The management of diabetes in everyday life study: Design and methods for a pragmatic randomized controlled trial comparing the effectiveness of text messaging versus health coaching.

Background African American patients with uncontrolled diabetes living in medically underserved areas need effective clinic-based interventions to improve self-care behaviors. Text messaging (TM) and health coaching (HC) are among the most promising low-cost population-based approaches, but little is known about their comparative effectiveness in real-world clinical settings. Objective Use a pragmatic randomized controlled trial design to determine the comparative effectiveness of TM and HC with enhanced usual care (EC) in African American adults with uncontrolled diabetes and multiple chronic health conditions. Methods/design The Management of Diabetes in Everyday Life (MODEL) study is randomizing 646 patients (n = 581with anticipated 90% retention) to 3 intervention arms: TM, HC, and EC. Participants are African American adults living in medically underserved areas of the Mid-South, age ≥ 18, with uncontrolled diabetes (A1c ≥ 8), one or more additional chronic conditions, and who have a phone with texting and voicemail capability. Primary outcome measures: the general diet, exercise, and medication adherence subscales of the revised Summary of Diabetes Self-Care Activities questionnaire assessed at one year. Secondary outcomes: diabetes-specific quality of life, primary care engagement, and average blood sugar (A1c). The study will also assess heterogeneity of treatment effects by six key baseline participant characteristics. Conclusions We describe the design and methods of the MODEL study along with design revisions required during implementation in a pragmatic setting. This trial, upon its conclusion, will allow us to compare the effectiveness of two promising low-cost primary care-based strategies for supporting self-care behaviors among African Americans individuals with uncontrolled diabetes. ClinicalTrials.gov registration number: NCT02957513.

Effect of Intensive Interdisciplinary Transitional Care for High-Need, High-Cost Patients on Quality, Outcomes, and Costs: a Quasi-Experimental Study.

BACKGROUND: Many health systems have implemented team-based programs to improve transitions from hospital to home for high-need, high-cost patients. While preliminary outcomes are promising, there is limited evidence regarding the most effective strategies. OBJECTIVE: To determine the effect of an intensive interdisciplinary transitional care program emphasizing medication adherence and rapid primary care follow-up for high-need, high-cost Medicaid and Medicare patients on quality, outcomes, and costs. DESIGN: Quasi-experimental study. PATIENTS: Among 2235 high-need, high-cost Medicare and Medicaid patients identified during an index inpatient hospitalization in a non-profit health care system in a medically underserved area with complete administrative claims data, 285 participants were enrolled in the SafeMed care transition intervention, and 1950 served as concurrent controls. INTERVENTIONS: The SafeMed team conducted hospital-based real-time screening, patient engagement, enrollment, enhanced discharge care coordination, and intensive home visits and telephone follow-up for at least 45 days. MAIN MEASURES: Primary difference-in-differences analyses examined changes in quality (primary care visits, and medication adherence), outcomes (preventable emergency visits and hospitalizations, overall emergency visits, hospitalizations, 30-day readmissions, and hospital days), and medical expenditures. KEY RESULTS: Adjusted difference-in-differences analyses demonstrated that SafeMed participation was associated with 7% fewer hospitalizations (- 0.40; 95% confidence interval (CI), - 0.73 to - 0.06), 31% fewer 30-day readmissions (- 0.34; 95% CI, - 0.61 to - 0.07), and reduced medical expenditures ($- 8690; 95% CI, $- 14,441 to $- 2939) over 6 months. Improvements were limited to Medicaid patients, who experienced large, statistically significant decreases of 39% in emergency department visits, 25% in hospitalizations, and 79% in 30-day readmissions. Medication adherence was unchanged (+ 2.6%; 95% CI, - 39.1% to 72.9%). CONCLUSIONS: Care transition models emphasizing strong interdisciplinary patient engagement and rapid primary care follow-up can enable health systems to improve quality and outcomes while reducing costs among high-need, high-cost Medicaid patients.

Unmet Primary Care Needs in Diabetic Patients with Multimorbidity in a Medically Underserved Area.

BACKGROUND: Diabetic patients with multimorbidity in medically underserved minority communities are less engaged in primary care and experience high emergency department (ED) utilization. This study assesses unmet primary care needs among diabetic patients in a medically underserved area (MUA). COMMUNITY CONTEXT: A suburb of Memphis-Whitehaven, Tennessee (Shelby County, ZIP codes 38109 and 38116)-majority African American (96.6%) with 30.5% below the poverty level. METHODS: Community case study using multiple data sources including diabetes registry, individual interviews, focus groups, and a survey of 30 ED patients with diabetes and multimorbidity. RESULTS: Diabetes registry data indicated that 95.5% of 5723 diabetic patients had multimorbidity. Over 91.5% were uncontrolled at some point in 2014 to 2015. Only 83% of patients with diabetes and multimorbidity reported having a primary care provider (PCP) and those without a PCP were more likely to report delays in needed care. Patients expressed strong interest in health coaching (88%) and receiving text messages from the doctor's office (73%). Individual patient interviews (n = 9) and focus groups (n = 11) revealed common primary care and self-care experiences and needs including diabetes education, improved patient-provider communication, health-care access and coverage, and strengthened primary care and community. CONCLUSION: This study demonstrates that almost 1 in 5 ED complex diabetic patients in an MUA do not have a PCP, and that difficulty accessing primary care often results in patients forgoing needed care. Qualitative findings support these conclusions. These results suggest that primary care capacity and infrastructure to support diabetes self-care need strengthening in MUAs.