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.

随着人口的年龄，预计阿尔茨海默氏病和相关疾病的发病率（痴呆症） 三倍。国家阿尔茨海默氏症的计划认识到，痴呆症（PWD）的人数是 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， 对PWD及其护理人员有效的有效护理。 PWD通常有许多行为和心理 痴呆症的症状（BPSD），包括躁动，抑郁和睡眠障碍，都影响质量 PWD和护理人员的生活。不幸的是，由于缺乏将循证护理插入的计划 特别是社区和临终关怀系统，PWD获得了不适当甚至有害的护理。我们有 开发了家庭痴呆症状管理（DSM-H）计划以实施痴呆症友好 照顾PWD及其社区中的护理人员。最初开发用于家庭医疗保健，我们有 修改了该计划用于临终关怀。 DSM-H Hospice Edition是一个系统级变更程序， 包括劳动力培训和代理水平的工作流程变化。通过临终关怀痴呆症 症状管理和生活质量（HAS-QOL）试验，在R61阶段，我们将：AIM 1：建立 实施DSM-H Hospice Edition的实用临床试验所需的基础设施。目标2：进一步 专门针对照顾PWD接受生命终止的临终关怀IDT成员量身定制DSM-H计划 适应临终关怀的大规模实施。 AIM 3：试点测试两个临终关怀机构的完整协议 并根据试点机构的反馈进一步完善协议。成功完成后 R61年结束时的里程碑，围绕可行性，适用性和保真度，我们将继续前进 在R33阶段，我们将：AIM 4：进行务实的随机阶梯楔形群集RCT 家庭计划的痴呆症状管理临终关怀版与高级痴呆症患者生活 在家中的25个临终关怀机构（主要结果）和 实施之前和之后的镇痛作用（次要结果）。目标5：比较临终关怀的速度 提供的连续，住院和临时暂时的护理时间以及在 实施之前和之后的疗养院（次要结果）。目标6：评估护理满意度 丧亲的初级护理人员。 （次要结果）探索目标7：评估DSM-的溢出效应 h对临终关怀患者的合并症和晚期痴呆症患者的临终关怀患者 谁住在疗养院。这是一个创新的建议，因为这将是第一个大规模务实的审判 在专注于PWD及其护理人员的临终关怀中，并且具有强大的科学前提，严格和潜力 可重复性。审判完成后，如果调查结果表明DSM-H Hospice Edition是 有效地提高护理质量并具有很高的采用和实施忠诚度，我们将开发一个 通过Hartford老年护理研究所进行技术援助中心，以传播护理模型。