Health Literacy Research in Rural Areas

Abstract

This report discusses successful approaches to conducting health literacy-directed studies with community clinics and agencies in rural areas of Louisiana. Some lessons learned from two studies in isolated rural areas with a history of health, educational, and economic disparities are presented. The first is a qualitative study eliciting patients’, providers’ and community members’ understanding, access and acceptance of clincial trials. The second is an overview of health literacy interventions that build on each other to improve annual colorectal cancer screening in rural commuity clinics. The results suggest rural providers and patients are interested in participating in clinical trials. To increase participation in clinical trials in rural areas, academic researchers need to develop ongoing “bi-directional” working relationships with rural clinics and agencies. The support of primary care providers trusted by patients is essential. Plain language and culturally appropriate patient education material developed with the input of patients and providers and on-going telephone outreach are effective in increasing initial colon cancer screening among low-income rural patients. More intensive strategies are needed to sustain annual screening. Implementation of health literacy research strategies may help address barriers to understanding and access to appropriate studies and preventive health services.

1. Introduction

Disparities exist in recruitment, retention and trust in clinical trials among individuals with limited health literacy, low socioeconomic status, as well as those who belong to racial and ethnic minorities and people living in rural areas. Participation of underrepresented populations in clinical trials is critical to improvement of health outcomes, healthcare delivery, and scientific innovation [1]. Despite well-known health disparities in rural areas, few studies are conducted among rural populations [2–3]. In the past five years less than 3% of the National Cancer Institute’s Cancer Control and Population Sciences trials have focused on rural populations [4]. The U.S. Department of Health and the U.S. National Institutes of Health are calling for health programs and research to address health care disparities in rural areas [4–6].

Rural residents suffer significant health inequities and encounter tangible and perceptual barriers to preventive services, health care, and health research which often are overlooked [7]. Rural adults tend to be older, poorer, under-insured and have lower literacy compared to adults in urban areas [8–10]. Individuals in rural areas also have higher rates of poor health behavior; they are more likely to smoke, have severe obesity, be physically inactive and are less likely be screened for colon or cervical cancer [11–12].

Systemic factors that contribute to increasing rural/ urban disparities in chronic illness and premature mortality include higher rural poverty rates across all races and ethnicities, distance to primary care, lower rates of preventive care, lack of public transportation, scarce community services, and persistent shortage of healthcare providers, particularly specialists [13–15, 9].

The greater understanding of barriers and facilitators of rural populations to participate in preventive care and clinical trials can better inform future studies [16–17, 3]. In looking at barriers though a health literacy lens, rural residents and providers have limited understanding and access to preventive services and medical research. The implementation of health literacy research strategies may help address barriers to understanding and access to appropriate studies and preventive health services.

The first study of two studies from the current authors illustrates a collaboration among rural and inner-city U.S. Federally Qualified Health Centers (FQHCs) and Council on Aging sites to assess the barriers and facilitators to rural population understanding, access and participation in clinical trials. The second study is a collaboration with rural FQHCs in a health literacy directed study to improve understanding, access, and completion of annual colorectal cancer screening.

2. Health Literacy Approaches to Establishing Collaboration in Rural Clinics and Agencies

In conducting studies in rural areas, it is important for urban-based academic researchers to establish relationships with rural clinic administrators, providers, and if appropriate, agency heads. The study protocol must be developed collaboratively, fit into the rural site’s operational procedures and culture and be acceptable to administrators, providers and patients. The sites where we have found good partners are FQHCs and Council on Aging Agencies.

FQHCs are government-supported clinics with a mandate to provide primary care services to vulnerable populations (by socioeconomic status, racial/ethnic minorities) regardless of insurance status. These clinics are strategically located in areas designated as medically underserved by the U.S. Department of Health and Human Services. FQHCs currently serve more than 22 million low income individuals across the country [18]. The U.S. National Council on Aging is a nonprofit advocacy and service organization that partners with government and community organizations to improve the health and economic security of adults age 50 and over, 70% are women and three-fourths spend an average of three hours a week at a center. Currently, there are more than 11,000 sites throughout the US; by 2020 they will serve more than 10 million older adults [19].

3. Barriers and Facilitators to Participation in Clinical Trials

Diverse participation of underrepresented groups in clinical trials biobanks is needed to identify the most effective treatments for diverse groups [1]. A qualitative study (conducted by the authors to explore barriers and facilitators to enrolling underrepresented populations in clinical trials and biobanking) involved 19 focus groups and seven telephone interviews in urban and rural areas of Louisiana to: 1) identify awareness, understanding, trust acceptance and access to clinical trials and biobanking among minority and rural adults; and 2) elicit clear, culturally appropriate language and recruitment strategies [20]. Of 121 participants, 30 were safety-net healthcare providers, 28 were primary care or oncology clinic patients, and 58 were participants in Council on Aging, or social or faith-based groups. Patients and community participants were predominately female (92%) and members of racial and ethnic minority groups, 72% were African American, 11% Hispanic; 22% lived in rural areas. Louisiana (LA) is a state in the southern region of the U.S.

The barriers to participation in clinical trials identified in rural areas included: limited knowledge about clinical trials and biobanks; lack of information on appropriate studies; and access to participation [20]. Additional barriers included: lack of public transportation and inconvenience of getting to an urban academic center; as well as mistrust and privacy concerns about clinical trials and biobanking. Patients and community participants were concerned about who would see the information, how it would be used, and if the disclosure would impact health benefits or insurance. Few patients or Council on Aging participants also had been asked to participate in a clinical trial; rural providers and administrators did not have relationships with academic researchers; and no prior structure existed to include rural patients in appropriate trials.

Some facilitators included: participant altruism; high interest in medical research) particularly studies that might benefit them or their families); and increased awareness of medical research and genomic studies because of television advertising. Participants suggested they sought easy to understand, culturally appropriate information; local access to studies; and most importantly the input of a trusted provider. As some participants said, ‘I always want to know what doc thinks.’

4. Suggestions for Clear Messages and Feasible Recruitment Strategies

Rural patients and Council on Aging participants did not understand the terms ‘clinical trials’, or ‘biobanking.’ They suggested using plain language terms such as study or medical research. Participants said:’ everyone understands what a study is.’

Meanwhile, ‘genomics’ sounded intimidating, scary. To explain biobanking, participants suggested a concrete explicit explanation: ‘your blood or tissue will be stored in a bank.’ Rural participants wanted to know where the bank was. Genomics researchers also were advised to limit detailed or scientific messages or materials and to provide brief, to-the-point explanation using everyday terms. Rural providers and patients liked the idea of a mobile health van that could come to their clinic for study visits. The providers felt this would improve access to trials and biobanking.

All rural primary care providers were interested in having clinical trial options available for their patients but said they did not have time to search for available trials. None of the participating primary care providers had looked for clinical trials appropriate for his or her patients on the internet. They also lacked relationships with academic physicians and researchers.

To increase the participation of rural and minority patients, providers suggested on site in-services or webinars to give them information about the clinical trials available for their patients and biobanking. For specific studies, they requested brief plain language information with talking points and a card they could give patients with a name and number to call for more information. Findings from this pilot study can help inform the development of education materials and strategies to increase participation of underrepresented groups in clinical trial and biobanking.

5. Improving Access, Understanding and Completion of Colonoscopy Screening Tests

Colorectal Cancer (CRC) mortality is 16% higher in rural areas than in cites [12, 21]. The disparity is largely because rural individuals are less likely to obtain CRC screening, which increases the time for diagnoses and treatment. A colonoscopy is not feasible in many rural areas because of a dearth of colonoscopy services and specialists [12]. Without insurance the cost of colonoscopy also would be prohibitive, which the case in Louisiana when these two studies were conducted. Also, during this time, rural FQHCs in LA did not use electronic health records. Below, the authors discuss two studies that built on each other to improve understanding, access, and use of annual colorectal cancer screening

The Health Literacy and Cancer Screening Project (National Cancer Institute R01) (n=961) and Interventions to Overcome Disparities in CRC Screening (American Cancer Society) (n=620) were randomized controlled trials conducted in predominantly rural FQHCs (n=10 Clinics). Most of the study participants were African Americans (66% and 67%) and 40% and 56% had low health literacy levels (reading below a night grade level) [22–25]. The baseline screening rates in rural clinics in both studies ranged from two to five percent.

6. Health Literacy Barriers and Facilitators Identified CRC Screening

At baseline in both studies, almost all rural patients suggested they had heard of CRC and the majority reported positive beliefs about CRC screening. More than 90% reported they would want to know if they had colon cancer [23, 24, 26–28]. Patients with low literacy were significantly less likely to know of CRC tests, believed it was helpful to find CRC early, and had completed a Fecal Occult Blood Test (FOBT). Of concern, the authors found two thirds of patients had never received a physician recommendation for CRC screening or been given an FOBT. At baseline, patients who reported they had been given an FOBT kit were significantly more likely to report they had previously completed CRC screening even after controlling for age, race, and literacy [27].

By using teach back in preliminary focus groups (to confirm patient understanding of FOBT test instructions and confidence in acting on these instructions), the authors quickly discovered most participants needed easier to read CRC materials, Fecal Immunochemical Test (FIT) instructions, and a confirmation of understanding. The current instructions for FIT and Colonoscopy tests were written on a 9th-10_th grade level, were unnecessarily complicated and not formatted for reading ease [28]. In contrast, the simplified FIT screening instructions developed with rural patients were written on a fifth-grade level, were organized from the perspective of the patient, and formatted for reading ease.

7. Health Literacy Interventions to Overcome Disparities in CRC Screening

The first rural CRC study conducted by the authors was a three-arm strategy with patients randomized to: 1) enhanced usual care receiving a recommendation and a FOBT kit; 2) a literacy-directed arm that received literacy and culturally appropriate CRC education and simplified FOBT instructions, from a research assistant who used teach back to confirm understanding; and 3) a nurse arm that received the same literacy and culturally appropriate education and materials from a study nurse - and received a follow-up call from the nurse. Patients who received the simplified materials with teach back were more likely to complete the FIT. Year one FOBT screening rates respectively by arm were: 39%, 57% and 61% [24]. In year 2, when all patients were mailed a letter and a FOBT, rates dropped (14% in usual care; 19% with additional mailed simplified instructions only; and 31% with added nurse follow-up phone call [29]. The results suggest the literacy appropriate education was effective. Although a follow-up motivational call by the nurse was helpful, higher screening rates were not sustained. The strategy also was not cost effective because the nurse arm was expensive and not economically/logistically feasible for low income rural clinics.

The second study was designed based from findings and lessons learned from the first intervention. All the enrolled patients were given the FIT with simplified instructions as well as simplified face-to-face education and FIT instructions combined with teach back. In the second study, patients were randomized and received an automated follow-up call or a personal call if they did not return their FIT within a month - and again if they did not return the FIT in two months. Both calls were health literacy as well as culturally appropriate for low income rural patients.

Year one CRC completion rates were 67% for those receiving a personal call by a prevention counselor and 69% for those receiving an automated call [22]. In year two, where patients were mailed a letter and FIT kit, 39% of patients who received personal call and 38% who received an automated call completed screening. This indicated that a follow-up reminder call is helpful, and the cost-effective automated call was just as effective as a personal call to prompt both initial and repeat annual CRC screening. Repeat screening results indicated more effective cost-effective approaches are needed to sustain CRC screening in low income clinics.

These studies help inform what is feasible and effective in rural FQHCs and what is needed to improve initial and long-term screening rates. It also is feasible for a rural clinic staff member to work part time as a study screening coordinator. The research suggests rural clinical staff members are effective providers of patient health literate, appropriate education and, simplified test instructions with teach back. While the authors’ health literacy education and materials and provision of FIT kits improved the initial CRC screening in low income rural patients, challenges remain in keeping patients activated for repeat follow-up annual tests.

8. Three Lessons Learned about Conducting Research in Rural FQHCs

• Providers and patients are interested in participating in clinical trials. To increase participation, academic researchers need to develop ongoing “bi-directional” working relationships with CEOs and medical and clerical staff. The support of a primary care physician is essential.

• Rural clinics. providers, and patients are more experienced with services rather than research. Hence, frequent on-site quality checks serve as a boost to confirm a clinic’s adherence to a study protocol. Some attention to the service orientation of an entire clinic is essential to generate participation (and needs to be repeated annually with a briefing about the research’s preliminary findings).

• The research needs to ideally benefit patients as well as clinic providers, administrators, and the researchers. Clinics, and if possible, study personal need to be incentivized or be clear about research benefits.

9. Recommendations

Academic researchers need to reach out to rural clinics and establish a trusting relationship. Studies need to be developed collaboratively with providers, patients, and researchers. To improve understanding and acceptance, rural patients and providers need to be involved in development of materials, messages, and education. The implementation of health literacy research strategies may help address unique barriers to understanding and access as well as the acceptance of preventive health services within rural areas.