A Multi-Site Cluster RCT of the Dementia Symptom Management At Home Program

项目摘要/摘要 随着人口老龄化，阿尔茨海默病及相关疾病(痴呆症)的发病率为 预计将增加两倍。大多数痴呆症患者(PWD)将在社区得到照顾。然而，支持 和确保在社区中为残疾人士提供适当护理的资源目前并不存在，如 应对阿尔茨海默病的国家计划。一种以社区为基础的护理形式，经常提供给 社区中的残障人士就是家庭保健。虽然这些临床医生经常照顾PWD，但很少有机构或家庭 健康临床医生做好了适当的准备，提供姑息性的、基于症状的、以患者和家庭为中心的 关爱这一弱势群体。有10,000多家技术娴熟的家庭医疗机构在 几乎全美每个县都有。因此，家庭医疗保健是一种尚未开发的现有资源 可以更有效地用于改善残疾人士和非正式残疾人的护理质量和生活质量 护理人员，减少使用率，并减少医疗支出。最需要关注的领域 改善是在管理疼痛和行为和心理障碍(BPSD)方面，因为他们 对PWD和照顾者的生活质量以及对医疗保健的利用都有重大影响。这个 痴呆症家庭症状管理计划(DSM-H)是一个跨专业的循证多学科的项目。 专门为家庭医疗保健机构开发的组件干预。它包括临床医生培训， 导师制和循证评估工具、CarePlans和照顾者教单。需求侧管理- H已经显示出很强的初步结果，因此这项研究将进行随机的多站点聚类 疗效试验。DSM-H将在三个不同家庭医疗保健的护理团队中随机实施 位于美国不同地区的机构。这项试验的目的是：1)衡量疗效 DSM-H对PWD患者的生活质量和症状严重程度的影响。2)评估DSM-H的效果 关于残疾人非正式照顾者的生活质量和身心健康。3)评估 DSM-H对残障人群医疗服务利用的影响这项研究将招募460名PWD-非正式 在入院时、入院后15天、30天和60天，照顾者和每个二元体将由 使用标准化评估工具的独立、盲目的研究助理。我们假设 DSM-H将提高PWD和照顾者的生活质量，改善症状管理，并减少 利用率。虽然其他干预措施侧重于基于家庭的模型，但以前的干预措施都没有使用过 既是一种跨专业模式，也是一种使用现有的广泛服务模式的模式。这项研究是 因此具有重大意义和创新性，因为它将是第一个测试潜在广泛传播的 和有效的循证姑息和症状管理干预，以提高生活质量 为残疾人及其接受家庭医疗保健的非正式照顾者提供服务。

PROJECT SUMMARY/ABSTRACT As the population ages, the incidence rate of Alzheimer’s Disease and Related Disorders (dementia) is expected to triple. Most persons with dementia (PWD) will be cared for in the community. However, the support and resources to ensure proper care is provided to PWD in the community is not currently present as noted in the National Plan to Address Alzheimer’s. One form of community-based care that is frequently provided to PWD in the community is home healthcare. While these clinicians often care for PWD, few agencies, or home health clinicians are appropriately prepared to provide palliative, symptom based, patient and family centered care for this vulnerable population. There are over 10,000 skilled home healthcare agencies providing care in almost every county across the United States. Thus, home healthcare is an untapped existing resource that could be utilized more effectively to improve the quality of care and quality of life for the PWD and their informal caregiver, reduce utilization, and decrease healthcare spending. The most concerning areas in need of improvement is in managing pain and behavioral and psychological disturbances (BPSD) in the PWD as they have significant effects on both PWD and caregiver quality of life, as well as on healthcare utilization. The Dementia Symptom Management at Home Program (DSM-H) is an interprofessional evidence-based multi- component intervention developed specifically for home healthcare agencies. It includes clinician training, mentorship and evidence-based assessment instruments, careplans and caregiver teaching sheets. The DSM- H has shown strong preliminary results, and therefore this study will perform a multi-site cluster randomized efficacy trial. The DSM-H will be randomly implemented in care teams at three diverse home healthcare agencies located in different regions of the United States. The aims of this trial are to: 1) Measure the effects of the DSM-H on quality of life and symptom severity in the PWD. 2) Assess the effects of the DSM-H on quality of life, and physical and mental health in the informal caregiver of the PWD. 3) Assess the effects of the DSM-H on healthcare utilization in the PWD. This study will recruit 460 PWD-informal caregiver dyads and each dyad will be assessed on admission, 15, 30 and 60 days post admission by an independent, blinded research assistant using standardized assessment instruments. We hypothesize that the DSM-H will improve quality of life of the PWD and caregiver, improve symptom management, and reduce utilization. While other interventions have focused on home-based models, no prior interventions have used both an interprofessional model and one where an existing, widespread, service model is used. This study is therefore significant and innovative as it will be the first to test the efficacy of a potentially widely disseminable and impactful evidence-based palliative and symptom management intervention for improving the quality of life for PWD and their informal caregivers receiving home healthcare.