Nursing Home Pain Management Algorithm Clinical Trial

描述（由申请人提供）：疗养院（NHs）的疼痛评估和管理缺陷有很好的记录。在这种情况下，未缓解的疼痛会导致较差的住院治疗结果，包括抑郁、活动能力下降、睡眠障碍、身体和社会功能受损。这项随机对照试验将评估疼痛管理算法与强烈扩散策略在改善NH居民身体功能和减少疼痛和抑郁方面的疗效。该研究的具体目的是：1)评估疼痛管理算法（ALG）结合强扩散策略，与疼痛教育（EDU）和弱扩散策略相比，在改善NH居民的自我保健，运动和活动能力，减少疼痛和抑郁方面的有效性；2)确定ALG依从性和组织因素与居民自我护理、运动、活动能力、疼痛和抑郁变化的关联程度，以及这些变量的变化与结果变化的关联程度；3)评估长期随访过程和结果变量变化的持续性；4)评估无法提供自我报告的严重认知障碍居民行为问题（以behavior - ad测量）与不适（以DS-DAT测量）之间的关系。NH疼痛管理算法是一系列决策工具，从与居民认知状态相匹配的定期、全面的疼痛评估开始，然后进行适合疼痛特征、严重程度和模式的镇痛治疗。该算法基于研究人员早期的研究，并与老年疼痛专家合作进行了调整。初步的试点测试证明了该算法的有效性。算法的实现将利用一个应用罗杰创新扩散理论原理的程序。实施方案强调对NH员工进行算法使用的教育；将算法应用于假设和实际案例研究的实践；建立由使用算法的专家意见领袖组成的NH疼痛小组；使用辅助和支持策略将算法嵌入到日常的，持续的疼痛管理实践中。随机对照试验将涉及20个设施，10个ALG和10个EDU。设施将是随机化的单位，尽管临床结果将在设施内的个体居民中进行测量。将评估来自510名居民（每个治疗组255名）的临床结果，以确定ALG的疗效。这项研究的结果将有助于NH工作人员有效地评估和治疗认知完好和受损居民的疼痛。长期随访将确定临床实践和住院治疗结果变化的持久性。

DESCRIPTION (provided by applicant): Pain assessment and management deficiencies in nursing homes (NHs) are well documented. Unrelieved pain in this setting results in poorer resident outcomes, including depression, decreased mobility, sleep disturbance, and impaired physical and social functioning. This randomized controlled trial will evaluate the efficacy of a pain management algorithm coupled with intense diffusion strategies in improving physical function and decreasing pain and depression among NH residents. Specific aims of the study are to: 1) Evaluate the effectiveness of a pain management algorithm (ALG) coupled with intense diffusion strategies, as compared with pain education (EDU) and weak diffusion strategies, in improving self-care, locomotion, and mobility, and decreasing pain and depression among NH residents; 2) Determine the extent to which adherence to the ALG and organizational factors are associated with changes in residents' self-care, locomotion, mobility, pain, and depression and the extent to which changes in these variables are associated with changes in outcomes; 3) Evaluate the persistence of changes in process and outcome variables at long-term follow-up and 4) Evaluate the relationships among behavioral problems (measured by the BEHAVE-AD) and discomfort (as measured by the DS-DAT) in severely cognitively impaired residents who are unable to provide self-report. The NH pain management algorithm is a series of decision-making tools that begin with regular, comprehensive pain assessment matched to residents' cognitive status and proceed through analgesic therapy appropriate to the character, severity, and pattern of pain. The algorithm is based on the investigators' earlier research and was adapted in collaboration with geriatric pain experts. Initial pilot testing demonstrated preliminary support for the effectiveness of the algorithm. Implementation of the algorithm will utilize a program that applies the principles of Roger's Diffusion of Innovations Theory. The implementation program emphasizes the education of NH staff in the use of the algorithm; practice in applying the algorithm to hypothetical and real case studies; establishment of NH pain teams comprised of opinion leaders who are experts in using the algorithm; and use of booster and supportive strategies to imbed the algorithm into everyday, ongoing pain management practices. The randomized controlled trial will involve 20 facilities, 10 ALG and 10 EDU. Facilities will be the unit of randomization, although clinical outcomes will be measured in individual residents within facilities. Clinical outcomes from 510 residents, 255 in each treatment arm, will be evaluated to determine the efficacy of the ALG. Findings from this study will assist NH staff to assess and treat pain effectively in cognitively intact and impaired residents. Long-term follow-up will establish the persistence of changes in clinical practice and resident outcomes.