Rationale and Design of a Multi‐Center Randomized Trial of Comprehensive Geriatric Assessment Consultation for Hospitalized Patients in an HMO

Abstract

Objective: To describe the evaluation of an interdisciplinary comprehensive geriatric assessment (CGA) consultation program for targeted hospitalized patients. Design: Multi-center randomized clinical trial (RCT) at four hospitals where patients were randomly assigned to CGA consultation or usual care by the attending physician, and a non-equivalent control group (NCG) at two hospitals. Setting: Six hospitals in a multi-specialty group practice model health maintenance organization (HMO). 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 nurse practitioner, social worker, and geriatrician at the four RCT hospitals. Main Outcome Measures: Functional and health status, mortality, rehospitalization, and cost-effectiveness of the CGA program at 1 year post-randomization; validation of targeting (inclusionary) criteria that identify subgroups of patients deriving benefit from CGA; and physician contamination (learning from CGA and changing treatment provided to control patients). Conclusions: A number of methodological issues need to be considered when conducting effectiveness trials of CGA. The concurrent design of a multi-center RCT, coupled with the NCG to determine physician contamination, is an innovative approach intended to determine more precisely the cost-effectiveness of CGA for frail hospitalized elderly persons. The large and heterogeneous patient population and the broad array of inclusionary criteria will permit the evaluation of the benefit of CGA for subgroups. All these features are intended to enhance the generalizability of study results.