Effect of a Pain Protocol on Discomfort in Dementia

描述：(申请人提供)人们不应该被留在痛苦中。这项研究的总体目的是改善痴呆症患者对身体和情感疼痛的评估和治疗。痴呆症不适评估(ADD)方案已经开发出来，以协助鉴别诊断和治疗过程。同时考虑身体需求和情感需求的二元论观点是《补充议定书》的一个基本特点，唯一的特点是，镇痛剂被用作评估过程的一部分。在两项先导性研究中对ADD方案的测试结果显示，在使用ADD方案后，显著减少了不适感，增加了止痛药和非药理学舒适干预措施的使用。将比较两组痴呆症患者(第一组：ADD方案；第二组：标准护理)的不适感、评估范围、干预范围和系列试验(定义为坚持干预)。将采用前测后测的实验设计，受试者和数据收集者均为盲人。根据大小和位置分层的八个长期护理机构将随机分配到治疗或控制条件下。这项研究将包括189名入院后至少4周的受试者，他们的迷你精神状态考试成绩为15分或以下，功能评估阶段(FAST)评分为6或7分。当受试者表现出可能的不适的行为/语言症状，而护理助理实施的基本护理干预措施没有改善这些症状时，将开始使用ADD方案。将被测量和比较的过程变量包括：评估范围、药理学和非药理学干预措施的范围以及干预措施的系列试验。结果变量是不适，将使用不适-DAT和Behavior-AD工具进行评估。计划的推理分析包括使用多变量的方差分析。还将测量几个子问题和交互变量。我们将检查试验组和对照组之间的不适差异是否取决于痴呆症的功能阶段或言语症状的存在。将描述体力活动、功能状态以及药理学和非药理学干预的使用。

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.