Rationale and design of the KP ENRICH trial: A food is medicine intervention in low-income high-risk adults with diabetes within Kaiser Permanente.

BACKGROUND: Food insecurity is associated with poor glycemic control and increased risk for diabetes-related complications. The clinical benefit of addressing these challenges through a medically supportive grocery prescription (GRx) program in patients with type 2 diabetes mellitus (T2D) remains unclear. We report the aims and design of a randomized clinical trial to evaluate the effectiveness of a 6-month GRx intervention on hemoglobin A1c (HbA1c) levels among low-income adults with T2D. METHODS: The Kaiser Permanente Evaluating Nutritional Interventions in Food-Insecure High-Risk Adults (KP ENRICH) Study is a pragmatic randomized trial enrolling 1100 participants within Kaiser Permanente Northern California and Southern California, two integrated health care delivery systems serving >9 million members. Medicaid-insured adults with T2D and baseline HbA1c ≥7.5% will be randomized at a 1:1 ratio to either GRx, delivered as $100 per month for select items from among a curated list of healthful food groups in an online grocery ordering and home-delivery platform along with biweekly digital nutrition educational materials, or control, consisting of free membership and deliveries from the online grocery platform but without curated food groups or purchasing dollars. The primary outcome is 6-month change in HbA1c. Secondary outcomes include 12-month change in HbA1c, and 6- and 12-month change in medical resource utilization, food security, nutrition security, dietary habits, diabetes-related quality of life, and dietary self-efficacy. CONCLUSIONS: The results of this large randomized clinical trial of GRx will help inform future policy and health system-based initiatives to improve food and nutrition security, disease management, and health equity among patients with T2D.

Factors Affecting Compliance with Diabetic Retinopathy Screening: A Qualitative Study Comparing English and Spanish Speakers.

Purpose: The purpose of this study was to understand individual-, social-, and system-level factors that affect compliance with recommended diabetic retinopathy (DR)-evaluations, and how these factors vary between English and Spanish speakers. Patients and Methods: We conducted a qualitative study using semi-structured interviews. Study subjects included Kaiser Permanente Southern California members with type II diabetes mellitus at least aged 26 years who spoke English or Spanish. Patients were divided into groups based on their adherence with DR evaluations. Our main outcome measure was the major themes expressed by patients that explained their compliance with DR evaluation. Results: Fifty-one participants were enrolled: 30 English speakers (11 nonadherent, 19 adherent) and 21 Spanish speakers (8 nonadherent, 13 adherent). Adherent patients were more likely to have had experience with diabetes and identify as being responsible for their own care. Substantially more non-adherent patients suggested that beliefs and attitudes were the reasons people missed retinopathy appointments. More English-speaking participants tended to be self-directed in managing their healthcare, whereas more Spanish speakers relied on others for help. English speakers also noted better relationships with their physicians. Spanish speakers outlined problems with insurance coverage and costs as barriers. Conclusion: These data suggest two specific intervention strategies that eye care providers could implement to improve adherence with diabetic retinopathy screening and follow up: incorporating a person with DR-related visual loss into the team of staff delivering diabetes support programs and communication campaigns including specific messaging to address fears related to vision loss.

Validation of the Pediatric Vision Scanner in a normal preschool population.

PURPOSE: To assess the Pediatric Vision Scanner (PVS), a handheld vision screening device designed to test for amblyopia and strabismus, in a general pediatric population. METHODS: In this prospective study, trained research staff screened 300 eligible children 24-72 months of age with no known eye conditions for amblyopia and strabismus using the PVS. A pediatric ophthalmologist masked to PVS screening results then performed a comprehensive eye examination. Sensitivity and specificity of the PVS was calculated with a 95% confidence interval. RESULTS: Based on the gold standard eye examination, 6 children (2%) had amblyopia and/or strabismus. The PVS detected all 6 cases, yielding a sensitivity rate of 100% (95% CI, 54%-100%). The PVS referred 45 additional children (15%) who had normal ophthalmic findings, yielding a specificity rate of 85% (95% CI, 80%-89%). The median acquisition time for the PVS was 28 seconds. CONCLUSIONS: The PVS detected amblyopia with high sensitivity in a nonenriched pediatric population. The device would allow children with amblyopia and/or strabismus to be referred to an eye care specialist as early as 2 years old. Given its short acquisition time, the PVS can be implemented in a pediatric clinic with minimal impact on workflow.

Parental Activation and Obesity-Related Health Behaviors Among a Racially and Ethnically Diverse Population of Low-Income Pediatric Patients: Protocol for a Cross-Sectional Survey Study.

BACKGROUND: Despite a recent decline in the obesity prevalence among preschool-aged children, obesity remains disproportionately high among children from low-income racial or ethnic minority families. Promoting healthy lifestyles (eg, obesity-preventative behaviors) in primary care settings is particularly important for young children, given the frequency of preventative health visits and parent-provider interactions. Higher adoption of specific health behaviors is correlated with increased patient activation (ie, skill, confidence, and knowledge to manage their health care) among adults. However, no published study, to date, has examined the relationship between parental activation and obesity-related health behaviors among young children. OBJECTIVE: The goal of this study is to measure parental activation in low-income parents of preschoolers in 2 large health systems and to examine the association with diet, screen-time, and physical activity behaviors. METHODS: We will conduct a cross-sectional study of parents of preschool-aged patients (2-5 years) receiving primary care at multiple clinic sites within 2 large health care systems. Study participants, low-income black, Hispanic, and white parents of preschool-aged patients, are being recruited across both health systems to complete orally administered surveys. RESULTS: Recruitment began in December 2017 and is expected to end in May 2018. A total of 267 low-income parents of preschool-aged children have been enrolled across both clinic sites. We are enrolling an additional 33 parents to reach our goal sample size of 300 across both health systems. The data analysis will be completed in June 2018. CONCLUSIONS: This protocol outlines the first study to fully examine parental activation and its relationship with parent-reported diet, physical activity, and screen-time behaviors among low-income preschool-aged patients. It involves recruitment across 2 geographically distinct areas and resulting from a partnership between researchers at 2 different health systems with multiple clinical sites. This study will provide new knowledge about how parental activation can potentially be incorporated as a strategy to address childhood obesity disparities in primary care settings. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/9688.

TREATMENT PATTERNS AND 2-YEAR VISION OUTCOMES WITH BEVACIZUMAB IN DIABETIC MACULAR EDEMA: An Analysis From a Large U.S. Integrated Health Care System.

PURPOSE: To assess health care utilization and vision outcomes over 2 years in patients receiving bevacizumab treatment in clinical practice for diabetic macular edema. METHODS: Patients with newly diagnosed diabetic macular edema who received an intravitreal bevacizumab injection within 12 months of initial diagnosis were identified from Kaiser Permanente's 350,000 patients with diabetes mellitus treated between 2008 and 2013. Snellen best-corrected visual acuity (BCVA), number of intravitreal injections, and patient characteristics were abstracted from the electronic record. The main outcome measure was change in BCVA. RESULTS: Three hundred and nine patients met the inclusion criteria and had 2 years of follow-up after their first bevacizumab injection. These patients had a mean of 3.1 injections (range, 1-17) during the 2-year follow-up. Mean BCVA improvement was 5.4 letters at 12 months and 5.3 letters at 24 months. Only 29.8% of patients demonstrated ≥3 lines of vision improvement from baseline, whereas 12.3% had ≥3 lines of vision loss from baseline at 24 months. CONCLUSION: This is the largest U.S. clinical practice-based study of bevacizumab use in diabetic macular edema. Consistent with national studies, the frequency of injection was low. Average BCVA improvement was lower than in anti-vascular endothelial growth factor trials. Significant BCVA improvement was achieved in approximately 30% of patients with newly diagnosed diabetic macular edema.