RATIONALE AND DESIGN OF A MULTICENTER RANDOMIZED TRIAL OF COMPREHENSIVE GERIATRIC ASSESSMENT CONSULTATION FOR HOSPITALIZED-PATIENTS IN AN HMO

Objective: To describe the evaluation of an interdisciplinary comprehe nsive geriatric assessment (CGA) consultation program for targeted hos pitalized patients. Design: Multi-center randomized clinical trial (RC T) at four hospitals where patients were randomly assigned to CGA cons ultation or usual care by the attending physician, and a non-equivalen t control group (NCG) at two hospitals. Setting: Six hospitals in a mu lti-specialty group practice model health maintenance organization (HM O). Participants: 3593 patients age 65 years or older meeting at least one of 13 inclusionary criteria at admission. Intervention: Screening by hospital staff and standardized CGA consultation conducted by a nu rse practitioner, social worker, and geriatrician at the four RCT hosp itals. Main Outcome Measures: Functional and health status, mortality, rehospitalization, and cost-effectiveness of the CGA program at 1 yea r post-randomization; validation of targeting (inclusionary) criteria that identify subgroups of patients deriving benefit from CGA; and phy sician contamination (learning from CGA and changing treatment provide d to control patients). Conclusions: A number of methodological issues need to be considered when conducting effectiveness trials of CGA. Th e concurrent design of a multi-center RCT, coupled with the NCG to det ermine physician contamination, is an innovative approach intended to determine more precisely the cost-effectiveness of CGA for frail hospi talized elderly persons. The large and heterogeneous patient populatio n and the broad array of inclusionary criteria will permit the evaluat ion of the benefit of CGA for subgroups. All these features are intend ed to enhance the generalizability of study results.