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ARS Home » Northeast Area » Boston, Massachusetts » Jean Mayer Human Nutrition Research Center On Aging » Research » Publications at this Location » Publication #177667
Title: STRATEGIES, TIME, AND COSTS ASSOCIATED WITH THE RECRUITMENT AND ENROLLMENT OF NURSING HOME RESIDENTS FOR A MICRONUTRIENT SUPPLEMENTATION CLINICAL TRIAL

Author
item GISMONDI, PAULA - TUFTS/HNRCA
item HAMER, DAVIDSON - BOSTON UNIV SCH PUB HLTH
item LEKA, LYNETTE - TUFTS/HNRCA
item DALLAL, GERARD - TUFTS/HNRCA
item FIATARONE-SINGH, MARIA - TUFTS/HNRCA
item MAYDANI, SIMIN - TUFTS/HNRCA

Submitted to: Journal of Gerontology Medical Science
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 11/17/2004
Publication Date: 11/1/2005
Citation: Gismondi, P.M., Hamer, D.H., Leka, L.S., Dallal, G., Fiatarone-Singh, M.A., Maydani, S.N. 2005. Strategies, time, and costs associated with the recruitment and enrollment of nursing home residents for a micronutrient supplementation clinical trial. Journal of Gerontology Medical Science. 60(11):1469-74.

Interpretive Summary: More than 40 percent of the United States population over the age of 65 years will spend some time in a nursing home. Physicians and nurses providing elderly care in nursing homes often lack scientifically valid data for their diagnostic and therapeutic decision-making as well as prevention and treatment strategies. Well-designed, rigorously conducted intervention trials are needed to address this issue. Several obstacles need to be overcome when using nursing home residents for studies. Our research accomplishments focused on several steps including gaining acceptance of the study by the nursing home administration, educating the nursing home personnel, identifying potential study subjects, determining their competency, obtaining consent from competent candidates and the health care proxies for incompetent residents, and the re-screening procedures, all consumed more personnel resources than had been estimated in preparing the study budget. The data presented in the article provide a retrospective assessment of the time and staff costs associated with recruitment and enrollment of nursing home residents in this intervention clinical trial. The result of this assessment indicates that enrollment of each participant required 15 hours of staff time at a cost of $515. The unit time and costs described above could be modified to meet the differing requirements of comparable studies. This information should help investigators who wish to work with nursing homes understand the complicated process for recruiting in this environment and for developing better budget projections for similar types of clinical trials, as well as grant reviewers and administrators in evaluating the suitability of the requested budget for such proposals.

Technical Abstract: 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. This report describes our experience in recruiting 617 nursing home residents for a multi-site, double-blind, randomized, placebo-controlled trial designed to determine the efficacy of a one-year period of vitamin E supplementation in preventing respiratory tract infections. Comparisons of the projected staffing costs and actual costs incurred are presented, utilizing a retrospective method for the determination of unit costs. 874 consents were initially 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/subject 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. 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 subjects.