Abstracts

Rationale: More than 1.6 million frail elderly reside in nursing homes (NH) in the US. Drugs are often prescribed with the assumption that stable doses will produce relatively constant concentrations and effects. Our long-term objective is to set up a viable recruiting strategy in a network of nursing homes that will require a minimal amount of NH staff time in order to study the variability of AED concentrations over time. Our goal is to determine the number of residents that need to be screened in order to enroll a nursing home resident into an AED research study. The purpose of this report is to provide preliminary results of an enrollment strategy that is currently being used by our research team in recruiting subjects from this special population. Methods: Our study funded by the National Institute of Aging began in September 2007. Inclusion criteria were nursing home residents who were taking particular AEDs as part of current clinical care, residents over the age of 60 years, and residents who do not reside in a rehabilitative care unit. Residents who agree to be in the study will provide a blood sample, a urine sample if possible, and undergo an examination including a cognitive assessment and measurements of memory, gait, and nystagmus at the time of blood collection for drug concentration measurement. The Institutional Review Board at the University of Minnesota and the equivalent entity at each nursing home approved this study. NH personnel identified candidates via pharmacy records. Appropriate subjects or guardians were then approached by NH staff and asked if our study team could speak with them concerning a study. If individuals signed a form (pre-consent form) to indicate that our team could contact them, their names and contact information were then forwarded to our research coordinator at the University of Minnesota. The number identified from the pharmacy records and the final number of subjects participating in the study were tallied for this report. Results: Currently two nursing homes are recruiting subjects on a regular basis. A total of 94 subjects were identified via pharmacy records as potential subjects. Of these, 38 subjects have completed the recruitment phase of the study resulting in 16 residents or guardians (42%) signing pre-consent forms. Due to factors such as not meeting inclusion criteria, becoming deceased, or refusal of resident after guardian permission 7 full consent forms were signed resulting in 4 subjects (14%) entering the study. We are currently in our second recruitment cycle and the remaining 56 subjects are being followed. Conclusions: Recruitment from nursing homes is complicated and time-consuming. Our results show that approximately 10 elderly nursing home residents need to be screened in order to enroll one subject into a study involving blood collection and outcome assessment. This number may decrease with refinement of our recruiting system; however, this data provides preliminary information for estimating the time and funding needed to recruit elderly nursing home residents into a study. Funded by NIH NIA 1R01AG026390-01A2