Abstracts

Rationale: There are over 1.6 million elderly nursing home residents in the US with approximately 10% being treated with antiepileptic drugs (AED). Our long-term objective was to create a viable recruiting strategy in a network of nursing homes that requires a minimal amount of nursing home staff time. This report provides an updated estimate of recruitment rates under the current HIPAA rules. Methods: The Institutional Review Board at the University of Minnesota and the equivalent entity at each nursing home approved this prospective study of the causes and consequences of fluctuating AED levels (Birnbaum, A., et al. Neurology 2003;60:555-559; Birnbaum, A.K., et al. Epilepsy Research 2012 e published). Inclusion criteria are nursing home residents who are taking one of four AEDs (phenytoin, levetiracetam, lamotrigine, gabapentin) as part of current clinical care and who are age greater than or equal to 60 years. Due to current HIPAA rules and limited access of study personnel, a recruitment procedure was created. The current strategy consists of a pharmacist or other employee with access to medication dispensing records in the nursing home, screening for patients meeting the above criteria and sending an unidentified list for our review. Upon our approval, potential subjects or guardians were approached by nursing home staff and asked if our study team could speak with them concerning a study. If subject/guardian agreed, a pre-consent form was signed 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. Eleven nursing homes in Minnesota, New York and California are participating in this study; however, only those homes in Minnesota (n=9) are included in this analysis since the recruiting strategy was identical in those cases. Results: A total of 524 subjects were identified via pharmacy records as potential subjects. Of these, 275 (53%) were approached by nursing home staff and 183 (35%) signed pre-consent forms. Due to factors such as not meeting inclusion criteria, becoming deceased, or refusal of resident after guardian permission 113 (22%) residents and/or guardians signed full consent forms and entered the study. The percent of residents recruited from a particular nursing home ranged from 16.3 to 50.0% with the average being 29.2%. Conclusions: There is variability in recruitment among nursing homes. A major barrier to recruiting subjects in a nursing home is the need to have nursing home staff approach potential subjects. This creates a system that is dependent on enthusiasm and time availability of personnel. Funded by NIH NIA 1R01AG026390-0