Improving primary care for depression in late life - The design of a multicenter randomized trial

BACKGROUND. Late life depression can be successfully treated with antidepre ssant medications or psychotherapy, but few depressed older adults receive effective treatment. RESEARCH DESIGN. A randomized controlled trial of a disease management prog ram for late life depression. SUBJECTS. Approximately 1,750 older adults with major depression or dysthym ia are recruited from seven national study sites. INTERVENTION. Half of the subjects are randomly assigned to a collaborative care program where a depression clinical specialist supervised by a psychi atrist and a primary care expert supports the patient's regular primary car e provider to treat depression. Intervention services are provided for 12 m onths using antidepressant medications and Problem Solving Treatment in Pri mary Care according to a stepped care protocol that varies intervention int ensity according to clinical needs. The other half of the subjects are assi gned to care as usual. EVALUATION. Subjects are independently assessed at baseline, 3 months, 6 mo nths, 12 months, 18 months, and 24 months. The evaluation assesses the incr emental cost-effectiveness of the intervention compared with care as usual. Specific outcomes examined include care for depression, depressive symptom s, health-related quality of life, satisfaction with depression care, healt h care costs, patient time costs, market and nonmarket productivity, and ho usehold income. CONCLUSIONS. The study blends methods from health services and clinical res earch in an effort to protect internal validity while maximizing the genera lizability of results to diverse health care systems. We hope that this stu dy will show the cost-effectiveness of a new model of care for late life de pression that can be applied in a range of primary care settings.