Strategies, time, and costs associated with the recruitment and enrollment of nursing home residents for a micronutrient supplementation clinical trial.

BACKGROUND: Concomitant with the substantial growth of the elderly population in the last decade, there has been a steady rise in the number of nursing home residents aged 65 years and older. Well designed, rigorously conducted clinical intervention trials provide an important source of data for evidence-based improvements in the medical care of nursing home residents. The information available on strategies for the recruitment and screening of participants for such studies in long-term care facilities, as well as the financial and time costs for carrying out these investigations, is limited. METHODS: This report describes our experience in recruiting 617 nursing home residents for a multisite, double-blind, randomized, placebo-controlled trial designed to determine the efficacy of a 1-year period of vitamin E supplementation in preventing respiratory tract infections. Comparisons of the projected staffing costs and actual costs incurred are presented, using a retrospective method for the determination of unit costs. RESULTS: Initially, 874 consents were obtained from 2815 potential participants, of which only 617 were enrolled. Each successful enrollment required an average of 15 hours of staff time at a combined personnel and supply cost of $515 per participant and a total study cost of $317,661. Several obstacles were encountered during the recruitment and enrollment process: resistance on the part of family or primary care provider; transfer out of facility; and changes in the medical condition of the patient, including death. DISCUSSION: The results of this report should prove useful to investigators developing budgets for nursing home-based clinical trials by providing a more accurate determination of the personnel needed and the costs associated with recruitment and enrollment of participants.