Working With Socially and Medically Complex Patients: When Care Transitions Are Circular, Overlapping, and Continual Rather Than Linear and Finite.

The care coordination program described here evolved from 5 years of trial and learning related to how to best serve our high-cost, high-utilizing, chronically ill, urban core patient population. In addition to medical complexity, they have daily challenges characteristic of persons served by Safety-Net health systems. Many have unstable health insurance status. Others have insecure housing. A number of patients have a history of substance use and mental illness. Many have fractured social supports. Although some of the best-known care transition models have been successful in reducing rehospitalizations and cost among patients studied, these models were developed for a relatively high functioning patient population with social support. We describe a successful approach targeted at working with patients who require a more intense and lengthy care coordination intervention to self-manage and reduce the cost of caring for their medical conditions. Using a diverse team and a set of replicable processes, we have demonstrated statistically significant reduction in the use of hospital and emergency services. Our intervention leverages the strengths and resilience of patients, focuses on trust and self-management, and targets heterogeneous "high-utilizer" patients with medical and social complexity.

A phase I study assessing the safety, clinical response, and pharmacokinetics of an experimental infliximab formulation for subcutaneous or intramuscular administration in patients with rheumatoid arthritis.

OBJECTIVE: To assess safety, clinical response, and pharmacokinetics of subcutaneous (SC) and intramuscular (IM) doses of an experimental formulation of infliximab [including experimental SC doses following administration of commercially-formulated intravenous (IV) infliximab] in patients with rheumatoid arthritis (RA) refractory to methotrexate. METHODS: In this randomized, open-label, 3-stage design, 43 subjects were enrolled in 7 dose groups. In Stage I, 15 subjects received single SC doses of 0.5, 1.5, or 3.0 mg/kg. In Stage II, 21 subjects received one of 3 regimens: 100 mg SC every 2 weeks (3 injections); 3 mg/kg commercially-formulated IV infliximab every 2 weeks (2 infusions) followed by 100 mg SC every 2 weeks (3 injections); or 100 mg IM every 2 weeks (3 injections). In Stage III, 7 subjects received 100 mg SC every 4 weeks (3 injections). RESULTS: No treatment-related serious adverse events were observed, and there were no serious injection site reactions. A low-titer infliximab antibody response was detected in 27% of subjects receiving single SC doses, 5% receiving multiple SC doses, and 43% receiving IM doses. SC administration yielded roughly dose-proportional increases in Cmax and AUC. American College of Rheumatology 20% response (ACR20) was achieved 2 weeks after the last injection by 86.7% of subjects receiving single SC doses, 85.7% receiving SC doses every 2 weeks, 85.7% receiving both IV and SC doses, 57.1% receiving multiple IM doses, and 80.0% receiving SC doses every 4 weeks. CONCLUSION: SC and IM treatment with this experimental infliximab formulation was well tolerated and was associated with a favorable ACR response.