People should not be left in pain. The overall intent of this study is to improve assessment and treatment of physical and affective pain in people with dementia. The Assessment of Discomfort in Dementia (ADD) Protocol has been developed to assist in the differential diagnosis and treatment process. A dualistic perspective in which physical and affective needs are considered in tandem is an essential feature of the ADD Protocol and, uniquely, analgesics are used as a part of the assessment process. Testing of the ADD Protocol in two pilot studies yielded significantly decreased discomfort and increased use of analgesics and non-pharmacological comfort interventions following use of the ADD Protocol. Discomfort, scope of assessment, scope and serial trialling (defined as persistence to intervene) of interventions will be compared in two groups of people with dementia (group I: ADD Protocol; group II: standard care). A pretest posttest experimental design with blinding of subjects and data collectors will be used. Eight long-term care facilities stratified based on size and location will be randomly assigned to the treatment or control conditions. A sample of 189 subjects with a Mini Mental State Exam Score of 15 or below, Functional Assessment Stage (FAST) score of 6 or 7, who are at least 4 weeks post-admission will be included in the study. Use of the ADD Protocol will be initiated when a subject exhibits behavioral/verbal symptoms of possible discomfort that are not ameliorated by basic care interventions implemented by a nursing assistant. Process variables that will be measured and compared are: scope of assessment, scope of pharmacological and non-pharmacological interventions, and serial trials of interventions. The outcome variable is discomfort and will be assessed using the Discomfort-DAT and BEHAVE-AD tools. Inferential analysis planned includes use of multivariate analysis of variance. Several subquestions and interaction variables will also be measured. Whether differences in discomfort between the experimental and control group are dependent on dementia functional stage or the presence of verbal symptoms will be examined. Physical activity, functional status, and use of pharmacological and non-pharmacological interventions will be described.
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