BAILA: A Randomized Controlled Trial of Latin Dancing to Increase Physical Activity in Spanish-Speaking Older Latinos.

BACKGROUND: Latinos are the fastest growing minority group of the older adult population. Although physical activity (PA) has documented health benefits, older Latinos are less likely to engage in leisure time PA than older non-Latino whites. Dance, popular among Latinos, holds promise as a culturally relevant form of PA. PURPOSE: To describe self-reported and device-assessed changes in PA as a result of a randomized controlled trial of BAILAMOS, a 4-month Latin dance program with a 4-month maintenance program, versus a health education control group. METHODS: Adults, aged 55+, Latino/Hispanic, Spanish speaking, with low PA levels at baseline, and risk for disability were randomized to the dance program (n = 167) or health education condition (n = 166). Data were analyzed using multilevel modeling with full information maximum likelihood. RESULTS: A series of multilevel models revealed significant time × group interaction effects for moderate-to-vigorous physical activity (MVPA), dance PA, leisure PA, and total PA. Exploring the interaction revealed the dance group to significantly increase their MVPA, dance PA, leisure PA, and total PA at months 4 and 8. Household PA and activity counts from accelerometry data did not demonstrate significant interaction effects. CONCLUSIONS: The study supports organized Latin dance programs to be efficacious in promoting self-reported PA among older Latinos. Efforts are needed to make dancing programs available and accessible, and to find ways for older Latinos to add more PA to their daily lives. CLINICAL TRIAL INFORMATION: NCT01988233.

Fit and Strong! Plus: Twelve and eighteen month follow-up results for a comparative effectiveness trial among overweight/obese older adults with osteoarthritis.

This comparative effectiveness trial compared the longer-term effectiveness (12 and 18 months) of the standard Fit & Strong! physical activity program to Fit & Strong! Plus, which combined physical activity and dietary weight loss. Outcomes were weight, diet quality, physical activity, osteoarthritis symptoms, performance measures, and anxiety/depression. In this study, 413 overweight/obese participants with OA, ≥60 years old and primarily African American, were randomly assigned to Fit & Strong! (F&S!) or Fit & Strong! Plus (F&S! Plus), with outcomes assessed at 2, 6, 12, and 18 months. 356 (86%) participants completed the 18-month visit. Compared with participants randomized to standard F&S!, F&S! Plus participants maintained longer-term benefits at 12 months in weight (mean change ± SE: -1.7 ± 0.3 kg for F&S! Plus vs -0.9 ± 0.3 kg for F&S!, p = 0.049), BMI (-0.6 ± 0.1 vs -0.3 ± 0.1 kg/m2, p = 0.04), waist circumference (-2.7 ± 0.6 vs -0.4 ± 0.6 cm, p = 0.004), and lower extremity strength (1.6 ± 0.2 vs 1.0 ± 0.2 chair stands, p = 0.046). At 18 months, F&S! Plus participants showed improved lower extremity strength (1.4 ± 0.2 vs. 0.7 ± 0.2 chair stands, p = 0.045. African American older adults in the F&S! Plus arm showed sustained modest improvements in weight, waist circumference, and lower extremity strength at 12 months and in lower extremity strength at 18 months compared to F&S!. Implications for the translation of evidence-based programs into community settings to support healthy behaviors in older adults are discussed.

Pragmatic statistical issues in biological research: Introduction to special series.

This is the introduction to a series of articles will be published over the next year in JMCC on statistical issues which commonly arise in types of studies published in the journal. Each article will cover a specific statistical topic and be prefaced with a typical related question that is likely to arise in laboratory and biomedical studies. There will be a discussion of the underlying statistical concepts followed by several websites which may be used to perform the relevant analysis on data.

Integrating a Medical Home in an Outpatient Dialysis Setting: Effects on Health-Related Quality of Life.

BACKGROUND: Integrating primary care has been proposed to reduce fragmented care delivery for patients with complex medical needs. Because of their high rates of morbidity, healthcare use, and mortality, patients with end-stage kidney disease (ESKD) may benefit from increased access to a primary care medical home. OBJECTIVE: To evaluate the effect of integrating a primary care medical home on health-related quality of life (HRQOL) for patients with ESKD receiving chronic hemodialysis. DESIGN: Before-after intervention trial with repeated measures at two Chicago dialysis centers. PARTICIPANTS: Patients receiving hemodialysis at either of the two centers. INTERVENTION: To the standard hemodialysis team (nephrologist, nurse, social worker, dietitian), we added a primary care physician, a pharmacist, a nurse coordinator, and a community health worker. The intervention took place from January 2015 through August 2016. MAIN MEASURES: Health-related quality of life, using the Kidney Disease Quality of Life (KDQOL) measures. KEY RESULTS: Of 247 eligible patients, 175 (71%) consented and participated; mean age was 54 years; 55% were men and 97% were African American or Hispanic. In regression analysis adjusted for individual visits with the medical home providers and other factors, there were significant improvements in four of five KDQOL domains: at 12 and 18 months, the Mental Component Score improved from baseline (adjusted mean 49.0) by 2.64 (p = 0.01) and 2.96 (p = 0.007) points, respectively. At 6 and 12 months, the Symptoms domain improved from baseline (adjusted mean = 77.0) by 2.61 (p = 0.02) and 2.35 points (p = 0.05) respectively. The Kidney Disease Effects domain improved from baseline (adjusted mean = 72.7), to 6, 12, and 18 months by 4.36 (p = 0.003), 6.95 (p < 0.0001), and 4.14 (p = 0.02) points respectively. The Physical Component Score improved at 6 months only. CONCLUSIONS: Integrating primary care and enhancing care coordination in two dialysis facilities was associated with improvements in HRQOL among patients with ESKD who required chronic hemodialysis.

Foreclosures and weight gain: Differential associations by longer neighborhood exposure.

While home foreclosure can lead to mental and physical health declines in persons experiencing the foreclosure, whether neighborhood foreclosures can affect the health of other residents is debatable. Using a racially/ethnically diverse sample of Chicago metropolitan area residents linked to foreclosure data from 2008 to 2014, we assessed whether exposure to neighborhood foreclosure fillings was associated with changes in objectively measured body mass index (BMI) over time. Using a retrospective longitudinal design, we employed fixed-effects regression models that controlled for individual- and neighborhood-level covariates to test the association of neighborhood foreclosures and BMI in >60,000 individuals and for individuals who did not move during the follow-up period. We also adjusted for the non-linear association of age and BMI and comorbidities and employed a series of sensitivity analysis to test for robustness. In fully adjusted models, a standard-deviation increase in neighborhood foreclosure filings within 500 m was associated with increases in BMI for individuals who did not move (nonmovers) (mean = 0.03 BMI units, 95% confidence interval: 0.01, 0.06). Neighborhood foreclosure rates were not associated with changes in BMI for the full sample. Given the potential deleterious effects of neighborhood foreclosure on individuals with longer exposure to the local vicinity, clarifying the potential health effects of neighborhood foreclosures would help policymakers when planning actions to prevent home losses, predatory home loans, and that aim to more efficiently return foreclosure properties to productive uses.

Co-learning with home care aides and their clients: collaboratively increasing individual and organizational capacities.

Changes in health care provide unprecedented opportunities for collaboration across research, education, and practice for the common goal of enhancing the well-being of older adults and their caregivers. This article describes how a pilot project, Promoting Seniors' Health with Home Care Aides, has synergistic education, research, and practice effects that enhance individual and organizational capacities. This pilot is an innovative partnership with home care aides to deliver a safe physical activity program appropriate for frail seniors in a real-life public home care program. The intervention and research occur in older adults' homes and thus provide rare opportunities for the research team and partners to learn from each other about dynamics of home care in older adults' life contexts. Co-learning is essential for continuous quality improvement in education, research and practice. The authors propose to establish "teaching home care" to ensure ongoing co-learning in gerontology and geriatrics.

Assessment of clinical and nonclinical characteristics associated with health-related quality of life in patients with high-grade gliomas: a feasibility study.

PURPOSE: Results from several studies suggest that there is value in evaluating the association between nonclinical characteristics of patients and quality of life (QoL), but few studies have focused on brain cancer. The primary goal of this feasibility study was to explore the relationship between clinical factors and nonclinical factors and QoL in brain cancer patients. METHODS: Participants in this cross-sectional study were drawn from two hospital sites. Eligible patients were 18-75 years old with a pathologically confirmed diagnosis of a brain cancer histology and stable disease after treatment. Data were obtained from medical chart review and a self-administered survey consisting of main study variables and two QoL standardized measures. Independent sample t test was used to determine differences between patient factors and QoL measures. RESULTS: The sample population was comprised of 26 patients with a median age at survey of 57.5 years (range 33-72). Quality of life was adversely associated with younger age, having underage children and living alone. Patients' meaning of QoL differed by gender, however most patients viewed it as affecting multiple aspects of their lives. CONCLUSIONS: Nonclinical characteristics were significantly associated with QoL more often than clinical characteristics. Identifying these factors may help improve the quality of care for these patients. This effort demonstrates the relevancy and feasibility of conducting a larger scale study to confirm or refute these findings.

Evaluating the initial impact of the revised Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) food packages on dietary intake and home food availability in African-American and Hispanic families.

OBJECTIVE: The present study assessed the impact of the 2009 food packages mandated by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) on dietary intake and home food availability in low-income African-American and Hispanic parent/child dyads. DESIGN: A natural experiment was conducted to assess if the revised WIC food package altered dietary intake, home food availability, weight and various lifestyle measures immediately (6 months) following policy implementation. SETTING: Twelve WIC clinics in Chicago, IL, USA. SUBJECTS: Two hundred and seventy-three Hispanic and African-American children aged 2-3 years, enrolled in WIC, and their mothers. RESULTS: Six months after the WIC food package revisions were implemented, we observed modest changes in dietary intake. Fruit consumption increased among Hispanic mothers (mean = 0·33 servings/d, P = 0·04) and low-fat dairy intake increased among Hispanic mothers (0·21 servings/d, P = 0·02), Hispanic children (0·34 servings/d, P < 0·001) and African-American children (0·24 servings/d, P = 0·02). Home food availability of low-fat dairy and whole grains also increased. Dietary changes, however, varied by racial/ethnic group. Changes in home food availability were not significantly correlated with changes in diet. CONCLUSIONS: The WIC food package revisions are one of the first efforts to modify the nutrition guidelines that govern foods provided in a federal food and nutrition assistance programme. It will be important to examine the longer-term impact of these changes on dietary intake and weight status.

PATHway: Intervention optimization of a prevention program for adolescents at-risk for depression in the primary care setting.

With as many as 13% of adolescents diagnosed with depressive disorders each year, prevention of depressive disorders has become a key priority for the National Institute of Mental Health (NIMH). Currently, we have no widely available interventions to prevent these disorders. To address this need, we developed a multi-health system collaboration to develop and evaluate the primary care based technology "behavioral vaccine," Competent Adulthood Transition with Cognitive-Behavioral Humanistic and Interpersonal Therapy (CATCH-IT). The full CATCH-IT program demonstrated evidence of efficacy in prevention of depressive episodes in clinical trials. However, CATCH-IT became larger and more complex across trials, creating issues with adherence and scalability. We will use a multiphase optimization strategy approach to optimize CATCH-IT. The theoretically grounded components of CATCH-IT include: behavioral activation, cognitive-behavioral therapy, interpersonal psychotherapy, and parent program. We will use a 4-factor (2x2x2x2) fully crossed factorial design with N = 16 cells (25 per cell, after allowing 15% dropout) to evaluate the contribution of each component. Eligible at-risk youth will be high school students 13 through 18 years old, with subsyndromal symptoms of depression. The study design will enable us to eliminate non-contributing components while preserving efficacy and to optimize CATCH-IT by strengthening tolerability and scalability by reducing resource use. By reducing resource use, we anticipate satisfaction and acceptability will also increase, preparing the way for an implementation trial.

BEhavioral Health Stratified Treatment (B.E.S.T.) to optimize transition to adulthood for youth with intellectual and/or developmental disabilities.

Youth with intellectual and/or developmental disabilities (IDD) often struggle with depression and anxiety, which adversely impacts transition to adulthood. Integrated behavioral health care coordination, wherein care coordinators and behavioral health specialists collaborate to provide systematic, cost-effective, patient-centered care, is a promising strategy to improve access to behavioral health services and address factors that impact transition to adulthood, including depression/anxiety symptoms. Current care coordination models (e.g., Title V Maternal and Child Health Bureau [MCHB]) do not include behavioral health services. The CHECK (Coordinated HealthCarE for Complex Kids) mental health model, hereby refined and renamed BEhavioral Health Stratified Treatment (B.E.S.T.), is a behavioral health intervention delivery program designed for integration into care coordination programs. This study aims to determine whether an integrated behavioral health care coordination strategy (i.e., MCHB care coordination plus B.E.S.T.) would be more acceptable and lead to better youth health and transition outcomes, relative to standard care coordination (i.e., MCHB care coordination alone). Results would guide future investment in improving outcomes for youth with IDD. This study is a two-arm randomized clinical trial of 780 transition-aged youth with IDD (13-20 years) to evaluate the comparable efficacy of MCHB Care Coordination alone vs. MCHB Care Coordination plus B.E.S.T. on the following outcomes: 1) decreased symptoms and episodes of depression and anxiety over time; 2) improved health behaviors, adaptive functioning and health related quality of life; 3) increased health care transition (HCT) readiness; and 4) improved engagement and satisfaction with care coordination among stakeholders.

Mammogram image quality as a potential contributor to disparities in breast cancer stage at diagnosis: an observational study.

BACKGROUND: In an ongoing study of racial/ethnic disparities in breast cancer stage at diagnosis, we consented patients to allow us to review their mammogram images, in order to examine the potential role of mammogram image quality on this disparity. METHODS: In a population-based study of urban breast cancer patients, a single breast imaging specialist (EC) performed a blinded review of the index mammogram that prompted diagnostic follow-up, as well as recent prior mammograms performed approximately one or two years prior to the index mammogram. Seven indicators of image quality were assessed on a five-point Likert scale, where 4 and 5 represented good and excellent quality. These included 3 technologist-associated image quality (TAIQ) indicators (positioning, compression, sharpness), and 4 machine associated image quality (MAIQ) indicators (contrast, exposure, noise and artifacts). Results are based on 494 images examined for 268 patients, including 225 prior images. RESULTS: Whereas MAIQ was generally high, TAIQ was more variable. In multivariable models of sociodemographic predictors of TAIQ, less income was associated with lower TAIQ (p < 0.05). Among prior mammograms, lower TAIQ was subsequently associated with later stage at diagnosis, even after adjusting for multiple patient and practice factors (OR = 0.80, 95% CI: 0.65, 0.99). CONCLUSIONS: Considerable gains could be made in terms of increasing image quality through better positioning, compression and sharpness, gains that could impact subsequent stage at diagnosis.

A national evaluation of community-based youth cessation programs: end of program and twelve-month outcomes.

Most youth cessation treatment research consists of efficacy studies in which treatments are evaluated under optimal conditions of delivery. Less is known about the effectiveness of youth cessation treatments delivered in real-world, community based settings. A national sample of 41 community-based youth cessation programs participated in a longitudinal evaluation to identify site, program, and participant characteristics associated with successful cessation. Validated quit rates were comparable to those in randomized controlled trials; 7-day abstinence at the end of program averaged 14% and 30-day abstinence at 12 months averaged 12%. Multivariate GEE models explored predictors of smoking cessation at the end of the programs and at 12 months. Results showed correlates of both short- and long-term cessation. Findings point to the importance of both individual and community-level variables, including motivation, opportunities for and encouragement to engage in activities outside of academics, having youth participate in treatment before they become highly dependent smokers, and community norms and ordinances that discourage youth purchase, use and possession of tobacco. Providing evidence-based treatment to youth in community-based settings results in successful cessation.

Community health worker intervention to improve tooth brushing in young children: Results from a cluster randomized controlled trial.

OBJECTIVES: Coordinated Oral health Promotion (CO-OP) Chicago is a cluster randomized controlled trial testing the efficacy of a community health worker (CHW) intervention to improve tooth brushing in low-income children. METHODS: Four hundred twenty children under 3 years old (mean 21.5 months) were recruited from 20 sites in or near Chicago, IL. Children were identified mainly as Black race (41.9%) or Hispanic ethnicity (53.8%) and most (85.2%) had Medicaid. Intervention families were offered four CHW home visits over 1 year. Brushing frequency was self-reported. Plaque score was determined from images collected in homes using disclosing solution. Analyses used GEE logistic models with variable selection at p < .05. RESULTS: At enrolment, 45.0% of families reported twice a day or more child brushing frequency, and child plaque scores were poor (mean of 1.9, SD: 0.6). Data were obtained from 87.1% of children at 6 months and 86.2% at 12 months. In the CHW intervention arm (10 sites, N = 211), 23.7% received 4 visits, 12.8% 3 visits, 21.3% 2 visits, 23.2% 1 visit and 19% no visits from CHWs. No intervention effect was seen for brushing frequency or plaque score. Child brushing frequency improvement over time was associated with a range of child and caregiver factors. The only factor associated with a change in plaque score over time was parent involvement in brushing. CONCLUSIONS: Oral-health-specific CHW services were not associated with improved brushing behaviours in these young children. However, caregiver involvement with brushing supported more quality brushing. More robust interventions are needed to support families during this critical developmental period.

Association between neighborhood disadvantage and children's oral health outcomes in urban families in the Chicago area.

Purpose: The prevalence of childhood caries in urban Chicago, compared with national and state data, indicates that neighborhood context influences oral health. Our objective was to delineate the influence of a child's neighborhood on oral health outcomes that are predictive of caries (toothbrushing frequency and plaque levels). Methods: Our study population represents urban, Medicaid-enrolled families in the metropolitan Chicago area. Data were obtained from a cohort of participants (child-parent dyads) who participated in the Coordinated Oral Health Promotion (CO-OP) trial at 12 months of study participation (N = 362). Oral health outcomes included toothbrushing frequency and plaque levels. Participants' neighborhood resource levels were measured by the Area Deprivation Index (ADI). Linear and logistic regression models were used to measure the influence of ADI on plaque scores and toothbrushing frequency, respectively. Results: Data from 362 child-parent dyads were analyzed. The mean child age was 33.6 months (SD 6.8). The majority of children were reported to brush at least twice daily (n = 228, 63%), but the mean plaque score was 1.9 (SD 0.7), classified as "poor." In covariate-adjusted analyses, ADI was not associated with brushing frequency (0.94, 95% CI 0.84-1.06). ADI was associated with plaque scores (0.05, 95% CI 0.01-0.09, p value = 0.007). Conclusions: Findings support the hypothesis that neighborhood-level factors influence children's plaque levels. Because excessive plaque places a child at high risk for cavities, we recommend the inclusion of neighborhood context in interventions and policies to reduce children's oral health disparities. Existing programs and clinics that serve disadvantaged communities are well-positioned to support caregivers of young children in maintaining recommended oral health behaviors.

Oral Health Behaviors for Young Low-Income Urban Children during the COVID-19 Pandemic: A Mixed Methods Analysis.

This research assessed oral health behaviors changes in urban families with young children during the stay-at-home period of the COVID-19 pandemic (Nov 2020-August 2021). Survey data on oral health behaviors were collected in homes at three points before COVID-19, and via phone during COVID-19. A subset of parents and key informants from clinics and social service agencies completed in-depth interviews via video/phone. Of the 387 parents invited, 254 completed surveys in English or Spanish (65.6%) during COVID-19. Fifteen key informant interviews (25 participants) and 21 family interviews were conducted. The mean child age was 4.3 years. Children identified as mainly Hispanic (57%) and Black race (38%). Parents reported increased child tooth brushing frequency during the pandemic. Family interviews highlighted changes in family routines that impacted oral health behaviors and eating patterns, suggesting less optimal brushing and nutrition. This was linked to changed home routines and social presentability. Key informants described major disruptions in oral health services, family fear, and stress. In conclusion, the stay-at-home period of the COVID-19 pandemic was a time of extreme routine change and stress for families. Oral health interventions that target family routines and social presentability are important for families during times of extreme crisis.

Oral health behaviors for young low-income urban children during the COVID-19 pandemic: a mixed methods analysis.

This research assessed oral health behaviors changes in urban families with young children during the stay-at-home period of the COVID-19 pandemic. Survey data on oral health behaviors were collected in homes at three points over one year before COVID-19, and then via phone during COVID-19. Multivariate logistic regression was used to model tooth brushing frequency. A subset of parents completed in-depth interviews via video/phone that expanded on oral health and COVID-19. Key informant interviews via video/phone were also conducted with leadership from 20 clinics and social service agencies. Interview data were transcribed and coded, and themes were extracted. COVID-19 data collection went from Nov 2020 - August 2021. Of the 387 parents invited, 254 completed surveys in English or Spanish (65.6%) during COVID-19. Fifteen key informant (25 participants) and 21 parent interviews were conducted. The mean child age was approximately 4.3 years. Children identified as mainly Hispanic (57%) and Black race (38%). Parents reported increased child tooth brushing frequency during the pandemic. Parent interviews highlighted significant changes in family routines that impacted oral health behaviors and eating patterns, suggesting less optimal brushing and nutrition. This was linked to changed home routines and social presentability. Key informants described major disruptions in their oral health services and significant family fear and stress. In conclusion, the stay-at-home period of the COVID-19 pandemic was a time of extreme routine change and stress for families. Oral health interventions that target family routines and social presentability are important for families during times of extreme crisis.

Design of the Building Research in CRC prevention (BRIDGE-CRC) trial: a 6-month, parallel group Mediterranean diet and weight loss randomized controlled lifestyle intervention targeting the bile acid-gut microbiome axis to reduce colorectal cancer risk among African American/Black adults with obesity.

BACKGROUND: Among all racial/ethnic groups, people who identify as African American/Blacks have the second highest colorectal cancer (CRC) incidence in the USA. This disparity may exist because African American/Blacks, compared to other racial/ethnic groups, have a higher prevalence of risk factors for CRC, including obesity, low fiber consumption, and higher intakes of fat and animal protein. One unexplored, underlying mechanism of this relationship is the bile acid-gut microbiome axis. High saturated fat, low fiber diets, and obesity lead to increases in tumor promoting secondary bile acids. Diets high in fiber, such as a Mediterranean diet, and intentional weight loss may reduce CRC risk by modulating the bile acid-gut microbiome axis. The purpose of this study is to test the impact of a Mediterranean diet alone, weight loss alone, or both, compared to typical diet controls on the bile acid-gut microbiome axis and CRC risk factors among African American/Blacks with obesity. Because weight loss or a Mediterranean diet alone can reduce CRC risk, we hypothesize that weight loss plus a Mediterranean diet will reduce CRC risk the most. METHODS: This randomized controlled lifestyle intervention will randomize 192 African American/Blacks with obesity, aged 45-75 years to one of four arms: Mediterranean diet, weight loss, weight loss plus Mediterranean diet, or typical diet controls, for 6 months (48 per arm). Data will be collected at baseline, mid-study, and study end. Primary outcomes include total circulating and fecal bile acids, taurine-conjugated bile acids, and deoxycholic acid. Secondary outcomes include body weight, body composition, dietary change, physical activity, metabolic risk, circulating cytokines, gut microbial community structure and composition, fecal short-chain fatty acids, and expression levels of genes from exfoliated intestinal cells linked to carcinogenesis. DISCUSSION: This study will be the first randomized controlled trial to examine the effects of a Mediterranean diet, weight loss, or both on bile acid metabolism, the gut microbiome, and intestinal epithelial genes associated with carcinogenesis. This approach to CRC risk reduction may be especially important among African American/Blacks given their higher risk factor profile and increased CRC incidence. TRIAL REGISTRATION: ClinicalTrials.gov NCT04753359 . Registered on 15 February 2021.

Coordinated Health Care Interventions for Childhood Asthma Gaps in Outcomes (CHICAGO) plan.

Background: Evidence-based strategies to improve outcomes in minority children with uncontrolled asthma discharged from the emergency department (ED) are needed. Objectives: This multicenter pragmatic clinical trial was designed to compare an ED-only intervention (decision support tool), an ED-only intervention and home visits by community health workers for 6 months (ED-plus-home), and enhanced usual care (UC). Methods: Children aged 5 to 11 years with uncontrolled asthma were enrolled. The change over 6 months in the Patient-Reported Outcomes Measurement Information System Asthma Impact Scale score in children and Satisfaction with Participation in Social Roles score in caregivers were the primary outcomes. The secondary outcomes included guideline-recommended ED discharge care and self-management. Results: Recruitment was significantly lower than expected (373 vs 640 expected). Of the 373 children (64% Black and 31% Latino children), only 63% completed the 6-month follow-up visit. In multivariable analyses that accounted for missing data, the adjusted odds ratios and 98% CIs for differences in Asthma Impact Scores or caregivers' Satisfaction with Participation in Social Roles scores were not significant. However, guideline-recommended ED discharge care was significantly improved in the intervention groups versus in the UC group, and self-management behaviors were significantly improved in the ED-plus-home group versus in the ED-only and UC groups. Conclusions: The ED-based interventions did not significantly improve the primary clinical outcomes, although the study was likely underpowered. Although guideline-recommended ED discharge care and self-management did improve, their effect on clinical outcomes needs further study.

Design of a trial to evaluate the impact of clinical pharmacists and community health promoters working with African-Americans and Latinos with diabetes.

BACKGROUND: Given the increasing prevalence of diabetes and the lack of patients reaching recommended therapeutic goals, novel models of team-based care are emerging. These teams typically include a combination of physicians, nurses, case managers, pharmacists, and community-based peer health promoters (HPs). Recent evidence supports the role of pharmacists in diabetes management to improve glycemic control, as they offer expertise in medication management with the ability to collaboratively intensify therapy. However, few studies of pharmacy-based models of care have focused on low income, minority populations that are most in need of intervention. Alternatively, HP interventions have focused largely upon low income minority groups, addressing their unique psychosocial and environmental challenges in diabetes self-care. This study will evaluate the impact of HPs as a complement to pharmacist management in a randomized controlled trial. METHODS/DESIGN: The primary aim of this randomized trial is to evaluate the effectiveness of clinical pharmacists and HPs on diabetes behaviors (including healthy eating, physical activity, and medication adherence), hemoglobin A1c, blood pressure, and LDL-cholesterol levels. A total of 300 minority patients with uncontrolled diabetes from the University of Illinois Medical Center ambulatory network in Chicago will be randomized to either pharmacist management alone, or pharmacist management plus HP support. After one year, the pharmacist-only group will be intensified by the addition of HP support and maintenance will be assessed by phasing out HP support from the pharmacist plus HP group (crossover design). Outcomes will be evaluated at baseline, 6, 12, and 24 months. In addition, program and healthcare utilization data will be incorporated into cost and cost-effectiveness evaluations of pharmacist management with and without HP support. DISCUSSION: The study will evaluate an innovative, integrated approach to chronic disease management in minorities with poorly controlled diabetes. The approach is comprised of clinic-based pharmacists and community-based health promoters collaborating together. They will target patient-level factors (e.g., lack of adherence to lifestyle modification and medications) and provider-level factors (e.g., clinical inertia) that contribute to poor clinical outcomes in diabetes. Importantly, the study design and analytic approach will help determine the differential and combined impact of adherence to lifestyle changes, medication, and intensification on clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01498159.