Scenario Tailored Opioid Messaging Program (STOMP) to Improve Risk Understanding in Young Adults
Phase: NA
Conditions: Pain, Postoperative, Medication Adherence, Opioid Use, Knowledge, Attitudes, Practice, Risk Reduction Behavior
Sponsor: University of Michigan

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
SPECIFIC AIMS 
Legitimate prescription opioid use during adolescence has been associated with later 
prescription opioid misuse and substance use disorder symptoms during adulthood.1,2 Thus, 
primary prevention interventions for older adolescents and young adults at the time of 
prescribing are imperative. With several million opioid prescriptions dispensed to adolescents 
and young adults each year in the United States,3 providers are uniquely positioned to address 
and mitigate opioid risks for these vulnerable groups. Indeed, despite a recent plateauing in 
prescribing rates, opioid-related poisonings, prescription misuse, opioid use disorder and 
unintentional overdose deaths continue to increase among our youth, suggesting an unrelenting 
effect of the opioid crisis and an urgent need for action.4-7 Recognizing the urgency for action, 
state laws have been widely enacted that, among other requirements, mandate informed 
consent for patients as well as parents of minors who are prescribed opioids. While the intent of 
such laws is to lessen the impact of the opioid crisis by increasing risk awareness, it is not clear 
whether such laws are sufficient to enhance risk understanding and mitigate risky behaviors 
without adversely impacting effective pain management.  
We previously demonstrated that opioid risk awareness alone (i.e., knowledge that adverse 
effects like addiction and excessive sedation can occur) was not related to safer opioid decision-
making among parents, whereas higher risk perceptions and analgesic risk avoidance 
preferences were strongly related.8 We have since similarly demonstrated that risk perceptions 
and analgesic preferences (but not simple risk awareness) were strongly associated with 
intentions to misuse prescription opioids among a large sample of adolescents and emerging 
adults.9 Finally, desire for pain and other symptom relief remains the most common motive for 
prescription opioid misuse among adolescents and young adults.10,11 Thus, modifiable targets to 
reduce risky prescription opioid decisions among adolescents/emerging adults include opioid 
risk perceptions, analgesic risk/benefit preferences and safe pain management knowledge.  
Our current research (R01DA044245) examines the ability of our interactive Scenario 
Tailored Opioid Messaging Program (STOMP) to shift these modifiable factors in a way that will 
improve parental opioid decision making and handling while simultaneously ensuring good pain 
management of their children. This intervention, thus, provides an innovative, balanced 
approach to address both the primary prevention of opioid-related adverse outcomes and 
effective pain management. Relevant to this supplement, we will modify STOMP messages and 
test their impact on opioid risk perceptions and risky decision-making among older adolescents 
and emerging adults who make most if not all analgesic treatment decisions for themselves.  
Supplemental funding via PA-18-591 will enable us to expand the target population of our 
current project to include older adolescents and emerging adults who are prescribed opioids for 
an acute pain condition and who are among those at highest risk for misuse. Specifically, 
funding will allow us to modify our STOMP messages to address the risks of opioid misuse and 
personal strategies to manage symptoms, and compare the effect of these STOMP messages 
to routine opioid analgesic consent information. These objectives fall within the scope of our 
currently funded project, but effectively expand our target enrollment to address the high priority 
need for primary prevention among youth. Thus, with supplemental funding, we aim to test the 
following hypothesis: 
1) Examine whether modified STOMP messages will improve opioid risk understanding, 
enhance misuse risk perceptions, improve analgesic self-efficacy, and opioid decision-
making among older adolescents and emerging adults (ages 15-24) who are prescribed 
opioids for post-procedure pain management. We hypothesize that older adolescents and 
young adults who are randomized to the intervention (versus routine opioid 
information/consent) will exhibit; (H1) Greater and sustained understanding of the potential 
risks of opioid misuse (H2) Decreased intentions to medically or non-medically misuse 
opioids for personal use, or share (divert) personal prescriptions with others. 

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2) Examine whether enhanced STOMP messaging will mitigate persistent/recurrent opioid use 
and later misuse among older adolescents and emerging adults. We hypothesize that opioid 
misuse risk perceptions mediate the relationship between prescription opioid use and later 
misuse, and that by enhancing risk perceptions, rates of opioid misuse intentions will 
decrease.  
 
With adequate funding, we have the unique ability to expand and test translatable strategies 
that could effectively mitigate adverse outcomes related to opioid prescribing. Our 
multidisciplinary team’s expertise related to opioid risks and pain management practices for 
youth and opioid misuse, combined with our ability to efficiently recruit and retain research 
subjects in clinical studies (current loss-to-follow-up is < 15%) supports the natural extension of 
our current project and will ensure completion within the timeframe of our current grant. This 
additional work will not only increase the impact of our research, but will lay the necessary 
foundation for a future longitudinal study of prescription opioid misuse among adolescents and 
emerging adults.   
 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
SIGNIFICANCE OF THIS SUPPLEMENT 
Adolescents and emerging adults, themselves, are vulnerable to opioid-related adverse 
outcomes given high rates of pain and exposure to prescribed opioids. More than 90% of 
healthy youth report recent pain for which most have self-treated with analgesics.13-15 
Additionally, more than 3 million opioid prescriptions are dispensed annually to manage pain in 
this population.3,16,17 These early pain and opioid exposures not only pose immediate threats to 
the well-being of our youth, but formulate analgesic perceptions that contribute to future use, 
misuse and abuse. For instance, 5% to 12.5% of opioid-naïve adolescents persistently or 
recurrently use a prescribed opioid following surgery or injury,18,19 presenting a high risk for 
dependence and later misuse. Furthermore, we and others have found that legitimate use and 
misuse of opioids during adolescence are highly associated with misuse during early and mid-
adulthood.1,20,21 Adolescents who are prescribed opioids by 12th grade are 33% more likely to 
misuse opioids by 23 years of age – even if they have no history of illicit substance use.1 
Additionally, medical and non-medical use of prescription opioids during adolescence is 
associated with an increased risk (50% and 260%, respectively) of substance use disorder 
symptoms at age 35.2 Lastly, even higher over-the-counter analgesic use during adolescence 
doubles the risk of later opioid misuse, underscoring the relationship between pain and the 
potential for opioid misuse.20  
The need for pain relief is the most common motivation for self-reported prescription 
opioid misuse among adolescents and young adults.11,22 Our Co-Is, Drs. Boyd and McCabe 
and colleagues found that prescription opioid misuse among adolescents and emerging adults 
is largely motivated by a need for pain relief and is influenced, in part by the perception that 
opioids are safe when prescribed by a doctor.11 Even when under the care of a physician for 
pain, 1 in 4 adolescents are non-adherent to their opioid prescriptions, sometimes doubling their 
doses to relieve pain.23 Additionally, easy access to personal, family or friends’ prescriptions 
provide the most common source for adolescents who misuse opioids to self-treat pain or for 
other reasons.24 One third of adolescents misuse their own past prescription and 56% that of a 
friend or family member who, in 80% of cases had the drug prescribed to them.20,22,25-29 Thus, 
healthcare providers are the most common original source for prescribed opioids that are 
misused by adolescents and, therefore, provide a critical avenue for risk mitigation and primary 
prevention interventions.  
Poor analgesic and opioid risk knowledge and perceptions contributes to risky misuse 
behaviors among adolescents and emerging adults. We recently surveyed 972 healthy 
community youth aged 15-24 years of age and found that nearly half had taken a prescribed 
opioid for pain and of these, 32% reported past misuse (i.e., taking more of the drug, taking it 
more frequently, or using it for an unrelated condition) and 26% indicated a willingness to 
misuse a prescribed opioid to manage pain.9 Similar to findings from our studies of parents, we 
demonstrated that intentions to misuse a prescribed opioid were strongly associated with lower 
perception of opioid misuse risk and stronger preferences for analgesic benefit or pain relief (vs. 
analgesic risk avoidance). We also found that past opioid misuse experience helped explain 
opioid misuse intentions. Importantly, we found no association between simple awareness of 
serious opioid-related adverse outcomes (e.g., addiction, excessive sedation, respiratory 
depression) and willingness to misuse a prescription opioid.  
Other studies of risky decision-making have demonstrated that adolescents and young adults 
respond more to the possibility of short-term benefit or reward (such as pain relief or other 
effects) than to the potential long-term and rare risks (such as addiction).33 College students 
also assign less risk to prescription analgesics than to other substances, and perceived harm is 
highly associated with higher risk of nonmedical misuse.34,35 These data may be, in part, 
explained by risk reappraisal that occurs after prescription analgesic use (or misuse), in that 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
experience with positive benefits and no adverse outcomes may lead to downward reappraisal 
of riskiness.36  Together, such data indicate a critical need to enhance prescription opioid risk 
perceptions and pain management understanding at the time of initial exposure and prior to risk 
reappraisal.  
Ongoing knowledge gap with regard to youth risk: Although brief interventions have been 
shown to reduce risky behaviors such as drinking and driving, and other substance use,37 to 
date, no studies have examined the efficacy of interventions toward shifting prescription opioid 
risk perceptions and reducing misuse behaviors in adolescents and young adults. Expanding 
our parent study can begin to fill this gap. Based on our preliminary data among adults and 
decision theory, we believe that our tailored opioid risk messaging intervention will improve risk 
knowledge and perceptions, minimize risky decisions, AND at the same time will enhance 
analgesic self-efficacy and pain outcomes for older adolescents and emerging adults. 
 
SCIENTIFIC PREMISE  
Heightening opioid risk perceptions, strengthening opioid risk aversion values and 
enhancing positive, non-opioid pain relieving practices at the time of opioid prescribing 
are theory-based strategies to mitigate future prescription opioid misuse among older 
adolescents and young adults. Similar to adults, older adolescents and young adults have 
been found to exhibit cognitive appraisal of risks and benefits during risky decision-making.38-41 
It has also been suggested that behaviors may be best modified in this age group by enhancing 
risk perceptions and risk avoidance values.33 Enhancing gist risk perceptions (i.e., global 
perceptions about health risks) has been found to decrease risky intentions such as drinking 
and driving or unprotected sex.41 Conversely, giving verbatim or quantitative information about 
low rates of negative outcomes (e.g., overdose, addiction) is believed to provide a “rational 
calculus of risk promotion” that endorses risk-taking and intentions, particularly among youth 
who focus on higher rates of short-term benefit.41 Novel prevention strategies aimed at 
enhancing risk perceptions and shifting reward preferences (i.e., strengthening the perceived 
benefits of health-promoting behaviors via gain-framing or positive outcome messages42) are, 
therefore, likely to be more successful in reducing risk-taking among adolescents than giving 
detailed risk rate information. Lastly, interventions that include visual aids have been found to be 
highly effective and memorable means to change and sustain risk perceptions and risky 
behavioral intentions among young adults.42 
 
Our interactive Scenario Tailored Opioid Message Program (STOMP) intervention was 
developed based on Fuzzy Trace Theory (FTT) with an aim to change the mental model of 
risk perceptions and shift preferences in a direction that will reduce risky opioid 
decisions and enhance best analgesic practices.  FTT describes how information (both 
taught and experienced) is processed to create mental representations ranging from precise 
data to fuzzy or simple gist representations. Based on this theory and consistent with other 
neurodevelopmental theories, risky decision-making is a function of the mental representations 
(verbatim and gist) of the options at hand (e.g., to misuse a prescribed drug or not). In addition 
to mental representations, reward sensitivity (i.e., the degree to which someone is benefit 
preferent), time preferences (i.e., desire for immediate reward over later ones), and opportunity 
(i.e., availability) also factor into risky decision-making. Thus, opioid misuse among adolescents 
and young adults reflects, to varying degrees, the degree to which the risk-taker desires the 
positive effect of the drug (reward), the ready availability of the drug, and the risk-taker’s 
cognitive appraisal of the option to misuse (riskiness). While opioid misuse behavior may initially 
be goal-directed (i.e., to obtain pain relief or benefit), the slippery slope to addiction is sharper 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
with opioids than, perhaps, other controlled substances. Thus, primary prevention of misuse 
behavior must begin with initial exposure to the drug. FTT suggests that the most appropriate 
and, perhaps, most malleable targets to prevent initial opioid misuse are the mental 
representations of options, that is, of opioid risk perception and analgesic preferences.41 
 
INNOVATION 
• 
This extension of our parent project is a natural extension of our innovative, interactive 
STOMP intervention to a group of older adolescents and young adults who are 
vulnerable to opioid misuse. 
• 
Our intervention aligns with the National Drug Control Strategy with an overall goal to 
increase risk recognition, prevent opioid-related adverse events and minimize the 
capacity for future misuse. 
• 
Our intervention uniquely combines scenario-tailored risk decision exercises with tailored 
risk messages and evidence based advice. Thus, the information has the ability to 
enhance target perceptions and improve competency or self-efficacy. 
 
Our multidisciplinary team brings expertise in acute post-procedure pain management, 
adolescent substance use behaviors (with a particular emphasis on prescription opioid misuse 
among adolescents and emerging adults),10,11,22,26,28,43 tailored decision-aid technology and 
evaluation of educational and behavioral interventions in the clinical setting.44-47 Increasing Dr. 
Malviya’s effort from a consulting role to an active co-investigator will bring a more prominent 
role regarding effective pain management strategies and interpretation of data.   
 
APPROACH 
With this supplement, we aim to expand the target population identified in our parent study to 
include older adolescents and emerging adults (ages 15-24 years) who are beginning to or are 
solely making analgesic decisions for themselves following a painful procedure.  
We will adapt STOMP messages to specifically address the risks of personal misuse of opioid 
analgesics and the potential risk of sharing prescribed opioids with others. We will modify the 
analgesic messages that address safe and effective pain management strategies and early 
opioid weaning.  
Using modified surveys but similar procedures as the parent project, we will test the effect of 
STOMP on the outcomes: opioid risk perceptions, misuse intentions and behaviors, persistent 
use and left-over disposal intention. 
 
Expanded sample inclusion and justification:  We will recruit up to 600 English speaking 
patients, aged 15-24 of all races who are expected to receive an opioid prescription for acute, 
short-term postoperative pain following elective ambulatory or short stay (<48 hrs) orthopedic, 
sports medicine, or other surgical procedures.  
Sample exclusions: We will exclude patients who are undergoing emergency procedures, 
cannot self-report their pain, have a hematologic-oncologic, kidney or liver condition (precluding 
the usual analgesic prescription patterns), or who have been recently treated for chronic pain.  
We will exclude subjects with significant mental health history that includes diagnoses with 
treatment for severe depression, bipolar disorder, psychoses, suicidal ideation. 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
Modified recruitment strategy and informed consent:  All participants ages 15-17 will be 
recruited with parental consent-assent document, either by phone or in person prior to surgery. 
We will recruit young adults by phone or in person prior to surgery. When potential participants 
are recruited by phone, we will then email an e-consent (e-parental permission/assent) for 
electronic signature as well as the baseline survey link, to be completed prior to surgery. All 
participants will be assigned a study ID and asked to complete the online survey prior to the day 
of surgery. This method allows the participant to complete the baseline survey in private, at 
home, without the added time pressure of the day of surgery. On the day of surgery, we will 
review all ongoing aspects of the study (i.e., additional surveys, timing, and collection of 
perioperative data).  
For subjects approached in person before surgery, we will obtain written informed consent and 
have the participant complete the baseline survey immediately thereafter and prior to surgery. 
  
Inclusion of women and minorities: Our sample will include male and female young adults 
with an expected regional distribution of race and ethnicity (see Inclusion of Minorities in parent 
project for breakdown). Our studies will have the unique ability to elucidate the contribution of 
sex and race on opioid perceptions, decisions, and risk behaviors, as we will control for these 
variables in the analyses. 
 
Feasibility: During 2017, more than 600 patients aged 15-24 underwent outpatient or short stay 
procedures and received an opioid prescription at discharge. We will allow 24 months to recruit 
subjects and collect data which should be sufficient given our target population, our collective 
clinical and research experience and that of our project manager. We expect that recruitment 
will be similar to if not better than past studies given the low risk nature of the study. As with our 
parent study, a modest monetary incentive will be provided in order to maximize participation 
and reduce the loss to follow-up. 
 
Potential benefits of the proposed research to the subjects and others: Participation offers 
the potential benefit for young adults to gain knowledge and awareness of opioid risks and to 
develop effective pain management and risk reduction competencies. The knowledge gained 
from our studies is directly translatable into practice with the potential to reduce the risks of 
opioids to young adults. 
 
Protection against risk (see Parent Protection of Human Subjects for more detail): Our 
opioid messages are developed with the guidance of pediatric pain and risk communications 
experts. The intervention poses no more than minimal risk to adolescents or young adults but 
may instead, offer potential benefit in terms of risk reduction, self-efficacy and pain management 
competency.  
We will minimize the risk for breach of confidentiality of all participants by training of study team 
members, use of electronic and physical security measures for data capture and storage, and 
by employing a Certificate of Confidentiality (automatic for NIH funded studies). Unique study 
identifiers (ID) for each subject will permit linkage between surveys and follow-up data while 
maintaining the privacy of every participant. ID links between subjects and their data will be kept 
separately in an encrypted file. Data will only be stored on fire-walled databases which will limit 
access only to those assigned appropriate permissions.  
Routine management will not be altered and we will exclude those who cannot, by nature of 
their underlying condition be safely prescribed the usual combination of opioids and non-opioids 
for postoperative pain. We will record all adverse events and will review non-serious AEs 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
quarterly and serious AEs as they are learned to determine the relationship to study 
participation and actions needed, if any (see DSMP).  
Data and safety monitoring plan (DSMP):  Our study specific DSMP provides details of how 
we will collect, review, evaluate and manage adverse events that may happen as part of routine 
care or study participation.  
 
Group assignment (same as parent study):  Patients will be randomly assigned a priori by 
computer generated randomization to either the Control Group (i.e., Routine provider 
written/verbal analgesic instruction) or one of two Intervention Groups: STOMP written (prose) 
feedback  (i.e., Routine provider information plus the STOMP written feedback or our enhanced 
STOMP Video feedback  (i.e., Routine provider information plus STOMP Video feedback).  
 
Outcomes  
Aim 1) Opioid risk perceptions, misuse risk perceptions, intentions to medically misuse, non-
medically misuse or divert left-over opioids 
Aim 2) Persistent opioid use after surgery, left-over opioid retention 
 
Measurements (only modifications from parent grant are described) 
 
• Opioid risk knowledge: Participant’s awareness of common and critical opioid risks will be 
assessed using the ADE knowledge instrument, where participants use nominal responses 
to record which are possible when taking opioids or when opioids are in the home.7,8,124 
These items were developed with established content and face validity and, together with 
risk perceptions, were found to have predictive validity.7,8 
 
• Opioid risk perceptions:  Perceived seriousness of opioid risks (e.g., excessive sedation, 
misuse, addiction) will be assessed using a 6 point Likert scale where 0=Not serious to 
5=Extremely serious.7,8,46 We have previously demonstrated predictive validity of these 
items toward situational and analgesic decisions.7,8,46 Perceived risk severity has been 
shown to predict intention and health behavior.82 
 
• Analgesic self-efficacy: Analgesic self-efficacy will be measured using a six item scale 
where participants will score their confidence to safely and effectively give and stop 
analgesics when managing their pain and other symptoms.126-128 Self-efficacy is the 
perceived confidence to perform specific behaviors to attain effective health outcomes.129 
Measures of medication self-efficacy mediate symptom management and health behavior 
and predict medication behavior and therapeutic change.130  
 
• Opioid decision-making: Situational decisional exercises will be modified to assess opioid 
use and potential misuse decision-making. We recently used similar decision-making 
scenarios to assess misuse intentions among 15-23 year olds, and demonstrated significant 
associations between risk understanding, past misuse behavior and misuse intentions.9 
Four scenarios will assess participants’ 1) willingness to misuse opioids either by taking 
higher doses (or more frequent dosing) of the personal prescription, 2) intention to misuse a 
previously prescribed opioid prescription for ongoing pain 3) intention to use a friend’s 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
prescribed opioid for ongoing pain 4) pain and symptom relief when opioid-related adverse 
events are present.  
   
 
• Analgesic adherence: Participants will record postoperative analgesics administered, self-
reported pain scores (i.e. 0-10 Numeric Rating Scale), and adverse effects the follow-up 
surveys. Opioids will be converted to oral morphine equivalents, and opioid and non-opioid 
consumption will be reported as total mg/kg given. Adherence will be reported as the 
percentage used of the total opioid and non-opioid doses prescribed. The number of left-
over doses of opioids will be calculated at discontinuation (amount dispensed minus amount 
used). We will assess intention to keep left-overs and reasoning at follow-up. 
 
• Pain interference: The PROMIS Adult Pain Interference Short Form will also be used to 
measure how much pain is interfering with participants’ activities at 1 and 2 weeks.48,49  
 
• Adverse side effects: Participants will document all analgesic-related side effects using the 
follow-up surveys.7 We will also review the clinic notes (6 months) for surgical and 
analgesic-related calls, return visits to the clinic or hospital, and analgesic refill orders, and 
persistent pain documentation. 
 
Measurements of Contributing Factors 
• Key biologic and other characteristics of the participant:  Participants will record their 
demographics including sex and race and ethnicity.  
 
• Substance Use: We will use the ASSIST measure for adults as a gross measure of risk 
factors for substance use disorder.50  
• Pain history and opioid familiarity: History of participant pain, opioid and non-opioid use 
will be assessed with simple categorical items.8,46  
 
• Pain relief preference (PR-Pref): This instrument assesses the participant’s desire to 
provide pain relief relative to their desire to minimize ADE risks. The instrument includes 7 
risk–beneﬁt items7,8,46 similar to those used to assess the importance patients place on 
chronic medication beneﬁts versus their concern for adverse effects.145-147 Agreement with 
each statement is ranked on a 5 point Likert scale from strongly disagree (-2) to strongly 
agree (+2), to yield a total score ranging from -12 to +12, where lower numbers indicate a 
preference for risk avoidance, higher numbers pain relief, and the middle range, indifference 
or ambivalence.145,147  We previously have demonstrated the instrument’s  internal 
consistency, construct and predictive validity (higher scores predict parental opioid 
administration).46    
 
• Surgical factors:  The procedure, prior injury, duration of surgery, all perioperative 
analgesics given and details of participant’s prescription and analgesic instructions will be 
recorded from the medical record.  
 
 
Study Procedures (SEE TABLE 1 BELOW)  
Group assignment:  Participants will be randomly assigned a priori by computer generated 
randomization to one of the three groups: the Control Group (i.e., Routine provider 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
written/verbal analgesic instruction), the STOMP written feedback (intervention) Group: (i.e., 
Routine provider information plus the STOMP written feedback) or the enhanced STOMP Video 
Feedback (intervention) Group (i.e., Routine provider information plus the STOMP Video 
feedback). 
All baseline and follow-up surveys are completed by the subjects using a Qualtrics survey 
link via their own smartphone or computer (or our iPAD if completed in person) to ensure 
completeness and privacy. Subjects will enter only an assigned, unique ID number with no other 
identifying information. STOMP (either written or video groups) will be provided together with 
each decision exercise (built into the survey itself). The electronic survey includes appropriate 
logic and prompts to minimize the potential for missing items.  
Subjects will be texted/emailed   survey links on day 0 (day before or on surgery), day 7, day 14, 
1 & 3 months after discharge. Table 1 depicts the study assessments completed at each 
timepoint. These will be automatically scheduled via our umich gmail system.  On each of the 
survey days, we will also send a text SMS reminder to participants (automated using the same 
process as our parent study). Subjects can opt to complete surveys via email link (Qualtrics) or 
via paper/pen (returned via mail). No more than 1 additional text reminder for each will be sent 
to subjects who have not completed their follow-up surveys. 
 
Sample Size Determination 
Our sample size is based on our recent findings that 26% of adolescents/young adults 
indicated a willingness to misuse a prescribed opioid for pain management. We need 426 
participants (142/group) to detect a clinically important effect of the STOMP intervention on 
misuse intention (i.e., decrease to 13%; 95% confidence and 80% power). This sample will 
be more than sufficient to detect an expected mean difference in opioid misuse risk 
perception between either intervention group and the control (MD 0.56, SD 1.21; sample 
needed = 122) and to test for a modest effect of the interventions in a factorial design 
(estimated eta squared 0.14; sample needed = 147). To allow for 30% loss to follow-up and 
to account for missing data, we will recruit up to 600 participants. 
 
 
 
Table 1. Sequence of study assessments  
Measures 
Time 0 
Baseline 
(preop) 
Time 0.1 
(Immediately 
Post-Session) 
Time 1 
(7 days) 
Time 2 
(14 days) 
Time 3 
(1 month) 
Time 4 
(3 months) 
Demographics 
x 
 
 
 
 
 
Pain, Analgesic and 
Misuse History  
x 
 
 
 
 
 
Pain relief Preference  
x 
 
 
x 
 
 
Opioid knowledge/ risk 
perceptions 
x 
x 
 
x 
x 
x 
Opioid misuse risk 
perceptions 
x 
x 
 
x 
x 
x 
Scenario (situational) 
decision-making 
x 
 
 
x 
x 
x 
Analgesic self-efficacy 
x 
x 
 
 
 
 
 
 
 
 
 
 
 
Pain interference  
 
 
x 
x 
x 
x 
Opioid left-over disposal 
 
 
 
x 
x 
x 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
Analgesic use and ADEs 
 
 
x 
x 
x 
x 
Perioperative data 
x 
 
 
Analgesic refill data 
 
 
x 
 
 
 
 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
DATA ANALYSES 
Generalized estimating equations (GEE) will be used to model both continuous (i.e., negative 
binomial and Gaussian) and binary outcomes (i.e., binomial) for each aim.151,152 All models will 
include both time-varying measures (e.g., opioid risk perceptions) and time-invariant covariates 
(e.g., sex, race, etc.) and will use either an independent or exchangeable correlation structure to 
correct for within subject correlations. Analyses will use Stata’s (STATA/SE v.13; STATA Corp., 
College Station, TX) ‘xtgee’ option as appropriate. All hypotheses per our conceptual model 
(Figure 3) will be tested at the 0.05 alpha level. Standardized coefficients and adjusted odds 
ratios will be computed to determine the relative effect size for each of the key independent 
variables.  
Missing data: The use of electronic surveys with built-in prompts for incomplete items will 
reduce the potential for missing responses. Patients will be contacted by phone, text or email 
(per their preference) to promote ongoing recording of postoperative data and to reduce the 
potential for missing data and LTF. We have used similar procedures to successfully ensure 
complete data and minimize loss to follow-up.8,25,94,153  
Any remaining missing data on surveys (e.g., assist or PR-Pref) will be examined for 
randomness and we will impute only partial non-response (e.g., missing 1 to 2 items of PR-Pref 
or assist) using a horizontal (i.e., per individual) approach. Largely incomplete or total survey 
non-response will be examined for non-randomness and potential bias (e.g., missing DAST-10). 
These missing data will not be imputed, however, outcomes will be compared for persons with 
missing vs. complete data to determine selection bias. We have adjusted our sample size to 
account for the potential for missing data. We will use pairwise deletion to use the available, 
complete cases to test our hypotheses.  
 
Aim 1: Using GEE, we will examine the association between the STOMP intervention and the 
outcomes (risk seriousness perception, and situational opioid decisions). It is hypothesized that, 
compared to controls, patients who receive the STOMP intervention will have 1) enhanced risk 
perceptions (continuous measure) and 2) improved opioid decisions (scenario-based). 
Hypotheses 1 and 2 will be tested using both main and interaction effect models. In the main 
effects models, STOMP group assignment is our binary independent variable of interest. Time 
by intervention interaction effect models will be used to examine whether the STOMP group has 
improved opioid risk perceptions and decisions at the follow-up assessments compared to the 
control group. It is expected that there will be no difference between the intervention group and 
control group at baseline. However, significant interaction effect terms should emerge for the 
intervention group at the follow-up assessments.  
 
 
 
Anticipated Problems and Solutions:    
The main potential limitation to achieving our aims is the efficient recruitment of eligible subjects 
and the potential LTF. Modest monetary incentives will be given for baseline and follow-up 
surveys which we’ve found to enhance recruitment rates and minimize LTF in high enrollment 
studies ($25 after completion of 1 month follow-up; $25 after receipt of 3 month follow-up 
survey).95,153 Participants will receive reminders by text, phone or email (per preference) which 
we have used to successfully reduce LTF and boost return of diaries in our previous longitudinal 
pain studies.8,46,153  We will evaluate our recruitment and retention rates quarterly to determine 
whether we are on target or whether we need to enhance our recruitment plan. 
 
 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
HUMAN SUBJECTS PROTECTIONS (Same as Parent Project with the following modifications) 
For this supplement, we expand our subject involvement to include up to 6005 English 
speaking adolescents and young adults (ages 15-24) who are prescribed opioids for acute, 
short-term postoperative pain following elective ambulatory/ short-stay surgical procedures. 
Males and females of all races will be recruited. 
Sampling Plan and Recruitment:  Given that adult patients, themselves, are the target 
population, we will contact potential participants at the time of surgery scheduling, in the 
preoperative clinic, or by phone or mail prior to the day of surgery to allow ample time to make 
an informed decision about taking part in the study and to allow time for completion of baseline 
surveys (prior to surgery). Participants will be provided a verbal synopsis of the study as well as 
a comprehensive written consent form.  Study procedures will not proceed until consent 
documents are signed.  
Potential Risks:   
• 
This study poses no more than minimal risk to participants who are aged 15-24. The 
primary risk to participants is potential for breach of confidentiality. Given our data 
collection and handling procedures as outlined in the parent study and re-emphasized 
below, the potential for breach is extremely unlikely.  
• 
Some adverse effects following surgery and during analgesic use are expected. We will 
be closely recording all opioid and surgery-related adverse events and will report these 
per our parent study DSMP and board review.  
Protection against risks:   
Confidentiality: We will minimize the risk of confidentiality breach by assuring privacy during 
our recruiting/consenting procedures, through the use of surveys and paperwork containing no 
identifiers (only assigned study ID links), and the maintenance of linkage lists, databases, etc. 
on institutional computers (protected by the use of secure login procedures).  Consent forms will 
be stored separately from datasheets, to avoid the additional possibility of linking materials. A 
Certificate of Confidentiality has been granted by NIH to further protect study participants from 
breach of confidentiality.   
Adverse Events: To ensure that our intervention poses no risk to safe or effective pain 
management, we will monitor all adverse events related to routine care (e.g., opioid-related drug 
effects, surgical events, and unplanned hospitalization) per our DSMP to determine whether 
either group (intervention or control) has been placed at greater risk for these events. Serious 
and non-serious events will be reviewed and reported as outlined in the DSMP.    
Potential Benefits of the Research to Human Subjects:  Since the nature of this study is to 
enhance and motivate safe use and management of opioid analgesics, those who take part and 
who are randomized to the intervention(s) might benefit from this knowledge and skill building 
program. Of note, our pilot data also showed that being in the Control group enhanced 
awareness of opioid-related ADEs (though did not have a significant effect on hypothetical 
decisions). Additionally, this study has the potential to yield information and interventions that 
may benefit participants in the future. This potential benefit of our ability to improve participant 
knowledge and decision-making around opioid risks far outweighs the minimal risks posed by 
study participation.  

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
Importance of Knowledge to be Gained:  High rates of prescription opioid misuse among 
adolescents and young adults and strong motivation for pain relief suggest a considerable lack 
of understanding of effective and safe use of prescription opioids and other analgesics. To date, 
educational interventions have not adequately addressed both the benefits and risks of opioid 
analgesics. Adolescents, therefore, continue to place themselves at risk for serious opioid-
related adverse events including death and misuse.  Our study will yield important information 
about new and innovative ways to provide older adolescents and young adults with the skills 
and information necessary to make safe and sound analgesic decisions – particularly with 
respect to high risk periods such as the postoperative period. The knowledge gained from this 
research is imperative to optimize the safety of opioid analgesics in the hands of adolescents 
and young adults.  
 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
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1. 
Miech R, Johnston L, O'Malley PM, et al. Prescription Opioids in Adolescence and Future Opioid 
Misuse. Pediatrics 2015;136:e1169-1177. 
2. 
McCabe SE, Veliz P, Schulenberg JE. Adolescent context of exposure to prescription opioids and 
substance use disorder symptoms at age 35: a national longitudinal study. Pain 2016;157:2173-
2178. 
3. 
Groenewald CB, Rabbitts JA, Gebert JT, et al. Trends in opioid prescriptions among children and 
adolescents in the United States: a nationally representative study from 1996 to 2012. Pain 
2016;157:1021-1027. 
4. 
Gaither JR, Leventhal JM, Ryan SA, et al. National Trends in Hospitalizations for Opioid 
Poisonings Among Children and Adolescents, 1997 to 2012. JAMA Pediatr 2016;170:1195-1201. 
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Jordan AE, Blackburn NA, Des Jarlais DC, et al. Past-year prevalence of prescription opioid 
misuse among those 11 to 30years of age in the United States: A systematic review and meta-
analysis. J Subst Abuse Treat 2017;77:31-37. 
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Martins SS, Segura LE, Santaella-Tenorio J, et al. Prescription opioid use disorder and heroin use 
among 12-34 year-olds in the United States from 2002 to 2014. Addict Behav 2017;65:236-241. 
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Curtin S, Tejada-Vera B, Warner M. Drug overdose deaths among adolescents aged 15-19 in the 
United States: 1999-2015. Hyattsville, MD: National Center for Health Statistics;2017. 
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Voepel-Lewis T, Zikmund-Fisher BJ, Smith EL, et al. Parents' Analgesic Trade-Off Dilemmas: How 
Analgesic Knowledge Influences Their Decisions to Give Opioids. Clin J Pain 2016;32:187-195. 
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Voepel-Lewis T, Boyd CJ, McCabe SE, et al. Intentions to misuse prescription opioids for pain 
among adolescents and emerging adults. Pediatrics 2018;Under Review. 
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Boyd CJ, Esteban McCabe S, Teter CJ. Medical and nonmedical use of prescription pain 
medication by youth in a Detroit-area public school district. Drug Alcohol Depend 2006;81:37-
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Boyd CJ, McCabe SE, Cranford JA, et al. Adolescents' motivations to abuse prescription 
medications. Pediatrics 2006;118:2472-2480. 
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Administration USFaD. How to Dispose of Unused Medicines. 2015; 
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm. Accessed 8/31/2016, 
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Huguet A, Miro J. The severity of chronic pediatric pain: an epidemiological study. J Pain 
2008;9:226-236. 
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Fouladbakhsh JM, Vallerand AH, Jenuwine ES. Self-treatment of pain among adolescents in an 
urban community. Pain Manag Nurs 2012;13:80-93. 
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King S, Chambers CT, Huguet A, et al. The epidemiology of chronic pain in children and 
adolescents revisited: a systematic review. Pain 2011;152:2729-2738. 
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Fortuna RJ, Robbins BW, Caiola E, et al. Prescribing of controlled medications to adolescents and 
young adults in the United States. Pediatrics 2010;126:1108-1116. 
17. 
Volkow ND, McLellan TA, Cotto JH, et al. Characteristics of opioid prescriptions in 2009. Jama 
2011;305:1299-1301. 
18. 
Harbaugh CM, Lee JS, Hu HM, et al. Persistent Opioid Use Among Pediatric Patients After 
Surgery. Pediatrics 2018;141. 
19. 
Whiteside LK, Russo J, Wang J, et al. Predictors of Sustained Prescription Opioid Use After 
Admission for Trauma in Adolescents. J Adolesc Health 2016;58:92-97. 
20. 
Fotiou A, Kanavou E, Richardson CR, et al. Misuse of prescription opioid analgesics among 
adolescents in Greece: The importance of peer use and past prescriptions. Drugs: Education, 
Prevention and Policy 2014;21:357-369. 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
21. 
McCabe SE, West BT, Cranford JA, et al. Medical misuse of controlled medications among 
adolescents. Arch Pediatr Adolesc Med 2011;165:729-735. 
22. 
McCabe S, Boyd CJ, Cranford JA, et al. Motives for nonmedical use of prescription opioids among 
high school seniors in the united states: Self-treatment and beyond. Archives of Pediatrics & 
Adolescent Medicine 2009;163:739-744. 
23. 
Saroyan JM, Evans EA, Segoshi A, et al. Interviewing and Urine Drug Toxicology Screening in a 
Pediatric Pain Management Center: An Analysis of Analgesic Nonadherence and Aberrant 
Behaviors in Adolescents and Young Adults. Clin J Pain 2016;32:1-6. 
24. 
Ross-Durow PL, McCabe SE, Boyd CJ. Adolescents' access to their own prescription medications 
in the home. J Adolesc Health 2013;53:260-264. 
25. 
Manchikanti L, Fellows B, Ailinani H, et al. Therapeutic use, abuse, and nonmedical use of 
opioids: a ten-year perspective. Pain Physician 2010;13:401-435. 
26. 
Boyd CJ, Young A, Grey M, et al. Adolescents' nonmedical use of prescription medications and 
other problem behaviors. J Adolesc Health 2009;45:543-550. 
27. 
McCabe SE, Cranford JA. Motivational subtypes of nonmedical use of prescription medications: 
results from a national study. J Adolesc Health 2012;51:445-452. 
28. 
McCabe SE, West BT, Boyd CJ. Motives for Medical Misuse of Prescription Opioids Among 
Adolescents. The Journal of Pain 2013;14:1208-1216. 
29. 
Miech R, Johnston LD, O'Malley PM, et al. Monitoring the future National survey results on drug 
use 1975-2015: Secondary Students. Ann Arbor: Institute for Social Research, University of 
Michigan;2016. 
30. 
Abou-Karam M, Dube S, Kvann HS, et al. Parental Report of Morphine Use at Home after 
Pediatric Surgery. J Pediatr 2015;167:599-604 e591-592. 
31. 
Maughan BC, Hersh EV, Shofer FS, et al. Unused opioid analgesics and drug disposal following 
outpatient dental surgery: A randomized controlled trial. Drug Alcohol Depend 2016. 
32. 
Voepel-Lewis T, Wagner D, Tait AR. Leftover prescription opioids after minor procedures: an 
unwitting source for accidental overdose in children. JAMA Pediatr 2015;169:497-498. 
33. 
Reyna VF, Farley F. Risk and Rationality in Adolescent Decision Making: Implications for Theory, 
Practice, and Public Policy. Psychol Sci Public Interest 2006;7:1-44. 
34. 
Arria AM, Caldeira KM, Vincent KB, et al. Perceived harmfulness predicts nonmedical use of 
prescription drugs among college students: interactions with sensation-seeking. Prev Sci 
2008;9:191-201. 
35. 
Fleary SA, Heffer RW, McKyer EL. Understanding nonprescription and prescription drug misuse 
in late adolescence/young adulthood. J Addict 2013;2013:709207. 
36. 
Grevenstein D, Nagy E, Kroeninger-Jungaberle H. Development of risk perception and substance 
use of tobacco, alcohol and cannabis among adolescents and emerging adults: evidence of 
directional influences. Subst Use Misuse 2015;50:376-386. 
37. 
Jensen CD, Cushing CC, Aylward BS, et al. Effectiveness of motivational interviewing 
interventions for adolescent substance use behavior change: a meta-analytic review. J Consult 
Clin Psychol 2011;79:433-440. 
38. 
Steinberg L. A Social Neuroscience Perspective on Adolescent Risk-Taking. Dev Rev 2008;28:78-
106. 
39. 
Gibbons FX, Houlihan AE, Gerrard M. Reason and reaction: the utility of a dual-focus, dual-
processing perspective on promotion and prevention of adolescent health risk behaviour. Br J 
Health Psychol 2009;14:231-248. 
40. 
Albert D, Steinberg L. Judgment and decision making in adolescence. Journal of Research on 
Adolescence 2011;21:211-224. 

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41. 
Reyna VF, Estrada SM, DeMarinis JA, et al. Neurobiological and memory models of risky decision 
making in adolescents versus young adults. J Exp Psychol Learn Mem Cogn 2011;37:1125-1142. 
42. 
Garcia-Retamero R, Cokely ET. Effective communication of risks to young adults: using message 
framing and visual aids to increase condom use and STD screening. J Exp Psychol Appl 
2011;17:270-287. 
43. 
McCabe SE, West BT, Boyd CJ. Medical use, medical misuse, and nonmedical use of prescription 
opioids: results from a longitudinal study. Pain 2013;154:708-713. 
44. 
Tait AR, Voepel-Lewis T, Zikmund-Fisher BJ, et al. The effect of format on parents' understanding 
of the risks and benefits of clinical research: a comparison between text, tables, and graphics. 
Journal of health communication 2010;15:487-501. 
45. 
Voepel-Lewis T, Zikmund-Fisher BJ, Boyd CJ, et al. Effect of a Scenario-Tailored Opioid Messaging 
Program on Parents' Risk Perceptions and Opioid Decision-Making. Clin J Pain 2017. 
46. 
Zikmund-Fisher BJ. The Right Tool Is What They Need, Not What We Have: A Taxonomy of 
Appropriate Levels of Precision in Patient Risk Communication. Medical Care Research and 
Review 2013;70:37S-49S. 
47. 
Zikmund-Fisher BJ, Fagerlin A, Roberts TR, et al. Alternate methods of framing information 
about medication side effects: incremental risk versus total risk of occurrence. Journal of health 
communication 2008;13:107-124. 
48. 
Amtmann D, Cook KF, Jensen MP, et al. Development of a PROMIS item bank to measure pain 
interference. Pain 2010;150:173-182. 
49. 
Cook KF, Bamer AM, Amtmann D, et al. Six patient-reported outcome measurement information 
system short form measures have negligible age- or diagnosis-related differential item 
functioning in individuals with disabilities. Arch Phys Med Rehabil 2012;93:1289-1291. 
50. 
Kelly SM, Gryczynski J, Mitchell SG, et al. Validity of brief screening instrument for adolescent 
tobacco, alcohol, and drug use. Pediatrics 2014;133:819-826. 
 
 

Voepel-Lewis Consent HUM00147378  NCT03863353 
 
******************DO NOT DELETE OR ALTER THIS PAGE****************** 
CAUTION:   IF YOU HAVE PRINTED THIS CONSENT FOR USE WITH PARTICIPANTS, IT IS NOT THE 
IRBMED APPROVED VERSION.  Access the approved/watermarked consent from the Documents Tab 
in the main study workspace.  The approved/watermarked document will not contain this cover page 
and will have the approval watermark present in the header. 
****************************************************************************** 
INSTRUCTIONS FOR EDITING THIS DOCUMENT 
1. Turn on Track Changes. 
2. Make necessary changes in consent, and update the footer intended for study team version control. 
3. Upload the revised consent into Section 10-1, maintaining the IRBMED standard naming convention 
as follows: 
• 
Consent - Tracked 
• 
Consent - Concise Subtitle – Tracked (provide a subtitle when there are multiple consents 
associated with the study) 
• 
Assent - Tracked 
• 
Parental Permission/Assent - Tracked 
• 
Parental Permission – Tracked 
 
NOTES:  
Words identified above in bold must not be changed; words identified in italics may be modified by the 
study team.  Informed consent subtitles should be a one or two word descriptor, such as: Consent – 
Genetic – Tracked or Consent – Blood Draw - Tracked. 
 
Each subsequent track changes version should be stacked on the previously uploaded track changes 
version.  
 
DO NOT delete any documents or stacks of documents from eResearch; these are retained for historical 
and regulatory reference purposes. 
 
DO NOT upload a clean version of the consent. 
 
---------------------------  IRB OFFICE USE ONLY  ------------------------------------ 
Study ID: HUM00147378 / Continuing Review ID: CR00078558 
Approval Date:  8/21/2019 
Document Finalized:  8/21/2019 12:00 PM 

Voepel-Lewis CT NCT03863353  IRB HUM00147378 
18 
 
University of Michigan 
Electronic Consent To Be Part Of A Research Study 
Name of Study and Researchers  
Title of Project: Evaluating an Interactive Opioid Risk Education Program (STOMP – Scenario-Tailored Opioid 
Messaging Program) for Young Adults 
Principal Investigator: Terri Voepel-Lewis, PhD, RN 
Funding Source: National Institute of Health 
GENERAL STUDY Information  
 
This study does not replace or interfere with your routine care in any way. 
Study Purpose:  This study will help us evaluate our new pain management education program, STOMP, that is meant to 
teach patients about some safe and effective ways to manage pain after surgery.  
Voluntary:  Taking part in this study is voluntary. Your choice of whether or not to take part will not affect the care you 
receive at the University of Michigan. Some of the questions may make you feel uncomfortable. If a question makes you 
uncomfortable, you can just skip it and go to the next question. 
Who:  We will recruit up to 600 young adults (ages 15-24) who are having surgery that is typically associated with pain 
during recovery. 
Study procedures: 
Surveys:   
• Those who take part will complete 5 brief surveys over 3 months. These surveys ask about your pain and pain 
reliever knowledge/perceptions, your past pain reliever use and other drugs you have used in the past.   
• The survey also asks about your preferences for pain relief, beliefs about pain reliever risks and what you might do 
to take care of your pain under specific conditions. 
Here is the survey schedule: 
Before Surgery 
1 week after 
surgery 
2 weeks after 
surgery 
1 month after 
surgery 
3 months after 
surgery 
Baseline survey 
(20 mins) 
<5 min survey 
10 min survey 
10 min survey 
 
$25 
10 min Final 
survey  
$25 
Past pain/symptom 
experience; 
Perceptions 
Pain/ pain reliever 
use 
Pain/ pain reliever 
use 
Perceptions 
Pain/ pain 
reliever use;  
Perceptions 
Pain/ pain reliever 
use;  
Perceptions 
 
Education:  With the first survey, two thirds of those who take part will get new information about how to manage 
pain.  Who gets this information is decided randomly, like flipping a coin..  
Health Information:  Lastly, we will separately collect information about your surgery and recovery (through 3 
months after surgery only) from your medical record. 
Risk to Privacy: All surveys will be completed on your smartphone, an iPad or computer.  
To keep your personal information private, we will give you a study ID number that you yourself will enter on all surveys. 
This ID will help us to link your surveys together and with the surgery information we record separately without 
disclosing your identity in our databases or in any analysis.  
No one outside our study team will be able to figure out whose surveys belong to you or others in the study. All 
identifiers will be destroyed once the study is complete. 

Voepel-Lewis CT NCT03863353  IRB HUM00147378 
19 
 
Benefits:  Some people who take part may learn something from being in this study that will help them better manage 
pain at home after surgery. Additionally, your part in the study will help us learn how we might improve the care we give 
to surgical patients in the future.  
 
Clinical Trial: A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a 
summary of the results. You can search this Web site at any time. 
 
With appropriate permissions, your de-identified information may also be shared with other researchers, here, 
around the world, and with companies. 
 
Your identifiable private information may be stripped of identifiers and used for future research studies or 
distributed to another researcher for future research studies without additional informed consent.  
 
Protecting your privacy:  To further protect your privacy, this research is covered by a Certificate of 
Confidentiality from the National Institutes of Health. The researchers with this Certificate may not disclose or 
use information or documents, that may identify you in any federal, state, or local civil, criminal, administrative, 
legislative, or other action, suit, or proceeding, or be used as evidence, for example, if there is a court 
subpoena, unless you have consented for this use. Information or documents, protected by this Certificate 
cannot be disclosed to anyone else who is not connected with the research except, if there is a federal, state, 
or local law that requires disclosure (such as to report child abuse or communicable diseases but not for 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); if you have 
consented to the disclosure, including for your medical treatment; or if it is used for other scientific research, as 
allowed by federal regulations protecting research subjects.  
 
The Certificate cannot be used to refuse a request for information from personnel of the United States federal 
or state government agency sponsoring the project that is needed for auditing or program evaluation by the 
NIH, which is funding this project or for information that must be disclosed in order to meet the requirements of 
the federal Food and Drug Administration (FDA).  You should understand that a Certificate of Confidentiality 
does not prevent you from voluntarily releasing information about yourself or your involvement in this research. 
If you want your research information released to an insurer, medical care provider, or any other person not 
connected with the research, you must provide consent to allow the researchers to release it. The Certificate of 
Confidentiality will not be used to prevent disclosure as required by federal, state, or local law of, such as child 
abuse and neglect, or harm to self or others.  
 
The Certificate of Confidentiality will not be used to prevent disclosure for any purpose you have consented to 
in this informed consent document. 
 
Research can lead to new discoveries, such as new tests, drugs, or devices. Researchers, their organizations, 
and other entities, including companies, may potentially benefit from the use of the data or discoveries. You will 
not have rights to these discoveries or any proceeds from them. 
 
Payment 

Voepel-Lewis CT NCT03863353  IRB HUM00147378 
20 
 
 
Those who take part will be paid up to $50 based on survey completion as noted in the table above.  
The University of Michigan accounting department will need your name, address, payment amount, and related 
information for tax reporting purposes.  
 
 
AUTHORIZATION TO RELEASE PROTECTED HEALTH INFORMATION  
Signing this form gives the researchers your permission to obtain, use, and share information about you for this 
study, and is required in order for you to take part in the study. Your permission expires at the end of the study, 
unless you cancel it sooner. You may cancel your permission at any time by contacting the researchers listed 
below (under Contact Information). 
 
Information about you may be obtained from any hospital, doctor, and other health care provider involved in 
your care, including: 
• 
Hospital/doctor's office records, including test results (X-rays, blood tests, urine tests, etc.) 
• 
All records relating to your condition, the treatment you have received, and your response to the 
treatment 
• 
Demographic information 
• 
Personal identifiers 
It’s possible that the researchers or others will need access to information about you during or after this study. 
For example: 
• 
The researchers may need the information to make sure you can take part in the study.   
• 
The researchers may need the information to check your test results or look for side effects.   
• 
The University of Michigan or a government agency may need the information to make sure that the 
study is done in a safe and proper manner.    
• 
Study sponsors or funders, or safety monitors or committees, may need the information to, make 
sure the study is done safely and properly, learn more about side effects, or analyze the results of 
the study. 
• 
The researchers may need to use the information to create a databank of information about your 
condition or its treatment. 
• 
Information about your study participation may be included in your regular UMHS medical record. 
• 
Federal or State law may require the study team to give information to the Food and Drug 
Administration (FDA) or other government agencies. For example, to prevent harm to you or others, 
or for public health reasons. 
The results of this study could be published in an article, but would not include any information that would let 
others know who you are.  
 
As a rule, the researchers will continue to use information about you until the study is over and will keep it 
secure until it is destroyed. Limited information about you may continue to be used after the study is over, for 
other research, education, or other activities. But use of this information would not reveal your identity. 
 
As long as your information is kept within the University of Michigan Health System, it is protected by the 
Health System’s privacy policies.  For more information see http://www.med.umich.edu/hipaa/npp.htm. Note 
that once your information has been shared with others, it may no longer be protected by the privacy 
regulations of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).   
 
 

Voepel-Lewis CT NCT03863353  IRB HUM00147378 
21 
 
 
Contact Information 
To find out more about the study, to ask a question or express a concern about the study, or to talk about any problems 
you may have as a study subject, you may contact one of the following: 
 
Principal Investigator: Terri Voepel-Lewis PhD, RN 
Mailing Address:  
1540 E. Medical Center Dr., Mott Children’s 
Hospital, Ann Arbor, MI 48109-4245 
Telephone: 734 936-0734 
Email: terriv@umich.edu 
Study Coordinator: Monica Weber, RN, BSN, 
CCRP 
Mailing Address:  
1540 E. Medical Center Dr., Mott Children’s 
Hospital, Ann Arbor, MI 48109-4245 
Telephone: 734 936-0734 
Email: monij@umich.edu 
 
You may also express a concern about a study by contacting the Institutional Review Board: 
University of Michigan Medical School Institutional Review Board (IRBMED) 
2800 Plymouth Road 
Building 520, Room 3214 
Ann Arbor, MI  48109-2800 
734-763-4768 
E-mail: irbmed@umich.edu 
 
 
If you are concerned about a possible violation of your privacy or concerned about a study, you may contact 
the University of Michigan Health System Compliance Help Line at 1-866-990-0111. 
SIGNATURES 
Research Subject: 
 
I understand the information printed on this form. My questions so far have been answered.   
 
Signature of Subject:  
  
 Date:  
 
 
Name (Print legal name):