Medical assistant-based care management for high-risk patients in small primary care practices: A cluster randomized clinical trial

Background: Patients with multiple chronic conditions are at high risk for potentially avoidable hospitalizations, which may be reduced by care coordination and self-management support. Medical assistants are an increasingly available resource for patient care in primary care practices. Objective: To determine whether protocol-based care management delivered by medical assistants improves care in patients at high risk for future hospitalization in primary care. Design: Two-year cluster randomized clinical trial. (Current Controlled Trials: ISRCTN56104508) Setting: 115 primary care practices in Germany. Patients: 2076 patients with type 2 diabetes, chronic obstructive pulmonary disease, or chronic heart failure and a likelihood of hospitalization in the upper quartile of the population, as predicted by an analysis of insurance data. Intervention: Protocol-based care management, including structured assessment, action planning, and monitoring delivered by medical assistants, compared with usual care. Measurements: All-cause hospitalizations at 12 months (primary outcome) and quality-of-life scores (12-Item Short Form Health Survey [SF-12] and EuroQol instrument [EQ-5D]). Results: Included patients had an average of 4 co-occurring chronic conditions. All-cause hospitalizations did not differ between groups at 12 months (risk ratio [RR], 1.01 [95% CI, 0.87 to 1.18]) and 24 months (RR, 0.98 [CI, 0.85 to 1.12]). Quality of life (differences, 1.16 [CI, 0.24 to 2.08] on SF-12 physical component and 1.68 [CI, 0.60 to 2.77] on SF-12 mental component) and general health (difference on EQ-5D, 0.03 [CI, 0.00 to 0.05]) improved significantly at 24 months. Intervention costs totaled $10 per patient per month. Limitation: Small number of primary care practices and low intensity of intervention. Conclusion: This low-intensity intervention did not reduce allcause hospitalizations but showed positive effects on quality of life at reasonable costs in high-risk multimorbid patients.