Testing the Impact of Appeals to Diversity and Inclusion in Pediatric Clinical Research Study Enrollment Videos: a Baseline Assessment Study
Phase: NA
Conditions: Patient Participation, Pediatric ALL
Sponsor: University of Pennsylvania

 
30 January 2020 
Title: 
Testing the Impact of Appeals to Diversity and Inclusion in Pediatric Clinical 
Research Study Enrollment Videos: A Randomized Pilot Study  
Short Title: Inclusion Appeals and Enrollment Equity 
 
 
 
 
 
 
 
 
Study Principal Investigator(s) 
Kevin B. Johnson, MD MS FAAP FAMIA FACMI 
B202 Richards Building 
3700 Hamilton Walk 
University of Pennsylvania | Philadelphia, PA 19104-6116 
215-573-5885 
Kevin.johnson1@pennmedicine.upenn.edu 
 
Andy SL Tan, PhD MPH MBA MBBS 
375 Longwood Ave LW662, Boston, MA 02215 
 
Andy.tan@asc.upenn.edu 
 

 
  
 
 
 
 
30 January 2020 
ABSTRACT 
Context: 
African and African American individuals are inadequately represented in clinical trials 
data—impacting the relevance of these trials to diseases that affect them. Although studies 
have demonstrated the value of video, little is known about the value of incorporating 
appeals to promote inclusion. 
Objectives: 
This study will assess whether video-based inclusion appeals improve African American 
children’s enrollment into the Children’s Hospital of Philadelphia (CHOP) research study 
registry. 
Study Design:  
The study will consist of two phases: a qualitative research phase and a randomized 
controlled trial phase. 
Setting/Participants: 
Phase 1 involves parents from the CHOP Research Family Partners and utilizes 
consensus/voting to review study design and materials. Phase 2 takes place in the CHOP 
primary care waiting rooms.  Ninety parents who self-identify as English-speaking 
African/African American adults will be enrolled. 
Study Interventions and Measures:  
Phase 1 has been described above. Phase 2 study participants will complete a demographic 
survey, before being randomized to receive one of three interventions: 
1. Short description of the registry 
2. video with inclusion appeal, questions about the perceived effectiveness of the video 
3. video without inclusion appeal, questions about the perceived effectiveness of the 
video.  
All participants will be invited to join a study enrollment registry.  

 
  
 
 
 
 
30 January 2020 
SCHEDULE OF STUDY PROCEDURES  
 
Study Phase 1 
Group Meeting 
Group Meeting 
Group Meeting 
Group Meeting 
Visit Number 
1 
2 
3 
4 
Informed Consent/Assent 
X 
 
 
 
Project discussion 
X 
X 
X 
X 
Video review 
 
X 
X 
 
Video discussion 
 
X 
X 
 
Video evaluation 
 
X 
X 
 
Enrollment plan 
X 
 
 
X 
 
Study Phase 2 
Screening 
Intervention 
Visit Number 
1 
1 
Study Days 
1 
 
Informed Consent/Assent 
X 
 
Review Inclusion/Exclusion 
Criteria 
X 
 
Randomization  
X 
 
Demographics/Medical History 
 
X 
Survey (video embedded if 
being shown) 
 
X 
Registry enrollment question 
 
X 
 
 
 

 
  
 
 
 
 
30 January 2020 
STUDY DIAGRAM 

 
  
30 January 2020 
1 BACKGROUND INFORMATION AND RATIONALE 
1.1 Introduction 
Improving diversity in research projects and national data repositories is critical to providing 
safe and effective care to marginalized groups. Unfortunately, certain groups, such as 
African Americans, are inadequately represented in much of the available data and in 
current clinical trials.  Recently, investigators have begun employing new messaging 
approaches to increase diversity in clinical trial enrollment. These messages are typically 
designed to inform, with no appeal for specific groups to act. Very little is known about the 
potential impact of inclusion appeals--direct appeals to historically marginalized groups 
calling on their need to be included in research studies. Applying the science of appeals to 
recruitment messages may improve the effectiveness of educational videos and lead to 
greater participation in research. This pilot study proposes to empirically study whether an 
inclusion appeal increases attempts to enroll children in studies. 
1.2 Name and Description of Investigational Product or Intervention 
The intervention will be a short video segment added to an informational video about 
Pediatric Clinical Research Study that will be tailored to appeal to the need for an inclusive 
population of study participants in clinical trials.  For this pilot study, we will target 
African/African American participants. 
1.3 Findings from Non-Clinical and Clinical Studies  
n/a 
1.4 Relevant Literature and Data 
Recently, investigators have begun employing new messaging approaches to increase 
diversity in clinical trial enrollment. For example, transportation theory-based messaging 
(immersion into a narrative world)1 and video narratives2 have demonstrated an impact on 
persuasion, while in the pediatric literature, video messaging has been used to improve 
parental participation in reading to children3,In pediatric studies, video enrollment 
messaging has had mixed results in terms of impacting marginalized groups4 5.  In our 
review of the literature, while these studies employ video messaging, investigators have not 
provided evidence that they applied the science of science communication to constructing 
 
1 Melanie C. Green and Timothy C. Brock, “The Role of Transportation in the Persuasiveness of Public 
Narratives.,” Journal of Personality and Social Psychology 79, no. 5 (November 2000): 701–21, 
https://doi.org/10.1037/0022-3514.79.5.701. 
2 Fuyuan Shen, Vivian C. Sheer, and Ruobing Li, “Impact of Narratives on Persuasion in Health 
Communication: A Meta-Analysis,” Journal of Advertising 44, no. 2 (April 3, 2015): 105–13, 
https://doi.org/10.1080/00913367.2015.1018467. 
3 Manuel E. Jimenez et al., “Enhancing Reach Out and Read With a Video and Text Messages: A Randomized 
Trial in a Low-Income Predominantly Latino Sample,” Academic Pediatrics 21, no. 6 (August 2021): 968–76, 
https://doi.org/10.1016/j.acap.2021.02.011. 
4 Jimenez et al. 
5 Paula M. Frew et al., “A Randomized Trial of Maternal Influenza Immunization Decision-Making: A Test of 
Persuasive Messaging Models,” Human Vaccines & Immunotherapeutics 12, no. 8 (August 2, 2016): 1989–96, 
https://doi.org/10.1080/21645515.2016.1199309. 

 
  
30 January 2020 
these videos and did not publish any evaluation of the message’s effectiveness at conveying 
its intended message. For example, a recent study by Skinner and colleagues6 investigated 
the role of an educational video on clinical trial enrollment among ethnic minorities. It 
showed no effect; however, it utilized a DVD-based intervention that was only watched by 
half the participants, which the authors acknowledged as a limitation. Finally, none of these 
projects appear to have included any sort of message that specifically appealed to a target 
audience.  Appeals are a well-established approach in communication that utilize evidence 
or emotional triggers to persuade the receiver to change his or her behavior.789 
1.5 Compliance Statement 
This study will be conducted in full accordance all applicable Children’s Hospital of 
Philadelphia Research Policies and Procedures and all applicable Federal and state laws and 
regulations including 45 CFR 46, 21 CFR Parts 50, 54, 56, 312, 314 and 812 and the Good 
Clinical Practice: Consolidated Guideline approved by the International Conference on 
Harmonisation (ICH). All episodes of noncompliance will be documented. 
The investigators will perform the study in accordance with this protocol, will obtain 
consent and assent, and will report unanticipated problems involving risks to subjects or 
others in accordance with The Children’s Hospital of Philadelphia IRB Policies and 
Procedures and all federal requirements. Collection, recording, and reporting of data will be 
accurate and will ensure the privacy, health, and welfare of research subjects during and 
after the study.  
2 STUDY OBJECTIVES 
Our research objective is to identify components of video messages that motivate behavior 
change.  
2.1 Primary Objective (or Aim) 
The primary objective is to compare intent to enroll in a research discovery site after seeing 
a video with an inclusion appeal versus one without such an appeal—focusing on parents 
and guardians who identify as African or African American. 
 
6 Jeannine S. Skinner et al., “The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge 
in Ethnic Minorities: A Randomized Control Trial,” Frontiers in Public Health 7 (2019): 104, 
https://doi.org/10.3389/fpubh.2019.00104. 
7 Joseph Petraglia, “The Importance of Being Authentic: Persuasion, Narration, and Dialogue in Health 
Communication and Education,” Health Communication 24, no. 2 (March 2009): 176–85, 
https://doi.org/10.1080/10410230802676771. 
8 Melanie B. Tannenbaum et al., “Appealing to Fear: A Meta-Analysis of Fear Appeal Effectiveness and 
Theories,” Psychological Bulletin 141, no. 6 (November 2015): 1178–1204, https://doi.org/10.1037/a0039729. 
9 Graton Aurélien and Mailliez Melody, “A Theory of Guilt Appeals: A Review Showing the Importance of 
Investigating Cognitive Processes as Mediators between Emotion and Behavior,” Behavioral Sciences (Basel, 
Switzerland) 9, no. 12 (November 20, 2019): E117, https://doi.org/10.3390/bs9120117. 

 
  
30 January 2020 
2.2 Secondary Objectives (or Aim) 
The secondary objective of this study is to assess message effectiveness and targetedness of 
a video inviting African/African American parents to participate in clinical trials involving 
their children. 
3 INVESTIGATIONAL PLAN 
3.1 General Schema of Study Design 
This project will include two phases, each of which is described below. The first phase of 
the study is designed to have members of the CHOP patient community review and evaluate 
the video and inclusion appeal message. Once the video has achieved a high level of 
perceived effectiveness, we will begin the second phase. The second phase of the study will 
be a 3-arm randomized controlled trial, focusing on parents of children cared for in CHOP 
primary care clinics who self-identify as African Americans proficient in verbal and written 
English, and with no history of prior trial participation.   
3.1.1 Trial  
The study will take place in primary care clinics throughout the CHOP ambulatory care 
system. 
Because this pilot will assess the impact of a video, the first phase of the study will consist 
of work leading to videos used through the rest of the study.  This phase will leverage work 
currently underway at the Children’s Hospital of Philadelphia (CHOP) to construct a library 
of messages aimed at improving parents’ knowledge about, and willingness to participate in, 
clinical research. Although some of these videos are constructed, none focus on the specific 
question that will be the focus of this research. We will work closely with a subset of 
CHOP’s Research Family Partners (RFP), who will assist with all aspects of script 
development, tailoring to the diverse community served by CHOP, and evaluation plan. The 
RFP will help us to identify at least two patient families who identify as African American 
wo have participated in trials to interview and record for this project. The rough video will 
be validated by a sample of RFP members who identify as being from a historically 
marginalized group. We will primarily evaluate perceived message effectiveness, using the 
six-item survey developed by KC Davis and colleagues.11 We will make iterative changes to 
the rough video until its perceived effectiveness averages 4.0 or greater on a 1 –5 scale.  We 
will create a separate video segment for the inclusion appeal. This separate segment will be 
reviewed and approved by the RFP using a similar method before being edited into a copy 
of the video. Once the video and inclusion appeal messages are finalized (we anticipate this 
taking no more than 3 meetings), we will finalize the two videos and complete post-
production to incorporate background music, improve color, audio balance and edit 
transitions. 
Once the videos are created and validated, we will conduct a 3-arm randomized trial, 
focusing on parents with children cared for by CHOP who self-identify as African or 
African Americans proficient in verbal and written English, and with no history of prior trial 
participation. We will work with the RFP to identify the ideal settings for recruitment, which 
may include clinics, community settings, and online social media sites. We are currently 

 
  
30 January 2020 
planning to invite participants to complete the study at a Penn or CHOP facility, rather than 
at home. Study participants will complete materials using an online survey completion and 
video display system (REDCap or Qualtrics). Each participant will complete questions about 
their age, gender identity, race/ethnicity, education attainment, and their child’s age and 
gender identity. We will then ask a subset of questions from the NIH Health Information 
National Trends Survey to assess clinical trials knowledge. After these questions, all eligible 
participants will be randomly show neither one of two videos (with or without the inclusion 
appeal) followed by a short survey about perceived effectiveness of the message or taken 
directly to the final question. The final question will ask if they are willing to receive 
messages about potential clinical trials for their child. If they select yes, they will be taken to 
the enrollment screen for the registry above and will be given assistance by the research 
coordinator to help them complete the process if required.  
Each participant will be paid $20 for participating in the study. The primary outcome will be 
intention to join a research registry called the Research Discovery Finder that notifies 
parents about research studies. We will measure attempts to join, rather than joining, in case 
the process of joining is too complicated or confusing. Based on data from two similar 
studies in adults137 we will need approximately 30 completed surveys per group to have 
80% power to detect a difference with a 0.05 significance level. Results will be reported 
using standard descriptive statistics. Between group differences in intent to enroll will be 
analyzed using chi-square analysis, with significance set at the 0.05 level. We will use a 
series of one-way between-group analyses of variance to determine the impact of the 
experimental video on dependent variables. 
3.1.2 Allocation to Treatment Groups and Blinding 
n/a 
3.1.3 Study Duration, Enrollment and Number of Sites 
The study duration per subject will be approximately 6 months for Phase 1 parents, and one 
visit for Phase 2 (including screening), with no planned follow-up.  
3.1.4 Total Number of Study Sites/Total Number of Subjects Projected 
The study will be conducted at one site in the Philadelphia area. 
It is expected that approximately 100 subjects will be enrolled to produce 90 evaluable 
subjects.  The study enrollment is planned to conclude in October 2022. 
3.2 Study Population 
Subjects that do not meet all of the below enrollment criteria may not be enrolled. Any 
violations of these criteria must be reported in accordance with IRB Policies and Procedures.   
3.2.1 Inclusion Criteria 
- 
English speaking (Phase 1 and 2) 
- 
Self-identified African or African American (Phase 2 only) 
- 
Not already enrolled in registry, no history of clinical trial participation (Phase 2 only) 
- 
At least one child in their care age newborn to 13 (Phase 2 only) 

 
  
30 January 2020 
3.2.2 Index/Case Subject Exclusion CriteriA 
- 
Parents under the age of 18 
- 
Parents with all children over the age of 13 
- 
Non-English speakers  
- 
Previously enrolled in CHOP's registry, history of clinical trial participation 
3.2.3 Control Subject Inclusion Criteria 
Same as 3.2.1 
3.2.4 Control Subject Exclusion Criteria 
Same as 3.2.2 
4 STUDY PROCEDURES 
4.1 Visit 1 (Phase 1) 
• Welcome and introductions 
• Participants will return signed informed consent (mailed to them before the visit.) 
• Participants will see a presentation about the goals of the study and be invited to ask 
questions. 
• Participants will see a first version of the video. 
• Participants will complete a video effectiveness survey. 
• Participants will discuss the video (open-ended, informed by the survey questions) 
Subsequent Visits (Phase 1, up to three additional visits) 
• Welcome and introduction 
• Participants will see a presentation about the goals of the study and summary of how 
the video has been changed. 
• Participants will see a revised version of the video. 
• Participants will complete a video effectiveness survey. 
• Participants will discuss the video (open-ended, informed by the survey questions) 

 
  
30 January 2020 
4.1 Visit 1 (Phase 2) 
Detailed description of study visit including all procedures.  
Potential participants will be invited to enroll in the study based on scheduled information 
and self-identified race/ethnicity. 
Upon arrival to clinic, potential participants will complete a brief screening form related to 
the inclusion criteria (English proficiency, able to watch a video or see an image, African/ 
African American race). If inclusion criteria are met, they will receive informed consent 
form (with review and discussion) and be asked to sign it. 
Participants will complete an online survey containing: (1) demographic questions (their 
age, gender identity, education attainment, and their child’s age and gender identity); (2) 
clinical trials knowledge, using a subset of questions from the NIH Health Information 
National Trends survey 
Participants will be randomly shown either: (1) one of two videos (with or without the 
inclusion appeal) followed by a short survey about perceived effectiveness of the message; 
or (2) a paragraph and image describing the CHOP Research Discovery Finder. 
Participants will be asked if they are willing to receive messages about potential clinical 
trials for their child from the CHOP Research Discovery Finder. If they select yes, they will 
be taken to the enrollment screen for the registry above and will be given assistance by the 
research coordinator to help them complete the process if required.  
Each participant will be paid $20 for participating in the study. 
Subject Completion/Withdrawal 
Subjects may withdraw from the study at any time without prejudice to their care.  The Investigator 
or the Sponsor (if applicable) may also withdraw subjects who violate the study plan, or to protect 
the subject for reasons of safety or for administrative reasons.  It will be documented whether or not 
each subject completes the study. 
Early Termination Study Visit 
Subjects who withdraw from the study after the study has begun and at least one question has been 
answered on the survey (out of time, lack of willingness or ability to continue, etc.) will be 
compensated as if the study had been completed. 
Safety Evaluation 
n/a 
5 STATISTICAL CONSIDERATIONS 
5.1 Primary Endpoint 
The primary endpoint will be the difference in intent to enroll between the three groups.  

 
  
30 January 2020 
5.2 Secondary Endpoints 
A secondary endpoints will be the difference in message effectiveness between the video 
with versus without the inclusion appeal, evaluated using a 6-question survey adopted from 
KC Davis and colleagues.11   
5.3 Statistical Methods 
5.3.1 Baseline Data  
Baseline and demographic characteristics will be summarized by standard descriptive 
summaries (e.g. means and standard deviations for continuous variables such as age and 
percentages for categorical variables such as gender). 
5.3.2 Efficacy Analysis 
For our assessment of differences between the three groups’ intent to enroll, we will use a 
series of one-way between-group analyses of variance to determine the impact of the 
experimental video vs. control video vs. no video on enrollment intent. 
5.4 Sample Size and Power 
Based on data from two similar studies in adults we will need approximately 20 completed 
surveys per group to have 80% power to detect a difference with a 0.05 significance level. 
Because our plan is to conduct the study before or after scheduled clinic visits, where illness, 
weather and transportation may impact a family’s ability to complete the study, we plan to 
enroll 90 patients to account for this attrition. 
5.5 Interim Analysis 
Interim analysis will not be necessary for this pilot study. 
6 SAFETY MANAGEMENT 
Since the study procedures are not greater than minimal risk, SAEs are not expected. If any 
unanticipated problems related to the research involving risks to subjects or others happen 
during the course of this study (including SAEs) they will be reported to the IRB in 
accordance with CHOP IRB SOP 408: Unanticipated Problems Involving Risks to Subjects. 
AEs that do not meet prompt reporting requirements will be summarized in narrative or 
other format and submitted to the IRB at the time of continuing review (if continuing 
reviews are required), or will be tracked and documented internally by the study team but 
not submitted to the IRB (if continuing reviews are not required).  
6.1 Definition of an Adverse Event 
An adverse event is any untoward medical occurrence in a subject who has received an 
intervention (drug, biologic, or other intervention).  The occurrence does not necessarily 
have to have a causal relationship with the treatment.  An AE can therefore be any 
unfavorable or unintended sign (including an abnormal laboratory finding, for example), 
symptom, or disease temporally associated with the use of a medicinal product, whether or 
not considered related to the medicinal product. 

 
  
30 January 2020 
All AEs (including serious AEs) will be noted in the study records and on the case report 
form with a full description including the nature, date and time of onset, determination of 
non-serious versus serious, intensity (mild, moderate, severe), duration, causality, and 
outcome of the event. 
6.2 Definition of a Serious Adverse Event (SAE) 
An SAE is any adverse drug experience occurring at any dose that results in any of the 
following outcomes:  
• death, 
• a life-threatening event (at risk of death at the time of the event),  
• requires inpatient hospitalization or prolongation of existing hospitalization, 
• a persistent or significant disability/incapacity, or 
• a congenital anomaly/birth defect in the offspring of a subject.   
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse drug event when, based upon 
appropriate medical judgment, they may jeopardize the subject and may require medical or 
surgical intervention to prevent one of the outcomes listed in this definition. 
A distinction should be drawn between serious and severe AEs.  A severe AE is a major 
event of its type.  A severe AE does not necessarily need to be considered serious.  For 
example, nausea which persists for several hours may be considered severe nausea, but 
would not be an SAE.  On the other hand, a stroke that results in only a limited degree of 
disability may be considered a mild stroke, but would be an SAE.  
6.2.1 Relationship of SAE to study drug or other intervention 
The relationship of each SAE to the study intervention should be characterized using one of 
the following terms in accordance with CHOP IRB Guidelines: definitely, probably, 
possibly, unlikely or unrelated.  
6.3 IRB/IEC Notification of SAEs and Other Unanticipated Problems 
The Investigator will promptly notify the IRB of all on-site unanticipated, serious Adverse 
Events that are related to the research activity. Other unanticipated problems related to the 
research involving risk to subjects or others will also be reported promptly. Written reports 
will be filed using the eIRB system and in accordance with the timeline below. External 
SAEs that are both unexpected and related to the study intervention will be reported 
promptly after the investigator receives the report. 
Type of Unanticipated 
Problem 
Initial Notification  
(Phone, Email, Fax) 
Written Report 
Internal (on-site) SAEs 
Death or Life Threatening  
24 hours 
Within 2 calendar days 

 
  
30 January 2020 
Internal (on-site) SAEs 
All other SAEs 
7 days 
Within 7 business days 
Unanticipated Problems 
Related to Research 
7 days  
Within 7 business days 
All other AEs 
N/A 
Brief Summary of important 
AEs may be reported at time 
of continuing review 
6.3.1 Follow-up report 
If an SAE has not resolved at the time of the initial report and new information arises that 
changes the investigator’s assessment of the event, a follow-up report including all relevant 
new or reassessed information (e.g., concomitant medication, medical history) should be 
submitted to the IRB. The investigator is responsible for ensuring that all SAE are followed 
until either resolved or stable.  

 
  
30 January 2020 
7 STUDY ADMINISTRATION 
7.1 Treatment Assignment Methods 
7.1.1 Randomizations 
One of three arms will be randomly presented to each participant through a specialized 
survey flow. Participants will then be administered one of three arms through a web-based 
randomizer. This data will be recorded and stored in Qualtrics.  
7.1.2 Blinding 
No blinding will be required. 
7.1.3 Unblinding 
N/A 
7.2 Data Collection and Management 
All data and records will be kept confidential and stored in Qualtrics 
 
All data will be backed up in a password protected file in Box, and will be analyzed using 
Excel and R. 
7.3 Confidentiality 
All data and records generated during this study will be kept confidential in accordance with 
Institutional policies and HIPAA on subject privacy. 
No identifiable data will be used for future study without first obtaining IRB approval or 
determination of exemption. The investigator will obtain a data use agreement between the 
provider (the PI) of the data and any recipient researchers (including others at CHOP) before 
sharing a limited dataset (PHI limited to dates and zip codes).  
7.4 Regulatory and Ethical Considerations 
7.4.1 Data and Safety Monitoring Plan 
The CHOP PI will monitor and review the study progress, subject safety, and the accuracy 
and security of the emerging data. 
7.4.2 Risk Assessment 
This study, which does not directly involve children, and which consists only of surveys 
conducted during a pre-scheduled clinic visit, qualifies as a minimal risk study. 
7.4.3 Potential Benefits of Trial Participation 
This study does not confer direct benefits (other than compensation) to participants. 

 
  
30 January 2020 
7.4.4 Risk-Benefit Assessment 
This study which has essentially no risk and a very small monetary benefit is justifiably 
more benefit than risk. 
7.5 Recruitment Strategy 
Participants in the first phase of the study will be selected from families already signed up 
for the Research Family Partners program at CHOP.  We are selecting no more than 9 
parents from this group to advise us on study design, video development, message 
effectiveness and targetedness. Meetings will be using teleconferencing software. 
Participants in the second phase will be invited to participate based on a review of the 
scheduled visits to the selected primary care sites each week. We will complete the study 
procedures in the waiting room or exam room before the visit (depending on the staffing and 
clinic flow, determined by asking the nurse manager each day we are in the clinic), and 
asking them to meet with us at the conclusion of the visit to complete the study if they are 
eligible and we were unable to complete the study initially.  We do not anticipate requiring 
advertising. 
7.6 Informed Consent/Assent and HIPAA Authorization 
Members of the research team will review the study and obtain informed consent. No 
additional HIPAA authorization is required.  Once a family member has agreed to 
participate, she will be given an iPad that displays a survey that already contains the 
patient’s research ID.  We will ask screening questions at that time. Parents/guardians who 
screen as eligible for the study will be invited to continue in the study after the visit.  
Surveys will be completed using researcher-provided iPads, and will be completed in the 
waiting room. Privacy will be assured through the use of headphones during the time the 
video is playing, and through the use of an iPad to collect the information. 
7.6.1 Screening  
We will complete screening in the clinic waiting room or exam room. The questions will be 
provided as a survey given to parents who are in the clinic and who are willing to be 
screened. 
7.6.2 Main Study 
A research coordinator (RC) will screen… 
The RC will screen patients while awaiting the start of their visit and then check for their 
eligibility. Once it is determined that they are interested in participating in the study. We 
will consent them, review their eligibility, and use Qualtrics randomization tool to assign the 
participant to one of the three arms.  
No HIPAA authorization form will be needed for this study. 

 
  
30 January 2020 
8 CONSENT/HIPAA AUTHORIZATION PLAN FOR SUBJECTS WHO REACH 
AGE OF MAJORITY 
n/a 
8.1 Waiver of Consent 
n/a 
8.2 Waiver of Assent 
Because the subjects of this research are parents and guardians, we will not require assent 
from their children.  
8.3 Waiver of HIPAA Authorization 
We request a waiver of HIPAA Authorization. The use or disclosure of protected health 
information involves no more than a minimal risk to the privacy of individuals (during 
the screening process, where we would see the age of the child, the identified 
race/ethnicity of the child, the language preference of the caregiver, and the name of the 
parents/guardians. All identifiers will be destroyed at the conclusion of data collection 
and payment. 
8.4 Payment to Subjects/Families 
8.4.1 Payments to subject for time, effort and inconvenience (i.e. 
compensation) 
Each participant will be paid $20 for participating in the study. We will assume that 
the study will begin once they have started the survey  
9 PUBLICATIONS 
Only aggregate and unidentifiable data will be found in publications of this work. 
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APPENDIX 
Append relevant information.