A Nursing Home Pragmatic Clinical Trial of APPROACHES (Aligning Patient Preferences: a Role Offering Alzheimer's patient, Caregivers, and Healthcare providers Education and Support)

疗养院实用方法临床试验（调整患者偏好：为阿尔茨海默病患者、护理人员和医疗保健提供者提供教育和支持的角色）

• 批准号: 10007077
• 负责人: SUSAN E HICKMAN
• 金额: $ 148.51万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-30 至 2022-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10007077
• 关键词: Admission activity; Advance Care Planning; Alzheimer' s Disease; Alzheimer' s disease related dementia; Caregivers; Caring; Cessation of life; Clinical; Cognitive; Data; Data Analyses; Data Set; Data Sources; Decision Making; Dementia; Diagnosis; Do Not Resuscitate Order; Documentation; Education; Electronic Health Record; Emergency department visit; Enrollment; Ensure; Enteral Feeding; Ethics; Family; Family Caregiver; Foundations; Goals; Health; Health Personnel; Health system; Healthcare; Hospitalization; Hospitals; Indiana; Infrastructure; Intervention; Lead; Life; Measures; Medical; Medicare claim; Modeling; Nursing Homes; Outcome; Outcome Measure; Outcome Study; Patient Care; Patient Preferences; Patients; Persons; Phase; Physicians; Pragmatic clinical trial; Procedures; Process; Protocols documentation; Provider; Quality of Care; Quality of life; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Regulation; Research; Role; Rural; Social Workers; Specialist; Standardization; Surveys; Testing; Training; Translations; United States Centers for Medicare and Medicaid Services; Work; arm; base; cohort; cost; data management; end of life; experience; hospice environment; hospitalization rates; improved; member; multi-component intervention; nursing intervention; operation; organizational structure; pragmatic trial; preference; primary outcome; programs; satisfaction; secondary outcome; treatment arm

PROJECT SUMMARY A significant number of patients Alzheimer's disease or related dementia diagnoses will be cared for in nursing homes near the end of life. Unfortunately, many of these patients experience unwanted and burdensome medical treatments, such as potentially avoidable hospitalizations, that negatively impact quality of life. Advance care planning (ACP) discussions with patients and family caregivers are important to explore goals in advance of a crisis and support informed, values-based decision-making. The ACP process helps ensure that preferences about treatments such as hospitalization are known, documented, and honored. Research indicates that ACP can reduce burdensome treatments and increase the likelihood that care will match documented preferences. Nursing homes are currently required by regulations to offer ACP to patients and families. However, there are no training requirements for nursing home staff and approaches to fulfilling this regulatory and ethical responsibility vary widely, resulting in inconsistent ACP. The “Aligning Patient Preferences – a Role Offering Alzheimer's patients, Caregivers, and Healthcare providers Education and Support (APPROACHES)” trial will test the ACP Specialist Program. Existing nursing home staff members will be trained to enhance care and reduce unwanted, burdensome hospitalizations through improved ACP procedures, standardized staff education on ACP, and systematic ACP facilitation. The primary trial outcome is hospital transfers (admissions and emergency department visits) per 1000 person-days alive. Consistent with the spirit of a pragmatic trial, study outcomes rely on data already collected for quality improvement, clinical or billing purposes. In the 18 month R21 pilot phase, the aims are to: 1) Establish the trial's organizational structure and processes; and 2) Pilot test the intervention in 4 nursing homes. In the R33 phase, a pragmatic cluster randomized clinical trial will be conducted in partnership with 3 nursing home corporations who operate a combined total of 206 diverse urban and rural facilities in 14 states. The aims of the 42 month R33 phase are to: 3) Evaluate the primary outcome of hospital transfers over 12 months among patients with dementia in intervention versus control nursing homes; and 4) Compare ACP documentation, measures of quality of care at the end of life, and patient and family satisfaction between the intervention versus control nursing homes. If successful, the ACP Specialist Program will be primed for rapid translation into nursing home practice to reduce unwanted, burdensome hospitalizations and improve quality of care for patients with dementia.

项目总结 相当数量的阿尔茨海默病或相关痴呆症患者将在护理中得到照顾 濒临生命终结的家园。不幸的是，这些患者中的许多人都经历了不想要的和负担的 医疗治疗，例如可能可以避免的住院治疗，对生活质量产生负面影响。 与患者和家庭护理人员讨论高级护理计划(ACP)对于探索以下目标非常重要 危机的提前和支持知情的、基于价值观的决策。机场核心计划程序有助于确保 关于住院等治疗的偏好是已知的，有记录的，也是受尊重的。研究 表明ACP可以减少繁重的治疗并增加护理匹配的可能性 有记录的首选项。目前，法规要求疗养院向患者提供ACP，并 家人。然而，没有对养老院工作人员的培训要求和实现这一要求的方法 监管和道德责任差异很大，导致了不一致的ACP。“对齐病人” 偏好-为阿尔茨海默氏症患者、照顾者和医疗保健提供者提供教育和 支持(方法)“试验将对ACP专家计划进行测试。现有的养老院工作人员将 接受培训，通过改进ACP来加强护理并减少不必要的、负担沉重的住院 程序，关于机场核心计划的标准化员工教育，以及系统的机场核心计划便利化。初步试验结果是 每1000人/日的医院转院(入院和急诊科就诊)。与一致 本着务实试验的精神，研究结果依赖于已经收集的用于质量改进、临床或 帐单目的。在18个月的R21试验阶段，目标是：1)建立试验的组织 结构和流程；以及2)在4家养老院进行干预的试点测试。在R33阶段，务实的 将与3家运营疗养院的公司合作进行整群随机临床试验 总共有14个州的206个不同的城乡设施。42个月的R33阶段的目标是 3)评估痴呆症患者在12个月内转院的主要结果 干预性疗养院与对照疗养院；以及4)比较ACP文件、护理质量衡量标准 在生命末期，干预组与对照组养老院患者与家属之间的满意度比较。如果 成功后，ACP专家计划将为快速转化为疗养院实践做好准备 减少不必要的、负担沉重的住院治疗，提高痴呆症患者的护理质量。