The FAME trial follows the specifications of the revised CONSORT criteria.8 This trial was a single-center study conducted at the Walter Reed Army Medical Center, a university-affiliated,suburban,tertiary care US military medical center. Eligible patients were recruited from the outpatient general medicine service and the Armed Forces Retirement Home, an affiliated retirement home of approximately 900 independently living military health care beneficiaries located in Washington,
DC, and were elderly men and women (65 years) taking 4 or more chronic medications daily, a population selected as being at increased risk for medication non adherence. Patients were excluded if they did not live independently (assisted living or nursing home residents were excluded) or in the presence of any serious medical condition for which 1-year survival was expected to be unlikely.
The Walter Reed Army Medical Center Department of Clinical Investigation, which is composed of the Clinical Investigation Committee, Human Use Committee, and the Central Investigative Regulatory Office, approved the study. Among 208 eligible patients approached for written informed consent, 200 patients volunteered to participate and 8 refused. Study patients were observed at the pharmacy clinics at both the Walter Reed Army Medical Center and Armed Forces Retirement Home. Study enrollment began on June 30, 2004, and was completed on July 6, 2005. The last follow-up visit occurred on August 30, 2006.