Methodology of an ongoing, randomized controlled trial to prevent falls through enhanced pharmaceutical care

Falls are the leading cause of both fatal and nonfatal injuries among adults aged > or =65 years in the United States. Past research suggests that individuals taking multiple medications are at increased risk of falls. Central nervous system-active drugs in particular have been associated with increased risk.

The goal of this research was to describe the design of a study evaluating the effectiveness of a community pharmacy-based falls prevention program. Also presented are the algorithms used to identify high-risk patients based on their prescription profile records and to deliver the experimental intervention.

The study is a randomized controlled trial. The target population was community-dwelling older adults (aged > or =65 years) at high risk for future falls because: (1) they had experienced > or =1 fall within the 12-month period preceding study enrollment; (2) they were currently using > or =4 chronic prescription medications; and (3) they were taking > or =1 of the high-risk medications targeted by the intervention. Participants were recruited using pharmacy prescription profile records. Individuals in the intervention group received a face-to-face medication consultation provided by a community pharmacy resident. Identification of drug therapy problems and therapeutic recommendations was guided by a series of algorithms developed for this study. All participants were followed up for 24 months. The primary study end points were: (1) time to first fall; and (2) proportion of participants who experienced > or =1 fall during the first year of follow-up.

Participant enrollment began in September 2005 and was completed in August 2007. A total of 186 individuals were enrolled in the study (mean [SD] age, 74.8 [6.9] years; 132 women, 54 men), and 67 have completed the first year of follow-up.

The study is using a rigorous randomized controlled research design, which will enhance the internal validity of its findings. Results of the study, which will be reported after the completion of follow-up data collection activities, will enable us to assess the effects of the intervention on both medication use and the incidence of falls. If the intervention is found to be effective, it will provide a resource for community pharmacists working with older adults at high risk of medication-related falls.