MD Buffum, VAMC, San Francisco; M Brod, Lewin Tag, San Francisco; L Sands, University of California, San Francisco; C Miaskowski, University of California, San Francisco

Objectives: The objectives of this research are (1) to elucidate the relationships between pain, discomfort, and agitation; and (2) to determine the influence that pain management has on decreasing the outcomes of discomfort, agitation, and confusion in nursing home residents. This study hypothesizes that patients receiving systematic, regularly scheduled pain medication will have less discomfort than the same patients receiving prn pain medication. A second hypothesis is that patients who have less discomfort will have less agitation and confusion.

Methods: Design: This study uses a randomized, double-blind, placebo-controlled, cross-over design. Each treatment arm lasts two weeks. The crossover point occurs without washout. One arm is acetaminophen 650 mg qid and placebo qid PRN. The other arm is placebo qid and acetaminophen 650 mg qid PRN. Patients are included who: are 55 years or older; have severe dementia; have a documented painful condition not requiring opiates or a current medication regimen; unable to report pain consistently or reliably; be present and accept treatment for study duration; have 1 or more episodes of agitation per day. Patients with schizophrenia or severe Parkinson’s are excluded. An RA (blind to treatment arm) tests each patient for discomfort, agitation, and confusion at baseline and two times per day on two days of the week for four weeks. Nurses rate patients for agitation each shift. Sample: Sixty-six patients are being recruited over a 3-year period. Sites involved in this study include the VAMC, San Francisco, Nursing Home Care Unit (NHCU); Jewish Home for the Aged; Golden Gate Healthcare Center in San Francisco; Palo Alto VA Health Care System, Nursing Home Care Units at Menlo Park and Livermore. Data Analysis: Repeated measures analyses will examine effect of treatment (drug vs. placebo) on the three outcome measures(agitation, confusion, and discomfort).

Results: Preliminary findings from 31 participants (7 men and 24 women), at baseline, reveal a mean age of 86.4 years (SD 7.2), a mean MMSE of 5.2 (SD 5), and a mean GDS of 5.8 (SD .42). Approximately 60% have degenerative joint disease, and 78% have severe cognitive decline. While 70% are unable to give an answer about being in pain, 30% are inconsistent in responses. The most frequent agitated behaviors include restlessness (51%), repetitive mannerisms (39%) and speech (27%), strange noises (21%), and wandering (18%). Study ends in March 2001.

Conclusions: None at this time.

Impact: It is expected that results from this study will have immediate and practical implications for the care and management of dementia patients. Findings from this study should provide scientific evidence for the need for regular pain assessment and evaluation of pain management strategies. The process of systematic pain treatment should result in improved care, better quality of life for long term care residents, and better use of staff resources, which may reduce costs and provide additional care to patients needing staff attention. A future direction will be to investigate the outcomes of ongoing pain assessment and management in demented patients, such as patient behaviors, staff time, and costs of care.