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Background As health systems transition to value-based care, improving transitional care (TC) remains a priority. Hospitals implementing evidence-based TC models often adapt them to local contexts. However, limited research has evaluated which groups of TC strategies, or transitional care activities, commonly implemented by hospitals correspond with improved patient outcomes. In order to identify TC strategy groups for evaluation, we applied a data-driven approach informed by literature review and expert opinion. Methods Based on a review of evidence-based TC models and the literature, focus groups with patients and family caregivers identifying what matters most to them during care transitions, and expert review, the Project ACHIEVE team identified 22 TC strategies to evaluate. Patient exposure to TC strategies was measured through a hospital survey (N = 42) and prospective survey of patients discharged from those hospitals (N = 8080). To define groups of TC strategies for evaluation, we performed a multistep process including: using ACHIEVE’S prior retrospective analysis; performing exploratory factor analysis, latent class analysis, and finite mixture model analysis on hospital and patient survey data; and confirming results through expert review. Machine learning (e.g., random forest) was performed using patient claims data to explore the predictive influence of individual strategies, strategy groups, and key covariates on 30-day hospital readmissions. Results The methodological approach identified five groups of TC strategies that were commonly delivered as a bundle by hospitals: 1) Patient Communication and Care Management, 2) Hospital-Based Trust, Plain Language, and Coordination, 3) Home-Based Trust, Plain language, and Coordination, 4) Patient/Family Caregiver Assessment and Information Exchange Among Providers, and 5) Assessment and Teach Back. Each TC strategy group comprises three to six, non-mutually exclusive TC strategies (i.e., some strategies are in multiple TC strategy groups). Results from random forest analyses revealed that TC strategies patients reported receiving were more important in predicting readmissions than TC strategies that hospitals reported delivering, and that other key co-variates, such as patient comorbidities, were the most important variables. Conclusion Sophisticated statistical tools can help identify underlying patterns of hospitals’ TC efforts. Using such tools, this study identified five groups of TC strategies that have potential to improve patient outcomes.

BACKGROUND: Evidence of the effectiveness of treatment for obesity delivered in primary care settings in underserved populations is lacking. METHODS: We conducted a cluster-randomized trial to test the effectiveness of a high-intensity, lifestyle-based program for obesity treatment delivered in primary care clinics in which a high percentage of the patients were from low-income populations. We randomly assigned 18 clinics to provide patients with either an intensive lifestyle intervention, which focused on reduced caloric intake and increased physical activity, or usual care. Patients in the intensive-lifestyle group participated in a high-intensity program delivered by health coaches embedded in the clinics. The program consisted of weekly sessions for the first 6 months, followed by monthly sessions for the remaining 18 months. Patients in the usual-care group received standard care from their primary care team. The primary outcome was the percent change from baseline in body weight at 24 months. RESULTS: All 18 clinics (9 assigned to the intensive program and 9 assigned to usual care) completed 24 months of participation; a median of 40.5 patients were enrolled at each clinic. A total of 803 adults with obesity were enrolled: 452 were assigned to the intensive-lifestyle group, and 351 were assigned to the usual-care group; 67.2% of the patients were Black, and 65.5% had an annual household income of less than $40,000. Of the enrolled patients, 83.4% completed the 24-month trial. The percent weight loss at 24 months was significantly greater in the intensive-lifestyle group (change in body weight, −4.99%; 95% confidence interval [CI], −6.02 to −3.96) than in the usual-care group (−0.48%; 95% CI, −1.57 to 0.61), with a mean between-group difference of −4.51 percentage points (95% CI, −5.93 to −3.10) (P

Background: Low health literacy is associated with poor health outcomes in many chronic diseases and may have an important role in determining surgical outcomes. This study aims to comprehensively review the current state of science on adult health literacy in surgery and to identify knowledge gaps for future research. Methods: Using the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, a systematic search was conducted to identify all studies from January 2002 through May 2018 that used validated instruments to assess health literacy among adult patients undergoing surgery. Studies were assessed for quality using the Newcastle-Ottawa scale and evaluated on findings by their focus on identifying health literacy levels, understanding associations with surgical outcomes, and/or developing interventions to address low health literacy. Key Results: There were 51 studies on health literacy with data from 22,139 patients included in this review. Low health literacy was present in more than one-third of surgical patients (34%, interquartile range 16%–50%). The most commonly used validated instrument for assessment of health literacy in the surgical population was the Newest Vital Sign. Most studies were focused on identifying the prevalence of low health literacy within a surgery population (84%, n = 43). Few studies focused on understanding the association of health literacy to surgical outcomes (12%, n = 6) and even fewer studies developed interventions to address health literacy (4%, n = 2). Discussion: Low health literacy is common among surgical patients. Important opportunities exist to better understand the role of health literacy in determining surgical outcomes and to develop more health literacy-sensitive models of surgical care. [ HLRP: Health Literacy Research and Practice . 2020;4(1):e45–e65.] Plain Language Summary: Health literacy has not been well-studied in surgery but likely plays an important role. In this article, we reviewed all current research on health literacy in surgery to help us understand where we are at and where we need to go. We found that low health literacy is common and we need more ways to address it in surgery.

Purpose The majority of colorectal cancer (CRC) research using the fecal immunochemical test (FIT) has studied short-term screening results in predominantly urban areas. The purpose of this study was to evaluate the effectiveness of 2 outreach strategies embedded in a health literacy intervention on repeat CRC screening in rural community clinics. Methods A 2-arm randomized controlled trial was conducted in 4 rural clinics in Louisiana. During a regularly scheduled clinic visit, participants ages 50-75 received a FIT kit and brief educational intervention. Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned. In year 2, materials were mailed, and follow-up calls were conducted as in year 1. The primary outcome was repeat FIT-the return of the FIT kit in both years. Participants Of 568 eligible participants, 55% were female, 67% were African American, and 39% had low health literacy. Findings Repeat FIT rates were 36.5% for those receiving the automated call and 33.6% for those receiving a personal call (P = .30). No annual FITs were returned in 30% of participants, while only 1 FIT was returned by 35% of participants (31% only year 1 and 4% only year 2). Conclusion Sustaining CRC screening with FIT is challenging in rural clinics. A lower cost automated call was just as effective as the personal call in promoting repeat annual screening. However, more intensive strategies are needed to improve long-term FIT screening among rural participants.

Background Significant disparities exist in colorectal cancer (CRC) screening rates among those of low socioeconomic status, with fewer years of education, lacking health insurance, or living in rural areas. Methods A randomized controlled trial was conducted to compare the effectiveness of 2 follow-up approaches to a health literacy intervention to improve CRC screening: automated telephone call or personal call. Patients aged 50 to 75 years residing in 4 rural community clinics in Louisiana were given a structured interview that assessed demographic, health literacy and CRC screening barriers, knowledge, and attitudes. All were given health literacy-informed CRC education, a patient-friendly CRC screening pamphlet, simplified fecal immunochemical test (FIT) instructions, and a FIT kit, and a "teach-back" method was used to confirm understanding. Patients were randomized to 1 of 2 telephone follow-up arms. If they did not mail their FIT kit within 4 weeks, they received a reminder call and were called again at 8 weeks if the test still was not received. Results A total of 620 patients were enrolled. Approximately 55% were female, 66% were African American, and 40% had limited literacy. The overall FIT completion rate was 68%: 69.2% in the automated telephone call arm and 67% in the personal call arm. Greater than one-half of the patients (range, 58%-60%) returned the FIT kit without receiving a telephone call. There was no difference noted with regard to the effectiveness of the follow-up calls; each increased the return rate by 9%. Conclusions Providing FIT kits and literacy-appropriate education at regularly scheduled clinic visits with a follow-up telephone call when needed was found to increase CRC screening among low-income, rural patients. The lower cost automated call was just as effective as the personal call.

BACKGROUND As health systems shift toward value-based care, strategies to reduce readmissions and improve patient outcomes become increasingly important. Despite extensive research, the combinations of transitional care (TC) strategies associated with best patient-centered outcomes remain uncertain. METHODS Using an observational, prospective cohort study design, Project ACHIEVE sought to determine the association of different combinations of TC strategies with patient-reported and postdischarge health care utilization outcomes. Using purposive sampling, the research team recruited a diverse sample of short-term acute care and critical access hospitals in the United States (N = 42) and analyzed data on eligible Medicare beneficiaries (N = 7,939) discharged from their medical/surgical units. Using both hospital- and patient-reported TC strategy exposure data, the project compared patients "exposed" to each of five overlapping groups of TC strategies to their "control" counterparts. Primary outcomes included 30-day hospital readmissions, 7-day postdischarge emergency department (ED) visits and patient-reported physical and mental health, pain, and participation in daily activities. RESULTS Participants averaged 72.3 years old (standard deviation =10.1), 53.4% were female, and most were White (78.9%). Patients exposed to one TC group (Hospital-Based Trust, Plain Language, and Coordination) were less likely to have 30-day readmissions (risk ratio [RR], 0.72; 95% confidence interval [CI] = 0.57-0.92, p < 0.001) or 7-day ED visits (RR, 0.72; 95% CI, 0.55-0.93, p < 0.001) and more likely to report excellent physical and mental health, greater participation in daily activities, and less pain (RR ranged from 1.11 to 1.15, p < 0.01). CONCLUSION In concert with care coordination activities that bridge the transition from hospital to home, hospitals' clear communication and fostering of trust with patients were associated with better patient-reported outcomes and reduced health care utilization.

Background The purpose of this study was to develop and administer surveys that assess patient and family caregiver experiences with care transitions and examine the psychometric properties of the surveys. The surveys were designed to ask about 1) the transitional care services that matter most to patients and their caregivers and 2) care outcomes, including the overall quality of transitional care they received, patient self-reported health, and caregiver effort/stress. Methods Survey items were developed based on a review of the literature, existing surveys, focus groups, site visits, stakeholder and expert input, and patient and caregiver cognitive interviews. We administered mail surveys with telephone follow up to patients recently discharged from 43 U.S. hospitals. Patients identified the caregivers who helped them during their hospital stay (Time 1 caregiver) and when they were home (Time 2 caregiver). Time 1 and Time 2 caregivers were surveyed by telephone only. The psychometric properties of the survey items and outcome composite measures were examined for each of the three surveys. Items that performed poorly across multiple analyses, including those with low variability and/or a high missing data, were dropped except when they were conceptually important. Results The analysis datasets included responses from 9282 patients, 1245 Time 1 caregivers and 1749 Time 2 caregivers. The construct validity of the three proposed outcome composite measures—Overall Quality of Transitional Care (patient and caregiver surveys), Patient Overall Health (patient survey) and Caregiver Effort/Stress (caregiver surveys) —was supported by acceptable exploratory factor analysis results and acceptable internal consistency reliability. Site-level reliability was acceptable for the two patient outcome composite measures, but was low for Caregiver Effort/Stress ( Conclusions Overall, the final patient and caregiver surveys are psychometrically sound and can be used by health systems, hospitals, and researchers to assess the quality of care transitions and related outcomes. Results from these surveys can be used to improve care transitions, focusing on what matters most to patients and their family caregivers.

Underserved and minority populations suffer from a disproportionately high prevalence of obesity and related comorbidities. Effective obesity treatment programs delivered in primary care that produce significant weight loss are currently lacking. The purpose of this trial is to test the effectiveness of a pragmatic, high intensity lifestyle-based obesity treatment program delivered within primary care among an underserved population. We hypothesize that, relative to patients who receive usual care, patients who receive a high-intensity, health literacy- and culturally-appropriate lifestyle intervention will have greater percent reductions in body weight over 24 months. Eighteen clinics (N = 803 patients) serving low income populations with a high proportion of African Americans in Louisiana were randomized to the intervention or usual car. Patients in the intervention participate in a high-intensity lifestyle program delivered by health coaches employed by an academic health center and embedded in the primary care clinics. The program consists of weekly (16 in-person/6 telephone) sessions in the first six months, followed by sessions held at least monthly for the remaining 18 months. Primary care practitioners in usual care receive information on weight management and the current Centers for Medicare and Medicaid Services reimbursement for obesity treatment. The primary outcome is percent weight loss at 24 months. Secondary outcomes include absolute 24-month changes in body weight, waist circumference, blood pressure, fasting glucose and lipids, health-related quality of life, and weight-related quality of life. The results will provide evidence on the effectiveness of implementing high-intensity lifestyle and obesity counseling in primary care settings among underserved populations. Trial Registration: ClinicalTrials.gov Identifier NCT02561221

The purpose of this pilot study was to assess Chronic Myeloid Leukemia (CML) patients’ adherence to, beliefs about, and barriers to oral anticancer agents (OAC) using brief self-report measures in community-based cancer clinics. Patients completed a structured interview including a health literacy assessment, a Brief Medication Questionnaire, two single-item self-report adherence questions, and the Medications Adherence Reasons Scale. Of the 86 participants, 88.4% were white, 55.8% male, mean age, 58.7 years, and 22.1% had limited health literacy. Nonadherence (missing at least one dose in the last week) was reported by 18.6% of participants and associated (p &lt, 0.003) with less-than-excellent perceived ability to take CML medications (16.3%). Black participants reported more difficulty taking CML medications than white participants (28.6% vs. 8.3%, p = 0.053). Among all participants, 43.0% reported their CML medicine was ineffective and 24.4% that taking CML pills was somewhat to very hard. The most common reasons for missing a dose were simply missed it (24.4%) and side effects (18.6%). Most patients perceived their ability to take CML medication was good to excellent, yet nearly one in five reported missing at least one dose in the last week. Brief, no-cost self-report assessments to screen CML patients’ OAC adherence, barriers, and beliefs could facilitate counseling in busy community cancer clinics.

Disparities exist in enrollment in clinical trials and biorepositories among adults with low socioeconomic status, racial and ethnic minority groups and individuals who live in rural areas. Diverse participation is necessary to identify the most effective treatments in different groups. The purpose of this study was to use qualitative methods to identify factors that may affect the likelihood that members of underrepresented groups choose to participate in clinical trials and/or biobanking. We conducted 14 focus groups and seven telephone interviews in urban and rural areas of Louisiana to: (1) identify barriers and facilitators to participation; and (2) elicit input in crafting clear, culturally appropriate language and recruitment strategies. Of 103 participants, 25 were safety-net healthcare providers, 18 were primary care or oncology clinic patients, and 60 were members of social and faith-based groups. Patients and community participants were English-speaking, 79% were African American, 81% were female and 24% lived in rural areas. Barriers to participation identified were lack of knowledge about clinical trials and biobanks; limited specific information and access to participation, trust and privacy concerns about clinical trials and biobanking Facilitators included: altruism, high interest in medical research particularly studies that might benefit them or their families; plain language, culturally appropriate information; convenient access to studies; and input of a trusted provider. In addition, all primary care providers were interested in having clinical trial options available for their patients but did not have time to search for available trials. Results of this study can inform the development of education materials and strategies to increase participation of underrepresented groups in clinical trial and biobanking.

BACKGROUND: Patient misunderstanding of prescription drug label instructions is a common cause of unintentional misuse of medication and adverse health outcomes. Those with limited literacy and English proficiency are at greater risk. OBJECTIVE: To test the effectiveness of a patient-centered drug label strategy, including a Universal Medication Schedule (UMS), to improve proper regimen use and adherence compared to a current standard. DESIGN: Two-arm, multi-site patient-randomized pragmatic trial. PARTICIPANTS: English- and Spanish-speaking patients from eight community health centers in northern Virginia who received prescriptions from a central-fill pharmacy and who were 1) ≥30 years of age, 2) diagnosed with type 2 diabetes and/or hypertension, and 3) taking ≥2 oral medications. INTERVENTION: A patient-centered label (PCL) strategy that incorporated evidence-based practices for format and content, including prioritized information, larger font size, and increased white space. Most notably, instructions were conveyed with the UMS, which uses standard intervals for expressing when to take medicine (morning, noon, evening, bedtime). MAIN MEASURES: Demonstrated proper use of a multi-drug regimen; medication adherence measured by self-report and pill count at 3 and 9 months. KEY RESULTS: A total of 845 patients participated in the study (85.6 % cooperation rate). Patients receiving the PCL demonstrated slightly better proper use of their drug regimens at first exposure (76.9 % vs. 70.1 %, p = 0.06) and at 9 months (85.9 % vs. 77.4 %, p = 0.03). The effect of the PCL was significant for English-speaking patients (OR 2.21, 95 % CI 1.13-4.31) but not for Spanish speakers (OR 1.19, 95 % CI 0.63-2.24). Overall, the intervention did not improve medication adherence. However, significant benefits from the PCL were found among patients with limited literacy (OR 5.08, 95 % CI 1.15-22.37) and for those with medications to be taken ≥2 times a day (OR 2.77, 95 % CI 1.17-6.53). CONCLUSIONS: A simple modification to pharmacy-generated labeling, with minimal investment required, can offer modest improvements to regimen use and adherence, mostly among patients with limited literacy and more complex regimens. Trial Registration (ClinicalTrials.gov): NCT00973180, NCT01200849.

Objectives Our objective was to determine the effectiveness of 3 approaches to encourage completion of fecal occult blood testing (FOBT) in the third year of the intervention. Methods Between 2008 and 2011, a quasi-experimental intervention was conducted in 8 predominantly rural Federally Qualified Health Centers. Clinics were randomly assigned to enhanced care (screening recommendation and FOBT kit mailed annually), education (patients additionally received a health literacy appropriate pamphlet and simplified FOBT instructions), or nurse support (same as education but with nurse follow-up). Participants included 206 patients with negative FOBTs in years 1 and 2; ages 50-85, 80% female, 70% African American, and 52% had limited health literacy. The main outcome measure was completion of a third annual FOBT. Results Third-year FOBT rates were 48% overall, 34.2% enhanced care, 59.6% education, and 47.4% nurse support (p = .21), even after adjustment for sex, marital status, and health literacy. Conclusion All mailed interventions were similarly effective in sustaining rates of FOBT screening. Post hoc analyses of the results analyzed by health literacy skills found that patients with both limited and adequate health literacy skills were more likely to complete FOBTs when mailed simplified instructions.

This three arm study was designed to make CRC screening with FOBTs more accessible, understandable and actionable for patients cared for in predominantly rural Federally Qualified Health Centers. Patients in an enhanced version of usual care received an annual CRC recommendation and FOBT kit; those in the education arm additionally received brief literacy and culturally appropriate education and those in the nurse arm received the education by a nurse manager who followed up by telephone. Baseline FOBT rates in this population were 3 %. We evaluated if FOBT rates could be sustained over 3 years. A three-arm, quasi-experimental evaluation was conducted among eight clinics in Louisiana. Screening efforts included: (1) enhanced usual care, (2) literacy-informed education of patients, and (3) education plus nurse support. Overall, 961 average-risk patients, ages 50-85, eligible for routine CRC screenings were recruited. The primary outcome was completing three annual FOBT tests. Of 961 patients enrolled, 381 (39.6 %) participants did not complete a single FOBT, 60.4 % completed at least one FOBT of which 318 (33.1 %) completed only one, 162 (16.9 %) completed two and 100 (10.4 %) completed three FOBTs over the 3-year period (the primary study outcome). The primary outcome, return of three FOBT kits over the 3-year period, was achieved by 4.7 % in enhanced care, 11.4 % in education and 13.6 % in the nurse arm (p = 0.005). Overall 3-year FOBT screening rates were not sustained with any of the three interventions, despite reports of promising interim results at years 1 and 2. New strategies for sustaining FOBT screening over several years must be developed.

Introduction: Colorectal cancer (CRC), the second leading cause of cancer death in the United States, can be significantly reduced if it is detected early. Although overall CRC screening rates have increased significantly, disparities persist among low-income individuals, adults with low literacy and those living in rural areas. These groups all have screening completion rates below 50%. Objectives: To assess patient knowledge, beliefs, and self-efficacy about CRC screening and compare the effectiveness of two health literacy informed telephone follow-up strategies to improve annual screening over a three-year period with fecal immunochemical test (FIT) in rural community clinics. Methods: A two-arm, randomized controlled trial is being implemented in four community clinics. Clinics reported CRC baseline screening rates of 3% to 5%. Eligible patients, age 50-75, were recruited at the clinic prior to a scheduled appointment. A research assistant (RA) conducted a baseline structured interview measuring CRC screening knowledge, beliefs, and self-efficacy. The RA then recommended screening and gave brief literacy and culturally appropriate education using a pamphlet (4th-grade level), the FIT kit with preaddressed envelope, simplified instructions (3rd-grade level) and a demonstration of how to use it. At four weeks patients who had not returned their kit received either 1) a personal follow-up call (PC) from a central prevention coordinator using motivational interviewing skills and reminding them to complete and mail FIT kits, or 2) an automated follow-up call (AC) using plain language and motivational messages encouraging patients to complete and mail the FIT. Outcomes include FIT completion after intervention, and again at 12 and 24 months. Results: 620 patients not up-to-date were enrolled: 308/AC and 306/PC; 66% were African American, 55% women; 40% had limited literacy. During Year 1, 69% completed screening in AC arm versus 67% in PC arm. During Year 2, percentage screened decreased: 40% screened in AC arm and 37% in PC arm. Number of patients who needed at least one follow-up call increased: 74% in both arms needed at least 1 reminder call. Among those called, 19% in the AC arm completed their kit versus 15% in the PC arm. To date in Year 3, 32% screened in AC and 34% in PC. Conclusions: Simplified instructions accompanied by a face-to-face demonstration of FIT, and use of “teach back” to confirm understanding with a follow-up call if needed, facilitated completion rates of all patients, particularly those with limited literacy. Providing FIT + literacy appropriate education at regularly scheduled clinic visit with follow-up call (if needed) increased CRC screening rates of low-income, rural patients. Sustaining annual screening with FIT is challenging. In year 2 < 40% completed FIT. Follow-up calls were essential. Only 1/4 completed FIT without phone prompt. Lower-cost automated call has proven to be just as effective as personal call in both years 1 and 2. FIT is only effective if completed annually. This abstract is also being presented as Poster B099. Citation Format: Connie L. Arnold, Terry C. Davis, James Morris, Peggy Murphy, Glenn Mills. CRC screening in rural community clinics using the fecal immunochemical test (FIT): Issues with repeat screening [abstract]. In: Proceedings of the Eleventh AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2018 Nov 2-5; New Orleans, LA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(6 Suppl):Abstract nr PR12.

69 Background: The Healthy People 2020 initiative aims to increase colorectal cancer (CRC) screening. The common CRC screening options are FIT, FOBT, sigmoidoscopy, and colonoscopy. Colonoscopy allows visualization of the entire colon and offers therapeutic benefit whereas stool tests are less invasive, cost-effective and are easily available. Inequities exist in CRC screening among rural residents which may be contributed to a lower level of education, income, health insurance and access to health care. The purpose of the study is to identify the impact of geographic region on the preference of CRC screening modality among Louisiana adults. Methods: We performed a retrospective cohort study among age-eligible Louisiana adults who had CRC screening either with colonoscopy or stool-based tests using the 2016 Behavioral Risk Factor Surveillance System database (n = 1372). We examined demographic characteristics among participants who had CRC screening with colonoscopy versus who had a stool-based test. Multivariable logistic regression analysis evaluated the association of geographic region and the preference of CRC screening. Results: Participants age 65-75 years old were 36% less likely to have a colonoscopy as compared to age 50-64 years (p = 0.0008). African Americans and Hispanic Americans were 34% (p < 0.006) and 55% (p = 0.057) less likely to have a colonoscopy as compared to Caucasian Americans, respectively. Medicaid and Medicare participants were 82% (p < 0.0001) and 52% (p < 0.0001) less likely to have a colonoscopy compared to participants with private insurance, respectively. After adjusting for age, race/ethnicity, education, income, and insurance the odds of screening colonoscopy was 29% lower for rural residents compared to urban residents of Louisiana (OR 0.71 95% CI 0.53 - 0.94). Conclusions: Individuals residing in rural parishes of Louisiana were more likely to have a stool-based test for CRC screening. Health care providers while considering the reliability and feasibility of CRC screening modality should also incorporate patient’s preferences while offering the screening tests to increase the rate of CRC screening.

Our previous three-arm comparative effectiveness intervention in community clinic patients who were not up-to-date with screening resulted in mammography rates over 50% in all arms.Our aim was to evaluate the effectiveness and cost-effectiveness of the three interventions on improving biennial screening rates among eligible patients.A three-arm quasi-experimental evaluation was conducted in eight community clinics from 2008 to 2011. Screening efforts included (1) enhanced care: Participants received an in-person recommendation from a research assistant (RA) in year 1, and clinics followed usual clinic protocol for scheduling screening mammograms; (2) education intervention: Participants received education and in-person recommendation from an RA in year 1, and clinics followed usual clinic protocol for scheduling mammograms; or (3) nurse support: A nurse manager provided in-person education and recommendation, scheduled mammograms, and followed up with phone support. In all arms, mammography was offered at no cost to uninsured patients.Of 624 eligible women, biennial mammography within 24-30 months of their previous test was performed for 11.0% of women in the enhanced-care arm, 7.1% in the education- intervention arm, and 48.0% in the nurse-support arm (p0.0001). The incremental cost was $1,232 per additional woman undergoing screening with nurse support vs. enhanced care and $1,092 with nurse support vs. education.Biennial mammography screening rates were improved by providing nurse support but not with enhanced care or education. However, this approach was not cost-effective.

Breast and colorectal cancer (CRC) screening in safety-net settings is underused.1-3 Screening rates for these cancers remain persistently lower among disadvantaged populations including low-income women, those with no health insurance, those with lower health literacy and fewer years of education, racial and ethnic minorities, and those who live in rural areas.4-14 The reduction of these screening disparities is a national public health priority.15 The Community Preventive Service Task Force's systematic review on the effectiveness of joint interventions to increase the rates of breast, cervical, and CRC screening found that one-on-one education, patient reminders, and enhancing access to screening services were effective.16 Another systematic review looking at multiple cancer screening also found that provider audits and culturally appropriate mail and telephone outreach improved breast and CRC screening rates.17 Few initiatives have been specifically developed to improve multiple-cancer screening rates in safety-net primary care clinics. In community clinics that participate in a county-funded health plan in Florida, a cancer screening office reminder system using chart stickers was effective in increasing joint rates of mammograms and fecal occult blood tests (FOBTs).18 Mammogram and FOBT screening rates among inner-city patients in Rochester, New York, increased with the use of a multimodal intervention of repeated letters and automated phone calls and a mailed FOBT kit with a point-of-care prompt if the patient had an appointment.19 An expansion of that study found that personal patient reminder calls and provider and patient prompts delivered at a patient-initiated visit were more effective in improving screening rates among poor and minority inner-city patients than were reminder letters alone or letters with automated calls.20 Although all of those interventions targeted 2 or more cancers, none targeted rural areas. Our team developed and evaluated a health literacy-informed intervention designed to promote mammogram and FOBT screening in rural and inner-city populations that were at higher risk for not undergoing cancer screening: low-income and uninsured women who were cared for in Federally Qualifed Health Centers (FQHCs) in Louisiana that were not participating in state or national screening programs. FQHCs are located in areas designated as medically underserved and provide care nationally to 20 million individuals regardless of their insurance status.21 The objective of this study was to test 3 strategies to promote joint breast and CRC screening: enhanced care, which ensured that women received screening recommendations and access to both tests; health literacy-informed educational materials with accompanying “teach back” to confirm comprehension; 22, 23 or use of the health literacy-informed education strategy with telephone follow-up by a nurse. All of the strategies promoted use of mammography at a rural community hospital or the nearest public hospital and of the FOBT, the most feasible, cost-effective screening option for CRC in low-income and uninsured patients.24-25 This report looks at whether women completed both tests. Given the resource-constrained FQHCs environment, we also evaluated the cost effectiveness of the interventions targeting breast and CRC. Cancer screening interventions are a priority in Louisiana because the state has high rates of cancer mortality, ranking third among states in breast cancer deaths and fourth in colon cancer deaths.26

BACKGROUND: This study was designed to develop and validate a brief adolescent health literacy assessment tool (Rapid Estimate of Adolescent Literacy in Medicine Short Form [REALM-TeenS]). METHODS: We combined datasets from 2 existing research studies that used the REALM-Teen (n = 665) and conducted an item response theory analysis. The correlation between scores on the original 66-item REALM-Teen and the proposed REALM-TeenS was calculated, along with the decision consistency across forms with respect to grade level assignment of each adolescent and coefficient α. The proposed REALM-TeenS was validated with original REALM-Teen data from a third independent study (n = 174). RESULTS: Items with the largest discriminations across the scale, from low to high health literacy, were selected for inclusion in REALM-TeenS. From those, a set of 10 items was selected that maintained a reasonable level of SE across ability estimates and correlated highly (r = 0.92) with the original REALM-Teen scores. The coefficient α for the 10-item REALM-TeenS was .82. There was no evidence of model misfit (root mean square error of approximation < 0.001). In the validation sample, REALM-TeenS scores correlated highly with scores on the original REALM-Teen (r = 0.92), and the decision consistency across both forms was 80%. In pilot testing, administration took ∼20 seconds. CONCLUSIONS: The REALM-TeenS offers researchers and clinicians a brief validated screening tool that can be used to assess adolescent health literacy in a variety of settings. Scoring guidelines ensure that reading level assessment is appropriate by age and grade.

Objectives To improve patient colonoscopy bowel preparation with a newly developed simplified instruction sheet in a safety-net hospital system. Methods Bowel preparation quality was compared in a retrospective chart review of 543 patients, 287 of whom received standard instructions (9th grade reading level) between November 2015 and February 2016, and 256 of whom received simplified instructions (6th grade level) between March and May 2016. Instructions were mailed to all patients. The primary outcome was bowel preparation quality recorded by the endoscopist as optimal or suboptimal preparation. Results 543 medical records were reviewed and results indicated a significant association between the instructions used and preparation quality with patients receiving simplified instructions being significantly more prepared (69.1% vs 65.5%) and having a lower cancellation rate (4.7% vs 10.5%), p = .042. Conclusions A no-cost simplified colonoscopy instruction sheet improved bowel preparation among patients in an academic safety-net health system.

Background: Rural women lag rural men and urban women in colon cancer (CRC) screening completion. Objective: To identify rural female patients’ knowledge, beliefs, barriers, self-efficacy, prior recommendation and completion of CRC screening using an FOBT and to compare these factors by health literacy (HL) level. Methods: This descriptive study was conducted between 2015 and 2016 in 4 rural community clinics in South Lousiana. Patients overdue for screening were given a structured interview by a research assistant. Results: 339 women were enrolled, mean age 58.5, 32% had limited HL, 66% were African American. Most (91.7%) had heard of CRC, yet only 71% knew of any CRC screening tests. Women with adequate HL had greater knowledge of specific tests than those with limited HL (78.4% vs 56.6%, p

Objective: The objective in this pre- and post-survey assessment was to compare the effectiveness of a health literacy-directed intervention designed to increase knowledge, beliefs, barriers, self-efficacy and behavior associated with CRC screening with FOBT among patients cared for in predominantly rural community clinics and the change in these characteristics over the first 15 months after enrolling in a study designed to assess screening strategies. Methods: Between 2008 and 2011, a quasi-experimental intervention was conducted in 8 predominantly rural Federally Qualified Health Centers. Patients were orally administered a 15-minute survey at enrollment by a clinic research assistant (RA) and at 15 months by phone by a central RA. Participants included 428 community clinic patients aged 50-85 (mean 58.5); the majority (79%) were female, 69% were African American, and 54% had limited health literacy. Results: There was significant improvement across all groups with the number of patients reporting they had been given information /education on CRC testing (p83%) as confirmed by study records.

OBJECTIVE: The aim of this study was to determine the frequency and nature of physician, nurse, and pharmacist verbal counseling at the time of a new prescription for an opioid-acetaminophen containing medication as recalled by patients. DESIGN: A mixed methods approach with data from cross sectional, structured interviews was used. SETTING: The settings were one academic emergency department in Chicago, IL and one outpatient pharmacy at a public hospital in Atlanta, GA. PATIENTS: One hundred forty-nine patients receiving a new prescription for an opioid-acetaminophen medication were enrolled. METHODS: Interviews assessed patient recall of counseling they received from their physician, nurse, and pharmacist upon receiving the new prescription. Their responses were unitized and assigned to categories. RESULTS: One hundred forty-nine patients were enrolled; 61.1% African American and 58.4% female. Seven major categories of responses were noted; frequencies of patient recall for counseling in these categories were reported. Four categories related to the content of the counseling discussion were 1) details of administration (patient recall counseling from: physician/nurse only 44.3%, pharmacist only 5.4%, both providers 12.8%); 2) activities to avoid and side effects (36.2%, 4.7%, 8.7%); 3) medication indication (32.9%, 4%, 4%); and 4) addictive potential (9.3%, 1.3%, 0%). Three categories describe patients' recall of the interaction in broad terms: 5) being referred to print informational material accompanying the prescription (MD/RN only 7.4%, pharmacist only 20.1%, both providers 2.7%); 6) having questions solicited (0%, 11.4%, 0%); 7) having no interaction relating to medication counseling (3.4%, 32.2%, 1.3%). CONCLUSIONS: Patients infrequently recall counseling from providers on topics that are important to prevent harm from opioid-acetaminophen prescriptions. Future patient-centered clinical research should target identifying optimal strategies to convey these critical messages. Language: en

Background: A comparative effectiveness intervention by this team improved initial fecal occult blood testing (FOBT) rates from 3% to 53% among community clinic patients. The purpose of this study was to evaluate the effectiveness and costs associated with a literacy-informed intervention on repeat FOBT testing. Methods: Between 2008 and 2011, a three-arm quasi-experiential comparative effectiveness evaluation was conducted in eight community clinics in Louisiana. Clinics were randomly assigned to receive: enhanced care, a screening recommendation, and FOBT kit annually; a brief educational intervention where patients additionally received a literacy appropriate pamphlet and simplified FOBT instructions; or nurse support where a nurse manager provided the education and followed up with phone support. In year 2, all materials were mailed. The study consisted of 461 patients, ages 50 to 85 years, with a negative initial FOBT. Results: Repeat FOBT rates were 38% enhanced care, 33% education, and 59% with nurse support (P = 0.017). After adjusting for age, race, gender, and literacy, patients receiving nurse support were 1.46 times more likely to complete repeat FOBT screening than those receiving education [95% confidence interval (CI), 1.14–1.06; P = 0.002] and 1.45 times more likely than those in enhanced care but this was not significant (95% CI, 0.93–2.26; P = 0.10). The incremental cost per additional person screened was $2,450 for nurse over enhanced care. Conclusion: A mailed pamphlet and FOBT with simplified instructions did not improve annual screening. Impact: Telephone outreach by a nurse manager was effective in improving rates of repeat FOBT, yet this may be too costly for community clinics. Cancer Epidemiol Biomarkers Prev; 23(1); 134–43. ©2013 AACR.

BACKGROUND We evaluated the effectiveness and cost-effectiveness of alternative interventions designed to promote mammography in safety-net settings.

Recent studies have linked patient misunderstanding of label instructions for as needed (PRN) medications to dosing errors. This study conducted a preliminary field test of patient-centered PRN label instructions. Patients participated in a hypothetical dosing experiment and were randomized to a patient-centered label (referred to as “Take-Wait-Stop”) or standard label. Participants were asked to demonstrate dosing the medicine over 24 hours. Three types of independent dosing errors were measured: (a) taking more than two pills at one time, (b) exceeding the maximum daily dose, and (c) waiting fewer than 4 hours between doses. Generalized linear models were used to assess the association between label type, health literacy, and sociodemographic characteristics. Participants' mean age was 39.8 years, 62.1% were female, 43.7% were White, and 72.4% had adequate literacy. Of participants, 31.8% who were shown the standard label demonstrated taking in excess of 6 pills in 24 hours compared with only 14.0% of participants who were shown the Take-Wait-Stop label (p = .05). Overall, only 1 person demonstrated he would take more than 2 pills in a single dose. Of the standard label group, 20.5% demonstrated dosing intervals of fewer than 4 hours compared with 23.3% of the Take-Wait-Stop label group (p = .75). In a multivariate model, participants who were exposed to the standard label were 2.5 times more likely to exceed the recommended maximum daily dose (95% CI [1.05, 7.70], p = .03). The Take-Wait-Stop label was beneficial in preventing participants from exceeding the maximum dose in 24 hours, although it did not significantly reduce other dosing errors.

Understanding and organizing medication regimens can be challenging, and many patients struggle to properly dose prescribed medicine, potentially leading to less effective treatment or even harm. Generic prescriptions are increasingly common and may change in appearance, adding further complexity. The authors aimed to investigate familiarity with the drug regimen among a cohort of patients with diagnosed hypertension. Specifically, they determined the prevalence of patients' knowledge of their prescribed drug names and dosages compared to those who relied only on physical characteristics (size, shape, color) of their medications. The relationship between patients' identification strategies, self-reported adherence, and health outcomes (blood pressure control, hospitalization) were investigated. Patients who were dependent on the visual identification of their prescription medicine reported worse adherence. In addition, they had significantly lower rates of blood pressure control and greater risk of hospitalization. The ability to identify prescribed medicines by name may be helpful for screening and responding to patients at greater risk of making medication errors or being less engaged with their regimen for adherence purposes.

Background We evaluated the effectiveness and cost-effectiveness of two interventions designed to promote colorectal cancer (CRC) screening in safety-net settings.

This article examines the relationship between literacy and colorectal cancer (CRC) screening knowledge, beliefs, and experiences, with a focus on fecal occult blood tests (FOBTs). Participants were 975 patients in 8 Louisiana federally qualified health centers. Participants were 50 years of age or older and not up to date with CRC screening; approximately half (52%) had low literacy (less than a 9th-grade level). Participants with low literacy were less likely than were those with adequate literacy to be aware of advertisements promoting CRC screening (58.7% vs. 76.3%, p < .0001) or to believe it was very helpful to find CRC early (74.5% vs. 91.9%, p < .0001). The majority of participants had positive beliefs about the benefits of CRC screening using FOBTs. Participants with low literacy had more perceived barriers to FOBT completion and were more likely to strongly agree or agree that FOBTs would be confusing, embarrassing, or a lot of trouble; however, none of these remained significant in multivariate analyses controlling for relevant covariates. Confidence in being able to obtain an FOBT kit was high among those with low and adequate literacy (89.8% vs. 93.1%, respectively, p = .20); yet multivariate analyses revealed a significant difference in regard to literacy (p = .04) with low-literacy participants indicating less confidence. There was no significant difference by literacy in ever receiving a physician recommendation for CRC screening (38.4% low vs. 39.0% adequate, p = .79); however, multivariate analyses revealed significant differences in FOBT completion by literacy (p = .036). Overall, findings suggest that literacy is a factor in patients’ CRC knowledge, beliefs, and confidence in obtaining a FOBT.

Background There is increasing concern over the risk of consumer unintentional misuse of non-prescription (a.k.a. ‘over-the-counter’) medications containing acetaminophen, which could lead to acute liver failure.

BACKGROUND Medication guides are required documents to be distributed to patients in order to convey serious risks associated with certain prescribed medicines. Little is known about the effectiveness of this information to adequately inform patients on safe use.

Between a third and one half of eligible adults in the United States have not received recommended colorectal cancer (CRC) screening services, with socioeconomically disadvantaged, racial/ethnic minority, and rural individuals at greatest risk for not being screened.1–6 Barriers have been extensively studied and include patient (eg, knowledge and awareness of screening, motivation, transportation, health insurance coverage),4,7–11 health system (physician shortages, insurance), and provider (rates of screening recommendation) factors.12–17 Previous research has found that low-income, medically underserved patients, despite provider perceptions, are aware of CRC, want to know if they have cancer, and have positive beliefs about fecal occult blood test (FOBT).7,9,16 This suggests that cost-effective interventions centered around annual occult blood testing can be a convenient method of screening and detecting CRC for safety net clinics such as Federally Qualified Health Centers (FQHCs) whose patients disproportionately face cost and access barriers to colonoscopy.7,18 Identifying effective, efficient, and sustainable practices that can improve CRC screening among less educated (and lower literate), lower-income adults could dramatically advance public health preventive practices and reduce known disparities. To date, a diverse set of interventions has been tried with variable success and intensity. These interventions range from public health strategies that usually involve mailed reminders or test kits to primary care-based education using decision aids, multimedia tools, or targeted provider education to promote recommendation and organizational change such as nurses giving FOBT cards, instructions, and reminders.7,11,12,19 To our knowledge, no research investigation has currently deconstructed the value of core elements that have been perceived as requisite components to primary care screening strategies to best understand exactly which activities are necessary to engage patients in screening. In this study, our purpose was to determine the effect of common components of primary care-based CRC screening interventions on FOBT completion within rural and urban community clinics, including: (1) a physician’s spoken recommendation, (2) providing information or education about FOBTs, and (3) a physician providing the FOBT kit. Each of these components may appear simple and easily administered, although each can be challenging to deliver and sustain in safety net environments. Therefore, a second purpose was to determine the relative effect of these interventions within rural and urban FQHCs. Finally, comparison of the effect of each intervention between rural and urban clinics was investigated to provide tailored guidance to support the development and implementation of CRC screening promotions for both low-income urban and rural patients in order to best achieve health care equity.

Background In the U.S., acetaminophen overdose has surpassed viral hepatitis as the leading cause of acute liver failure, and misuse contributes to more than 30,000 hospitalizations annually. Half to two thirds of acetaminophen overdoses are unintentional, suggesting the root cause is likely poor understanding of medication labeling or failure to recognize the consequences of exceeding the recommended maximum daily dosage. Purpose Elicit subject feedback about active ingredient and dosing information on over-the-counter (OTC) acetaminophen and elicit feedback on proposed plain-language text and icons. Methods Six focus groups, preceded by individual interviews, were conducted in April 2010 among 45 adults in two cities from two clinics and an adult basic education center. The individual interviews evaluated knowledge of OTC pain relievers, attention to product label information and literacy level while the group discussion elicited preference for label messages and icons. Analyses were conducted from April to June 2010. Results Forty-four percent read at or below the 6th-grade level. Individual interviews revealed that ® . The groups achieved consensus on a preferred icon for acetaminophen, desired explicit statement of potential liver damage in the warning against simultaneous use of acetaminophen products, and indicated preference for an icon and wording for maximum dose. Conclusions With the high prevalence of OTC use, a consumer-centered approach to developing icons and messages to promote awareness and safe use of acetaminophen could benefit consumers.

The objectives of the study were to analyze literacy in 194 consecutive patients at an academic rheumatology setting with the Rapid Estimate of Adult Literacy in Medicine (REALM) and an "Arthritis-Adapted" REALM (A-REALM), and to compare responses to one another and to demographic and clinical measures.The REALM and A-REALM are two 66-item word recognition tests. Both were administered to 194 consecutive patients in usual rheumatology care. Multidimensional Health Assessment Questionnaire (MDHAQ) scores for physical function, pain, fatigue, and global estimate, and laboratory assessments also were available. Descriptive statistics and analyses of agreement were computed.REALM and A-REALM administration involved 2 to 3 minutes each. Scores below 61, indicating a reading level at eighth grade or less, were seen in 35 (18%) of 194 patients on the REALM and 46 patients (24%) on the A-REALM. No patient was classified as having severely low literacy at or below a third-grade level. However, words not read correctly by 10% or more of the patients on the REALM included diagnosis (14%), osteoporosis (17%), and inflammatory (10%), and on the A-REALM, rheumatologist (11%), cartilage (14%), and symptom (14%). REALM and A-REALM scores were correlated significantly (Pearson r = 0.94, P0.001). Almost all patients (33/35) with REALM scores of less than 61 also had A-REALM scores of less than 61, less formal education, and poorer clinical status on all measures, most not statistically significant.Low literacy is an important underrecognized problem in medical care, which may be assessed easily in standard care using the REALM or A-REALM. Further attention to literacy-associated barriers may reduce socioeconomic disparities in health.

In 2008, 14.6% of households in the United States (more than 49 million people) were food insecure, or at risk of going hungry because of an inability to afford food.1 Food insecurity exists whenever “the availability of nutritionally adequate and safe foods or the ability to acquire acceptable foods in socially acceptable ways [e.g., without resorting to emergency food supplies, scavenging, stealing or other coping strategies] is limited or uncertain.”2[p.1560] There are a number of ways in which food insecurity might impair diabetes self-management. First, to maintain caloric intake, food-insecure adults often shift their diets toward energy-dense, nutritionally-poor foods (such as refined carbohydrates, added sugars, and added fats), which diabetic patients are counseled to avoid in order to optimize glycemic control. Such foods are less expensive than equicaloric portions of fruits, vegetables, and dairy products.3,4 Second, daily caloric and carbohydrate intake may fluctuate widely in response to food availability, making blood glucose levels unpredictable and complicating the development of optimal medication and insulin regimens.5,6 Finally, the cost of food among those with food insecurity may present a competing demand with costs of diabetes medication and supplies. Prior research has shown that food insecurity is associated with suboptimal glycemic control among adults with diabetes,7,8 but mechanisms for this association have not been studied. We hypothesized that the association between food insecurity and suboptimal glycemic control is due to increased difficulty with diabetes self-management and more frequent episodes of clinically significant hypoglycemia (which may encourage clinicians to relax glycemic targets).

35 Background: Colorectal cancer (CRC), the second leading cause of cancer death in the US, can be significantly reduced if it is detected early. Although overall CRC screening rates have increased significantly, disparities persist among low income individuals, adults with low literacy and those living in rural areas. Methods: Randomized controlled trial to assess the effectiveness of 2 health literacy informed phone follow-up strategies to improve annual screening with Fecal Immunochemical Test (FIT) in 4 rural community clinics. Eligible patients, age 50-75, were recruited. After consenting, a research assistant (RA) recommended screening and gave literacy and culturally appropriate education using a pamphlet, the FIT kit, simplified instructions and a demonstration of how to use it, At 4 weeks patients who had not returned their kit receive either 1) a personal follow-up call (PC) from a central RA using motivational interviewing skills and reminding them to complete FIT kits; or 2) an automated follow-up call (AC) using plain language and motivational messages encourages patients to complete the FIT. During years 2 and 3, FIT kits were mailed to patients. Follow-up call procedures previously used were followed. Results: 620 patients not up-to-date were enrolled: 308/AC & 306/PC; 66% were African American, 55% women; 40% had limited literacy. During Year 1, 69% completed screening in AC arm versus 67% in PC arm. During Year 2, percentage screened decreased: 40% screened in AC arm and 37% in PC arm. Number of patients that needed at least one follow-up called increased: 74% in both arms needed at least 1 reminder call. Among those called, 19% in the AC arm completed their kit versus 15% in the PC arm. To date in Year 3, 32% screened in AC and 34% in PC. Conclusions: Simplified instructions accompanied by a face-to-face demonstration of FIT, use of “teach back” to confirm understanding with a follow-up call if needed, facilitated completion rates of all patients, particularly those with limited literacy. The less costly and time consuming automated call was equally effective as a personal call. Screening rates in years 2 and 3 declined. CRC screening with FIT is only effective when completed annually. Clinical trial information: RSG-13-021-01 - CPPB.

Introduction: Colorectal cancer (CRC), the second leading cause of cancer death in the United States, can be significantly reduced if it is detected early. Although overall CRC screening rates have increased significantly, disparities persist among low-income individuals, adults with low literacy, and those living in rural areas. These groups all have screening completion rates below 50%. Objectives: To assess patient knowledge, beliefs, and self-efficacy about CRC screening and compare the effectiveness of two health literacy informed telephone follow-up strategies to improve annual screening over a three-year period with fecal immunochemical test (FIT) in rural community clinics. Methods: A two-arm, randomized controlled trial is being implemented in four community clinics. Clinics reported CRC baseline screening rates of 3% to 5%. Eligible patients, age 50-75, were recruited at the clinic prior to a scheduled appointment. A research assistant (RA) conducted a baseline structured interview measuring CRC screening knowledge, beliefs, and self-efficacy. The RA then recommended screening and gave brief literacy and culturally appropriate education using a pamphlet (4th-grade level), the FIT kit with preaddressed envelope, simplified instructions (3rd-grade level), and a demonstration of how to use it. At four weeks patients who had not returned their kit received either 1) a personal follow-up call (PC) from a central prevention coordinator using motivational interviewing skills and reminding them to complete and mail FIT kits, or 2) an automated follow-up call (AC) using plain language and motivational messages encouraging patients to complete and mail the FIT. Outcomes include FIT completion after intervention, and again at 12 and 24 months. Results: 620 patients not up to date with screening were enrolled: 64% African American, 56% women, 40% inadequate literacy. Although 90% reported having heard of CRC, only 64% knew a test to check for CRC. 70% reported that a provider had recommended CRC screening in the past and 91% reported they would want to know if they have CRC. Self-efficacy was high, with over 90% indicating they would return the kit to the lab. Screening results: 620 patients enrolled (AC: n=308 / PC: n=306); 418 (68%) completed tests (AC: n=213 (69%) / PC: n=205 (67%)). Follow-up calls for unreturned kits--AC: 124 (40%) people called--29 returned FIT (9.4% of people called completed FIT). PC: 127 (41%) people called--26 returned FIT (9.4% of people called completed FIT). 2nd-year screening: 255 second kits mailed out to date (AC: n=128/PC: n=125); 98 (38.5%) completed tests (AC: n=49 (38%) / PC: n=49 (39%)). Follow-up calls for unreturned kits--AC: 89 (70%) people called—19 returned FIT (14.8% of people called completed FIT). PC: 82 (66%) people called—17 returned FIT (13.6% of people called completed FIT). Discussion: Implementing health literacy influenced CRC education, and screening strategies using the FIT and phone reminders dramatically increased FIT completion in rural community clinics. The less costly and time-consuming automated call was equally effective as a personal call. Citation Format: Connie L. Arnold, Terry C. Davis, Alfred Rademaker, James Morris, Glenn Mills. Sustaining annual colorectal cancer screening in rural community health clinics using the fecal immunochemical test (FIT) [abstract]. In: Proceedings of the Tenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2017 Sep 25-28; Atlanta, GA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2018;27(7 Suppl):Abstract nr B11.

Background: Disparities exists in recruitment in clinical trials and biorepositories among minority groups, rural residents and individuals with low SES.Objective. Identify barriers and facilitators to awareness, understanding and acceptance of clinical trials and biobanking among safety-net patients and providers and support group participants and African American (AA) social and church groups. Methods: We conducted 14 focus groups and 7 individual interviews January - May 2017 in urban and rural communities in Louisiana. Sites included safety-net oncology and primary care clinics, social service agencies, social and faith based groups. Themes were identified. Results: 103 individuals participated: 78 clinic patient and community participants, 25 providers; 24% participants lived in rural areas. Patients and community members ranged in age from 45-88; 85% were female, 78% AA. Participants had an increasing awareness of clinical trials and personalized medicine due to ads on TV. Low income and minority patients were open to participating in genomic trials and biobanking even if it would not benefit them directly. Cancer patients and Alzheimer family caregivers were highly interested in clinical trials that might benefit them or their family. Community participants were less trusting of clinical trials than patients. All said information and recommendations about clinical trials would be most effective and actionable if it comes from a trusted physician. Terms such as clinical trials and biobanking were scary to some and not understood - medical studies and a bank to store blood and tissue were clearer. African American participants indicated that a recruitment message needs to be “ALL people are needed for studies to improve treatments” rather than “AA have been underrepresented and most treatments based on whites” which raises suspicion. Some participants were concerned with who would see data and if it would be a barrier to jobs or insurance - despite being told of protections in place for confidentiality. Rural and urban providers (n=25) were interested in being more involved in clinical trials. They lacked time to identify trials and explain them to patients. They wanted brief, plain language handouts with talking points and a card to give patients to call for more information. Transportation to academic centers is a barrier to patient participation in clinical trials. Very few patients, caregivers or providers had looked for clinical trials on the internet or social media. Conclusions: African American and white adults were interested in clinical trials but not clear how to learn about them. Most were willing to participate but had never been asked. Recommendation to participate in a clinical trial is most effective coming from a trusted physician. Methods for getting community providers and the public useful information needs to be created with target audiences. Citation Format: Terry Davis, Connie Arnold, Lucio Miele, Glenn Mills. Biobanking and genomic research: Understanding and acceptance of safety-net patients, primary care providers and minority groups [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 3010.

The relationship between literacy and health outcomes are well documented in adult medicine, yet specific causal pathways are not entirely clear. Despite an incomplete understanding of the problem, numerous interventions have already been implemented with variable success. Many of those who proposed earlier strategies assumed the problem to originate from reading difficulties only. Given the timely need for more effective interventions, it is of increasing importance to reconsider the meaning of health literacy to advance our conceptual understanding of the problem and how best to respond. One potentially effective approach might involve recognizing the known associations between a larger set of cognitive and psychosocial abilities with functional literacy skills. Here we review the current health literacy definition and literature and draw on relevant research from the fields of education, cognitive science, and psychology. In this framework, a research agenda is proposed that considers an individual's "health-learning capacity," which refers to the broad constellation of cognitive and psychosocial skills from which patients or family members must draw to effectively promote, protect, and manage their own or a child's health. This new, related concept will lead, ideally, to more effective ways of thinking about health literacy interventions, including the design of health-education materials, instructional strategies, and the delivery of health care services to support patients and families across the life span.

A brief, 8-item assessment of HIV treatment knowledge and action was developed and evaluated. Patients with HIV were interviewed in 2001 at infectious disease clinics in Shreveport, LA and Chicago, IL. Analyses on demographics, self-reported medication adherence, and responses to the Rapid Estimate of Adult Literacy in Medicine (REALM) and new, Brief Estimate of Health Knowledge and Action-HIV version (BEHKA-HIV) were performed in 2007. The BEHKA-HIV demonstrated high internal consistency, and construct validity. Lower scores on the BEHKA-HIV were independently associated with poorer rates of HIV medication adherence, scores 4-5 out of 8, AOR 2.6 (95% CI 1.9-3.6), and scores 0-3, AOR 11.4 (95% CI 8.2-15.9), as were the lowest scores on the REALM, AOR 3.3 (95% CI 1.3-8.7). The BEHKA-HIV is a psychometrically sound tool for assessing health knowledge and action regarding HIV treatment, and predicting non-adherence to HIV medications.

Objective To assess the efficacy of a literacy-appropriate weight loss intervention targeting providers and patients in improving physicians’ weight loss counseling and patients’ self-reported beliefs, and self-efficacy. Methods The study took place in a public hospital nephrology clinic. The intervention included two physician workshops and a small group patient education. Physician–patient communication was observed and coded. Structured interviews assessed patient recall of weight loss recommendations, weight-related beliefs, and self-efficacy. Results 64 patient visits were observed before and after the intervention. 75% of patients were African American, 96% lacked private insurance, 71% had low literacy skills; mean body mass index (BMI) of 35 kg/m2. Physician counseling improved significantly post-intervention, particularly in assessing, supporting and advising patients about weight loss and exercise. Patients reported increases in recall of weight loss recommendations and were more likely to report greater confidence about losing weight (52% vs. 70%, p Conclusions This pilot study offers promising directions to address provider and patient barriers to weight loss education and counseling in a public hospital. Practice implications Hospital-based weight loss interventions need to target both physicians and patients.

Prior studies have linked limited literacy to poorer HIV medication adherence, although the precise causal pathways of this relationship have only been initially investigated.To examine whether social stigma is a possible mediator to the relationship between literacy and self-reported HIV medication adherence.Structured patient interviews with a literacy assessment, supplemented by medical chart review, were conducted among patients receiving care at infectious disease clinics in Shreveport, Louisiana and Chicago, Illinois. Literacy was measured using the Rapid Estimate of Adult Literacy in Medicine (REALM), while stigma was measured using items taken from the Patient Medication Adherence Questionnaire (PMAQ).Two hundred and four consecutive patients participated.Approximately one-third of the patients (30.4%) were less than 100% adherent to their regimen, and 31.4% had marginal (7th-8th grade) or low (or = 6th grade) literacy. In multivariate analyses, patients with low literacy were 3.3 times more likely to be non-adherent to antiretroviral regimens (95% CI 1.3-8.7; p0.001). Perceived social stigma was found to mediate the relationship between literacy and medication adherence (AOR 3.1, 95% CI 1.3-7.7).While low literacy was a significant risk factor for improper adherence to HIV medication regimens in our study, perceived social stigma mediated this relationship. Low literacy HIV intervention strategies may also need to incorporate more comprehensive psychosocial approaches to overcome stigma barriers.

We examined the relationship between patient literacy level and self-reported HIV medication adherence, while estimating the mediating roles of treatment knowledge and self-efficacy on this relationship.Structured patient interviews with a literacy assessment, supplemented by medical chart review, were conducted among 204 consecutive patients receiving care at infectious disease clinics in Shreveport, Louisiana and Chicago, Illinois. Literacy was measured using the Rapid Estimate of Adult Literacy in Medicine (REALM), while the Patient Medication Adherence Questionnaire (PMAQ) was used to assess medication self-efficacy and adherence to antiretroviral regimens in the past 4 days.Approximately one-third of patients (30.4%) were less than 100% adherent to their regimen, and 31.4% had marginal to low literacy skills. In multivariate analyses, low literate patients were 3.3 times more likely to be non-adherent to their antiretroviral regimen (p0.001). Patients' self-efficacy, but not knowledge, mediated the impact of low literacy on medication adherence (AOR 7.4, 95% CI 2.7-12.5).While low literacy was a significant risk factor for improper adherence to HIV medication regimens in our study, self-efficacy mediated this relationship.Comprehensive intervention strategies that go beyond knowledge transfer may be needed to address self-efficacy among patients across all literacy levels to be successful in the management of difficult medication schedules.

Objectives Empirical evidence regarding cancer screening and health literacy is mixed. Cancer is the leading cause of death in Asian Americans, yet screening rates are notably low. Using a population-based sample, we determined if health literacy: (1) was associated with breast and cervical cancer screening, and (2) helped to explain Asian cancer screening disparities. Methods We analyzed the 2007 California Health Interview Survey for Asian (Japanese, Chinese, Filipino, Korean, Vietnamese, other Asian) and white women within age groups relevant to US Preventive Services Task Force (USPSTF) screening guidelines: cervical: ages 21–65 (n = 15,210) and breast: ages 50–74 (n = 11,163). Multilevel logistic regression models predicted meeting USPSTF screening guidelines both with and without self-reported health literacy controlling for individual-level and contextual-level factors. Results Low health literacy significantly (p

Objectives Cancer is the leading cause of death among Asian Americans. Chinese Americans comprise the largest Asian American ethnic group. Low health literacy (LHL) is associated with lower cancer screening rates, but this association has not been studied in Chinese Americans. We examined the relationship between LHL and meeting US Preventive Service Task Force (USPSTF) guidelines for cervical, colorectal and breast cancer screening among Chinese Americans. Design Observational study of Chinese respondents in the 2007 California Health Interview Survey, a population-based survey. Interview languages included English, Cantonese and Mandarin. Setting California, USA Participants Chinese respondents in age/gender groupings appropriate for USPSTF cancer screening guidelines (cervical: women ages 21–65, n=632; colorectal: men or women ages 50–75, n=488; and breast: women ages 50–74, n=326). Outcomes Relationships were tested using multivariable logistic regression models controlling for healthcare access and demographic factors, including limited English proficiency (LEP). The combined effects of having both LHL and LEP were specifically examined. LHL was measured by 2-items on perceived ease-of-use of written medical materials. All study variables were self-reported. Results Cancer screening percentages among Chinese Americans were 77.8% for cervical, 50.9% for colorectal (47.9% for women and 54.2% for men), and 85.5% for breast. LHL was associated with lower odds of meeting breast cancer screening guidelines (OR 0.41; 95% CI 0.20 to 0.82). Respondents with both LHL and LEP were significantly less likely to have up-to-date colorectal (OR 0.49; 95% CI 0.25 to 0.97) and breast cancer screening (OR 0.21; 95% CI 0.08 to 0.54) than those with neither health communication barrier. In all multivariable models, having seen a physician in the past year was a significant predictor of an up-to-date screening. Conclusions In Chinese Americans, LHL and LEP were negatively associated with up-to-date breast and colorectal cancer screening, independent of a recent physician visit. Efforts to promote cancer screening among Chinese Americans should consider and address LHL, LEP and physician access barriers.

Despite growing evidence of the magnitude and consequences of low health literacy, little, if any, work has explored how federal health agencies or other organizations are responding to this proble...

Objective: To assess patient understanding and use of oral contraceptive pills (OCPs) and determine if these are associated with literacy. Methods: Four hundred OCP users from a southern public health family planning clinic were orally tested post visit for literacy, demographics, contraceptive knowledge, OCP use, side effects, and adherence. Results: Patients were predominately African American (86%); 78% had completed high school and 42% read below a 9th grade level. Most (94%) understood what to do when they missed one pill, yet few knew the correct action to take after missing two or three pills (19% and 3% respectively); 33% reported missing one or more pills in the past 2 weeks. Literacy was not associated with OCP use, knowledge, or adherence. Conclusion: Patients of all literacy levels had limited understanding of OCP side effects and what to do about multiple missed pills. This puts them at risk for misuse.

Purpose. The common causes for misunderstanding prescription drug warning labels (PWLs) among adults with low literacy were studied. Methods. A total of 74 patients reading at or below the sixth-grade level and receiving care at the primary care clinic at the Louisiana State University Health Sciences Center in Shreveport were recruited to participate in structured interviews. Patients were asked to interpret and comment on eight commonly used warning labels found on prescription medications. Correct interpretation was determined by expert panel review of patients’ verbatim responses. Qualitative methods were employed to code responses and generate themes regarding the misunderstanding of these PWLs. Results. Among this sample of patients with low literacy skills, rates of correct interpretation for the eight warning labels ranged from 0% to 78.7%. With the exception of the most basic label, less than half of all patients were able to provide adequate interpretations of the warning label messages. Five themes were derived to describe the common causes for misunderstanding the labels: single-step versus multiple-step instructions, reading difficulty of text, use of icons, use of color, and message clarity. Labels were at greater risk for being misunderstood if they included multiple instructions, had a greater reading difficulty, included unfamiliar terms, or used confusing icons that were discordant with text messages. Participants also frequently imposed an incorrect meaning on label colors, which led to further confusion. Conclusion. Patients with low literacy skills demonstrated a lower rate of correct interpretation of the eight most commonly used PWLs than did those with higher literacy skills. Multiple-step instructions, reading difficulty of text, the use of icons, the use of color, and message clarity were the common causes of label misinterpretation.