Health Literacy Training for Improved Health Care Utilization

Recruiting at 1 trial location

Overseen By Sarah Hiller-Venegas

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Victoria D. Ojeda

Disqualifiers: Under 18, Not San Diego resident, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 18

Duration: 12 weeks

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best way to teach health literacy to adults involved with the justice system in the past three years. It compares two approaches: one where participants work with a health coach and service navigator, and another where they use self-study materials (the "Self-study" approach) and a service report to independently access resources. The trial examines whether these methods improve access to healthcare and health insurance coverage over the long term. It suits English-speaking residents of San Diego County who have been on parole, probation, or court-diverted and have access to a cell phone. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance health literacy and access to care for justice-involved individuals.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems unlikely that you would need to stop, as the study focuses on health literacy and not on medication effects.

What prior data suggests that these health literacy teaching methods are safe for Justice Involved Adults?

Previous studies have found that programs teaching health literacy are safe and well-received by participants. This trial aims to teach health literacy to Justice Involved Adults (JIA) using two methods: sessions with a coach and self-study. Both methods involve learning about health services over 12 weeks.

Because this program does not involve medication or medical procedures, it carries very low risk. Participants either meet with health coaches or use online resources to better understand healthcare, avoiding side effects common in drug trials. Overall, participants have responded positively to similar educational programs, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to boost health literacy and improve healthcare utilization. Unlike traditional methods that often rely on passive information delivery, this trial includes two distinct approaches: a Coach-guided program and a Self-study program. The Coach-guided approach offers personalized support with a health coach and a service navigator, providing tailored guidance and assistance, which is uncommon in current options. On the other hand, the Self-study approach empowers individuals to independently access resources, offering flexibility and convenience. These methods could potentially transform how people engage with healthcare, leading to better health outcomes and more efficient use of services.

What evidence suggests that these health literacy interventions could improve healthcare access and utilization for Justice Involved Adults?

Research has shown that improving health literacy can help people access and use healthcare services more effectively. Previous studies have demonstrated that health literacy programs successfully teach people, especially those with limited resources, how to navigate the healthcare system. This trial will compare two approaches: the Coach-guided arm, where participants receive in-person or phone guidance from a Health Coach and Service Navigator, and the Self-study arm, where participants use self-guided materials and a comprehensive Service Navigation report. Early results suggest that Justice Involved Adults (JIA) who receive guidance or use self-study materials can learn to use health services better. This approach may also lead to better health insurance coverage and long-term use of healthcare. Evidence supports that both guided help and self-study methods can effectively teach health literacy to this group. ^{1 2 3 4 5}

Who Is on the Research Team?

Victoria Ojeda, PhD, MPH

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 living in San Diego County who have been involved with the justice system within the last three years (on parole, probation, or court-diverted) and are not currently incarcerated. Participants must understand English, have access to a cell phone, and be willing to follow study procedures.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

Not incarcerated at time of enrollment

Justice involved in the past 3 years (on parole, probation, court diverted)

Exclusion Criteria

Cannot provide informed consent

Incarcerated at enrollment

Adults who have current or prior convictions related to sexual violence/abuse (Penal Code [PC] 290), lewd acts with a child (PC 288), child abduction (PC 280), or arson (PC 451)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in either a coach-guided health literacy intervention or a self-study design over 12 weeks

12 weeks

12 sessions (in-person or phone call) for coach-guided group; self-study for control group

Follow-up

Participants complete surveys to assess healthcare access and use, health insurance coverage, and regular source of care

6 months

Surveys at 6 months and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Self-study
• UCSD RELINK

Trial Overview The UCSD RELINK study is testing whether coach-guided health literacy sessions or self-study methods can improve healthcare access and insurance coverage among Justice Involved Adults. It involves meeting with a coach or completing online training over 12 weeks and filling out surveys at different times.

How Is the Trial Designed?

Group I: Coach-guided Experimental Treatment 1 Intervention

In person or phone call with an assigned Health Coach for about 1 hour per week for 12 weeks to complete the Health Literacy course, and with an assigned Service Navigator for 30 minutes per week for 12 weeks to address health and social service needs.

Group II: Self study Active Control 1 Intervention

Self-guided printed or online version of the Health Literacy course (approximately 1 hour per week for 12 weeks) and comprehensive Service Navigation report with recommended referrals to services, providers, and contact information for service providers so that the participant can access these resources independently (i.e., without Navigator assistance).

Who Is Running the Clinical Trial?

Victoria D. Ojeda

Lead Sponsor

Trials

1

Recruited

300+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

In a study of 112 Medicaid patients discharged from a hospital, health literacy levels varied significantly, with 54% scoring at a high-school grade level on a health literacy test, but this did not correlate with higher rates of emergency visits or readmissions within 90 days post-discharge.

Factors such as being younger, female, or living with children were associated with better health literacy, but overall, health literacy was not linked to adverse healthcare outcomes, suggesting that other factors, like race, may play a more critical role in post-discharge care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postdischarge Correlates of Health Literacy Among Medicaid Inpatients. Copeland, LA., Zeber, JE., Thibodeaux, LV., et al.[2019]

The review identified only 7 studies that effectively evaluated interventions aimed at improving health literacy in community populations, highlighting a significant gap in evidence to support national health literacy policies.

Most included studies focused on developing functional and interactive health literacy skills, but the overall lack of systematic testing and reliable measurement tools indicates a need for more rigorous research in this area to inform effective health education and communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving health literacy in community populations: a review of progress. Nutbeam, D., McGill, B., Premkumar, P.[2019]

A systematic review identified 11 health literacy instruments, with some screening questions showing promise for effectively identifying patients with low health literacy through computer-based methods.

There is a need for more consistent screening questions and better psychometric data for these instruments, suggesting that a single reliable question could be sufficient for assessing health literacy in eHealth applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy screening instruments for eHealth applications: a systematic review. Collins, SA., Currie, LM., Bakken, S., et al.[2022]

Low health literacy is linked to negative patient outcomes, highlighting the importance of patients' ability to understand and use health information for making informed healthcare decisions.

The article emphasizes the need for targeted interventions to improve health literacy among affected patient groups, which is crucial for enhancing the quality of healthcare delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy: implications for teaching the adult patient. Bass, L.[2019]

The Health Literacy Instrument for Adults (HELIA) was developed and validated through a study involving 323 adults, demonstrating strong psychometric properties, including a five-factor structure that explains 52.9% of the variance in health literacy.

HELIA showed good internal consistency (Cronbach's alpha between 0.72 and 0.89) and stability (ICC = 0.84), making it a reliable tool for measuring health literacy across various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a short and easy-to-use instrument for measuring health literacy: the Health Literacy Instrument for Adults (HELIA). Tavousi, M., Haeri-Mehrizi, A., Rakhshani, F., et al.[2020]

A study of 4045 Asian-American and Pacific Islander adults in California found that low health literacy is significantly associated with factors such as being male, having low socioeconomic status, limited English proficiency, and being foreign born.

The findings emphasize the need for targeted public health initiatives to improve health literacy in this population, as low health literacy can hinder effective communication and understanding of health information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of Low Health Literacy Among Asian-American and Pacific Islanders in California. Becerra, MB., Becerra, BJ., Daus, GP., et al.[2022]

A study involving 64 older Spanish-speaking ESL immigrant women revealed that discussions about diet-related colon cancer prevention highlighted varying levels of health literacy, with many participants showing low functional health literacy in their general information requests.

The findings suggest that while there is a continuum of health literacy needs among these women, there was a lack of critical health literacy discussions, indicating a need for culturally appropriate information to enhance their understanding and actions regarding healthy eating.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of the health literacy framework to diet-related cancer prevention conversations of older immigrant women to Canada. Thomson, MD., Hoffman-Goetz, L.[2012]

In a study of 402 Spanish-speaking Hispanic adults accessing healthcare in the Midwest, 36% were found to have low health literacy levels, with significant differences based on gender, education, and country of origin.

Specifically, 45% of males and 61% of individuals with less than a 7th grade education exhibited low health literacy, highlighting the need for targeted health education interventions in these groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing health literacy levels of Spanish-speaking Hispanic patients in Spanish at federally qualified health centers (FQHCs) in the Midwest. De Alba, A., Britigan, DH., Lyden, E., et al.[2022]

A review of 20 studies in pediatric otolaryngology revealed that much of the educational material is written at a reading level too high for effective public health communication, which may hinder understanding.

Parents often struggle to recall information provided during informed consent, but incorporating visual and multimodal elements into education significantly enhances their comprehension and retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy in pediatric otolaryngology: A scoping review. Aaronson, NL., Joshua, CL., Boss, EF.[2018]

A novel shared decision making (SDM) training program for socially disadvantaged Australians effectively empowers adults with lower literacy by promoting active participation in healthcare decisions, moving away from passive approaches.

Educators found that while the SDM content aligned well with institutional goals of learner empowerment, additional time and resources were needed to help learners fully grasp complex SDM concepts and terminology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Qualitative insights into the experience of teaching shared decision making within adult education health literacy programmes for lower-literacy learners. Muscat, DM., Morony, S., Smith, SK., et al.[2022]

A collaborative effort among clinical, academic, and community partners led to the creation of a clinic readiness assessment and a pilot intervention aimed at improving patient-provider communication and health literacy.

The pilot project highlighted the importance of partnerships in developing effective health literacy initiatives, resulting in valuable lessons that will guide future expansions of the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Clinical-Academic-Community Collaboration to Improve Health Literacy. Friedman, DB., Arent, MA., Yelton, B., et al.[2021]

A training session for 166 healthcare workers significantly improved their perceived knowledge of health literacy and their intention to use clear communication techniques, indicating the effectiveness of such training.

Participants initially overestimated their understanding of health literacy, highlighting the need for better initial training and ongoing education in this area to enhance healthcare delivery to patients with low health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health literacy awareness training for healthcare workers: improving knowledge and intentions to use clear communication techniques. Mackert, M., Ball, J., Lopez, N.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05605054?cond=ucsd%20relink&rank=1

UCSD RELINK: Connecting Adults To Supportive Services An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/trial/NCT05605054

UCSD RELINK: Connecting Adults To Supportive Services The goal of this randomized intervention study is to learn about effective health literacy teaching methods in Justice Involved Adults (JIA).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11290280/

A randomized clinical trial testing a health literacy intervention ... A randomized clinical trial testing a health literacy intervention to reduce disparities in access to care among Justice-Impacted Adults (JIA)

4. clinicaltrial.be clinicaltrial.be/en/details/261916?per_page=100&only_recruiting=0&only_eligible=0

UCSD RELINK: Connecting Adults To Supportive Services This study will implement a longitudinal mixed-methods randomized clinical trial (RCT) to assess the impact of the UCSD RELINK coach-guided ...

5. clinicaltrials.ucsd.edu clinicaltrials.ucsd.edu/health-care-utilization

UCSD Health Care Utilization Clinical Trials for 2025 The goal of this randomized intervention study is to learn about effective health literacy teaching methods in Justice Involved Adults (JIA).