Effect of a Pain Protocol on Discomfort in Dementia

说明：（由申请人提供）人们不应该处于痛苦之中。本研究的总体目的是改善痴呆症患者身体和情感疼痛的评估和治疗。痴呆症不适评估（ADD）协议的制定是为了协助鉴别诊断和治疗过程。同时考虑生理和情感需求的二元视角是ADD协议的一个基本特征，而且，止痛剂被作为评估过程的一部分。在两项试点研究中，对ADD方案的测试表明，在使用ADD方案后，不适感显著减少，镇痛药和非药物舒适干预的使用增加。将比较两组痴呆患者（第一组：ADD方案；第二组：标准治疗）干预措施的不适程度、评估范围、范围和连续试验（定义为持续干预）。采用前测后测实验设计，对受试者和数据收集者进行盲法。8个长期护理设施将根据规模和位置分层，随机分配到治疗或控制条件。本研究将纳入189名在入学后至少4周内，心理状态测试分数为15分或以下，功能评估阶段（FAST）分数为6分或7分的受试者。当受试者表现出可能不适的行为/语言症状，且护理助理实施的基本护理干预措施无法改善时，将开始使用ADD方案。将被测量和比较的过程变量有：评估范围、药理学和非药理学干预的范围以及干预的系列试验。结果变量是不适，将使用discomfortable - dat和behavior - ad工具进行评估。计划的推断分析包括使用多变量方差分析。几个子问题和交互变量也将被测量。实验组和对照组之间的不适差异是否取决于痴呆功能阶段或语言症状的存在，将进行研究。将描述身体活动、功能状态以及药物和非药物干预的使用。

DESCRIPTION: (provided by applicant) 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.