Effect of a Pain Protocol on Discomfort in Dementia

描述（由申请人提供）：该研究项目的总体目标是改善对晚期痴呆患者不适的评估和治疗。这项研究是对两种干预措施的测试，旨在实现这一目标。描述：这一竞争性继续研究的目的是比较系列临床干预加减轻不适负担干预（STI加DBR）与STI单独干预在五个结果上的效果：不适、行为症状、压力（皮质醇）、不适合并症和急性护理服务的使用。STI的开发是为了协助鉴别诊断和治疗过程：重点是早期识别和纠正与不适有关的问题。我们最近的CT显示使用STI可以有效减少不适。尽管STI有效，但我们发现在指导治疗以持续改善舒适度方面存在局限性。因此，我们开发了DBR干预措施来补充STI。DBR的重点是在较长时间内尽量减少临床可预防和可治疗的不适负担。我们将检查过程变量（评估范围、治疗范围、治疗稳定性、增加治疗、停止治疗、静态护理和反应性护理）的组间差异；并计划评估与剂量有关的干预措施的效果。此外，我们建议通过测量人员配备水平、离职水平和养老院文化对住院护理和住院结果的群体差异的相互作用，来检验组织特征对住院护理的影响。采用双盲方法的两组重复测量实验设计来比较两种研究条件。12家长期护理机构将根据规模、位置和医疗补助报销百分比进行分层，然后随机分配到其中一组。总共122个样本（61名受试者/组）将提供至少80%的能力来检测任何两组之间的效应量为0.63。当受试者表现出可能不适的行为/言语症状，且基本护理干预措施无法改善时，将开始使用性传播感染。护理性传播感染加DBR组受试者的护士将根据使用性传播感染获得的有效治疗信息启动DBR。计划的推论分析包括：用于重复测量的混合模型、方差分析、卡方分析和用于测试剂量反应的回归模型。

DESCRIPTION (provided by applicant): The overall goal of this program of study is to improve assessment and treatment of discomfort in people with advanced dementia. This study is a test of two interventions designed to meet that goal. Description: The purpose of this competing continuation is to compare the effect of the Serial Jrial intervention plus Discomfort Burden Reduction intervention (STI plus DBR) to the STI alone on five outcomes: discomfort, behavioral symptoms, stress (cortisol), discomfort comorbidities, and use of acute care services. The STI was developed to assist in the differential diagnosis and treatment process: the focus is on early identification and correction of problems associated with discomfort. Our recent CT demonstrated that use of the STI was effective in decreasing discomfort. Despite the effectiveness of the STI, we found limitations in directing treatment that sustained improvements in comfort. Thus, we have developed the DBR intervention to supplement the STI. The DBR focuses on minimizing the clinically preventable and treatable burden of discomfort over a longer time period. We will examine group differences in process variables (scope of assessment, scope of treatment, stabilization of treatment, treatments added, treatment stopped, static cares and reactive cares); and plan to evaluate the efficacy of interventions in relation to dose. In addition, we propose to examine the effect of organizational characteristics on care received by measuring the interaction of staffing level, turnover level, and nursing home culture on group differences in resident care and resident outcomes. A two group repeated measures experimental design with double blinding procedures will be used to compare the two study conditions. Twelve long-term care facilities will be stratified based on size, location, and % Medicaid reimbursement, and then randomly assigned to one of the groups. A total sample of 122 (61 subjects/group) will provide at least 80% power to detect an effect size of 0.63 between any two groups. Use of the STI will be initiated when a subject exhibits behavioral/verbal symptoms of possible discomfort that are not ameliorated by basic care interventions. Nurses caring for subjects in the STI plus DBR group will initiate the DBR based upon information regarding effective treatment gained by using the STI. Inferential analyses planned include: mixed models for repeated measures, analysis of variance, Chi square and regression models for testing dose response.