Effect of a Pain Protocol on Discomfort in Dementia

疼痛方案对痴呆症不适的影响

• 批准号: 6640382
• 负责人: CHRISTINE R KOVACH
• 金额: $ 35.96万
• 依托单位: UNIVERSITY OF WISCONSIN MILWAUKEE
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-01 至 2005-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6640382
• 关键词: analgesia; analgesics; behavioral /social science research tag; clinical research; clinical trials; cognition; cognitive behavior therapy; dementia; functional ability; human middle age (35-64); human old age (65+); human subject; human therapy evaluation; medical rehabilitation related tag; method development; nurse performance; nursing intervention; outcomes research; pain; paralinguistic behavior; patient oriented research; verbal behavior

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.

描述：（由申请人提供）人们不应该处于痛苦之中。这项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) 方案的制定是为了协助鉴别诊断和治疗过程。同时考虑身体和情感需求的二元视角是 ADD 方案的基本特征，并且独特的是，镇痛药被用作评估过程的一部分。在两项试点研究中对 ADD 方案进行的测试显示，使用 ADD 方案后，不适感显着减少，镇痛药和非药物舒适干预措施的使用增加。 将在两组痴呆症患者中比较干预措施的不适感、评估范围、范围和连续试验（定义为干预的持续性）（第一组：ADD 方案；第二组：标准护理）。将使用对受试者和数据收集者进行盲法的前测后测实验设计。根据规模和位置分层的八个长期护理机构将被随机分配到治疗或控制条件。研究将纳入 189 名受试者样本，这些受试者的迷你精神状态考试分数为 15 或以下，功能评估阶段 (FAST) 分数为 6 或 7，且入院后至少 4 周。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该症状时，将开始使用 ADD 方案。将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 Discomfort-DAT 和 BEHAVE-AD 工具进行评估。计划的推理分析包括使用多元方差分析。还将测量几个子问题和交互变量。将检查实验组和对照组之间不适的差异是否取决于痴呆功能阶段或言语症状的存在。将描述身体活动、功能状态以及药物和非药物干预措施的使用。