as appropriate.  
 
13.0 Provisions to Monitor the Data to Ensure the Safety of Subjects (if applicable) 

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This pilot trial is intended to establish the methodological feasibility of a randomized controlled trial of an 
educational intervention targeting changes in dental opioid prescribing practices. Since the current pilot is 
a non-medication trial, all unexpected Adverse Events (AEs) will be reported to the MUSC Committee on 
Human Research and NIDA only, and not to the FDA.  
 
Definition of AE and SAE. 
Adverse events are defined as any untoward medical occurrence that may present itself during treatment or 
administration of an intervention, and which may or may not have a causal relationship with the treatment. 
Serious adverse events are defined as any medical occurrence that: 
• Results in death, 
• Is life-threatening, 
• Requires inpatient hospitalization or prolongation of existing hospitalization, 
• Results in persistent or significant disability/incapacity, 
• Is a congenital anomaly/birth defect. 
 
OR 
• Requires intervention to prevent one of the above outcomes. 
 
All AEs will be reported as soon as possible and within ten working days of the investigator first learning 
of the event. Serious AEs (SAEs) will be reported within 24-business hours. The MUSC IRB AE reporting 
requirements are as follows: All deaths that occur during the study or 30 days post termination from the 
study are required to be reported as adverse events even if they are expected or unrelated.  Other adverse 
events are reportable to the MUSC IRB if the AE is unexpected AND related or possibly related AND 
serious or more prevalent than expected. All three criteria must be met for an AE to be reported to the 
MUSC IRB. The IRB definition of unexpected is that the AE is not identified in nature, severity or 
frequency in the current protocol, informed consent, investigator brochure or with other current risk 
information. The definition of related is that there is a reasonable possibility that the adverse event may 
have been caused by the drug, device or intervention. Reportable AEs are reviewed by the IRB Chair and 
reported to the IRB Board at the next meeting. The proposed pilot trial will investigate changes in 
knowledge, motivation, and self-efficacy of dental providers’ implementation of risk mitigation strategies 
when prescribing opioid analgesics. Study outcomes do not assess clinical outcomes among participants 
(dentists). It is extraordinarily unlikely that a participant in the proposed trial will experience a medical 
occurrence meeting the aforementioned criteria for AE/SAE as a result of their participation in this trial. 
 
Reporting Mechanisms of IRB Actions to NIDA. Any significant actions taken by the local IRB, as well as 
protocol changes, will be relayed to NIDA. AEs and SAEs occurring during the course of the trial will be 
collected, documented, and reported in accordance with reporting requirements (see above). All research 
staff involved with adverse event reporting will receive general and protocol specific AE/SAE training 
including identification, assessment and evaluation, and documentation and reporting.  
 
Report of Changes or Amendments to the Protocol. Any significant actions taken by the local IRB - 
including but not limited to requested protocol changes, amendments, and progress reports - will be relayed 
to NIDA in a timely manner. 
 
Trial Stopping Rules. Given that this is a pilot feasibility trial, we do not anticipate that results will show 
statistically overwhelming significant differences between groups, particularly at interim analysis points; 
however, if they do, the blind will the candidate will consult with her mentorship team regarding the 
decision to break the blind and terminate the pilot trial at that time. 
 

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Collection and Reporting of AEs and SAEs. AEs/SAEs will be documented and reported as per protocol 
and IRB requirements. The candidate and research/mentorship team will identify adverse events and obtain 
all available information to assess severity, seriousness, study relatedness, expectedness, outcome and the 
need for change or discontinuation in the study intervention.  Adverse events will be documented on AE 
Logs and AE Case Report Forms (CRFs). Additional relevant AE information, if available, will be 
documented in a progress note in the research record as appropriate to allow monitoring and evaluating of 
the AE. If the AE meets the definition for serious, appropriate SAE protocol specific reporting forms will 
be completed and disseminated to the appropriate persons and within the designated timeframes as indicated 
above. For each AE/SAE recorded, the research staff will follow the AE/SAE until resolution, stabilization 
or until the participant is no longer in the study as stated in the protocol. 
 
In the unlikely event that a reportable SAE is identified, the PI will initiate an SAE form, and the following 
individuals will be notified by facsimile transmission within 24 hours of the PI’s initial knowledge of the 
SAE:   
 
i. 
The Principal Investigator (Dr. McCauley, a clinical psychologist) and Primary Mentor (Dr. Brady, 
a psychiatrist) will provide oversight, consultation, assessment and documentation as 
appropriate of the SAE.    
 ii. 
The research staff will notify the MUSC institutional review board (IRB) and complete the AE 
report form in conjunction with the PI. Communication with the IRB is through email, memos, 
official IRB forms, and online reporting. 
iii. 
The NIH program officer. 
iv. 
The data safety monitoring board members. 
 
If complete information is not available when the initial 24-hour SAE report is disseminated, follow-up 
information will be gathered to enable a complete assessment and outcome of the event.  This information 
may include hospital discharge records, autopsy reports, clinic records, etc.  The research staff will attach 
copies of source documents to the SAE report for review by the PI and for forwarding to the NIH program 
officer as appropriate within 2 weeks of the initial SAE report. In addition, the PI will provide a signed, 
dated SAE summary report, which will be sent to the NIDA Medical Safety Officer within two weeks of 
the initial SAE report. 
 
We will report adverse events to the MUSC IRB online as soon as possible, but no later than 10 working 
days after the investigator first learns of the event. The MUSC IRB AE reporting requirements have been 
presented above. In brief, MUSC’s policy for reporting serious adverse events is as follows: It is the 
investigator’s responsibility to report all serious adverse events to the HIC (Human Investigators 
Committee) and the sponsor within 24 hours after learning of the event. An “Adverse Event Report Form” 
must be completed and submitted to the HIC office. A description of the serious adverse event and 
treatment, if any, must accompany the form. The HIC chairperson, designated representatives, or the full 
HIC, as determined by the chairperson, reviews the report. If the reaction is severe, the investigator may be 
requested to discontinue the research pending further review by the HIC. Investigators must ensure that the 
NIH is informed of actions, if any, taken by the IRB as a result of its continuing review. Any adverse event 
will be reported to NIDA in an individual adverse event report. 
 
Management of SAEs or Other Study Risks. Adverse events will be monitored throughout the study and any 
event will be followed to resolution or stabilization. All serious adverse events will be reported immediately 
to the IRB and NIDA. The PI (Dr. McCauley) will provide continuous, close monitoring with prompt 
reporting of adverse events to the IRB and NIDA, and will follow MUSC’s adverse event reporting policy. 
In addition, Dr. McCauley and the mentorship/consultation team will evaluate the progress of the study at 
bi-weekly study team meetings, including periodic assessments of data quality and timeliness, participant 

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recruitment and retention, participant risk versus benefit, and other factors that can affect study outcome. 
We will also consider factors external to the study, such as scientific or therapeutic developments that may 
have an impact of the safety of participants or the ethics of the study. 
 
Protection of Confidentiality. All data will be stored in a confidential manner (i.e., on a Secure Socket Layer 
(SSL) 128-bit encryption server located at MUSC) so as to protect the confidentiality of subject information. 
Participants in this pilot RCT will be assigned a secure log-in and access code. Log-in information will be 
associated with PHI (including email address) for the purposes of contacting them at one-month post-
intervention for follow-up assessment. All contact information used to recruit and retain study participants 
will be stored electronically on MUSC’s secure network in a password protected file and will be destroyed 
at the conclusion of the project. Access to research records (paper and computerized) will be restricted to 
the project staff. Specifically, access to de-identified study data will be limited to named project 
investigators (including the PI and her Mentorship/Consultation team, NIH audit personnel, and MUSC 
IRB audit personnel). Data will be maintained per an IRB-approved protocol. When study results are 
published or presented, only aggregate reports of the results will be used and subjects’ identity will not be 
revealed. All analyses will be conducted on de-identified data only.  
 
Plans for Interim Analysis of Efficacy Data. Given that this is a pilot feasibility trial, recruitment rates are 
one of the primary outcomes, and we do not anticipate that results show statistically overwhelming 
significant differences between groups; therefore, we do not plan to break the blind for interim analysis of 
efficacy data. 
 
Responsibility for Data and Safety Monitoring. The PI will be responsible for monitoring the study with 
regular oversight provided by her primary mentor, Dr. Kathleen Brady. The outcomes database will be 
examined for missing data, unexpected distributions or responses, and outliers at the close of the trial.  
 
Frequency of DSM Reviews. All AEs will be reviewed weekly by the PI and her mentor team and will be 
reviewed bi-annually by the Data Safety Monitoring Board (DSMB) during the completion of the pilot. 
 
Content of DSM Report. A DSM Report will be filed with the IRB and NIDA on a yearly basis, unless 
greater than expected problems occur. The report will include subject characteristics, retention and 
disposition of study subjects, quality assurance issues and reports of AEs, significant/unexpected AEs and 
serious AEs. We will report results at the end of the pilot trial. Confidentiality will be maintained during all 
phases of the trial including monitoring, review, and response to monitoring recommendations. 
 
DSM Board Plan. The study PI will create a DSMB to monitor the overall participant safety, the rate and 
severity of adverse events, and the validity and integrity of the data. The panel will include 3 researchers 
with experience in addictions research and provider-level interventions, as well as a statistician. The board 
may be called at any point if needed for unexpected AEs, etc. Modification will be made in the procedures 
and/or the protocol if necessary based on the recommendations of the board.  
 
14.0 Withdrawal of Subjects  
All participation is voluntary and participants may withdraw from the study at any time. Given the low risk 
for adverse events associated with this study, we do not anticipate many circumstances under which 
participants would be withdrawn from the study without their consent; however, should it be discovered 
that a participant does not meet inclusion/exclusion criteria subsequent to their enrollment, they will notified 
via email that their study participation has been terminated. Should this occur, affected participants will be 
remunerated for their time spent engaged with the study and a protocol deviation will be completed with 
the IRB for documentation.  

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Should a participant contact the study PI and voluntarily withdraw from the study, they will be remunerated 
consistent with the extent of their participation to that time and will not be contacted for subsequent data 
collection; however, data provided prior to voluntary withdrawal will be kept for analysis, unless the 
participant specifically asks for that data to be withdrawn from the study. 
 
15.0 Risks to Subjects 
Given the nature of the proposed trial (i.e., not testing a medical intervention), AEs and SAEs (as defined 
above) are highly unlikely to occur in the context of the current pilot trial. Although also unlikely, two 
minor risks to participants exist and will be managed. Some participants may become offended when asked 
questions pertaining to their personal experiences and opinions related to opioid analgesic prescribing 
practices. Our experience (PI and mentor/consultant team) in previous and ongoing investigations indicates 
that this risk is minimal. Thus, based on the team’s extensive experience, we expect low to non-existent 
rates of participant distress, and should a participant become offended, they can discontinue participation 
at any time.  
 
Another potential risk of participation is related to issues of participant privacy and confidentiality. We will 
implement several previously successful procedures to keep data confidential. Participants will not use their 
names to log onto the website, nor will they provide any other form of identifying information during their 
completion of the ROPEs intervention/control. Further, de-identified (log-in coded) data will be collected 
and stored via a secure server. For participants completing the ROPEs data platform assessments, primary 
data will be housed on a secure MUSC server using Secure Sockets Layer 128-bit encryption. Further, 
assessment (pre-intervention, post-intervention, one-month follow-up) data for this study will be stored 
electronically in de-identified manner using participant identification numbers (USERID). Only members 
of the study team will have access to the linkage document associating USERID with identifying and 
contact information. Identifying information will be used only for the purposes of participant 
reimbursement, linkage of assessment data from various time-points, and contact for follow-up. 
Participants’ identifying information and linkage to data USERID will be stored on a secure MUSC server 
in a password protected file and will be destroyed at the conclusion of the study. 
 
16.0 Potential Benefits to Subjects or Others 
Participants in the proposed research may benefit from knowledge gained regarding (a) standard prescribing 
practices of dentists; (b) the safe and appropriate use, storage, and disposal of opioid analgesic medications; 
and (c) available opioid prescribing risk mitigation tools. Although there is a small reimbursement for 
participants (i.e., $50 for completion of pre-intervention assessments; $50 for completion of post-
intervention assessments; $100 for completion of one-month post intervention follow-up assessment), we 
do not believe that this reimbursement constitutes a substantial benefit for participation.  
 
Potential benefits to others also exist. The public health implications of this project are significant and the 
findings will provide empirical evidence to inform policies and programs that address the urgent need for 
effective interventions targeting opioid misuse and diversion in frontline healthcare settings. Specifically, 
this project will result in a fully developed and piloted ROPEs intervention to enhance dentists’ knowledge, 
motivation, and skill toward implementing recommended risk mitigation strategies when prescribing POs. 
The pilot RCT evaluation will result in critical data establishing the feasibility of methods and validation 
of assessments, as well as produce preliminary data regarding ROPEs potential efficacy in improving dental 
provider knowledge, motivation, and self-efficacy to implement PO risk mitigation strategies. Finally, the 
prescriber education and intervention content – while specific to dental practitioners – will provide a 
template with the potential for adaptation to address the opioid prescribing practices of other frontline 
healthcare practitioners, such as primary care, emergency medicine, and pain management practices. 

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17.0 Sharing of Results with Subjects 
All data will be analyzed and reported in an aggregate, de-identified manner. Key results will be posted in 
compliant manner on clinicaltrials.gov. Findings will also be disseminated via peer-reviewed publications, 
professional presentations, and to practice groups (upon request). Individual participants may request a 
report of aggregate findings from the PI directly and this option will be noted in the informed consent 
document. 
 
18.0 Drugs or Devices  
Not Applicable to the current study. 
 
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