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OBJECTIVE: Studies have consistently shown that African American individuals lose less weight in response to behavioral interventions, but the mechanisms leading to this result have been understudied. METHODS: Data were derived from the PROmoting Successful Weight Loss in Primary CarE in Louisiana (PROPEL) study, which was a cluster-randomized, two-arm trial conducted in primary care clinics. In the PROPEL trial, African American individuals lost less weight compared with patients who belonged to other racial groups after 24 months. In the current study, counterfactual mediation analyses among 445 patients in the intervention arm of PROPEL were used to determine which variables mediated the relationship between race and weight loss. The mediators included treatment engagement, psychosocial, and lifestyle factors. RESULTS: At 6 months, daily weighing mediated 33% (p = 0.008) of the racial differences in weight loss. At 24 months, session attendance and daily weighing mediated 35% (p = 0.027) and 66% (p = 0.005) of the racial differences in weight loss, respectively. None of the psychosocial or lifestyle variables mediated the race-weight loss association. CONCLUSIONS: Strategies specifically targeting engagement, such as improving session attendance and self-weighing behaviors, among African American individuals are needed to support more equitable weight losses over extended time periods.
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Estilo de Vida , Redução de Peso , Humanos , Negro ou Afro-Americano , Fatores Raciais , Grupos Raciais , Redução de Peso/fisiologiaRESUMO
OBJECTIVE: This study tested whether initial weight change (WC), self-weighing, and adherence to the expected WC trajectory predict longer-term WC in an underserved primary-care population with obesity. METHODS: Data from the intervention group (n = 452; 88% women; 74% Black; BMI 37.3 kg/m2 [SD: 4.6]) of the Promoting Successful Weight Loss in Primary Care in Louisiana trial were analyzed. Initial (2-, 4-, and 8-week) percentage WC was calculated from baseline clinic weights and daily at-home weights. Weights were considered adherent if they were on the expected WC trajectory (10% at 6 months with lower [7.5%] and upper [12.5%] bounds). Linear mixed-effects models tested whether initial WC and the number of daily and adherent weights predicted WC at 6, 12, and 24 months. RESULTS: Percentage WC during the initial 2, 4, and 8 weeks predicted percentage WC at 6 (R2 = 0.15, R2 = 0.28, and R2 = 0.50), 12 (R2 = 0.11, R2 = 0.19, and R2 = 0.32), and 24 (R2 = 0.09, R2 = 0.11, and R2 = 0.16) months (all p < 0.01). Initial daily and adherent weights were significantly associated with WC as individual predictors, but they only marginally improved predictions beyond initial weight loss alone in multivariable models. CONCLUSIONS: These results highlight the importance of initial WC for predicting long-term WC and show that self-weighing and adherence to the expected WC trajectory can improve WC prediction.
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Estilo de Vida , Obesidade , Humanos , Feminino , Masculino , Obesidade/terapia , Obesidade/epidemiologia , Louisiana , Redução de Peso , Atenção Primária à Saúde , Índice de Massa CorporalRESUMO
BACKGROUND: Currently there are limited data as to whether dietary intake can be improved during pragmatic weight loss interventions in primary care in underserved individuals. METHODS: Patients with obesity were recruited into the PROPEL trial, which randomized 18 clinics to either an intensive lifestyle intervention (ILI) or usual care (UC). At baseline and months 6, 12, and 24, fruit and vegetable (F/V) intake and fat intake was determined. Outcomes were analyzed by repeated-measures linear mixed-effects multilevel models and regression models, which included random cluster (clinic) effects. Secondary analyses examined the effects of race, sex, age, and food security status. RESULTS: A total of 803 patients were recruited. 84.4% were female, 67.2% African American, 26.1% received Medicaid, and 65.5% made less than $40,000. No differences in F/V intake were seen between the ILI and UC groups at months 6, 12, or 24. The ILI group reduced percent fat at months 6, 12, and 24 compared to UC. Change in F/V intake was negatively correlated with weight change at month 6 whereas change in fat intake was positively associated with weight change at months 6, 12, and 24 for the ILI group. CONCLUSIONS: The pragmatic weight loss intervention in primary care did not increase F/V intake but did reduce fat intake in an underserved population with obesity. F/V intake was negatively associated with weight loss at month 6 whereas percent fat was positively correlated with weight loss throughout the intervention. Future efforts better targeting both increasing F/V intake and reducing fat intake may promote greater weight loss in similar populations. TRIAL REGISTRATION: NCT Registration: NCT02561221.
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Ingestão de Alimentos , Populações Vulneráveis , Humanos , Feminino , Masculino , Obesidade/terapia , Redução de Peso , Atenção Primária à SaúdeRESUMO
BACKGROUND: Diverse, equitable and inclusive participation in clinical research is needed to ensure evidence-based clinical practice and lessen disparities in health outcomes. Yet, clinical trial participation remains critically low in minoritized communities, particularly among Blacks. The Louisiana Community Engagement Alliance against COVID-19 Disparities (LA-CEAL) was launched in response to the disproportionate impact of COVID-19 on Black Louisianans to understand community barriers and preferences and increase inclusive participation in research. This study aims to understand perceptions regarding COVID-19 trial participation among underrepresented Louisianans. METHODS: A rapid assessment integrating cross-sectional, surveys among federally qualified health center (FQHC) patients and community residents, and focus group discussions (FGDs) from community representatives was conducted in 2020-2021. Factors and perceptions underlying trial participation were identified using logistic regression models and thematic analyses, respectively. RESULTS: Quantitative findings (FQHC: N=908, mean age=46.6 years, 66.4% Black; community: N=504, mean age=54.2 years, 93.7% Black) indicated that 0.9% and 3.6%, respectively, ever participated in a COVID-19 trial. Doctors/Healthcare providers were most trusted (FQHC=55.1%; community=59.3%) sources of information about trials. Advancing age was associated with increased odds of being very willing to participate (ORFQHC=1.03, 95% CI 1.02-1.05; ORCommunity=1.02, 95% CI 1.00-1.04). Qualitative data (6 FGDs, 29 attendees) revealed limited awareness, experimentation/exploitation-based fears, and minimal racial/ethnic representation among trialists as barriers to participation. CONCLUSION: COVID-19 trial participation rates were low in our sample. Altruism was a key facilitator to participation; fear, mistrust, and low awareness were predominant barriers. Community-centered approaches, engaging informed providers and trusted community members, may facilitate inclusive trial participation.
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COVID-19 , Humanos , Pessoa de Meia-Idade , Pesquisa Qualitativa , Estudos Transversais , COVID-19/epidemiologia , Grupos Focais , LouisianaRESUMO
Using data from the Louisiana Department of Public Health, we explored the spatial relationships between the Social Vulnerability Index (SVI) and COVID-19-related vaccination and mortality rates. Publicly available COVID-19 vaccination and mortality data accrued from December 2020 to October 2021 was downloaded from the Louisiana Department of Health website and merged with the SVI data; geospatial analysis was then performed to identify the spatial association between the SVI and vaccine uptake and mortality rate. Bivariate Moran's I analysis revealed significant clustering of high SVI ranking with low COVID-19 vaccination rates (1.00, p < 0.001) and high smoothed mortality rates (0.61, p < 0.001). Regression revealed that for each 10% increase in SVI ranking, COVID-19 vaccination rates decreased by 3.02-fold (95% CI = 3.73-2.30), and mortality rates increased by a factor of 1.19 (95% CI = 0.99-1.43). SVI values are spatially linked and significantly associated with Louisiana's COVID-19-related vaccination and mortality rates. We also found that vaccination uptake was higher in whites than in blacks. These findings can help identify regions with low vaccination rates and high mortality, enabling the necessary steps to increase vaccination rates in disadvantaged neighborhoods.
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BACKGROUND: Most health literacy measures require in-person administration or rely upon self-report. OBJECTIVE: We sought to develop and test the feasibility of a brief, objective health literacy measure that could be deployed via text messaging or online survey. DESIGN: Participants were recruited from ongoing NIH studies to complete a phone interview and online survey to test candidate items. Psychometric analyses included parallel analysis for dimensionality and item response theory. After 9 months, participants were randomized to receive the final instrument via text messaging or online survey. PARTICIPANTS: Three hundred six English and Spanish-speaking adults with ≥ 1 chronic condition MAIN MEASURES: Thirty-three candidate items for the new measure and patient-reported physical function, anxiety, depression, and medication adherence. All participants previously completed the Newest Vital Sign (NVS) in parent NIH studies. KEY RESULTS: Participants were older (average 67 years), 69.6% were female, 44.3% were low income, and 22.0% had a high school level of education or less. Candidate items loaded onto a single factor (RMSEA: 0.04, CFI: 0.99, TLI: 0.98, all loadings >.59). Six items were chosen for the final measure, named the HL6. Items demonstrated acceptable internal consistency (α=0.73) and did not display differential item functioning by language. Higher HL6 scores were significantly associated with greater educational attainment (r=0.41), higher NVS scores (r=0.55), greater physical functioning (r=0.26), fewer depressive symptoms (r=-0.20), fewer anxiety symptoms (r=-0.15), and fewer barriers to medication adherence (r=-0.30; all p<.01). In feasibility testing, 75.2% of participants in the text messaging arm completed the HL6 versus 66.2% in the online survey arm (p=0.09). Socioeconomic disparities in completion were more common in the online survey arm. CONCLUSIONS: The HL6 demonstrates adequate reliability and validity in both English and Spanish. This performance-based assessment can be administered remotely using commonly available technologies with fewer logistical challenges than assessments requiring in-person administration.
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Letramento em Saúde , Adulto , Humanos , Feminino , Masculino , Reprodutibilidade dos Testes , Idioma , Inquéritos e Questionários , Transtornos de Ansiedade , PsicometriaRESUMO
OBJECTIVES: To examine Influenza and COVID-19 vaccine concerns and uptake among adult patients in a Southern safety-net health system. METHODS: Trained research assistants conducted a structured telephone interview from April to October 2021. Of 118 participants, mean age was 57.7 years, 63.6% were female, 55.1% were Black, 42.4% white, and 54.2% reported rural residence. RESULTS: Among participants, 44.9% had received the influenza vaccine during the 2020 to 2021 season, and 66.1% had received the COVID-19 vaccine. Participants who received the influenza vaccine were more likely to report getting a COVID-19 vaccine compared to those who reported not getting a flu vaccine (81.1% vs 53.8%, P = .002). Black adults were significantly less likely than white adults (29.2% vs 46.0%, P = .048) and bordering on significance, males less likely than females (27.9% vs 41.3%, P = .054) to have reported receiving both vaccines. Of note, 25.4% of participants did not get either vaccine. The most common reasons for not getting the influenza vaccine were not being concerned about getting the flu (13.8%) and belief the vaccine gave them the flu (12.3%). The primary reasons for not getting a COVID-19 vaccine were concern about vaccine safety (22.5%), concern about side effects (20.0%), and belief they were not going to get sick (20.0%). CONCLUSIONS: These findings could help direct regional vaccine messaging and clinical communication to improve vaccine uptake among underserved populations.
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Vacinas contra COVID-19 , Vacinas contra Influenza , Provedores de Redes de Segurança , Vacinação , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , COVID-19/prevenção & controle , Vacinas contra COVID-19/efeitos adversos , Vacinas contra Influenza/efeitos adversos , Influenza Humana/prevenção & controle , Vacinação/psicologia , Vacinação/estatística & dados numéricosRESUMO
We examined COVID-19 concerns, vaccine acceptance, and trusted sources of information among patients in a safety-net health system in Louisiana. The participants were surveyed via structured telephone interviews over nine months in 2021. Of 204 adult participants, 65% were female, 52% were Black, 44.6% were White, and 46.5% were rural residents. The mean age was 53 years. The participants viewed COVID-19 as a serious public health threat (8.6 on 10-point scale). Black adults were more likely to perceive the virus as a threat than White adults (9.4 vs. 7.6 p < 0.0001), urban residents more than rural (9.0 vs. 8.2 p = 0.02), females more than males (8.9 vs. 8.1 p = 0.03). The majority (66.7%) had gotten the COVID-19 vaccine, with females being more likely than males (74.7 vs. 54.5% p = 0.02). There was no difference by race or rural residence. Overall, participants reported that physicians were the most trusted source of COVID-19 vaccine information (77.6%); followed by the CDC/FDA (50.5%), State Department of Health (41.4%), pharmacists (37.1%), nurses (36.7%); only 3.8% trusted social media. All sources were more trusted among black adults than White adults except family and social media. These findings could help inform efforts to design trustworthy public health messaging and clinical communication about the virus and vaccines.
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Examine COVID-19 knowledge, concerns, behaviors, stress, and sources of information among patients in a safety-net health system in Louisiana. Research assistants surveyed participants via structured telephone interviews from April to October 2020. The data presented in this study were obtained in the pre-vaccine availability period. Of 623 adult participants, 73.5% were female, 54.7% Black, and 44.8% lived in rural small towns; mean age was 48.69. Half (50.5%) had spoken to a healthcare provider about the virus, 25.8% had been tested for COVID-19; 11.4% tested positive. Small town residents were less likely to be tested than those in cities (21.1% vs 29.3%, p = 0.05). Knowledge of COVID-19 symptoms and ways to prevent the disease increased from (87.9% in the spring to 98.9% in the fall, p < 0.001). Participants indicating that the virus had 'changed their daily routine a lot' decreased from 56.9% to 39.3% (p < 0.001). The main source of COVID-19 information was TV, which increased over time, 66.1-83.6% (p < 0.001). Use of websites (34.2%) did not increase. Black adults were more likely than white adults (80.7% vs 65.6%, p < 0.001) to rely on TV for COVID-19 information. Participants under 30 were more likely to get COVID-19 information from websites and social media (58.2% and 35.8% respectively). This study provides information related to the understanding of COVID-19 in rural and underserved communities that can guide clinical and public health strategies.
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COVID-19 , Mídias Sociais , Adulto , COVID-19/epidemiologia , Feminino , Comportamentos Relacionados com a Saúde , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , SARS-CoV-2 , Inquéritos e QuestionáriosRESUMO
Colorectal cancer (CRC) screening has been shown to decrease CRC mortality, yet significant disparities persist among those living in rural areas, from minority backgrounds, and those having low income. The purpose of this two-arm randomized controlled trial is to test the effectiveness and fidelity of a stepped care (increasing intensity as needed) approach to promoting 3-year adherence to CRC screening via fecal immunochemical testing (FIT) or colonoscopy in rural community clinics serving high rates of low-income and minority patients. We hypothesize that, compared to enhanced usual care (EUC), patients receiving the multifaceted CRC screening intervention will demonstrate higher rates of CRC screening completion over 3 years. Participants from six federally qualified health centers (FQHCs; N = 1200 patients) serving predominately low-income populations in rural Louisiana will be randomized to the intervention or EUC arm. All participants will receive health literacy-directed CRC counseling, simplified materials about both the FIT and colonoscopy procedures, and motivational interviewing to aid in the determination of test preference. Participants in the intervention arm will also receive motivational reminder messages from their primary care provider (via audio recording or tailored text) for either a scheduled colonoscopy or return of a completed FIT. Participants in the EUC arm will receive the standard follow-up provided by their clinic or colonoscopy facility. The primary outcome will be completion of either colonoscopy or annual FIT over 3 years. Results will provide evidence on the effectiveness of the intervention to decrease disparities in CRC screening completion related to health literacy, race, and gender. Trial registration:Clinicaltrials.gov Identifier NCT04313114.
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Neoplasias Colorretais , População Rural , Colonoscopia/métodos , Neoplasias Colorretais/diagnóstico , Centros Comunitários de Saúde , Detecção Precoce de Câncer/métodos , Humanos , Programas de Rastreamento/métodos , Sangue OcultoRESUMO
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 < 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.
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Antineoplásicos , Leucemia Mielogênica Crônica BCR-ABL Positiva , Administração Oral , Antineoplásicos/uso terapêutico , Feminino , Humanos , Leucemia Mielogênica Crônica BCR-ABL Positiva/tratamento farmacológico , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Projetos PilotoRESUMO
BACKGROUND: Intensive lifestyle interventions (ILIs) are the first-line approach to effectively treat obesity and manage associated cardiometabolic risk factors. Because few people have access to ILIs in academic health centers, primary care must implement similar approaches for a meaningful effect on obesity and cardiometabolic disease prevalence. To date, however, effective lifestyle-based obesity treatment in primary care is limited. We examined the effectiveness of a pragmatic ILI for weight loss delivered in primary care among a racially diverse, low-income population with obesity for improving cardiometabolic risk factors over 24 months. METHODS: The PROPEL trial (Promoting Successful Weight Loss in Primary Care in Louisiana) randomly allocated 18 clinics equally to usual care or an ILI and subsequently enrolled 803 (351 usual care, 452 ILI) adults (67% Black, 84% female) with obesity from participating clinics. The usual care group continued to receive their normal primary care. The ILI group received a 24-month high-intensity lifestyle-based obesity treatment program, embedded in the clinic setting and delivered by health coaches in weekly sessions initially and monthly sessions in months 7 through 24. RESULTS: As recently demonstrated, participants receiving the PROPEL ILI lost significantly more weight over 24 months than those receiving usual care (mean difference, -4.51% [95% CI, -5.93 to -3.10]; P<0.01). Fasting glucose decreased more in the ILI group compared with the usual care group at 12 months (mean difference, -7.1 mg/dL [95% CI, -12.0 to -2.1]; P<0.01) but not 24 months (mean difference, -0.8 mg/dL [95% CI, -6.2 to 4.6]; P=0.76). Increases in high-density lipoprotein cholesterol were greater in the ILI than in the usual care group at both time points (mean difference at 24 months, 4.6 mg/dL [95% CI, 2.9-6.3]; P<0.01). Total:high-density lipoprotein cholesterol ratio and metabolic syndrome severity (z score) decreased more in the ILI group than in the usual care group at both time points, with significant mean differences of the change of -0.31 (95% CI, -0.47 to -0.14; P<0.01) and -0.21 (95% CI, -0.36 to -0.06; P=0.01) at 24 months, respectively. Changes in total cholesterol, low-density lipoprotein cholesterol, triglycerides, and blood pressure did not differ significantly between groups at any time point. CONCLUSIONS: A pragmatic ILI consistent with national guidelines and delivered by trained health coaches in primary care produced clinically relevant improvements in cardiometabolic health in an underserved population over 24 months. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02561221.
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Fatores de Risco Cardiometabólico , Atenção Primária à Saúde/métodos , Adulto , Análise por Conglomerados , Feminino , Humanos , Estilo de Vida , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Fatores de TempoRESUMO
We examined knowledge of Alzheimer's disease and related dementias (ADRD), resources, and research opportunities among older African American (AA) and Caucasian caregivers. A mixed methods design integrated qualitative (focus group) and quantitative (survey) data from Northwest Louisiana. Eight focus groups (59 adults, 92% female, 78% AA, 25% rural) revealed limited knowledge. Quantitative findings from 117 ADRD caregivers (83% female, 72% AA, 30% limited heath literacy, 27% low income) indicated participants obtained information from providers (54%), friends and relatives (32%), and the internet (37%). Barriers to care were cost (24%) and lack of family agreement (17%). Few families used adult daycare (8%) or support groups (28%). Concerns about research participation were violation of privacy (30%) and fear of patient distress (27%). Distrust of doctors was minimal (3%). Findings did not vary by race. There is a need for clear, literacy-appropriate information about ADRD, caregiver resources, and clinical trials.
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Doença de Alzheimer , Cuidadores , Adulto , Negro ou Afro-Americano , Feminino , Grupos Focais , Humanos , Masculino , População RuralRESUMO
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<0.001). There were no significant between-group differences in serious adverse events. CONCLUSIONS: A high-intensity, lifestyle-based treatment program for obesity delivered in an underserved primary care population resulted in clinically significant weight loss at 24 months. (Funded by the Patient-Centered Outcomes Research Institute and others; PROPEL ClinicalTrials.gov number, NCT02561221.).
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Disparidades em Assistência à Saúde , Estilo de Vida Saudável , Obesidade/terapia , Populações Vulneráveis , Redução de Peso , Adulto , Idoso , Dieta Redutora , Exercício Físico , Feminino , Letramento em Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/etnologia , Obesidade/fisiopatologia , Educação de Pacientes como Assunto , Atenção Primária à Saúde , Fatores Socioeconômicos , Adulto JovemRESUMO
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.
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Letramento em Saúde , Detecção Precoce de Câncer , Pessoal de Saúde , Humanos , Pesquisa Qualitativa , População RuralRESUMO
INTRODUCTION: The purpose of this report is to describe barriers and solutions to the implementation and optimization of a pragmatic trial that tests an evidence-based, patient-centered, low literacy intervention promoting diabetes self-care in rural primary care clinics. METHODS: The two-arm pragmatic trial has been implemented in six rural family medicine clinics in Arkansas. It tests a self-management education and counseling intervention for patients with type 2 diabetes compared to enhanced usual care. Barriers and solutions were identified as issues arose and through interviews with clinic directors and clinic administrators and a focus group, interviews, and tracking reports with clinic health coaches who delivered the intervention. RESULTS: Barriers to optimizing enrollment, intervention delivery, and data collection were addressed through targeted education of and relationship building with leadership, changing enrollment oversight, and ongoing training of health coaches. CONCLUSIONS: Successful implementation and optimization of this pragmatic clinical trial in rural primary care clinics was achieved through establishing common goals with clinic leadership, minimizing demands on clinic staff and administration, frequent contact and ongoing support of health coaches, and collaborative troubleshooting of issues with delivering the intervention.
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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.