PROVEN: PRagmatic trial Of Video Education in Nursing homes

描述(由申请人提供)：疗养院(NHS)是一种复杂的医疗保健系统，为越来越多的患有晚期合并症的患者提供服务。NHS经常负责指导这些患者做出治疗方向的决定。NH患者通常得到积极的治疗，这可能与他们的喜好不一致，而且临床益处很小。确定NHS可以用来更好地促进目标导向的护理和优化资源的有效方法，是研究、公共卫生和临床的优先事项。提前护理计划(ACP)是与更好的姑息治疗结果相关的最一致的可修改因素。传统的ACP依赖于对假设的健康状态和治疗的口头描述。这种方法是有限的，因为复杂的情景很难想象，咨询不一致，语言解释受到识字和语言障碍的阻碍。为了解决这些缺点，我们开发了ACP视频决策支持工具，并在小型随机对照试验(RCT)中展示了它们的有效性。虽然包括夏威夷州在内的几个大型医疗保健系统已经开始采用这些视频，但这些努力并不是为了严格评估结果；这是广泛实施之前的关键一步。这项提案的总体目标是通过与2个在全国运营492个NHS的大型医疗保健系统合作，规划和实施一个务实的分组RCT，以评估ACP视频决策支持工具在NH环境中的有效性。在18个月的时间里，一套ACP视频决策支持工具将在干预NHS的设施范围内实施。控制NHS将采用他们惯常的ACP做法。将使用已建立的数据源，即链接到医疗保险和最低数据集数据库的最先进的电子病历，对所有结果进行评估。UH2规划阶段的目标是建立项目的组织和领导结构(目标1)，开发进行试验的所有程序和基础设施(目标2)，并在2个NHS试行方案(目标3)。在U3实施阶段，我们将在多达266个NHS(133/ARM)(目标1)中进行试验。将在3组患者中比较干预组和对照组NHS的结果：1.长期居住在患有有针对性的晚期慢性病(痴呆症、心力衰竭和慢性阻塞性肺病)的居民(目标2)、2.患有这些晚期疾病的急诊后入院治疗(目标3)，以及所有其他没有目标晚期疾病的NH患者(目标4)。结果将包括：1.医院转院，2.预先指示，3.其他繁重的治疗，以及4.临终关怀的使用。在长期住院的晚期疾病队列中，超过12个月的医院转移是主要的试验结果。影响：NHS为最虚弱和脆弱的患者提供服务。在这种情况下，需要采取干预措施，提供更多以患者为中心的、具有成本效益的护理。机场核心计划提供更好的服务 这是一个改善保健服务的机会。视频决策支持是统一提供ACP的一种实用而创新的方法。这项工作有可能改善NHS为数百万美国老年人提供的护理，并使未来在这一背景下进行务实试验成为可能。

DESCRIPTION (provided by applicant): Nursing homes (NHs) are complex health care systems that serve increasingly sick patients with advanced comorbid conditions. NHs are often charged with guiding these patients through decisions about the direction of their treatment. NH patients commonly get aggressive care that may be inconsistent with their preferences and of little clinical benefit. Identifying effective approaches that NHs can use to better promote goal-directed care and optimize resources, is a research, public health, and clinical priority. Advance care planning (ACP) is the most consistent modifiable factor associated with better palliative care outcomes. Traditional ACP relies on verbal descriptions of hypothetical health states and treatments. This approach is limited because complex scenarios are difficult to envision, counseling is inconsistent, and verbal explanations are hindered by literacy and language barriers. To address these shortcomings, we developed ACP video decision support tools and have shown their efficacy in small randomized controlled trials (RCTs). While several large health care systems, including the state of Hawaii, have begun to adopt the videos, these efforts are being not designed to rigorously evaluate outcomes; a critical step prior to widespread implementation. The overall objective of this proposal is to plan and conduct a pragmatic cluster RCT to evaluate the effectiveness of ACP video decision support tools in the NH setting by partnering with 2 large health care systems which operate 492 NHs nationwide. Over an 18-month period, a suite of ACP video decision support tools will be implemented facility-wide in the intervention NHs. Control NHs will employ their usual ACP practices. All outcomes will be assessed using established data sources, namely, state-of-the-art electronic medical records linked to Medicare and Minimum Data Set databases. The UH2 planning phase aims are to establish the project's organizational and leadership structure (Aim 1) develop all processes and infrastructure to conduct the trial (Aim 2), and pilot test the protocol in 2 NHs (Aim 3). In the U3 implementation phase, we will conduct the trial in up to 266 NHs (133/arm) (Aim 1). Outcomes will be compared in the intervention vs. control NHs among 3 patient groups; i. long-stay residents with targeted advanced chronic illnesses (dementia, heart failure, and chronic obstructive lung disease) (Aim 2), ii. post-acute care admissions with these advanced illnesses (Aim 3), and iii. all other NH patients without the targeted advanced illnesses (Aim 4). Outcomes will include: 1. hospital transfers, 2. advance directives, 3. other burdensome treatments, and 4. hospice use. Hospital transfers over 12-months in the long-stay advanced illness cohort, is the primary trial outcome. IMPACT: NHs serve the most frail and vulnerable patients. Interventions to deliver more patient-focused, cost- effective care in this setting are needed. Better ACP offers an opportunity to improve NH care. Video decision support is a practical and innovative approach to uniformly provide ACP. This work has the potential to improve the care provided to millions of older Americans in NHs and enable future pragmatic trials in this setting.