Effect of a Pain Protocol on Discomfort in Dementia

描述（由申请人提供）：本研究计划的总体目标是改善晚期痴呆患者不适的评估和治疗。这项研究是对旨在实现这一目标的两种干预措施的测试。产品描述：这种竞争性延续的目的是比较连续Jrial干预加不适负担减轻干预（STI加DBR）与STI单独对五种结局的影响：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。制定STI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相关的问题。我们最近的CT显示，STI的使用有效地减少了不适。尽管STI的有效性，我们发现在指导治疗，持续改善舒适度的局限性。因此，我们制定了DBR干预措施，以补充STI。DBR侧重于在较长时间内最大限度地减少临床上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;并计划评价与剂量相关的干预措施的有效性。此外，我们建议通过测量人员配备水平，营业额水平和护理之家文化对居民护理和居民成果的群体差异的相互作用来研究组织特征对护理的影响。将采用双盲程序的两组重复测量实验设计比较两种研究条件。12个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例样本（61例受试者/组）将提供至少80%的把握度来检测任何两组之间0.63的效应量。当受试者表现出可能不适的行为/言语症状，且基本护理干预无法改善时，将开始使用STI。照顾STI + DBR组受试者的护士将根据使用STI获得的有效治疗信息启动DBR。计划的推断分析包括：重复测量的混合模型、方差分析、卡方和回归模型，用于检验剂量反应。

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.