The Hospice Advanced dementia Symptom Management and Quality of Life Trial (HAS-QOL)

临终关怀晚期痴呆症症状管理和生活质量试验 (HAS-QOL)

• 批准号: 10248435
• 负责人: Abraham Aizer Brody
• 金额: $ 113.28万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10248435
• 关键词: Adoption; Advanced Malignant Neoplasm; Affect; Age; Aggressive behavior; Agitation; Alzheimer' s Disease; Analgesics; Antipsychotic Agents; Area; Award; Back; Behavioral Symptoms; Caregiver support; Caregivers; Caring; Cessation of life; Communities; Dementia; Dementia caregivers; Diagnosis; Discipline of Nursing; Disease; Effectiveness; Ensure; Evidence based intervention; Evidence based practice; Extramural Activities; Feedback; Geriatric Nursing; Goals; Health system; Healthcare; Home; Home Care Services; Home Health Aides; Home Health Care Agencies; Hospice Care; Hospice Programs; Hospital Mortality; Hour; Incidence; Infrastructure; Inpatients; Institutes; Institutionalization; Intervention; Length of Stay; Level of Evidence; Life; Long-Term Care; Measurement; Measures; Mental Depression; Modeling; Nursing Homes; Outcome; Pain; Pain management; Patients; Persons; Pharmacology; Phase; Population; Pragmatic clinical trial; Program Effectiveness; Protocols documentation; Psychosocial Assessment and Care; Public Health; Quality of Care; Quality of life; Randomized; Reproducibility; Resort; Safety; Serious Adverse Event; Site; Sleep disturbances; Statistical Methods; Symptoms; System; Testing; Training; Visit; Work; advanced dementia; base; burden of illness; burnout; care systems; clinical care; comorbidity; data management; end of life; end of life care; evidence base; falls; hospice environment; human data; human subject; implementation fidelity; implementation intervention; improved; innovation; inpatient service; intervention refinement; member; patient home care; pragmatic trial; primary caregiver; primary outcome; programs; psychological symptom; respite care; satisfaction; secondary outcome; symptom management; trial design; working group

As the population ages, the incidence rate of Alzheimer's Disease and Related Disorders (dementia) is expected to triple. The National Alzheimer's Plan recognizes that while the number of persons with dementia (PWD) is increasing substantially, the healthcare and long term care systems are unprepared to provide high quality, effective and efficient care to the PWD and their caregivers. PWD often have many behavioral and psychological symptoms of dementia (BPSD) including agitation, depression and sleep disturbances, that affect both the quality of life of the PWD and the caregiver. Unfortunately, due to a lack of programs to insert evidence-based care into the community, and hospice system specifically, PWD receive inappropriate and even harmful care. We have developed the Dementia Symptom Management at Home (DSM-H) Program to implement dementia friendly care for PWD and their caregivers in the community. Initially developed for use in home healthcare, we have modified the program for use in hospice. The DSM-H Hospice Edition is a systems level change program that includes workforce training, and agency level workflow changes. Through the Hospice Advanced Dementia Symptom Management and Quality of Life (HAS-QOL) Trial, in the R61 phase, we will: Aim 1: Establish the infrastructure necessary for implementing a pragmatic clinical trial of the DSM-H Hospice Edition. Aim 2: Further tailor the DSM-H program specifically for hospice IDT members caring for PWD receiving end of life care and adapt for wide-scale implementation in hospice. Aim 3: Pilot test the complete protocol in 2 hospice agencies and refine the protocol further based on feedback from the pilot agencies. Following successful completion of the milestones at the end of the R61 year surrounding feasibility, applicability, and fidelity, we will move forward with the R33 phase where, we will: Aim 4: Conduct a pragmatic, randomized stepped wedged cluster RCT of the Dementia Symptom Management at Home Program Hospice Edition with advanced dementia patients living at home (N=30/agency per month) in 25 hospice agencies comparing antipsychotics (Primary Outcome) and analgesic use (Secondary Outcome) before and after implementation. Aim 5: Compare the rates of hospice continuous, inpatient and temporary respite care hours provided, and rate of permanent institutionalization in a nursing home prior to and after implementation (Secondary Outcomes). Aim 6: Assess care satisfaction of the bereaved primary caregiver. (Secondary Outcome) Exploratory Aim 7: Assess the spillover effects of the DSM- H on hospice patients who are identified as having dementia as a comorbidity, and advanced dementia patients who are living in nursing homes. This is an innovative proposal as it would be the first large-scale pragmatic trial in a hospice focused on PWD and their caregivers, and has a strong scientific premise, rigor and potential for reproducibility. Following completion of the trial, should the findings show that the DSM-H Hospice Edition is effective in improving quality of care and has high adoption and implementation fidelity, we will develop a technical assistance center through the Hartford Institute for Geriatric Nursing to disseminate the model of care.

随着人口老龄化，阿尔茨海默病及相关疾病（痴呆）的发病率预计 到三倍。国家阿尔茨海默病计划认识到，虽然患有痴呆症 (PWD) 的人数 大幅增加，医疗保健和长期护理系统没有准备好提供高质量、 为残疾人及其护理人员提供有效和高效的护理。残疾人常常有许多行为和心理问题 痴呆症 (BPSD) 症状包括烦躁、抑郁和睡眠障碍，这些症状都会影响睡眠质量 残疾人及其护理人员的生活。不幸的是，由于缺乏将循证护理纳入其中的计划 在社区，特别是临终关怀系统中，残疾人接受了不适当甚至有害的护理。我们有 制定居家痴呆症症状管理 (DSM-H) 计划，以实施痴呆症友好型计划 照顾残疾人士及其社区照顾者。最初开发用于家庭医疗保健，我们有 修改了用于临终关怀的程序。 DSM-H 临终关怀版是一个系统级变更计划， 包括劳动力培训和机构级别工作流程变更。通过晚期痴呆临终关怀中心 症状管理和生活质量 (HAS-QOL) 试验，在 R61 阶段，我们将： 目标 1：建立 实施 DSM-H 临终关怀版实用临床试验所需的基础设施。目标 2：进一步 专门为照顾接受临终关怀的残疾人的临终关怀 IDT 成员量身定制 DSM-H 计划，以及 适应临终关怀的广泛实施。目标 3：在 2 个临终关怀机构对完整方案进行试点测试 并根据试点机构的反馈进一步完善协议。成功完成后 R61 年末围绕可行性、适用性和保真度的里程碑，我们将继续前进 在 R33 阶段，我们将： 目标 4：进行务实的、随机的、阶梯式的楔形集群 RCT 痴呆症症状家庭管理计划临终关怀版与晚期痴呆症患者一起生活 在 25 个临终关怀机构家中（N=30/机构每月）比较抗精神病药物（主要结果）和 实施前后镇痛剂的使用（次要结果）。目标 5：比较临终关怀费率 提供的连续、住院和临时暂托护理时间，以及永久收容率 实施前后的疗养院（次要结果）。目标 6：评估患者的护理满意度 失去亲人的主要照顾者。 （次要成果）探索性目标 7：评估 DSM 的溢出效应 H 被确定为患有痴呆症共病的临终关怀患者和晚期痴呆症患者 住在疗养院的人。这是一个创新的提议，因为这将是第一个大规模的务实试验 在一家专注于残疾人及其护理人员的临终关怀医院中，具有强大的科学前提、严谨性和潜力 再现性。试验完成后，结果是否表明 DSM-H 临终关怀版是 有效提高护理质量并具有较高的采用和实施保真度，我们将开发 技术援助中心通过哈特福德老年护理研究所传播护理模式。