Improving Health Insurance Literacy Among Utah's Hispanic Population
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Sponsor: University of Utah

Clinical Development 
Clinical Trial Protocol ID:  IRB_00138483  
IMPROVING HEALTH INSURANCE LITERACY AMONG UTAH’S HISPANIC 
COMMUNITY 
Principal or Coordinating Investigator: Anne Kirchhoff 
Site Name 
Investigator 
Staff Name(s) 
University of Utah/Huntsman Cancer 
Institute 
Anne Kirchhoff 
Heydon Kaddas 
 
Austin Waters 
Perla Vaca Lopez 
Judy Ou 
Karely van Thiel Berghuijs 
Site Name 
Investigator 
Staff Name(s) 
Utah Health Policy Project 
Anne Kirchhoff 
Heydon Kaddas 
Austin Waters 
Perla Vaca Lopez 
Judy Ou 
Karely van Thiel Berghuijs 
 
 
 
Document type: Draft Protocol Summary 
Version number: v3 
Release date: 10.4.23 
 
 
 

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Table of Contents 
Clinical Development ....................................................................................................... 1 
Protocol Synopsis ............................................................................................................ 3 
Amendments ..................................................................................................................... 6 
1. Background and Introduction ..................................................................................... 7 
2. Purpose and Objectives .............................................................................................. 8 
3. Study Population .......................................................................................................... 9 
3.1 Inclusion Criteria: ................................................................................................................ 9 
3.2 Exclusion Criteria: .............................................................................................................. 9 
4. Study design ............................................................................................................... 10 
5. Study Procedures ....................................................................................................... 10 
5.1 Recruitment/Participant Identification Process ............................................................ 10 
5.1.1 Enrollment Goals ...................................................................................................................... 10 
5.1.2. Process ..................................................................................................................................... 10 
5.2 Informed Consent ............................................................................................................. 11 
5.3 Study duration ................................................................................................................... 11 
5.4 Randomization .................................................................................................................. 11 
5.5 Procedures ......................................................................................................................... 11 
6. Data Collection ........................................................................................................... 11 
7. Risks and Benefits ..................................................................................................... 12 
8. Cost and Compensation ............................................................................................ 13 
9. Statistical Methods, Data Analysis and Interpretation .......................................... 13 
9.1  Aim 2 .................................................................................................................................. 14 
9.2 Aim 3 ................................................................................................................................... 15 
References ...................................................................................................................... 14 
 
 
 
 
 
 

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Protocol Synopsis 
Protocol number 
 00138483 
Title 
IMPROVING HEALTH INSURANCE LITERACY 
AMONG UTAH’S HISPANIC COMMUNITY  
 
Sponsor and Clinical 
Phase 
The National Center for Advancing Translational 
Sciences of the National Institutes of Health, Award 
Number(s) UL1TR002538 
Study type  
Primary Objective(s)  
We wconducted with the purpose of gaining feedback 
on an existing health insurance education program 
(HIEP), originally created for young adult cancer 
patients. We will do this by the following study aims: 
Aim 2. Pilot test the HIEP with Hispanic community 
members to further refine the intervention and 
evaluate its efficacy.   
Study design 
Non-Experimental and/or Descriptive Research 
Design 
• Survey/Questionaire Research  
Experimental and/or Interventional Research 
Design 
• Prospective social/ Behavioral Intervention or 
Experiment 
Population 
Hispanic community members 
Inclusion criteria 
 -18-64 years of age 
-Self-identify as Hispanic 
-Speak English and or Spanish 
-Resident of Utah 
-Primary policyholder 
-Recently enrolled in any kind of health insurance within 
the past year 
  
Exclusion criteria 
- Younger than 18 years of age 
Hispanic Community Members: 
- Not Hispanic of Latinx in origin 
Key Informants: 
- Work for an organization that does not serve the 
Hispanic or Latinx community 

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Data analysis 
Analysis of the pre-post health literacy survey 
results: McNemar’s tests will identify significant 
changes in the percent of questions answered correctly. 
We will utilize logistic regression models with 
generalized estimating equations to calculate the odds 
of improvement in health insurance literacy while 
accounting for within-person clustering. Models will 
control for acculturation and/or preferred language, 
current insurance status, sex, and age. We will stratify 
models to obtain group-specific effect estimates by 
current insurance status, sex, 10-year age groups, and 
employment status. 
 
 
 
 
 

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Amendment 4  
The amendment was necessary to remove personnel off the IRB who were no longer 
part of the team. The following sections reflected this change:  
1.Contact and title - Study introduction 
2. Study Location and Sponsors 
3. Study information - consent process 
4. Resources and Responsibilities 
Amendment 3 
We submitted the translated (Spanish) version of approved documents: this includes 
submitting the consent, baseline, follow up survey, and outline of the education pilot 
program. We also added new study personnel. The following sections reflect this 
change  
1. Documents and attachments 
2. Section 2: Study Location & Sponsors  
Amendment 2  
Amendment 2 was necessary because we needed to add new study personnel. We 
also needed to change the inclusion criteria to be more specific to our target population 
for aim 2 and to increase recruitment efforts, we also included social media as a form of 
recruitment. The consent form also needed to be submitted for this aim. For quality 
purposed, we decided to also include for the pilot sessions to be recorded. Participate 
compensation for aim 2 was decreased. Funding for the project ended and we needed 
to remove the sponsor from the study. We also increased the timeframe of the study 
since more time is needed to complete the study. The following sections reflect this 
change: 
1. Study location and sponsors (Section 1, section 3) 
2. Participants (section 5) 
3. Study information (section 3, section 4a, section 4b, and section 6) 
4. Consent process (Section 1) 
5. Risk and Benefits (Section 4a and section 4c) 
6. Data Monitoring Plan (Section 5) 
7. Resources & Responsibilities (Section 1) 
8. Documents and Attachments 
Amendment 1  
Translation of approved study documents needed to be submitted since a substantial 
portion of participants will be Spanish speaking. 

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1. Study information - Consent Process, Documents and attachments. 
 
 
 
 
 
 

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1. Background and Introduction  
The 2010 Patient Protection and Affordable Care Act (ACA) increased health insurance 
coverage nationally by providing subsidies to lower insurance costs and expanding 
Medicaid. Through the ACA, funding was earmarked for health insurance navigators at 
community organizations to assist uninsured individuals in enrolling for coverage 
through the Health Insurance Marketplaces and Medicaid. In Utah, the Utah Health 
Policy Project (UHPP) is a trusted community resource, focused on advancing 
sustainable health care solutions for underserved Utahns through better access, 
education, and public policy. UHPP frequently works with the Hispanic community, who 
comprise 80% of the clients they serve.  UHPP enrollment efforts have been stymied in 
recent years due to federal budget cuts that defunded health insurance navigators and 
the lack of state resources available to replenish cuts to the health insurance navigator 
program. 
The goal of our CCTS project is to create materials to improve health insurance literacy 
for UHPP’s Hispanic clients. Health insurance literacy is one’s ability to make informed 
decisions about choosing and using health insurance. By providing Hispanic community 
members with resources to improve their understanding of insurance, this effort can 
help to address the gaps in navigation services and allow them to make informed 
decisions about selecting and using their insurance coverage. In this grant, we will 
adapt materials for Hispanic community members from Dr. Kirchhoff’s existing health 
insurance literacy program that was designed for cancer patients (NCI R01 
(1R01CA242729). The content of the current literacy program includes information on 
insurance types (e.g., public vs. private), information on insurance cost sharing 
mechanisms (e.g., deductibles), an overview of health insurance laws including the 
ACA, and cost reduction strategies (e.g., understanding in- vs. out-of-network 
providers). However, the current program was not designed for a general population 
audience nor considering the cultural or linguistic needs of the Hispanic 
community. Thus, during the CCTS grant, we will adapt and pilot test the revised 
program with Hispanic community members recruited by the UHPP. 
 
 

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2. Purpose and Objectives 
The purpose of this study is to adapt a health insurance education program to the 
Hispanic/Latinx population Utah’s population. 
Aim 2. Pilot test the HIEP with Hispanic community members to further refine the 
intervention and evaluate its efficacy. We will then refine the intervention by pilot 
testing the adapted intervention with Hispanic community members (n=10-15) recruited 
by UHPP. Pilot testing of the HIEP will be conducted to identify acceptability of content 
and potential implementation issue areas, as well as any discordance in cultural values, 
beliefs, or feelings about health insurance. 
 
 

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3. Study Population 
Age of Participants: 18-64 years old 
Sample Size: All Centers: 75 
 
3.1 Inclusion Criteria: 
-18-64 years of age 
-Self-identify as Hispanic 
-Speak English and or Spanish 
-Resident of Utah 
-Primary policyholder 
-Recently enrolled in any kind of health insurance within the past year 
 
3.2 Exclusion Criteria: 
- Younger than 18 years of age 
Hispanic Community Members: 
- Not Hispanic of Latinx in origin 
 
 
 

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4. Study design  
Non-Experimental and/or Descriptive Research Design: 
• Survey/Questionnaire Research  
Experimental and/or Interventional Research Design: 
• Prospective social/behavioral intervention or experiment  
5. Study Procedures 
5.1 Recruitment/Participant Identification Process 
5.1.1 Enrollment Goals 
Aim 2. Pilot test the HIEP with Hispanic community members to 
further refine the intervention and evaluate its efficacy.  
• Hispanic community members (n=10-15)  
 
5.1.2. Process 
o Prior to the beginning of recruitment for the interviews with Hispanic 
community members, the Kirchhoff Team and UHPP staff will work 
together to develop a culturally tailored survey in English and Spanish 
(which will be submitted for approval via an amendment). All documents 
will be translated from English to Spanish and submitted for IRB approval 
prior to recruitment of any participants. Participants will be identified 
through the recruitment methods outlined above.  
Aim 2 
o Once the intervention is adapted we will again work with UHPP to recruit 
additional new Hispanic community members to pilot test the intervention. 
Pilot testing will be conducted primarily by UHPP staff. Prior to the start of 
the pilot test, participants will be asked to consent using a consent cover 
letter. The pilot session will be recorded through Zoom or audio recorded 
with team recorders for fidelity purposes. Pilot testing will include a short 
pre-post survey to assess change in health insurance literacy. The post 
survey may also include a short audio recorded interview about the 
intervention and areas of improvement. Pilot activities will primarily be 
conducted by UHPP staff but may be conducted a member of the 
Kirchhoff team. 
o Further refinement of the intervention materials and statistical analyses 
will be conducted by the Kirchhoff Team, again contextualized by UHPP. 
o Feedback on the results of each phase of the study will be elicited from 
UHPP staff. The Kirchhoff team will then lead manuscript writing for each 
aspect of the study with assistance from UHPP. All members of the 
UHPP team mentioned above have been trained in Human Subjects 

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Research jointly by CCTS and the IRB and are present on this 
application. 
 
5.2 Informed Consent 
Location(s) where consent will be obtained: 
Utah Health Policy Project  
Out in the community  
Over the phone 
Online  
 
Description of the consent process(es), including the timing of consent: Study 
staff/UHPP staff/CCTS staff will reach out to referred participants to gauge 
interest in the study an obtain consent. There is no minimum amount of time 
between digital approach and consent as this study is quite minimal risk. 
Potential participants will be given as much or as little time to decide if they would 
like to participate as they would like. Study staff will be available throughout to 
answer any questions. The voluntary nature of research studies will be stressed 
when potential participants are approached. Participants will be informed prior to 
the start of the interview/engagement studio/pilot test that they may stop at any 
time and have the right not to answer any question. Potential participants will be 
allowed to schedule their interview/pilot test whenever they find appropriate and 
will be encouraged to ask questions to the study coordinator, before the 
interview/pilot testing is conducted. 
 
5.3 Study duration 
o Study duration will be approximately 3 years  
 
5.5 Procedures 
o Prior to the beginning of recruitment for the interviews with Hispanic 
community members, the Kirchhoff Team and UHPP staff will work 
together to develop a culturally tailored survey and interview script in 
English and Spanish (which will be submitted for approval via an 
amendment). All documents will be translated from English to Spanish 
and submitted for IRB approval prior to recruitment of any participants. 
o Participants will be identified through the recruitment methods outlined 
above. Qualitative interviews and studio sessions will be conducted with 
the purpose of gaining feedback on an existing health insurance 
education program (HIEP), originally created for young adult cancer 
patients in the HIAYA CHAT Study. 

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Aim 2 
o Once the intervention is adapted we will again work with UHPP to recruit 
additional new Hispanic community members to pilot test the intervention. 
Pilot testing will be conducted primarily by UHPP staff. Prior to the start of 
the pilot test, participants will be asked to consent using a consent cover 
letter. The pilot session will be recorded through Zoom or audio recorded 
with team recorders for fidelity purposes. Pilot testing will include a short 
pre-post survey to assess change in health insurance literacy. The post 
survey may also include a short audio recorded interview about the 
intervention and areas of improvement. Pilot activities will primarily be 
conducted by UHPP staff but may be conducted a member of the 
Kirchhoff team. 
o Further refinement of the intervention materials and statistical analyses 
will be conducted by the Kirchhoff Team, again contextualized by UHPP. 
o Feedback on the results of each phase of the study will be elicited from 
UHPP staff. The Kirchhoff team will then lead manuscript writing for each 
aspect of the study with assistance from UHPP. All members of the 
UHPP team mentioned above have been trained in Human Subjects 
Research jointly by CCTS and the IRB and are present on this 
application. 
6. Data Collection 
The team will use the Research Electronic Data Capture (REDCap) software 
application to collect and manage the data for this project. The REDCap 
database is on a secure server maintained by the Huntsman Cancer Institute 
(HCI) bioinformatics shared resource and the HCI Computer and Technology 
Group (CATG). 
 
Voice recordings will be stored securely on the Kirchhoff Team drive at 
Huntsman Cancer Institute or on password protected computers at HCI. 
 
7. Risks and Benefits 
o The potential risks to participants are minimal. Participants may feel slight 
psychological distress when answering questions about health insurance and 
cost concerns. 
o There is also a risk of breach of confidentiality of the participants. 
o No direct benefit. From the societal perspective though, the benefits include 
improved knowledge about the Hispanic perceptions of health insurance. 

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8. Cost and Compensation 
• There is no cost to be in this study  
▪ 
There will be gift card compensation available for participants,  
o Pilot testing pre and post surveys: $40 
9. Statistical Methods, Data Analysis and Interpretation 
Further refinement of the intervention materials and statistical analyses will be 
conducted by the Kirchhoff Team, again contextualized by UHPP. 
Feedback on the results of each phase of the study will be elicited from UHPP staff. The 
Kirchhoff team will then lead manuscript writing for each aspect of the study with 
assistance from UHPP. All members of the UHPP team mentioned above have been 
trained in Human Subjects Research jointly by CCTS and the IRB and are present on 
this application. 
Analysis of the pre-post health literacy survey results: McNemar’s tests will identify 
significant changes in the percent of questions answered correctly before and after 
intervention. We examine differences in Health Insurance Literacy Measure before and 
after intervention. We will stratify this variable by age and language spoken.  
 
 
 
 
 
 
 
 
 
 
 
 
 

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References 
 
1. Noe-Bustamante L, Lopez MH, Krogstad JM. U.S. Hispanic population surpassed 60 million in 
2019, but growth has slowed. Pew Research Center;2020. 
2. 
Kem C. Gardner Policy Institute. U.S. Census Bureau Estimates for Race and Hispanic Origin, 
Vintage 2019. University of Utah David Eccles School of Business Kem C. Gardner Policy 
Institute;2020. 
3. 
Aragones A, Hayes SL, Chen MH, González J, Gany FM. Characterization of the Hispanic or 
latino population in health research: a systematic review. Journal of immigrant and minority 
health. 2014;16(3):429-439. 
4. 
Foundation KF. Uninsured Rates for the Nonelderly by Race/Ethnicity. 2019; 
https://www.kff.org/uninsured/state-indicator/nonelderly-uninsured-rate-by-
raceethnicity/?currentTimeframe=0&sortModel=%7B%22colId%22:%22Black%22,%22sort%22
:%22desc%22%7D. Accessed 11/11/2020. 
5. 
Obama B. United States Health Care Reform: Progress to Date and Next Steps. JAMA : the 
journal of the American Medical Association. 2016;316(5):525-532. 
6. 
French MT, Homer J, Gumus G, Hickling L. Key Provisions of the Patient Protection and 
Affordable Care Act (ACA): A Systematic Review and Presentation of Early Research Findings. 
Health services research. 2016;51(5):1735-1771. 
7. 
Courtemanche C, Marton J, Ukert B, Yelowitz A, Zapata D. Early Impacts of the Affordable Care 
Act on Health Insurance Coverage in Medicaid Expansion and Non-Expansion States. Journal of 
Policy Analysis and Management. 2017;36(1):178-210. 
8. 
Clemans-Cope L, Long SK, Coughlin TA, Yemane A, Resnick D. The Expansion of Medicaid 
Coverage under the ACA: Implications for Health Care Access, Use, and Spending for 
Vulnerable Low-income Adults. Inquiry. 2013;50(2):135-149. 
9. 
Buchmueller TC, Levy HG. The ACA’s Impact On Racial And Ethnic Disparities In Health 
Insurance Coverage And Access To Care. Health Affairs. 2020;39(3):395-402. 
10. 
Pollitz K, Tolbert J. Data Note: Limited Navigator Funding for Federal Marketplace States. 
Kaiser Family Foundation;2020. 
11. 
Pérez-Escamilla R, Garcia J, Song D. HEALTH CARE ACCESS AMONG HISPANIC 
IMMIGRANTS: ¿ALGUIEN ESTÁ ESCUCHANDO? [IS ANYBODY LISTENING?]. NAPA 
Bull. 2010;34(1):47-67. 
12. 
States NRCUPoHitU. Access to and Quality of Health Care. In: Tienda M, Mitchell F, eds. 
Hispanics and the Future of America. Vol 10. Washington DC: National Academies of Press; 
2006. 
13. 
Ghaddar S, Byun J, Krishnaswami J. Health insurance literacy and awareness of the Affordable 
Care Act in a vulnerable Hispanic population. Patient Education and Counseling. 
2018;101(12):2233-2240. 
14. 
Krogstad JM, Gonzalez-Barrera A, Noe-Bustamante L. U.S. Latinos among hardest hit by pay 
cuts, job losses due to coronavirus. Online: Pew Research Center;2020. 
15. 
Hofstede G. Culture's consequences: Comparing values, behaviors, institutions and 
organizations across nations. Vol 2nd. Thousand Oaks, CA: Sage; 2001. 
16. 
Hall ET. Beyond culture. Garden City, NY: Anchor Press; 1976. 
17. 
Paez KA, Mallery CJ, Noel H, et al. Development of the Health Insurance Literacy Measure 
(HILM): conceptualizing and measuring consumer ability to choose and use private health 
insurance. Journal of health communication. 2014;19 Suppl 2:225-239. 
18. 
Marin G, Sabogal F, Marin BV, Otero-Sabogal R, Perez-Stable EJ. Development of a Short 
Acculturation Scale for Hispanics. Hispanic Journal of Behavioral Sciences. 1987;9(2):183-205. 
19. 
Wu YP, Thompson D, Aroian KJ, McQuaid EL, Deatrick JA. Commentary: Writing and 
Evaluating Qualitative Research Reports. Journal of pediatric psychology. 2016;41(5):493-505. 

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Protocol Version 03 
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20. 
Elo S, Kyngas H. The qualitative content analysis process. Journal of advanced nursing. 
2008;62(1):107-115. 
21. 
Saldana J. The Coding Manual for Qualitative Researchers. London, UK: Sage Publishing; 2013.