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）的发病率预计将上升 三倍。国家阿尔茨海默氏症计划认识到，虽然痴呆症（PWD）患者的人数是 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， 为残疾人及其照顾者提供有效和高效的护理。PWD通常有许多行为和心理上的 痴呆症状（BPSD），包括激动，抑郁和睡眠障碍，影响质量 残疾人和照顾者的生活。不幸的是，由于缺乏将循证护理纳入 社区，特别是临终关怀系统，残疾人得到不适当的，甚至是有害的照顾。我们有 制定了痴呆症症状管理家庭（DSM-H）计划，以实施痴呆症友好 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 修改了临终关怀的程序DSM-H临终关怀版是一个系统级更改程序， 包括劳动力培训和机构一级的工作流程变化。临终关怀晚期痴呆 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 这是实施DSM-H临终关怀版实用临床试验所必需的基础设施。目标2：进一步 专门为临终关怀IDT成员定制DSM-H计划，以照顾接受临终关怀的PWD， 适应临终关怀医院的大规模实施。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意见进一步完善协议。在成功完成 在R61年底围绕可行性、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：进行一项务实的、随机化的阶梯式楔形群集RCT， 老年痴呆症症状管理在家庭计划临终关怀版与先进的老年痴呆症患者的生活 在25家临终关怀机构中，比较抗精神病药物（主要结局）和 实施前和实施后的镇痛剂使用（次要结局）。目标5：比较临终关怀的比率 提供的连续、住院和临时喘息护理小时数， 实施前后的养老院（次要结局）。目标6：评估患者的护理满意度 失去亲人的主要照顾者（次要结果）探索性目标7：评估DSM的溢出效应- H对临终关怀患者谁被确定为有痴呆症作为一种合并症，和先进的痴呆症患者 住在疗养院的人这是一个创新的建议，因为它将是第一个大规模的务实试验 在一个专注于PWD及其护理人员的临终关怀中， 再现性试验完成后，如果结果显示DSM-H临终关怀版 有效地提高护理质量，并具有高度的采用和实施保真度，我们将开发一个 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。