Health Literacy and Health-care Resource Utilization Following Gastrostomy Tube Placement in Pediatric Patients.

INTRODUCTION: Parental health literacy and neighborhood socioeconomic disadvantage are associated with adverse health outcomes and increased health-care resource utilization in children. We sought to evaluate the association between community-level health literacy and neighborhood socioeconomic disadvantage and their relationships with outcomes of pediatric patients undergoing gastrostomy tube (GT) placement. METHODS: Pediatric patients who underwent GT placement from 2000 to 2019 were identified using the IBM MarketScan Research database. Claims data were merged with the health literacy index (HLI) and area deprivation index (ADI), measures of community-level health literacy and neighborhood socioeconomic disadvantage, respectively. We used multivariate logistic regression to estimate factors associated with postoperative 30- and 90-day ED visits (EVs) and 30-day readmissions. RESULTS: A total of 4374 pediatric patients underwent GT placement. In this cohort, 6.1% and 11.4% had 30-day and 90-day EV; and 30-day readmissions in 19.75%. HLI was lower in those with 30-(244.6 ± 6.1 versus 245.4 ± 6.1; P = 0.0482) and 90-(244.5 ± 5.8 versus 245.5 ± 6.1; P = 0.001) day EV, and 30-day readmission (244.5 ± 5.56 versus 245.4 ± 6.1; P = 0.001) related to GT. ADI was lower in those with 90-day EV (55.1 ± 13.1 versus 55.9 ± 14.6; P = 0.0244). HLI was associated with decreased odds of 30- (adjusted odds ratio: 0.968; 95% confidence interval: 0.941-0.997) and 90-day (adjusted odds ratio: 0.975; 95% confidence interval: 0.954-0.998) EV following GT placement. ADI was also significantly associated with 30 and 90-day EV following GT placement. CONCLUSIONS: In pediatric patients undergoing GT placement, higher ecologically-measured health literacy and neighborhood socioeconomic disadvantage are associated with decreased health-care resource utilization, as evidenced by decreased ED visits. Future studies should focus on the role of individual parental health literacy in outcomes of pediatric surgical patients.

Impact of including drug spending in oncology alternative payment models.

OBJECTIVES: To develop a method for determining the effect of including drug costs in alternative payment models (APMs). STUDY DESIGN: Retrospective claims analysis. METHODS: Using the Oncology Care Model as an example, we developed an oncology episode payment model for a commercial payer using historical claims data. We defined 6-month episodes of chemotherapy. Using claims data, we characterized episodes and developed a risk adjustment model. We used bootstrapping to estimate the variation in episode cost with drugs included and without. RESULTS: Episode costs were approximately $100,000. Although absolute cost variation was higher when we included drugs, the percent of total cost represented by variation was lower. Under reasonable assumptions about potential savings from drug and nondrug spending, our results suggest that including drugs in APMs can improve the risk-benefit trade-off faced by provider groups. We introduce a risk-mitigated sharing rate that may enable inclusion of drugs in APMs without substantially increasing downside risk. CONCLUSIONS: We have developed a method to assess whether the inclusion of drug spending in APMs is a good decision for provider groups. Including drug costs in episode payments for oncology patients may be preferable for many provider groups.

Evaluating A Nonemergency Medical Transportation Benefit For Accountable Care Organization Members.

Nonemergency medical transportation benefits, often using smartphone application-based ridesharing services, are increasingly being offered as part of population health management programs. However, the impact of these programs on health care use and costs remains understudied. We conducted a mixed-methods evaluation of a nonemergency medical transportation benefit offered to members of a Medicare accountable care organization (ACO) within a large academic health system, the UNC Health Alliance ACO. Participation in the transportation program was associated with a greater number of per person per year outpatient visits (9.2) and higher outpatient spending ($4,420) than in a comparison group. However, there was no difference in inpatient admissions or emergency department visits, and the program was not cost saving. Qualitative analyses revealed that participants were highly satisfied with the program, reporting that it eased financial burdens and made them feel safer, more empowered, and better able to take control of their health. These findings suggest that although transportation programs are commonly introduced as ways to contain health care spending, it may be better to think of them as programs to improve health care access for people facing difficult circumstances.

Recommendations for Assessment of Social, Emotional, and Behavioral Health for the National Children's Study.

The Social Emotional Behavioral (SEB) Team of the National Children's Study (NCS) was tasked with making recommendations for assessment of important aspects of social-emotional health and function in children. This paper describes the constructs recommended for assessment along with the rationale for their assessment. These constructs, representing aspects of Social Relationships, Social Capital, Temperament, Negative Affect, Externalizing Behavior, Social Competence, Self-efficacy, Self-image, Psychological well-being, Ethnic/racial Socialization, Perceived Discrimination, Sexual Orientation, Religiosity, and Perceived Stress and Resilience were identified as being critical to the understanding of children's health and development from birth to age 21.

Association between Food Insecurity and Health-Related Quality of Life: a Nationally Representative Survey.

BACKGROUND: Food insecurity, limited or uncertain access to enough food for an active, healthy life, affected over 37 million Americans in 2018. Food insecurity is likely to be associated with worse health-related quality of life (HRQoL), but this association has not been measured with validated instruments in nationally representative samples. Given growing interest understanding food insecurity's role in health outcomes, it would be useful to learn what HRQoL measures best capture the experience of those with food insecurity. OBJECTIVE: To determine the association between food insecurity and several validated HRQoL instruments in US adults. DESIGN: Cross-sectional. PARTICIPANTS: US adults (age ≥ 18), weighted to be nationally representative. MAIN MEASURES: Food insecurity was assessed with three items derived from the USDA Household Food Security Survey Module. HRQoL was assessed using PROMIS-Preference (PROPr), which contains 7 PROMIS domains, self-rated health (SRH), Euroqol-5D-5L (EQ-5D), Health Utilities Index (HUI), and Short Form-6D (SF-6D). KEY RESULTS: In December 2017, 4142 individuals completed at least part of the survey (31% response rate), of whom 4060 (98.0%) reported food security information. Of survey respondents, 51.7% were women, 12.5% self-identified as black, 15.8% were Hispanic, and 11.0% did not have a high school diploma. 14.1% of respondents reported food insecurity. In adjusted analyses, food insecurity was associated with worse HRQoL across all instruments and PROMIS domains (p < .0001 for all). The magnitude of the difference between food-insecure and food-secure participants was largest with the SF-6D, EQ-5D, and PROPr; among individual PROMIS domain scores, the largest difference was for ability to participate in social roles. CONCLUSIONS: Food insecurity is strongly associated with worse HRQoL, with differences between food-secure and food-insecure individuals best measured using the SF-6D, EQ-5D, and PROPr. Future work should develop a specific instrument to measure changes in HRQoL in food insecurity interventions.

Transition Readiness Not Associated With Measures of Health in Youth With IBD.

BACKGROUND: It remains unclear how transition readiness is associated with various domains of health in children and young adults. Our objective was to describe the transition readiness of children and young adults with inflammatory bowel disease (IBD) and examine its associations with demographic factors, IBD activity, and measures of physical, psychological, and social health. METHODS: We recruited children ages 12 to 17 and young adults ages 18 to 20 from 2 internet-based cohorts sponsored by the Crohn's & Colitis Foundation. Participants self-reported demographics, IBD activity, transition readiness, health-related quality of life, and Patient-Reported Outcomes Information Systems domains of physical, psychological, and social health. RESULTS: Among 361 pediatric and 119 adult participants, age and female sex were associated with transition readiness. The association was greater in the pediatric cohort. Having IBD in remission was associated with worse transition readiness in the pediatric cohort only (beta = 0.3; P = 0.003). Health-related quality of life and Patient-Reported Outcomes Information Systems measures of fatigue, pain interference, and sleep disturbance were not associated with transition readiness in either children or adults. We observed few small associations between psychological or social health and transition readiness. Better transition readiness was associated with greater anxiety in adults (beta = -0.02; P = 0.02) and greater peer relationships among children (beta = 0.01; P = 0.009). CONCLUSIONS: In children and young adults with IBD, transition readiness was associated with older age and female sex. Associations between transition readiness and physical, psychological, and social health were either small, inconsistent across age groups, or nonexistent.

Longitudinal Effect of Ambient Air Pollution and Pollen Exposure on Asthma Control: The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Asthma Study.

OBJECTIVE: Although exposure to air pollution and pollen is associated with asthma exacerbation and increased health care use, longitudinal effects of fine particulate matter 2.5 (PM2.5), ozone (O3), and pollen exposure on asthma control status in pediatric patients are understudied. This study investigated effects of exposure to PM2.5, O3, and pollen on asthma control status among pediatric patients with asthma. METHODS: A total of 229 dyads of pediatric patients with asthma and their parents were followed for 15 months. The Asthma Control and Communication Instrument was used to measure asthma control, which was reported weekly by parents during a 26-week period. PM2.5 and O3 data were collected from the US Environmental Protection Agency Air Quality System. Pollen data were obtained from Intercontinental Marketing Services Health. Mean air pollutant and pollen exposures within 7 days before the reporting of asthma control were used to estimate weekly exposures for each participant. Linear mixed-effects models were performed to test associations of PM2.5, O3, and pollen exposure with asthma control status. Sensitivity analyses were performed to evaluate the robustness of findings by different exposure monitoring days per week and distances between monitoring sites and participants' residences. RESULTS: Elevated PM2.5 concentration and pollen severity were associated with poorer asthma control status (P < .05), yet elevated O3 concentration was marginally associated with better asthma control (P < .1). CONCLUSIONS: Poorer asthma control status was associated with elevated PM2.5 and pollen severity. Reducing harmful outdoor environmental ambient exposure may improve asthma outcomes in children and adolescents.

Meal Delivery Programs Reduce The Use Of Costly Health Care In Dually Eligible Medicare And Medicaid Beneficiaries.

Delivering food to nutritionally vulnerable patients is important for addressing these patients' social determinants of health. However, it is not known whether food delivery programs can reduce the use of costly health services and decrease medical spending among these patients. We sought to determine whether home delivery of either medically tailored meals or nontailored food reduces the use of selected health care services and medical spending in a sample of adults dually eligible for Medicare and Medicaid. Compared with matched nonparticipants, participants had fewer emergency department visits in both the medically tailored meal program and the nontailored food program. Participants in the medically tailored meal program also had fewer inpatient admissions and lower medical spending. Participation in the nontailored food program was not associated with fewer inpatient admissions but was associated with lower medical spending. These findings suggest the potential for meal delivery programs to reduce the use of costly health care and decrease spending for vulnerable patients.

Successful long-term weight loss among participants with diabetes receiving an intervention promoting an adapted Mediterranean-style dietary pattern: the Heart Healthy Lenoir Project.

OBJECTIVE: To examine weight change by diabetes status among participants receiving a Mediterranean-style diet, physical activity, and weight loss intervention adapted for delivery in the southeastern USA, where rates of cardiovascular disease (CVD) are disproportionately high. RESEARCH DESIGN AND METHODS: The intervention included: Phase I (months 1-6), an individually tailored intervention promoting a Mediterranean-style dietary pattern and increased walking; Phase II (months 7-12), option of a 16-week weight loss intervention for those with BMI≥25 kg/m2 offered as 16 weekly group sessions or 5 group sessions and 10 phone calls, or a lifestyle maintenance intervention; and Phase III (months 13-24), weight loss maintenance intervention for those losing ≥8 pounds with all others receiving a lifestyle maintenance intervention. Weight change was assessed at 6, 12, and 24-month follow-up. RESULTS: Baseline characteristics (n=339): mean age 56, 77% female, 65% African-American, 124 (37%) with diabetes; mean weight 103 kg for those with diabetes and 95 kg for those without. Among participants with diabetes, average weight change was -1.2 kg (95% CI -2.1 to -0.4) at 6 months (n=92), -1.5 kg (95% CI -2.9 to -0.2) at 12 months (n=96), and -3.7 kg (95% CI -5.2 to -2.1) at 24 months (n=93). Among those without diabetes, weight change was -0.4 kg (95% CI -1.4 to 0.6) at 24 months (n=154). CONCLUSIONS: Participants with diabetes experienced sustained weight loss at 24-month follow-up. High-risk US populations with diabetes may experience clinically important weight loss from this type of lifestyle intervention. TRIAL REGISTRATION NUMBER: NCT01433484.

Patterns of care for clinically distinct segments of high cost Medicare beneficiaries.

BACKGROUND: Efforts to improve the efficiency of care for the Medicare population commonly target high cost beneficiaries. We describe and evaluate a novel management approach, population segmentation, for identifying and managing high cost beneficiaries. METHODS: A retrospective cross-sectional analysis of 6,919,439 Medicare fee-for-service beneficiaries in 2012. We defined and characterized eight distinct clinical population segments, and assessed heterogeneity in managing practitioners. RESULTS: The eight segments comprised 9.8% of the population and 47.6% of annual Medicare payments. The eight segments included 61% and 69% of the population in the top decile and top 5% of annual Medicare payments. The positive-predictive values within each segment for meeting thresholds of Medicare payments ranged from 72% to 100%, 30% to 83%, and 14% to 56% for the upper quartile, upper decile, and upper 5% of Medicare payments respectively. Sensitivity and positive-predictive values were substantially improved over predictive algorithms based on historical utilization patterns and comorbidities. The mean [95% confidence interval] number of unique practitioners and practices delivering E&M services ranged from 1.82 [1.79-1.84] to 6.94 [6.91-6.98] and 1.48 [1.46-1.50] to 4.98 [4.95-5.00] respectively. The percentage of cognitive services delivered by primary care practitioners ranged from 23.8% to 67.9% across segments, with significant variability among specialty types. CONCLUSIONS: Most high cost Medicare beneficiaries can be identified based on a single clinical reason and are managed by different practitioners. IMPLICATIONS: Population segmentation holds potential to improve efficiency in the Medicare population by identifying opportunities to improve care for specific populations and managing clinicians, and forecasting and evaluating the impact of specific interventions.

Responsiveness to Change in PROMIS(®) Measures among Children with Asthma: A Report from the PROMIS(®) Pediatric Asthma Study.

OBJECTIVE: To compare the responsiveness to change of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) asthma impact, pain interference, fatigue, depressive symptoms, mobility, and peer relationship scales to a legacy scale, the Paediatric Asthma Quality of Life Questionnaire (PAQLQ). METHODS: Two hundred and twenty-nine child-parent dyads from public insurance programs were enrolled. PROMIS pediatric short forms (SFs) and the PAQLQ were used to measure health-related quality of life across four time points (T1-T4) over 2 years. The Asthma Control and Communication Instrument was used to measure the change in asthma control, and the Global Rating of Change (GRC) Index for breathing problems and overall health was used to measure the change in health status. Responsiveness was tested by comparing the changes in health-related quality of life with the changes in asthma control and health status over time using t tests, generalized estimating equations, and relative validity approaches. Magnitudes of the responsiveness between the Pediatric PROMIS and PAQLQ were assessed through statistical significance, Cohen's d effect size (ES), and standardized response mean (SRM). RESULTS: The PROMIS asthma impact scale and all PAQLQ scales exhibited significant responsiveness (p's<0.05) and small to medium ES/SRM when anchored to asthma control, GRC breathing problems, and overall health. Relative validity, especially related to change in asthma control status and GRC breathing problems, was equivalent. PROMIS pain interference, fatigue, and mobility SFs also indicated adequate responsiveness. CONCLUSIONS: The PROMIS asthma impact SF indicated similar responsiveness to the PAQLQ scales. Due to its brevity and responsiveness, the PROMIS asthma impact SF is useful for clinical practice or research.

Known-groups validity of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) in adolescents and young adults with special healthcare needs.

PURPOSE: To examine known-groups validity of the Patient-Reported Outcomes Measurement Information System (PROMIS(®)) Short Forms (SFs) for adolescents and young adults with special healthcare needs (SHCN) using data collected from the PROMIS Linking Study. METHODS: In total, 292 adolescents aged 14-17.9 years and 300 young adults aged 18-20 years with SHCN from the PROMIS Linking Study were used for analyses. Presence of SHCN was classified into three categories (medication use, service use, and functional limitations). HRQoL was measured with the PROMIS Pediatric and Adult SFs. Differences in health-related quality of life (HRQoL) domain scores between SHCN sample and the norms of the PROMIS pediatric and adult calibration samples, respectively, were compared using t tests. Associations of HRQoL scores with the presence of individual SHCN categories were tested using linear regression. RESULTS: All HRQoL domain scores for the SHCN samples were significantly worse than the respective calibration samples. Adolescents and young adults with SHCN-related service use and functional limitations reported worse HRQoL than those without service use and functional limitations (p's < 0.01). CONCLUSIONS: PROMIS Pediatric and Adult SFs possess satisfactory known-groups validity related to SHCN status.

Caregivers' health literacy and gaps in children's Medicaid enrollment: findings from the Carolina Oral Health Literacy Study.

BACKGROUND AND OBJECTIVES: Recent evidence supports a link between caregivers' health literacy and their children's health and use of health services. Disruptions in children's health insurance coverage have been linked to poor health care and outcomes. We examined young children's Medicaid enrollment patterns in a well-characterized cohort of child/caregivers dyads and investigated the association of caregivers' low health literacy with the incidence of enrollment gaps. METHODS: We relied upon Medicaid enrollment data for 1208 children (mean age = 19 months) enrolled in the Carolina Oral Health Literacy project during 2008-09. The median follow-up was 25 months. Health literacy was measured using the Newest Vital Sign (NVS). Analyses relied on descriptive, bivariate, and multivariate methods based on Poisson modeling. FINDINGS: One-third of children experienced one or more enrollment gaps; most were short in duration (median = 5 months). The risk of gaps was inversely associated with caregivers' age, with a 2% relative risk decrease for each added year. Low health literacy was associated with a modestly elevated risk increase [Incidence Rate Ratio (IRR) = 1.17 (95% confidence interval (CI) 0.88-1.57)] for enrollment disruptions; however, this estimate was substantially elevated among caregivers with less than a high school education [IRR = 1.52 (95% CI 0.99-2.35); homogeneity p<0.2]. CONCLUSIONS: Our findings provide initial support for a possible role of caregivers' health literacy as a determinant of children's Medicaid enrollment gaps. Although the association between health literacy and enrollment gaps was not confirmed statistically, we found that it was markedly stronger among caregivers with low educational attainment. This population, as well as young caregivers, may be the most vulnerable to the negative effects of low health literacy.

Getting hip to vitamin D: a hospitalist project for improving the assessment and treatment of vitamin D deficiency in elderly patients with hip fracture.

BACKGROUND: Vitamin D deficiency is common in elderly patients with hip fracture, and clinical practice guidelines recommend screening this population. Our hospitalist group cares for all patients admitted with hip fracture, yet lacked a standardized approach to screening for and treating vitamin D deficiency in this population. OBJECTIVES: To standardize and improve the assessment and treatment of vitamin D deficiency in elderly patients with hip fracture. DESIGN: Quality improvement implementation. SETTING: Tertiary academic hospital. PATIENTS: Adults age >50 years with hip fracture. INTERVENTIONS: We implemented a computerized hip fracture order set with preselected orders for 25-OH vitamin D level and initial supplementation with 1000 IU/day of vitamin D. We presented a review of the literature and performance data to our hospitalist group. MEASUREMENTS: Percentage of patients with acute hip fracture screened for vitamin D deficiency and percentage of deficient or insufficient patients discharged on recommended dose of vitamin D (50,000 IU/wk if level <20 ng/mL). RESULTS: The percentage of patients screened for vitamin D deficiency improved from 37.2% (n = 196) before implementation to 93.5% (n = 107) after (P < 0.001). The percentage of deficient or insufficient patients discharged on the recommended vitamin D dose improved from 40.9% to 68.0% (P = 0.008). The prevalence of vitamin D deficiency or insufficiency (25-OH vitamin D level <30 ng/mL) was 50.0%. CONCLUSIONS: Simple interventions, consisting of a change in computerized order set and presentation of evidence and data from group practice, led to significant improvement in the assessment and treatment of vitamin D deficiency in elderly patients with hip fracture.

Influence of caregivers and children's entry into the dental care system.

OBJECTIVES: Early preventive dental visits are essential in improving children's oral health, especially young children at high risk for dental caries. However, there is scant information on how these children enter the dental care system. Our objectives were as follows: (1) to describe how a population-based cohort of young Medicaid-enrolled children entered dental care; and (2) to investigate the influence of caregiver characteristics on their children's dental care-seeking patterns. METHODS: We relied on Medicaid claims and interview data of caregiver-child dyads who were enrolled in the Carolina Oral Health Literacy study during 2007-2008. The analytical cohort comprised 1000 children who had no dental visits before enrollment. Additional information was collected on sociodemographic characteristics, oral health status, health literacy, dental neglect, and access to care barriers. Our analyses relied on descriptive, bivariate, and multivariate methods. RESULTS: During the 25-month median follow-up period, 39% of the children (mean baseline age: 16 months) entered the dental care system, and 13% of their first encounters were for emergency care. Caregivers' dental neglect emerged as a significant predictor of nonentrance. Children with reported oral health problems at baseline were more likely to enter the dental care system compared with children with better oral health, but they were also more likely to require emergency care. CONCLUSIONS: Caregivers have a pivotal role in children's oral health and care. Interventions aimed at improving children's oral health should involve community outreach to engage caregivers in a culturally appropriate manner when their children are infants or toddlers.

New English and Spanish social health measures will facilitate evaluating health determinants.

OBJECTIVE: To develop psychometrically sound, culturally relevant, and linguistically equivalent English and Spanish self-report measures of social health guided by a comprehensive conceptual model and applicable across chronic illnesses. METHODS: The Patient-Reported Outcomes Measurement Information System (PROMIS) Social Health Workgroup implemented a mixed methods approach to evaluate earlier results (v1.0); expand and refine domain definitions and items; translate items into Spanish; and obtain qualitative feedback. Computer-based and paper/pencil questionnaire administration was conducted with a variety of U.S. respondent samples during 2009-2012. Analyses included exploratory factor analysis (EFA), confirmatory factor analysis (CFA), two-parameter logistic item response theory (IRT) modeling, evaluation of differential item functioning (DIF), and evaluation of criterion and construct validity. RESULTS: Qualitative feedback supported the conceptualization of the Social Health domain framework (Social Function and Social Relationships subcomponents). Validation testing participants (n = 2,208 English; n = 644 Spanish) were diverse in terms of gender, age, education, and ethnicity/race. EFA, CFA, and IRT identified 7 unidimensional factors with good model fit. There was no DIF by language, and good evidence of criterion and construct validity. CONCLUSIONS: PROMIS English and Spanish language instruments (v2.0), including computer-adaptive tests and fixed-length short forms, are publicly available for assessment of Social Function (Ability to Participate in Social Roles and Activities, and Satisfaction with Social Roles and Activities) and Social Relationships (Companionship; Emotional, Informational and Instrumental Support; and Social Isolation). Measures of social health will play a key role in applications that use ecologic (or determinants of health) models that emphasize how patients' social environments influence their health.

Who needs inpatient detox? Development and implementation of a hospitalist protocol for the evaluation of patients for alcohol detoxification.

BACKGROUND: Clinicians caring for patients seeking alcohol detoxification face many challenges, including lack of evidence-based guidelines for treatment and high recidivism rates. OBJECTIVES: To develop a standardized protocol for determining which alcohol dependent patients seeking detoxification need inpatient versus outpatient treatment, and to study the protocol's implementation. DESIGN: Review of best evidence by ad hoc task force and subsequent creation of standardized protocol. Prospective observational evaluation of initial protocol implementation. PARTICIPANTS: Patients presenting for alcohol detoxification. INTERVENTION: Development and implementation of a protocol for evaluation and treatment of patients requesting alcohol detoxification. MAIN MEASURES: Number of admissions per month with primary alcohol related diagnosis (DRG), 30-day readmission rate, and length of stay, all measured before and after protocol implementation. RESULTS: We identified one randomized clinical trial and three cohort studies to inform the choice of inpatient versus outpatient detoxification, along with one prior protocol in this population, and combined that data with clinical experience to create an institutional protocol. After implementation, the average number of alcohol related admissions was 15.9 per month, compared with 18.9 per month before implementation (p = 0.037). There was no difference in readmission rate or length of stay. CONCLUSIONS: Creation and utilization of a protocol led to standardization of care for patients requesting detoxification from alcohol. Initial evaluation of protocol implementation showed a decrease in number of admissions.

Single-item or two-item literacy screener to predict the S-TOFHLA among adult hemodialysis patients.

OBJECTIVE: We compared single-item (SILS) and two-item (TILS) literacy screeners in predicting Short Test of Functional Health Literacy in Adults (S-TOFHLA) scores. METHODS: Adult hemodialysis patients completed SILS, which determines need for assistance when reading written medical information; TILS (last grade completed and self-reported reading ability); and S-TOFHLA. Receiver operator characteristic curves (ROC) and stratum specific likelihoods were calculated. RESULTS: Of 227 participants, median S-TOFHLA was 24 (IQR 15-34). 129 (55%) participants had adequate, 70 (30%) inadequate, and 37 (16%) marginal health literacy. SILS and TILS predicted S-TOFHLA scores equivalently. Test characteristics predicting inadequate health literacy were: SILS sensitivity for threshold >1, 54% (95%CI: 44, 64), for >2, 39% (29, 49) and specificity for >1, 73% (64, 80), for >2, 93% (87, 97), area under the ROC of 0.67 (0.60-0.74); TILS sensitivity for threshold >1, 72% (62, 80), for >2, 30% (21, 40) and specificity for >1, 54% (45, 63), for >2, 86% (79, 92), area under the ROC of 0.66 (0.59-0.73). CONCLUSION: SILS and TILS had similar test characteristics in predicting S-TOFHLA. PRACTICE IMPLICATIONS: While a positive result on either test increases the likelihood that a patient has low health literacy, the SILS is easier to administer and score.

Clinic-based versus outsourced implementation of a diabetes health literacy intervention.

BACKGROUND: We compared two implementation approaches for a health literacy diabetes intervention designed for community health centers. METHODS: A quasi-experimental, clinic-randomized evaluation was conducted at six community health centers from rural, suburban, and urban locations in Missouri between August 2008 and January 2010. In all, 486 adult patients with type 2 diabetes mellitus participated. Clinics were set up to implement either: 1) a clinic-based approach that involved practice re-design to routinely provide brief diabetes education and counseling services, set action-plans, and perform follow-up without additional financial resources [CARVE-IN]; or 2) an outsourced approach where clinics referred patients to a telephone-based diabetes educator for the same services [CARVE-OUT]. The fidelity of each intervention was determined by the number of contacts with patients, self-report of services received, and patient satisfaction. Intervention effectiveness was investigated by assessing patient knowledge, self-efficacy, health behaviors, and clinical outcomes. RESULTS: Carve-out patients received on average 4.3 contacts (SD = 2.2) from the telephone-based diabetes educator versus 1.7 contacts (SD = 2.0) from the clinic nurse in the carve-in arm (p < 0.001). They were also more likely to recall setting action plans and rated the process more positively than carve-in patients (p < 0.001). Few differences in diabetes knowledge, self-efficacy, or health behaviors were found between the two approaches. However, clinical outcomes did vary in multivariable analyses; carve-out patients had a lower HbA1c (ß = -0.31, 95 % CI -0.56 to -0.06, p = 0.02), systolic blood pressure (ß = -3.65, 95 % CI -6.39 to -0.90, p = 0.01), and low-density lipoprotein (LDL) cholesterol (ß = -7.96, 95 % CI -10.08 to -5.83, p < 0.001) at 6 months. CONCLUSION: An outsourced diabetes education and counseling approach for community health centers appears more feasible than clinic-based models. Patients receiving the carve-out strategy also demonstrated better clinical outcomes compared to those receiving the carve-in approach. Study limitations and unclear causal mechanisms explaining change in patient behavior suggest that further research is needed.