Case management for depression by health care assistants in small primary care practices: a cluster randomized trial.

<bold>Background: </bold>Case management by health care assistants in small primary care practices provides unclear benefit for improving depression symptoms.<bold>Objective: </bold>To determine whether case management provided by health care assistants in small primary care practices is more effective than usual care in improving depression symptoms and process of care for patients with major depression.<bold>Design: </bold>Cluster randomized, controlled trial. A central automated system generated the randomization scheme, which was stratified by urban and rural practices; allocation sequence was concealed until groups were assigned.<bold>Setting: </bold>74 small primary care practices in Germany from April 2005 to September 2007.<bold>Patients: </bold>626 patients age 18 to 80 years with major depression.<bold>Intervention: </bold>Structured telephone interview to monitor depression symptoms and support for adherence to medication, with feedback to the family physician.<bold>Measurements: </bold>Depression symptoms at 12 months, as measured by the Patient Health Questionnaire-9 (PHQ-9); secondary outcomes were patient assessment of chronic illness care, adherence to medication, and quality of life.<bold>Results: </bold>A total of 310 patients were randomly assigned to case management and 316 to usual care. At 12 months, 249 intervention recipients and 278 control patients were assessed; 555 patients were included in a modified intention-to-treat-analysis (267 intervention recipients vs. 288 control patients). Compared with control patients, intervention recipients had lower mean PHQ-9 values in depression symptoms (-1.41 [95% CI, -2.49 to -0.33]; P = 0.014), more favorable assessments of care (3.41 vs. 3.11; P = 0.011), and increased treatment adherence (2.70 vs. 2.53; P = 0.042). Quality-of-life scores did not differ between groups.<bold>Limitation: </bold>Patients, health care assistants, family physicians, and researchers were not blinded to group assignment, and 12-month follow-up of patients was incomplete.<bold>Conclusion: </bold>Case management provided by primary care practice-based health care assistants may reduce depression symptoms and improve process of care for patients with major depression more than usual care.<bold>Primary Funding Source: </bold>German Ministry of Education and Research. [ABSTRACT FROM AUTHOR]