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.


CONCLUSIONS
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.
Gismondi
Paula M
PM
DVM, Nutritional Immunology Laboratory, Jean Mayer/USDA Human Nutrition Research Center on Aging Tufts University, 711 Washington St., Boston, MA 02111, USA.
Hamer
Davidson H
DH
Leka
Lynette S
LS
Dallal
Gerard
G
Fiatarone Singh
Maria A
MA
Meydani
Simin N
SN
D002986:Clinical Trials as Topic / Q000191:economics*; D004311:Double-Blind Method; D006801:Humans; D007258:Informed Consent; D009735:Nursing Homes; D010919:Placebos; D014810:Vitamin E / Q000008:administration & dosage*
D010919:Placebos; D014810:Vitamin E