CommunityRx-Hunger: A Hospital-based Intervention for Primary Caregivers of Children Admitted to the Hospital
Phase: NA
Conditions: Food Insecurity
Sponsor: University of Chicago

 
1
 
CommunityRx-Hunger (CRx-H) Study Protocol 
NCT04171999 
Final approved version: 
February 8, 2022 
 
 
 

 
2
Study Protocol  
 
Table of Contents 
Original Protocol…………………………………………………………………………………..3 
Final Protocol…………………………………………………………………………………….16 
Summary of Major Changes to Protocol………………………………………………………...36 
 

 
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CommunityRx for Hunger (CommunityRx-Hunger or CRx-H) 
 
Study Protocol: Original Approved Version 
 
 
 
 
 
Principal Investigator: Stacy Tessler Lindau, MD, MAPP 
 
UCHICAGO IRB # 20-0324 
 
ClinicalTrials.Gov Identifier NCT: 04171999 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version #4:  02/11/2019

 
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Table of Contents 
 
A. Introduction…………………………………………………………………………………...5 
  A1 
Background………………………………………………………………………………..5 
  A2 
Purpose…………………………………………………………………………………….5 
  A3 
Aim 1……………………………………………………………………………………...6 
  A4 
Aim 2 ……………………………………………………………………………………..6 
 
B. Study Design…………………………………………………………………………………..6 
  B1 
Overview OR Design Summary…………………………………………………………..6 
  B2 
CommunityRx- Hunger (CRX-H) Intervention………………………………….………..7 
  B3 
Duration…………………………………………………………………………………...8 
  B4     Location……………………………………………………………………………………9 
  B5 
Special Precautions………………………………………………………………………..9 
  B6 
Experimental controls and use of placebos……………………………………….……….9 
  B7 
Type and number of experimental subjects……………………………………….………9 
  B8 
Inclusion Criteria…………………………………………………………………...……10 
  B9 
Exclusion Criteria………………………………………………………………………..10 
 
C. Statistical Plan………………………………………………………………………….……10 
 
D. Safety and Monitoring………………………………………………………………………10 
  D1 
Potential Risks and benefits………………………………………………………...……10 
  D2 
Monitoring of Safety……………………………………………………………………..11 
  D3 
Payment…………………………………………………………………………………..11 
  D4 
Informed Consent……………………………………………………………………...…12 
  D5 
Confidentiality…………………………………………………………………………...12 
  D6 
Recruiting Methods………………………………………………………………………13 
  D7  Notification of physician…………………………………………………………………14 
  D8 
Anticipated coordination…………………………………………………………………14 
  D9 
Pregnancy Test………………………………………………………………………...…14 
  D10 Exclusion of Women, Minorities, and/or Children………………………………………14 
  D11 Drugs……………………………………………………………………………………..14 
 
E. Bibliography…………………………………………………………………………………15 
 
 
 

 
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A. Introduction 
A1. Background 
Food insecurity is a prevalent, modifiable and overlooked determinant of health and health 
disparities along socioeconomic and racial lines in the U.S.1-3 When a child becomes 
seriously injured or ill, the parent becomes a caregiver, responsible for managing the 
significant tasks of living and coping with a child’s illness while also managing self- and 
family care.4,5 Hunger due to food insecurity can compromise decision-making and 
communication. Food insecurity can cause shame about failing to meet an ill child’s basic 
needs and is stigmatizing.6-8 The higher burden of food insecurity among lower income 
caregivers is a potentially mutable factor that likely contributes to socioeconomic disparities 
in adult and child health; self-efficacy has been associated with both food insecurity9,10 and 
lower SES,11,12 and is emerging as a key factor on the causal pathway linking illness 
management and coping processes to caregiver and child health.13,5  
 
The Centers for Medicare & Medicaid Services (CMS), the American Academy of Pediatrics 
(AAP) and others are calling for healthcare-based screening and intervention to address food 
insecurity, endorsing growing evidence about deleterious effects on health and healthcare.14-
17 The AAP, with the Food Research & Action Center (FRAC), provides a web-based Toolkit 
to support adoption of food insecurity interventions in the clinical setting.18 Most caregivers 
and healthcare providers agree it is acceptable for providers to address food insecurity and 
other basic needs, yet physicians rarely do.19-22 Barriers include provider concerns about 
compromising satisfaction with care by causing feelings of stigma and lack of knowledge 
about community resources to address food insecurity and other health-related social needs 
(HRSNs).19,20  
 
The CommunityRx-Hunger (CRx-H) intervention, described in this program of research, is 
an adaptation of CommunityRx (CRx), a proven clinical solution that systematically matches 
people, using evidence-based algorithms, to nearby community resources for wellness, self-
care and caregiving.23 CRx-H targets two key management processes, identified in Grey and 
colleagues’ Self- and Family Management of Chronic Conditions Framework,24 that align 
both with the AAP/FRAC Toolkit recommendations18 and routine hospital discharge 
workflows. The current study aims to pretest the administration of the intervention and data 
collection protocols to inform the design of a larger randomized controlled trial.   
 
A2. Purpose  
This study aims to improve adult and child health by sensitively intervening to support food 
insecure caregivers with a hospitalized child. The target population is racially and ethnically 
diverse with a very high rate of food insecurity. The overall objective of the proposed 
program of research is to evaluate the health and healthcare impact of CommunityRx-Hunger 
(CRx-H), a scalable self- and family management intervention for food insecure caregivers 
of hospitalized children. The long-term goal of this research program is to promote public 
health and reduce health disparities due to socioeconomic disadvantage. 
 
The over-arching aims of the program of research are: 

 
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A3: Aim 1 
 
Among caregivers of hospitalized children who screen positive for food insecurity, evaluate 
the effects of CRx-H versus usual care on self-efficacy (primary outcome), severity of 
caregiver and child food insecurity, adult and child nutrition and health, and child healthcare 
utilization (secondary outcomes).  
 
A4: Aim 2 
 
Among all caregivers of hospitalized children (food insecure and food secure), evaluate the 
effects of CRx-H versus usual care on caregiver satisfaction with care (primary outcome), 
caregiver and child health and caregiver stigma during hospitalization (secondary outcomes).  
 
Findings will yield an understanding of how best to leverage a child’s hospitalization to 
sensitively and effectively intervene to support food insecure caregivers. Results will inform 
whether and how CRx-H should be implemented in practice. This research will inform 
science, policy and practice in the rapidly growing field of healthcare interventions to address 
food insecurity and other health-related social needs. 
 
This pretest study aims to identify optimal processes for administering the planned 
intervention and to optimize the efficiency and flow of baseline and follow-up survey 
administration and interval communications with participants. Findings from this pretest will 
be used to inform the larger randomized trial. 
 
B. Study Design 
B1. Overview  
The first step in the proposed program of research is to pretest administration of the 
intervention and data collection procedures to inform the design of a larger randomized 
controlled trial (RCT). Interviewers will administer both in-person and telephone-based 
surveys. Human subjects involved in this pretest include 10 food insecure caregivers and 10 
food secure caregivers (20 caregivers total) and the hospitalized child (20 children total) of 
these caregivers. All human subjects will be consecutively screened for inclusion and 
enrolled as described in Section H. Type and Number of Experimental Subjects. Following 
screening, participants will be assigned to the CommunityRx-Hunger intervention, described 
below.  
B2. CommunityRx-Hunger Intervention 
 
Caregivers will receive CRx-H in addition to usual care. Near the time when a child is being 
prepared for hospital discharge, the CRx-H intervention will be initiated by a member of the 
research team. The intervention will include: (a) a brief, structured educational intervention 
about the common non-medical needs of families after a child’s hospitalization, including the 
problem of food insecurity in households with children (e.g., “Did you know that 1 in 5 US 
households with children are struggling to access and afford healthy food, or enough food to 

 
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support a healthy lifestyle?”) and co-occurring needs, like housing, legal and financial 
assistance, and transportation, (b) delivery and review of a HealtheRx for nearby, vetted 
resources to address these needs (SNAP/WIC enrollment, food support, services to meet 
other basic needs), and (c) coaching on how to activate community resources and the 
community resource navigator (a member of the research team), including a series of 
automated text messages.  
 
The proposed CommunityRx-Hunger intervention includes a proactive text messaging 
protocol; we will pretest the text messaging protocol to ensure its smooth operation. All 
caregivers will receive, in addition to the educational component and review of the 
HealtheRx, an initial text message (during the discharge process) and can reply “stop” at any 
time to prevent additional messages. During this pretest, the navigator will respond to text 
messages within 24 hours during regular work days and within 48 hours of weekends or 
holidays. Table 2 describes the frequency and content of the first week of automated text 
messages sent to caregivers in the CRx-H intervention who do not reply “stop.” The content 
of these messages is based on a text messaging experiment conducted during the CMMI 
HCIA CRx study.  
 
Table 2. Frequency and content of CRx-H automated text messages  
Frequency  
Time frame  
Content 
Once 
During the discharge 
process 
“When you were getting ready to leave the hospital 
with your child, you agreed to receive text messages 
from us. I’m Kelsey. I’m available to help you find 
resources in your area. Do you need help?” 
Weekly 
Between discharge 
and 30 days post 
discharge 
“Hi, this is Kelsey from your child’s hospital team. 
I’m checking in to make sure you have the food and 
other resources you need. Are there resources I can 
help you with? Reply or call 773-844-2219 for help.”  
 
 
Eligible caregivers enrolled in the pretest will participate in an in-person baseline survey 
during the child’s index hospitalization and a telephone-based follow-up survey 7 days 
following the child’s discharge. Surveys will elicit self-reported data in the following 
domains: caregiver sociodemographic characteristics (e.g., age, race/ethnicity, sex (measured 
by self-reported gender) employment, household composition), health and healthcare 
characteristics (e.g., at both the caregiver and child level: health, severity of food insecurity, 
and nutrition; at the child level: healthcare utilization), knowledge, attitudes, beliefs and 
experiences (e.g., caregiver self-efficacy, satisfaction with care, healthcare-related stigma, 
knowledge of food and other related resource supports), and resource use characteristics 
(e.g., use of food or other related resource supports, enrollment in SNAP/WIC, contact with 
Community Resource Navigator). Additionally, we will access, collect and analyze data from 
the child’s electronic medical record (EMR) for recruiting and other research purposes, 
including analysis of healthcare utilization data. The pretest will yield observations to 
optimize EMR chart abstraction processes.   
 
B3. Duration 

 
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The duration of this protocol is approximately 6 months. This will allow for enrollment of 
participants into the pretest of the intervention and administration of baseline and one week 
follow-up survey. This timeframe will also allow for preliminary data analysis and 
presentation of findings to our CommunityRx-Hunger Advisory Board for feedback and 
iteration of our trial design.  
 
B4. Location 
Research under this protocol will be conducted by researchers in the Department of 
Obstetrics and Gynecology at the University of Chicago (located at 5841 S. Maryland Ave., 
Chicago, IL, 60637) and the Comer Children’s Hospital (located at 5721 S. Maryland Ave, 
Chicago, IL 60637). Additional research (e.g., data preparation and analyses) will be 
conducted in Dr. Stacy Lindau’s research laboratory, located in the Medical Center 2050, 
rooms R-311 and R-315. 
 
B5. Special Precautions 
Protected health information (PHI) will be collected for research purposes and special 
precautions will be made to protect these data. We will identify new admissions to the 
children’s hospital via the EMR, accessing the patient’s name, medical record number and 
other, non-PHI information for recruitment of caregivers. In addition to the unique identifier 
applied by the REDCap computer assisted personal interviewing (CAPI) software, we will 
use caregiver’s name and telephone number to facilitate scheduling and completion of the 
follow-up survey at one week. We will collect patient name and medical record number 
(MRN) in order to access the child’s EMR. Because we will compensate caregivers for 
participation in the telephone-based follow-up survey, we will use the caregiver’s name and 
address or email address for compensation payment purposes.   
  
Because PHI will be accessed and collected for this program of research, there is a risk of 
loss of confidentiality. To protect confidentiality, we will implement a plan to protect data in 
all its forms from improper use and disclosure using HIPAA compliant policies and 
procedures; see Section N. Procedures to Maintain Confidentiality for more information.  
 
B5. Experimental controls and use of placebos  
This pretest does not employ the use of experimental controls or placebos.  
 
B6. Type and number of experimental subjects 
Human subjects involved in this pretest includes 20 caregivers of hospitalized children, 
including 10 food insecure caregivers and 10 food secure caregivers. Additionally, 20 
children (of the enrolled caregiver) will be enrolled. All caregivers will be screened for 
inclusion by accessing the electronic medical record to identify new hospital admissions and 
patient ZIP code. Caregivers will be recruited for study participation within 72 hours of their 
child’s admission. All caregivers in this pretest will be assigned to the CRx-H intervention. 
We will only enroll one caregiver per hospitalized child. If multiple caregivers identify as 
providing equal care to the child, we will randomly select one caregiver.  
 

 
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B7. Inclusion criteria:  
 
• Resides in the 16 ZIP code primary service area geography 
• Has access to a cell phone and provide the research interviewer with the cell phone 
number 
• Agrees to receive text messages from the study 
• Self-identifies as the primary caregiver of a child younger than 18 years of age admitted 
to Comer Children Hospital’s general, intensive care, or transplant units.  
 
B8. Exclusion criteria: 
 
• Caregivers of hospitalized healthy newborns 
• Caregivers of children who are admitted for less than 24 hours or who are expected at 
baseline to be hospitalized more than 30 days 
• Children who are wards of the state and/or families currently under investigation by the 
Department of Children and Family Services (DCFS)  
 
C. Statistical analysis 
The purpose of this research is to pretest our intervention administration and data collection 
procedures. We will collect baseline and one week survey data. To this end, preliminary 
descriptive statistics will be used to summarize, overall and by study arm, sociodemographic 
characteristics and primary and secondary outcomes at each measured time point. The mean, 
standard deviation, median, and inter-quartile range will be generated for continuous 
variables; frequency counts and percentages will be generated for categorical variables. We 
will evaluate the pretest data for missingness, systematic item non-response, and out of range 
values and prepare our data management analytic code.  
 
D. Safety and Monitoring 
D1. Potential Risks and Benefits 
 
This program of research involves no more than minimal risk or no more risk than is 
encountered in routine medical and psychological examinations. The risks of participation in 
this protocol include a potential loss of confidentiality or psychological or emotional 
discomfort associated with the interview questions. Every effort will be made to ensure 
subject confidentiality and that risks due to loss of confidentiality are minimal compared to 
the protocols in place to protect human subjects’ data. To date, more than 113,000 
individuals have participated in CommunityRx intervention studies with no known adverse 
events or breaches of confidentiality. All data collected from human subjects will be 
collected using standard survey or abstraction procedures. Whenever possible, the surveys 
will be conducted in a private room in the clinical setting or via telephone. Psychological 
and/or emotional discomfort associated with the survey questions is possible. Subjects will 
be informed that they can decline to answer any question and can terminate the survey at any 
time. Explanatory and debriefing statements will be included in the surveys to help the 
interviewer monitor and respond appropriately to discomfort, including termination of the 
survey if necessary. Alternatives to participation include not participating in the research; 

 
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participation is completely voluntary. Additional protections against these risks are described 
in Sections M and N, Informed Consent and Confidentiality, respectively. 
 
There is no direct benefit to human subjects involved in the research beyond the information 
provided during usual care and the CommunityRx-Hunger intervention. Participants, 
however, may gain personal satisfaction in contributing to research to address the 
humanitarian issue of food insecurity. Potential risks include a breach of confidentiality and 
are both minimal and reasonable in relation to the anticipated benefits to research participants 
and hospitalized children.  
 
C. Monitoring of Safety 
The proposed data collection presents no more than minimal risk or no more risk than is 
encountered in routine medical or psychological examinations. As described, no surveys will 
be conducted without explicit documentation of informed consent/assent and individuals will 
be provided with appropriate information about confidentiality when enrolling in the study 
and will indicate acceptance of these risks upon consent. Because we are not proposing a 
multi-site clinical trial, a Phase III trial, or a drug study, this study will not employ a Data 
and Safety Monitoring Board. Procedures are in place to ensure confidentiality and provide 
full informed consent as discussed below. 
 
The Lindau Lab has listed the Principal Investigator and study coordinator phone numbers on 
all study correspondence and forms. The purpose of the phone numbers is to provide 
respondents with a number to call if they have questions about any aspect of the study. 
During the study, should a subject express intent to harm themselves or others, we will 
contact a health or public safety professional. We will give only the subject’s name, contact 
information, and why we feel he or she is at risk of harming themselves or others. This report 
will not be linked to his or her survey information. Subjects have the right to refuse to speak 
to the mental health professional. If the interview procedure results in the observation of 
elder or child abuse, all research personnel will act in compliance with Illinois State law in 
regards to mandatory reporting of abuse.  
 
Research staff will strictly adhere to the procedures for enrolling participants and collecting 
data as outlined by the investigators. At the conclusion of the study, all hard copy materials, 
with the exception of the consent copies, will be destroyed and electronic files will be deleted 
or archived in password-protected files. Informed consent documents will be stored for at 
least 3 years following the completion of the study (defined by the last publication related to 
the study). Due to the small sample sizes associated with the pretest, these data will not be 
made publicly available. 
 
D2. Payment 
Caregivers enrolled in the pretest will receive $15 in compensation for completion of the 
baseline interview (approximately 25 minutes) and $25 in compensation for completion of 
the one-week follow-up survey (approximately 30 minutes). Compensation will not be 
prorated for partial completion of the baseline and one-week follow-up surveys but every 

 
11 
effort will be made to allow for ample time to complete the surveys and participants can 
refuse to answer any question they do not want to answer. Participation is voluntary.  
 
D3. Informed Consent 
We will obtain written informed consent from all caregivers enrolled in the pretest. Because 
we propose to access, view and analyze data from the hospitalized child’s electronic medical 
record, we will obtain assent from children between the ages of 7-17; we are requesting a 
waiver of assent for children under 7 years of age. Caregivers will be asked to also provide 
permission for the hospitalized child to participate in this research in this way. Because this 
study poses no more than minimal risk, permission from only one parent may be required. 
Research interviewers will guide caregivers through the informed consent document, 
providing statements to address: that the study involves research; the study’s purpose, 
duration, procedures followed, risks and benefits, alternatives to participation, and 
confidentiality of records; to whom they should direct questions or contact in case of 
research-related injury; and statements regarding voluntary participation, refusal to 
participate, and discontinuation of participation. The researcher will provide adequate time 
for the potential subject to ask questions and will answer these questions before requesting 
the caregiver’s signature. The informed consent process for caregivers enrolled in the pretest 
will take place in or near the patients’ hospital room following recruitment, according to 
caregiver preference. We will obtain the caregivers signature to signify consent and on the 
same document, their permission. We will also document the provision of assent of the child 
between 7-17 years.  
 
No surveys with human subjects will be conducted without explicit documentation of the 
informed consent process executed with each participant. Informed consent/assent documents 
will be iterated using approved consent documents from the recently completed CRx 
pragmatic clinic trial of patients (N=411) receiving care in the University of Chicago’s 
Primary Care Group and Emergency Departments. The consent documents for that study 
were adapted from consent documents developed in collaboration with a literacy consultant 
and members of the community. Consent forms will only be available in English; forms will 
be printed in large font and written in easily understandable language. Consent documents 
will be printed in duplicate, with a copy each going to the respondent and to Lindau 
Laboratory receipt control. Paper forms will be kept secure in locked cabinets in locked 
rooms. Consent documents will be received at the Lindau Laboratory by Ms. Abramsohn, 
Director of Research and Data Governance, to confirm participation in the study for data 
collection, validation, and data analysis purposes. A final copy of all consent/assent 
documents will be submitted to the IRB for review and approval. 
 
D5. Confidentiality 
The proposed research with human subjects, as presented above, presents no more than 
minimal risk or no more risk than is encountered in routine psychological examinations. Any 
potential risks may be due to emotional or psychological discomfort associated with the 
surveys or a breach of confidentiality. As described in detail above, no surveys will be 
completed without explicit documentation of informed consent and individuals will be 

 
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provided appropriate information about privacy and confidentiality when enrolling in the 
study and will indicate acceptance of these risks upon consent.  
 
The Lindau Laboratory has strict and secure procedures for protecting against and 
minimizing potential risks to human subjects’ data. All survey data will be entered directly 
into REDCap, a password-protected database managed by the Center for Research 
Informatics (CRI) at the University of Chicago (cri.uchicago.edu). CRI provides a HIPAA-
compliant data storage and computing environment that has achieved security accreditation 
by the Biological Sciences Division’s Risk Management Group. Depending on connectivity 
capabilities at the time of the survey, data will either be saved to the secure servers in the 
Department of Ob/Gym at the University of Chicago via a secure wireless connection, or 
research staff will connect computers manually to Department of Ob/Gym servers at the end 
of each collection day. All devices used by researchers to collect or access research files will 
be encrypted. Only approved research analysts in the Lindau Laboratory will have access to 
files that link participant’s PHI to their unique identifiers for the purposes of creating de-
identified and limited datasets. 
 
All hard copies of project materials will be stored in locked file cabinets in locked offices at 
University of Chicago. Servers in the University of Chicago Department of Ob/Gym are 
protected through a combination of a Microsoft-based firewall technology and the physical 
barrier of a Linksys router that is installed between the server and its internet connection. 
Laptop computers used to collect data will be encrypted and password protected. All data 
transmitted to secure servers will be encrypted. Analytic files will be de-identified prior to 
analysis, unless a limited dataset is needed to complete the analysis. Limited datasets will 
only be accessed by approved analysts on this IRB protocol, and will not be shared. Per the 
HIPAA Privacy Rule, any analytic datasets will limit the use or disclosure of PHI to the 
minimum necessary, if any at all, to accomplish the intended research purposes. These 
controls meet or exceed the strictness of practices legislated and enforced by the University 
of Chicago Biological Sciences Division and hospitals for protected health information. 
 
Procedures are in place to ensure confidentiality and provide informed consent as discussed 
above. Numeric coding of surveys/interviews and secure containment of files that link 
participant’s responses from PHI will also minimize this risk. Finally, the Lindau Laboratory 
will provide a contact phone number that will be included on all study correspondence and 
forms. The purpose of this phone number is to provide respondents with a single number to 
call if they have questions about any aspect of the study. 
 
 
D6. Recruiting Methods 
Researchers in the Lindau Laboratory will access electronic medical record (EMR) 
registration data to identify potential caregivers of newly admitted pediatric patients for 
inclusion in the pretest of this intervention based on ZIP code. Research interviewers will 
identify the hospital room number for the pediatric patient and, with permission of the 
patient’s physician (to be obtains be Drs. Lindau or Burnet) approach potentially eligible 
caregivers (identified by a yellow wrist band given to caregivers upon admission) in the 
child’s hospital room or unit (if admitted to the intensive care or transplant units). Research 

 
13 
interviewers will explain that the caregiver may be eligible for a research study and, if 
interested, further screen for eligibility.  
 
D7. Notification of physician 
Notification of the hospitalized child’s treating physician for permission to enroll will occur 
using a multi-pronged approach. First, we will educate all treating physicians and residents 
working in the target units about the study during the pretesting phase and give treating 
physicians the opportunity to opt out of study participation. Secondly, we will use these 
education sessions to identify how treating physicians wish to be contacted for permission 
(e.g., via text, email, phone, text page or through the electronic medical record system). We 
will use that communication as documentation of treating physician permission. Lastly, we 
will also educate nursing staff about the study. Nurse engagement will be helpful should we 
need to reach a treating physician during clinical rounds.  
 
D8. Anticipated coordination 
Inter-departmental faculty coordination will be facilitated by regular research meetings 
attended by Dr. Lindau (PI) and other Co-Investigators and key personnel. Faculty will also 
regularly communicate by email and phone calls as necessary. 
  
D9. Pregnancy test 
Not applicable. 
 
D10. Exclusion of women, minorities and/or children 
This study will not exclude women, minorities or children.  
 
D11. Drugs 
No drugs will be given to subjects as part of this study.

 
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innovation that connects clinics to communities. Health Aff (Millwood). 2016;35(11). 
PMID: 27834242 
24. Grey M, Knafl K, McCorkle R. A framework for the study of self- and family 
management of chronic conditions. Nurs Outlook. 2006 Oct;54(5):278–286. PMID: 
17027605 
 

 
16 
CommunityRx for Hunger (CRx-H) 
 
Study Protocol: Original Approved Version 
 
 
 
 
 
Principal Investigator: Stacy Tessler Lindau, MD, MAPP 
 
UCHICAGO IRB # 20-0324 
 
ClinicalTrials.Gov Identifier NCT: 04171999 
 
 
 
 
 
 
 
 
 
 
 
 
 
Version #10:  02/08/2022

 
17 
Table of Contents 
 
A. Introduction …………………………………………………………………………………18 
  A1 
Background………………………………………………………………………………18 
  A2 
Purpose…………………………………………………………………………………...18 
  A3 
Aim 1…………………………………………………………………………………….19 
  A4 
Aim 2…………………………………………………………………………………….19 
  A5 
Aim 3 ……………………………………………………………………………………19 
 
B. Study Design…………………………………………………………………………………19 
  B1 
Introduction………………………………………………………………………………19 
  B2 
CommunityRx-Hunger (CRX-H) Intervention…………………………………………..20 
  B3 
Duration………………………………………………………………………………….23 
  B4     Location…………………………………………………………………………………..23 
  B5 
Special Precautions………………………………………………………………………23 
  B6 
Use of SFTP Server……………………………………………………………………...24 
  B7 
Experimental controls and use of placebos………………………………………………24 
  B8 
Type and number of experimental subjects……………………………………………...25 
  B9 
Inclusion Criteria ………………………………………………………………………..25 
  B10 Exclusion Criteria………………………………………………………………………..25 
 
C. Statistical Plan……………………………………………………………………………….26 
 
D. Safety and Monitoring………………………………………………………………………26 
  D1 
Potential Risks and benefits……………………………………………………………...26 
  D2 
Monitoring of Safety……………………………………………………………………. 27 
  D3 
Payment…………………………………………………………………………………..27 
  D4 
Informed Consent……………………………………………………………………...…28 
  D5 
Child Assessment………………………………………………………………………...28 
  D6 
Confidentiality…………………………………………………………………………...29 
  D7 
Recruiting Methods………………………………………………………………………31 
  D8  Notification of physician…………………………………………………………………31 
  D9 
Anticipated coordination…………………………………………………………………32 
  D10 Pregnancy Test…………………………………………………………………………...32 
  D11 Exclusion of Women, Minorities, and/or Children………………………………………32 
  D12 Drugs……………………………………………………………………………………..32 
 
E. Bibliography…………………………………………………………………………………33

 
18 
 
A. Introduction 
A1. Background 
Food insecurity is a prevalent, modifiable and overlooked determinant of health and health 
disparities along socioeconomic and racial lines in the U.S.1-3 When a child becomes 
seriously injured or ill, the parent becomes a caregiver, responsible for managing the 
significant tasks of living and coping with a child’s illness while also managing self- and 
family care.4,5 Hunger due to food insecurity can compromise decision-making and 
communication. Food insecurity can cause shame about failing to meet an ill child’s basic 
needs and is stigmatizing.6-8 The higher burden of food insecurity among lower income 
caregivers is a potentially mutable factor that likely contributes to socioeconomic disparities 
in adult and child health; self-efficacy has been associated with both food insecurity9,10 and 
lower SES,11,12 and is emerging as a key factor on the causal pathway linking illness 
management and coping processes to caregiver and child health.13,5  
 
The Centers for Medicare & Medicaid Services (CMS), the American Academy of Pediatrics 
(AAP) and others are calling for healthcare-based screening and intervention to address food 
insecurity, endorsing growing evidence about deleterious effects on health and healthcare.14-
17 The AAP, with the Food Research & Action Center (FRAC), provides a web-based Toolkit 
to support adoption of food insecurity interventions in the clinical setting.18 Most caregivers 
and healthcare providers agree it is acceptable for providers to address food insecurity and 
other basic needs, yet physicians rarely do.19-22 Barriers include provider concerns about 
compromising satisfaction with care by causing feelings of stigma and lack of knowledge 
about community resources to address food insecurity and other health-related social needs 
(HRSNs).19,20  
 
The CommunityRx-Hunger (CRx-H) intervention, described in this program of research, is 
an adaptation of CommunityRx (CRx), a proven clinical solution that systematically matches 
people, using evidence-based algorithms, to nearby community resources for wellness, self-
care and caregiving.23 CRx-H targets two key management processes, identified in Grey and 
colleagues’ Self- and Family Management of Chronic Conditions Framework,24 that align 
both with the AAP/FRAC Toolkit recommendations18 and routine hospital discharge 
workflows. The current study aims to pretest the administration of the intervention and data 
collection protocols to inform the design of a larger randomized controlled trial.   
 
A2. Purpose  
This study aims to improve adult and child health by sensitively intervening to support food 
insecure caregivers with a hospitalized child. The target population is racially and ethnically 
diverse with a very high rate of food insecurity. The overall objective of the proposed 
program of research is to evaluate the health and healthcare impact of CommunityRx-Hunger 
(CRx-H), a scalable self- and family management intervention for food insecure caregivers 
of hospitalized children. The long-term goal of this research program is to promote public 
health and reduce health disparities due to socioeconomic disadvantage. 
 

 
19 
The over-arching aims of the program of research are: 
 
A3. Aim 1 
 
Among caregivers of hospitalized children who screen positive for food insecurity, evaluate 
the effects of CRx-H versus usual care on self-efficacy (primary outcome), severity of 
caregiver and child food insecurity, adult and child nutrition and health, and child healthcare 
utilization (secondary outcomes).  
 
A4. Aim 2 
 
Among all caregivers of hospitalized children (food insecure and food secure), evaluate the 
effects of CRx-H versus usual care on caregiver satisfaction with care (primary outcome), 
caregiver and child health and caregiver stigma during hospitalization (secondary outcomes).  
 
A4. Aim 3 
  
Assess food insecure caregivers’ perspectives about: (a) their experiences with and attitudes 
toward the CRx-H intervention, (b) the role of stigma as a barrier to self- and family 
management, and (c) how healthcare providers can sensitively and effectively intervene to 
support food insecure caregivers. This aim will inform implementation science for CRx-H 
and other healthcare-based interventions that address stigmatizing social conditions. 
 
Findings will yield an understanding of how best to leverage a child’s hospitalization or 
similar clinical encounter to sensitively and effectively intervene to support food insecure 
caregivers. Results will inform whether and how CRx-H should be implemented in practice. 
This research will inform science, policy and practice in the rapidly growing field of 
healthcare interventions to address food insecurity and other health-related social needs. 
 
The pretest of this study aims to identify optimal processes for administering the planned 
intervention and to optimize the efficiency and flow of baseline and follow-up survey 
administration and interval communications with participants. This pretest also aims to 
understand our feasibility to conduct participant recruitment, enrollment, intervention 
delivery and data collection remotely given the shifting healthcare landscape in the current 
COVID-19 pandemic. Findings from this pretest will be used to inform the larger 
randomized trial, which aims to improve adult and child health by sensitively intervening to 
support food insecure caregivers with a hospitalized child. 
 
B. Study Design 
B1. Introduction 
The first step in the proposed program of research is to pretest the double-blind, randomized 
controlled trial procedures and administration of the intervention and data collection 
procedures to inform the design of a larger randomized controlled trial (RCT). We will also 
test the feasibility of enrolling participants into a brief, qualitative survey at the end of their 
pretest participation. This interview will assess caregivers’ perspectives on the impact of 

 
20 
COVID-19 pandemic on their child’s health, caregiving and self-care and mimic the 
recruitment process used in the larger trial. Following completion of the pretest, we will 
implement a larger double-blind, randomized controlled trial using procedures described 
below.  
 
Interviewers will administer telephone-based surveys; self-administration of a web-based 
follow-up survey will also be offered. We will enroll 660 caregivers (both food secure and 
food insecure, 20 caregivers enrolled in the pretest and 640 caregivers enrolled in the larger 
RCT). We will also attempt to enroll the child patient insofar as to view and collect dates of 
specific doctor’s visits from their electronic medical record. All human subjects will be 
consecutively screened for inclusion and enrolled as described in Section P. Recruiting 
Methods. Following screening for eligibility (including food security status), consent and 
baseline survey collection, participants will be randomized to either usual care or usual care 
plus the CommunityRx-Hunger intervention using REDCap functionality. Once randomized, 
an electronic alert will be sent to the Clinical Trials Manager to assign an interventionist. The 
interventionist will contact the potential participant by phone or text to schedule a time to 
deliver the CommunityRx-Hunger intervention remotely via web-conferencing technology 
(e.g., Zoom, FaceTime) on their personal cell phone or an iPad or tablet. If an iPad or tablet 
is needed, researchers in the Lindau Laboratory will communicate with staff members in 
Child Life Services (CLS) to deliver iPads/tablets to the caregiver in the hospital, and 
provide a brief training on how to use the iPad/tablet and get connected to the web-based 
conferencing technology. Researchers in the Lindau Lab will also print a hard copy 
HealtheRx to networked printers in the CLS offices; Specialists will place this hard copy 
HealtheRx in the patient’s paper chart for delivery at discharge. Child Life Services sees 
every child in the hospital as part of their usual daily operations and provides iPads/tablets to 
patients for their use. A letter of support from Jennie Ott, MS, Director of Child Life 
Services, describing their engagement in this study, is enclosed with this protocol. Usual care 
is described below in Section G. Use of Controls or Placebos.    
 
B2. CommunityRx-Hunger (CRx-H) Intervention 
 
Caregivers will receive CRx-H in addition to usual care. The intervention will include: (a) a 
brief, structured educational intervention about the common non-medical needs of families 
after a child’s hospitalization, including the problem of food insecurity in households with 
children (e.g., “Many families with children find it hard to get enough healthy food. A child’s 
hospital stay can make it even harder.”) and co-occurring needs, like housing, legal and 
financial assistance, and transportation, (b) delivery and review of a HealtheRx for nearby, 
vetted resources to address these needs (SNAP/WIC enrollment, food support, services to 
meet other basic needs), and (c) coaching on how to activate community resources and the 
community resource navigator (a member of the research team), including a series of 
automated text messages.  
 
Upon discharge, to “boost” the intervention delivered earlier in the stay by a researcher, the 
discharging nurse will hand a copy of the printed HealtheRx with the other printed discharge 
information. Of note, the HealtheRx has been delivered by hundreds of UCM nurses during 
discharge encounters with tens of thousands of patients and parents/caregivers in the UCM 

 
21 
pediatric and adult emergency department settings during two prior CommunityRx trials 
(IRB13-0771 and IRB14-0358). We know from these prior studies that nursing involvement 
will not negatively impact nurses’ daily clinical workflows or nursing operations.   
 
Two nurse researchers (Emily Cheng and Katelyn DeAlmeida) will oversee the delivery of 
the booster and liaise with the Lindau Lab to track fidelity of booster delivery. Researchers in 
the Lindau Lab will generate and print the HealtheRx for Child Life Specialists who will 
place it in the same folder outside the patient room where the nurses pick up the other paper 
discharge materials. In addition to handing caregivers the printed HealtheRx, the nurse may 
remind parents/caregivers that they will receive a text message from the navigator and that 
they can contact the navigator for help with resources. Nurses handing out the HealtheRx 
will not be serving in a research role. Nursing staff routinely provide supportive community 
resource information to patients and families as a function of their routine clinical discharge 
activities, using a range of information delivery methods that are neither standard, systematic 
nor particularly personalized to resources in an individual’s community. When discharging 
patients whose parent/caregiver is enrolled in this study, the nurse will use the personalized 
HealtheRx as the mechanism for providing this information as a substitute for other 
strategies. Nurses will not be restricted in any way from sharing other information or using 
other modes of information delivery about supportive resources. Ms. Cheng and DeAlmeida 
have completed their Human Subjects training and will be added to the study protocol. A 
letter of support for this engagement from Emily Chase, PhD, RN (Senior VP, Patient Care 
Service and Chief Nursing Officer, UCM) is enclosed with this protocol.  
 
In addition to the printed HealtheRx discussed during intervention delivery, the HealtheRx 
will be texted and emailed to the participant within 24 hours of intervention delivery, and 
again upon discharge as a booster of the intervention.  
 
All caregivers randomized to the intervention will receive, in addition to the educational 
component and review of the HealtheRx, a series of proactive text messages to which the 
caregiver can reply “stop” at any time to prevent additional messages. The navigator will 
respond to text messages within 24 hours during regular work days and within 48 hours of 
weekends or holidays. The content of these messages is based on a text messaging 
experiment conducted during the CMMI HCIA CRx study; text message content will be 
submitted with this proposal for review.   
 
All caregivers enrolled in this study will receive text messages to support scheduling and 
reminders for follow-up surveys.  
 
All caregivers will complete the baseline survey during the child’s index hospitalization and 
follow-up surveys at the following intervals following the child’s discharge:  
 
7 days 
one month 
three months 
six months 
12 months  

 
22 
 
In between the six month and 12 month survey, we will send caregivers a “check-in” text 
message reminding them of their 12 month survey and confirming their contact information.  
 
Caregivers will be given the following options for completing the follow-up surveys: 
 
1) over the phone during one session,  
2) over the phone during multiple sessions 
  
3) using a web-based survey.  
 
Web-based surveys will be administered using REDCap.  
 
Surveys will elicit self-reported data in the following domains:  
 
caregiver sociodemographic characteristics (e.g., age, race/ethnicity, sex and gender, 
employment, household composition) 
 
health and healthcare characteristics (e.g., at both the caregiver and child level: health, 
severity of food insecurity, and nutrition; at the child level: healthcare utilization) 
 
knowledge, attitudes, beliefs and experiences (e.g., caregiver self-efficacy, satisfaction 
with care, healthcare-related stigma, knowledge of food and other related resource 
supports) 
 
resource use characteristics (e.g., use of food or other related resource supports, 
enrollment in SNAP/WIC, contact with Community Resource Navigator).  
 
Additionally, we will access, collect and analyze data from the child’s electronic medical 
record (EMR) for recruiting and other research purposes, including analysis of healthcare 
utilization data. The pretest will yield observations to optimize EMR chart abstraction 
processes. If needed to supplement healthcare utilization data, we will obtain health 
insurance claims for the child. The informed consent/assent process will inform study 
participants of the rationale for accessing these data and request participants’ permission to 
do so.   
 
Following completion of their last follow-up survey, a purposeful sample of participants will 
be invited to complete an in-depth qualitative interview. Caregivers will be informed about 
the purpose of the study and, if interested, undergo informed consent (described below in 
Section M. Informed Consent). The interview administered during pretest will elicit 
caregivers’ 1) perspectives on the impact of COVID-19 stay-at-home order on caregiving and 
self-care; 2) experiences with virtual or remote service delivery; and 3) comfort with web-
based technologies for communication. The interview administered following the larger RCT 
will elicit caregivers’ perspectives about: (a) their experiences with and attitudes toward the 
CRx-H intervention, (b) the role of stigma as a barrier to self- and family management, and 
(c) how healthcare providers can sensitively and effectively intervene to support food 
insecure caregivers.  

 
23 
 
To assess the dynamics of food security status over time, especially during a global 
pandemic, we are also going to evaluate food security scores and other screening data (e.g., 
parent and child patient age, ZIP code, dates of hospital admission and discharge, etc.) 
among all caregivers screened for inclusion (but perhaps not enrolled) in the study.  
 
B3. Duration 
The duration of this protocol is approximately four years. This will allow for ongoing 
recruitment of participants into the study and administration of baseline and all follow-up 
surveys and interviews. This timeframe also allows for data analysis and manuscript 
development and ongoing presentation of findings to our CommunityRx-Hunger Advisory 
Board for feedback.  
 
B4. Location 
Research under this protocol will be conducted by researchers in the Department of 
Obstetrics and Gynecology at the University of Chicago (located at 5841 S. Maryland Ave., 
Chicago, IL, 60637) and the Comer Children’s Hospital (located at 5721 S. Maryland Ave, 
Chicago, IL 60637). Additional research (e.g., data preparation and analyses) will be 
conducted in Dr. Stacy Lindau’s research laboratory, using networked computers located in 
the Medical Center 2050, rooms R-311 and R-315. 
 
B5. Special Precautions 
Protected health information (PHI) will be collected for research purposes and special 
precautions will be made to protect these data. We will identify new admissions to the 
children’s hospital or Day Treatment Rooms via the EMR, accessing the patient’s name, 
medical record number, certain dates (e.g., date of admission or appointment, anticipated 
date of discharge), caregiver name and contact information (often provided in the 
Demographics section of the EMR) and other, non-PHI information for recruitment of 
caregivers. In addition to the unique identifier applied by the REDCap computer assisted 
personal interviewing (CAPI) software, we will use caregiver’s name, telephone number and 
email address to facilitate scheduling and completion of the follow-up surveys. We will ask 
participants to provide us with an alternative contact (e.g., name, phone number, email 
address) that we can reach out to if we should lose contact with the enrolled caregiver. We 
will ask participants to tell this person that they have listed them as an alternative contact for 
this study. We will collect patient name and medical record number (MRN) in order to access 
the child’s EMR. From EMR data, we will abstract healthcare utilization data (e.g., doctor’s 
visits, hospitalizations, emergency department visits) and access the child’s health insurance 
payer and unique beneficiary identification to obtain their health insurance claims, if needed. 
Because we will compensate caregivers for their participation, we will use the caregiver’s 
email and mailing address for compensation payment purposes.    
 
Certain survey data elements collected in the REDCap database will be sent securely to 
Mosio, a secure text messaging platform, to facilitate the proactive text messaging 
protocol and manage survey scheduling and reminders for all participants and NowPow, a 

 
24 
systematic resource referral platform, to generate the HealtheRx for intervention 
participants. Elements of PHI sent to Mosio include the participant’s name, telephone 
number and certain dates (e.g., date of study enrollment, date of discharge). Elements of 
PHI sent to NowPow to generate a personalized HealtheRx include: participant name, 
participant home address, date of birth and other non-PHI data elements. Data will be 
securely transferred from REDCap to Mosio and NowPow through a custom secure 
integration created by the Center for Research Informatics. 
 
Qualitative interviews will be audio recorded and transcribed using AWS Transcribe by 
Amazon. AWS Transcribe has been reviewed by the University of Chicago Biological 
Sciences Division’s Information Security Office and approved for this use. Interviews will 
be de-identified upon transcription.  
 
Because PHI will be accessed and collected for this program of research, there is a risk of 
loss of confidentiality. To protect confidentiality, we will implement a plan to protect data in 
all its forms from improper use and disclosure using HIPAA compliant policies and 
procedures; see Section N. Procedures to Maintain Confidentiality for more information.  
 
B6. Use of SFTP Server 
 
NowPow will transfer files to the Lindau Lab by uploading them via Secure File Transfer 
Protocol (SFTP) to a dedicated location on a secure server; the files will then be retrieved by 
personnel in the Lindau Lab. All files will be end-to-end encrypted using a public RSA key 
generated by the Lindau Lab. 
 
The SFTP server is maintained by the Research Computing Group in the Department of 
Public Health Sciences (Ryan Carter, Systems Administrator). It is located in a secure server 
room within the Billings Hospital building. The room is a dedicated server room with raised 
floor, redundant cooling and appropriate power and fire suppression systems. Access to the 
room is controlled and monitored via keycard, and a video surveillance system is used to 
continuously monitor access from within. In addition to machines belonging to Public Health 
Sciences, the room also houses systems belonging to the fMRI Unit and the Cancer Center. 
Only systems administrators from these three groups have access. 
 
The SFTP server is located on a dedicated machine running only the SFTP service. All 
remote access to the SFTP server (both user and administrator access) requires key-based 
authentication (password authentication is disabled). The server is configured to place all 
users in their own “chrooted jail” upon login which strongly limits their access to a single 
root directory (i.e., the system can no longer reference paths outside that directory). In this 
case, this will be a dedicated directory created for use by NowPow and the Lindau Lab. 
Backups are encrypted and stored in a secure, physically separate location within the 
hospital. Backups are transferred to that location electronically. At no time are backups 
stored on portable media (e.g., tape or USB drives) or taken off-site. 
 
B7. Experimental controls and use of placebos  

 
25 
Caregivers in this study will be randomized to either usual care or usual care plus the 
CommunityRx-Hunger intervention. 
 
Caregivers randomized to usual care will receive information in the standard “Caregiver FYI 
Admissions Packet” from hospital admission staff about all available retail food options in 
the hospital and the self-serve food pantries operated by Feed1st. Due to the COVID-19 
pandemic, availability and information about food resources in and around the hospital is 
changing rapidly. We will continue to work closely with Comer staff to keep this information 
up to date and posted in various places. In addition to food resources, this packet includes 
information about visiting hours, parking, hospital amenities, safety restrictions, and 
patient/caregiver rights and responsibilities. The Feed1st pantries are listed as a food resource 
for families in need of “free, nutritious food items.” Signage in the Feed1st pantries include 
information for a Community Resource Navigator. Usual care also includes referral to social 
work according to the discretion of the healthcare team. Similarly, caregivers of patients 
seeking care in the Day Treatment Rooms will receive information about food resources 
around the hospital and have access to the Feed1st pantries and referral to social work as 
needed. 
 
B7. Type and number of experimental subjects 
Caregivers will be approached for enrollment using the methods described below in Section 
P. Recruiting Methods. All caregivers will be screened for inclusion by accessing the 
electronic medical record to identify new hospital admissions and patient ZIP code. 
Caregivers will be recruited for study participation within 72 hours of their child’s admission. 
We will enroll up to 660 caregivers (20 caregivers enrolled for pretesting and 640 caregivers 
enrolled in the full RCT), and, if possible, the hospitalized child. We will only enroll one 
caregiver per hospitalized child. If multiple caregivers identify as providing equal care to the 
child, we will randomly select one caregiver.  
 
B8. Inclusion criteria  
 
• Speaks either English or Spanish 
• Resides in the target ZIP code geography 
• Has access to a cell phone and provide the research interviewer with the cell phone 
number 
• Agrees to receive text messages from the study 
• Self-identifies as the primary caregiver of a child younger than 18 years of age admitted 
to Comer Children’s Hospital or for treatment in the Day Treatment Rooms.  
 
B9. Exclusion criteria 
 
• Minor caregivers who are not emancipated minors according to Illinois State law  
• Non-parental minor caregivers 
• Caregivers of hospitalized healthy newborns 
• Caregivers of children who are admitted for less than 24 hours 
• Caregivers of children hospitalized at that time with a diagnosis of disordered eating 

 
26 
 
C. Statistical Plan 
We will collect screening, baseline and follow-up survey data. To this end, descriptive 
statistics will be used to summarize, overall and by study arm, sociodemographic 
characteristics and primary and secondary outcomes at each measured time point. The mean, 
standard deviation, median, and inter-quartile range will be generated for continuous 
variables; frequency counts and percentages will be generated for categorical variables. We 
will evaluate the data for missingness, systematic item non-response, and out of range values 
and prepare our data management analytic code. The main analyses will follow the principle 
of intent-to-treat. Additional a priori quantitative analyses will be conducted as needed to 
answer the research questions. 
 
Qualitative interview data will be systematically collected and analyzed using directed 
content analysis.25 Directed content analysis uses findings from extant literature to ask 
pointed questions about the concept under study and to structure coding of the qualitative 
data. We will operationally define codes in a codebook prior to data analysis. Initial analysis 
will begin with a full read of the interview transcripts for, upon first impression, instances of 
textual data that align with the codes in the codebook. Actual coding of textual data will 
occur upon second pass of the transcripts, using the codebook. Any textual data that were 
identified in the first-pass read of the transcript but not coded using the codebook will be 
given a new code. Two experienced qualitative researchers, Dr. Jessica Jerome (who has 
completed Human Subjects training and will be added to the IRB protocol) and Emily 
Abramsohn, MPH, will use ATLAS.ti26 to independently code and analyze the qualitative 
data. After analysis of the first 5 interviews, using the principles of theoretical sampling,27 
both the sample strata and the interview guide will be evaluated and, if needed, revised to 
ensure compatibility with emerging theory about the self-management intervention. Drs. 
Lindau and Lowder, also experienced qualitative analysts, will read and code a sub-set of the 
transcripts and contribute their clinical expertise in interpretation of qualitative data. They 
will serve as adjudicators when consensus cannot be reached by the two primary coders. 
Based on our experience with several prior qualitative studies, interviews with 24 food 
insecure caregivers will be sufficient to reach theoretical saturation.28, 29  
 
 
D. Safety and Monitoring 
 
D1. Potential risks and benefits 
This program of research involves no more than minimal risk or no more risk than is 
encountered in routine medical and psychological examinations. The risks of participation in 
this protocol include a potential loss of confidentiality or psychological or emotional 
discomfort associated with the survey or interview questions. Every effort will be made to 
ensure subject confidentiality and that risks due to loss of confidentiality are minimal 
compared to the protocols in place to protect human subjects’ data. To date, more than 
113,000 individuals have participated in CommunityRx intervention studies with no known 
adverse events or breaches of confidentiality. All data collected from human subjects will be 

 
27 
collected using standard survey or abstraction procedures. The surveys will be conducted via 
telephone or with a web-based survey link. Psychological and/or emotional discomfort 
associated with the survey questions is possible. Subjects will be informed that they can 
decline to answer any question and can terminate the survey or interview at any time. 
Explanatory and debriefing statements will be included in the surveys and interviews to help 
the interviewer monitor and respond appropriately to discomfort, including termination of the 
survey or interview if necessary. Alternatives to participation include not participating in the 
research; participation is completely voluntary. Additional protections against these risks are 
described in Sections M and N, Informed Consent and Confidentiality, respectively. 
 
There is no direct benefit to human subjects involved in the research beyond the information 
provided during usual care and the CommunityRx-Hunger intervention. Participants, 
however, may gain personal satisfaction in contributing to research to address the 
humanitarian issue of food insecurity. Potential risks include a breach of confidentiality and 
are both minimal and reasonable in relation to the anticipated benefits to research participants 
and hospitalized children.  
 
D2. Monitoring of safety 
The proposed data collection presents no more than minimal risk or no more risk than is 
encountered in routine medical or psychological examinations. As described, no surveys will 
be conducted without explicit documentation of informed consent/assent and individuals will 
be provided with appropriate information about confidentiality when enrolling in the study 
and will indicate acceptance of these risks upon consent. Because we are not proposing a 
multi-site clinical trial, a Phase III trial, or a drug study, this study will not employ a Data 
and Safety Monitoring Board. Procedures are in place to ensure confidentiality and provide 
full informed consent as discussed below. 
 
The Lindau Lab has listed the Principal Investigator and study coordinator phone numbers on 
all study correspondence and forms. The purpose of the phone numbers is to provide 
respondents with a number to call if they have questions about any aspect of the study. 
During the study, should a subject express intent to harm themselves or others, we will 
contact a health or public safety professional. We will give only the subject’s name, contact 
information, and why we feel he or she is at risk of harming themselves or others. This report 
will not be linked to his or her survey information. Subjects have the right to refuse to speak 
to the mental health professional. If the interview procedure results in the observation or 
suspicion of elder or child abuse, all research personnel will act in compliance with Illinois 
State law in regards to mandatory reporting of abuse.  
 
Research staff will strictly adhere to the procedures for enrolling participants and collecting 
data as outlined by the investigators. At the conclusion of the study, all hard copy materials 
will be destroyed and electronic files will be deleted or archived in password-protected files. 
Informed consent document files will be stored for at least 6 years following the completion 
of the study (defined by the last publication related to the study). Due to the small sample 
sizes associated with the pretest, these data will not be made publicly available. 
 
D3. Payment 

 
28 
Caregivers enrolled in the pretest will receive $20 in compensation for completion of the 
baseline interview (approximately 25 minutes) and $25 in compensation for completion of 
each follow-up survey (approximately 30 minutes, administered at 7 days, one month, three 
months, six months and 12 months following hospital discharge). Caregivers will receive $50 
in compensation for their participation in the qualitative survey (approximately 45 minutes). 
Baseline interview compensation will be provided in the form of an e-gift card and emailed 
immediately to the participant. Compensation for follow-up surveys will either be emailed 
(e-gift cards) or mailed (physical gift cards), based on participant preference. Compensation 
will not be prorated for partial completion of the baseline and follow-up surveys but every 
effort will be made to allow for ample time to complete the surveys and participants can 
refuse to answer any question they do not want to answer. Participation is voluntary.  
 
D4. Informed Consent 
Because we plan to conduct recruitment and enrollment for the randomized controlled trial 
remotely, we will employ e-consent procedures, facilitated by REDCap. We will obtain 
informed consent as follows: 
 
Caregivers 18 years of age or older: We will obtain written informed consent via e-consent 
from all caregivers 18 years of age or older. Caregivers will provide their e-signature by 
typing their full name into a signature field. Caregivers will date the form and provide their 
e-signature to indicate their informed consent. 
 
Caregivers 17 years of age and younger: We will obtain written informed consent via e-
consent from all parental caregivers younger than age 18 who are eligible to consent for 
participation in research. Parental caregivers ages 17 years of age and younger will be 
eligible to participate if they are an emancipated minor under Illinois state law (750 ILCS 
30/5). A child of such a parental emancipated minor may assent to participate in the study 
with parental permission, as described further below. Non-parental caregivers ages 17 and 
younger in Illinois cannot have guardian or custodial status; these individuals will therefore 
not be eligible to participate.  
 
D5. Child assent 
 
Because we propose to access, view and analyze data from the hospitalized child’s electronic 
medical record and health insurance claims, we will obtain assent from a child between the 
ages of 7-17 who is the child of an enrolled caregiver. We are requesting a waiver of assent 
for children under 7 years of age and any children intubated or otherwise unable to provide 
assent. Inability to provide assent will be determined by the PI in conjunction with the 
treating physician. If and when a child between the ages of 7-17 regains assent capacity, 
assent will be obtained. Because this study poses no more than minimal risk, permission from 
only one parent may be required. We will attempt to obtain caregiver permission and child 
assent upon the caregiver’s initial e-consent to the research. However, if the caregiver needs 
additional time to consider their child’s participation, we will continue the discussion at each 
follow-up time point until the caregiver provides permission or refuses.  
 

 
29 
Research interviewers will guide caregivers through the informed consent document, 
providing statements to address: that the study involves research; the study’s purpose, 
duration, procedures followed, risks and benefits, alternatives to participation, and 
confidentiality of records; to whom they should direct questions or contact in case of 
research-related injury; and statements regarding voluntary participation, refusal to 
participate, and discontinuation of participation. The researcher will provide adequate time 
for the potential subject to ask questions, and the e-consent procedures ask additional 
questions to assess subject comprehension. Once all questions have been discussed and 
answered, the researcher will request that the caregiver electronically sign the consent form 
by typing their full name into the signature field and verify their identity by confirming their 
child’s date of birth. We will confirm child date of birth with the date that is recorded in the 
child’s EMR. The caregiver will receive an electronic copy of the signed consent form for 
their records. We will also document caregiver’s permission to approach and assent the child 
patient. If the parent should decide at a later time point that they do consent to their child’s 
participation, we will send them a link to a blank version of the IRB-approved informed 
consent form and ask that they sign the line under “Permission for my Child’s Participation.” 
We will not re-consent participants at this point because the consent process as it stands takes 
~15 minutes and repeating this process would be burdensome to the participant and not be 
necessary as we already have their consent for their own participation. Participants will 
receive a PDF copy of this form as an addendum to their existing consent form. The 
informed consent process will take place over the phone (either in the patients’ hospital room 
or by the caregiver’s personal phone) following recruitment. We are requesting a waiver of 
documentation of consent for participation in the qualitative interview, and will obtain verbal 
consent immediately before the interview. Similar to the process for consent for participation 
in the RCT, researchers will guide caregivers through an informed consent script and ask for 
their verbal consent before proceeding with the interview. A copy of the informed consent 
script will be emailed to the participant for their records. The informed consent document is 
enclosed in this submission for review.  
 
No surveys or interviews with human subjects will be conducted without explicit 
documentation of the informed consent process executed with each participant. Informed 
consent/assent documents will be iterated using approved consent documents from the 
recently completed CRx pragmatic clinic trial of patients (N=411) receiving care in the 
University of Chicago’s Primary Care Group and Emergency Departments. The consent 
documents for that study were adapted from consent documents developed in collaboration 
with a literacy consultant and members of the community. Consent documents will be written 
in easily understandable language and, in addition to English, be translated into Spanish. We 
have hired bilingual Research Assistants to enroll participants who speak Spanish or will 
make use of the hospital Language Line for interpretation and translation. Confirmation of 
consent will be collected and stored in REDCap for the RCT, or documented in REDCap for 
the interview, and only accessible to approved researchers to confirm participation in the 
study for data collection, validation, and data analysis purposes. A final copy of all 
consent/assent documents will be submitted to the IRB for review and approval. 
 
D6. Confidentiality 

 
30 
The proposed research with human subjects, as presented above, presents no more than 
minimal risk or no more risk than is encountered in routine psychological examinations. Any 
potential risks may be due to emotional or psychological discomfort associated with the 
surveys or a breach of confidentiality. As described in detail above, no surveys will be 
completed without explicit documentation of informed consent and individuals will be 
provided appropriate information about privacy and confidentiality when enrolling in the 
study and will indicate acceptance of these risks upon consent.  
 
The Lindau Laboratory has strict and secure procedures for protecting against and 
minimizing potential risks to human subjects’ data. All survey data will be entered directly 
into REDCap, a password-protected database managed by the Center for Research 
Informatics (CRI) at the University of Chicago (cri.uchicago.edu). CRI provides a HIPAA-
compliant data storage and computing environment that has achieved security accreditation 
by the Biological Sciences Division’s Risk Management Group. Data will be saved to the 
secure servers in the Department of Ob/Gym at the University of Chicago via a secure 
wireless connection on a secure, password-protected tablet, or research staff will enter 
REDCap data directly on Ob/Gym departmental computers using the secure, password-
protected Ob/Gym internet network. Data are backed up at the end of each collection day. 
Data will never be stored locally on tablets. Only approved research analysts in the Lindau 
Laboratory will have access to files that link participant’s PHI to their unique identifiers for 
the purposes of creating analytic datasets. 
 
REDCap will integrate electronically with the Mosio texting platform (www.mosio.com) to 
facilitate the text message protocol for human subjects in the intervention group and manage 
survey scheduling and reminders for all participants. To this end, REDCap will push the 
subject’s name, telephone number and date of discharge to Mosio. Mosio provides a secure 
messaging and data storage environment and has been approved for use by the University of 
Chicago Information Security Office. Only approved researchers in the Lindau Lab will have 
access to data stored by Mosio and will have the ability to securely download data directly to 
computers within the Ob/Gym network.  
 
REDCap will integrate electronically with NowPow (www.nowpow.com) to facilitate 
generation of the HealtheRx. Data will be pushed from REDCap to NowPow via a custom 
secure integration to create the participant’s profile in NowPow, including name, address, 
date of birth and other non-PHI data. Any data sent to NowPow from REDCap to generate 
the personalized HealtheRx will be assigned a secondary unique ID in order to prevent any 
connection to the subjects’ responses in REDCap. NowPow is seamless, secure and HIPAA-
compliant. Data are backed up automatically and encrypted in-transit, at-rest, and end-to-end. 
De-identified metadata will be transferred to researchers in the Lindau Laboratory using a 
secure file transfer protocol (SFTP); details described above. All devices used by researchers 
to collect or access research files will be encrypted. Only approved research analysts in the 
Lindau Laboratory will have access to files that link participant’s PHI to their unique 
identifiers for the purposes of creating analytic datasets. 
Any hard copies of project materials will be stored in locked file cabinets in locked offices at 
University of Chicago. Servers in the University of Chicago Department of Ob/Gym are 
protected through a combination of a Microsoft-based firewall technology and the physical 

 
31 
barrier of a Linksys router that is installed between the server and its internet connection. 
Laptop computers used to collect data will be encrypted and password protected. All data 
transmitted to secure servers will be encrypted. Analytic files will be de-identified prior to 
analysis or limited to the minimum amount of data necessary to accomplish the intended 
research purposes per the HIPAA Privacy Rule. Any analytic datasets will limit the use or 
disclosure of PHI to the minimum necessary, if any at all, to accomplish the intended 
research purposes. Only IRB-approved researchers on this protocol will have access to the 
data. These controls meet or exceed the strictness of practices legislated and enforced by the 
University of Chicago Biological Sciences Division and hospitals for protected health 
information. 
 
Procedures are in place to ensure confidentiality and provide informed consent as discussed 
above. Numeric coding of surveys/interviews and secure containment of files that link 
participant’s responses from PHI will also minimize this risk. Finally, the Lindau Laboratory 
will provide a contact phone number that will be included on all study correspondence and 
forms. The purpose of this phone number is to provide respondents with a single number to 
call if they have questions about any aspect of the study. 
 
D7. Recruiting methods 
Researchers in the Lindau Laboratory will access electronic medical record (EMR) 
registration data to identify potential caregivers of newly admitted pediatric patients and 
patients seeking care in the Day Treatment Rooms for inclusion in based on ZIP code and 
anticipated discharge date. Research assistants will contact potentially eligible caregivers by 
1) identifying the hospital room number for the pediatric patient and calling the bedside 
phone; 2) identifying the caregiver listed in the Demographics section of the EMR and 
sending a text message to the phone number listed; and 3) calling the phone number listed for 
the caregiver listed in the Demographics section of the EMR. Research interviewers will 
explain that the caregiver may be eligible for a research study and, if interested, further 
screen for eligibility. Recruitment scripts for the various modes of contact have been 
submitted for review with this protocol. If eligible, researchers will guide participants 
through the informed consent process as described in Section M. Informed Consent.  
 
Once their participation in the RCT is complete, certain caregivers will be approached for 
inclusion in a qualitative interview. Researchers will contact caregivers by email, text 
message and phone. Research interviewers will explain that the caregiver may be eligible for 
a research study and, if interested, further screen for eligibility. Recruitment scripts for the 
various modes of contact have been submitted for review with this protocol. If eligible, 
researchers will guide participants through the informed consent process as described in 
Section M. Informed Consent.   
 
D8. Notification of physician 
Notification of the hospitalized child’s treating physician for permission to enroll will occur 
using a multi-pronged approach. First, we will educate all treating physicians and residents 
working in the target units about the study during the pretesting phase and give treating 
physicians the opportunity to opt out of study participation. Secondly, we will use these 

 
32 
education sessions to identify how treating physicians wish to be contacted for permission 
(e.g., via text, email, phone, text page or through the electronic medical record system). We 
will use that communication as documentation of treating physician permission. Lastly, we 
will also educate nursing staff about the study. Nurse engagement will be helpful should we 
need to reach a treating physician during clinical rounds.  
 
D9. Anticipated coordination 
Inter-departmental faculty coordination will be facilitated by regular research meetings 
attended by Dr. Lindau (PI) and other Co-Investigators and key personnel. Faculty will also 
regularly communicate by email and phone calls as necessary.  
 
D10. Pregnancy test 
Not applicable. 
 
D11. Exclusion of women, minorities and/or children 
This study will not exclude women, minorities or children.  
 
D12. Drugs 
No drugs will be given to subjects as part of this study.  
 
 
 
 

 
33 
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3. Gundersen C, Ziliak JP. Food insecurity and health outcomes. Health Aff (Millwood). 
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4. Gibson MJ, Kelly KA, Kaplan AK. Family Caregiving and Transitional Care: A Critical 
Review. Family Caregiver Alliance, National Center on Caregiving; 2012.  
5. Grey M, Schulman-Green D, Knafl K, Reynolds NR. A revised Self- and Family 
Management Framework. Nurs Outlook. 2015 Mar;63(2):162–70. PMID: 25771190 
6. Bruce JS, De La Cruz MM, Moreno G, Chamberlain LJ. Lunch at the library: examination 
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embarrassment in the UK. Sociology. 2016 Dec;50(6):1072–1088.  
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14. Alley DE, Asomugha CN, Conway PH, Sanghavi DM. Accountable Health Communities 
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social needs in clinical settings: The Accountable Health Communities screening tool. 
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Social-Needs-in-Clinical-Settings.pdf 
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Screening and Referral for Older Patients in Primary Care: A Resource Guide and Toolkit 
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Food Research & Action Center; 2017 Feb. Available from: http://frac.org/aaptoolkit 
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25. Hsieh H-F, Shannon SE. Three Approaches to Qualitative Content Analysis. Qual Health 
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10.1056/NEJMra1510063 
 
 
 

 
36 
Summary of major changes to the CommunityRx-Hunger RCT protocol, by research 
component 
 
Per the recommendation of The University of Chicago’s Institutional Review Board, V1 of this 
study’s protocol, approved 2/11/2019, included only the study’s pre-test protocol. Following 
completion of the pre-test, again per the IRB’s recommendation, V1 was amended for the full 
trial (approved 11/3/2020). The majority of differences between V1 and V10 presented above 
include: a) planned differences between the pre-test protocol and full trial protocol (e.g., sample 
size, number of follow-up surveys) and b) revisions to allow remote enrollment of participants 
and remote administration of the intervention (conducted in person in the pre-test protocol) due 
to restrictions related to the COVID-19 pandemic. All changes were approved by the 
Institutional Review Board. 
 
Other major changes made following approval of the full trial protocol include:  
  
February 2021 three changes were made to accelerate the enrollment rate to compensate for 
COVID-19 pandemic-related delays in the trial launch: 
• Expansion of ZIP code elgibility criteria  
• Increase in baseline compensation to $20  
• Updates to recruitment scripting and text messages 
 
 
March 2021: 
• Expansion of eligibility criteria to include caregivers of children hospitalized >30 days  
in the Neonatal Intensive Care Unit (a high need population, especially during the 
COVID-19 pandemic) to improve study generalizability  
• Revision of procedures to obtain parental consent for access to their child’s medical 
record data to allow this consent to occur after study enrollment (e.g., at a follow-up 
survey) when rapport was better established with participants 
 
 
 
 

 
37