Feeding in Elderly Late-Stage Dementia: The FIELD Trial

描述(由申请人提供)：晚期痴呆症患者中的喂养是有争议的，因为这一弱势群体缺乏陈述其偏好的认知能力。此外，食物和水的提供受到文化的限制，这使得提供者和照顾者很难做出决策。因此，针对这一弱势群体的研究方法的设计和选择是非常具有挑战性的。已发表的综述和二次数据分析报告称，晚期痴呆症患者的管饲是常见的做法。然而，现有的文献表明，管饲并不能改善营养状况、减少并发症或提高存活率。描述性研究报告说，在这个群体中，专心的手工喂养保持了生活质量，并保持了照顾者的互动。试管喂养与其他喂养方法(如专门的人工喂养)相比，没有进行随机疗效试验，因此提供者没有坚实的实践证据基础。然而，即使缺乏证据，管喂晚期痴呆症患者是许多提供者和机构的常见做法。医生们承认，就晚期痴呆症患者的喂养提出建议和做出决定是困难的。因此，照顾者缺乏指导和信息，无法为他们所爱的人做出明智的决定。由于这些问题，我们试图在随机和受控的环境中比较管喂和手喂，以确定疗效。这笔R21赠款的主要目的是提供支持，以进行一项关于晚期痴呆症患者随机分为两种不同喂养方式的可行性的试点研究：故意手工喂养和肠道管喂养。此外，我们将确定照顾者和医生是否有能力参与关于参与随机喂养试验的知情同意过程的共享和知情决策。此外，我们还将确定我们的人工喂养和管饲方案的实用性。此外，我们将确定所有数据收集(工作人员和照顾者)的意愿和可行性，并估计完成率和流失率及其原因。这个问题极大地影响了美国的公共健康，因为每年有数千根喂养管被放置在晚期痴呆症患者身上，而没有必要的支持证据来改善结果。回顾文献表明，在这一脆弱人群中放置喂养管并不能改善存活率或其他可测量的临床结果。我们打算利用从这个试点项目中吸取的经验教训，为一项多中心随机前瞻性试验提供RO1 NIH赠款，比较管饲法和手饲法，评估包括存活率在内的一系列临床结果。与公共卫生相关：进食问题对晚期痴呆症患者至关重要，因为这些人变得依赖他人帮助进餐。尽管文献显示这一弱势群体的临床结果没有改善，但在某些情况下，管状喂养是建立的。在进行多点研究以建立实践标准之前，需要解决关于医生转介患者和照顾者给予同意的意愿的形成问题。我们建议在这项初步研究中开发这些材料和测试方案。

DESCRIPTION (provided by applicant): Feeding among persons with late-stage dementia is controversial as this vulnerable group lacks the cognitive capacity to state their preference. Furthermore, the provision of food and fluid is culturally bound, which makes decision-making difficult for providers and caregivers. As such, the design and choice of research methods with this vulnerable population is exceptionally challenging. Published reviews and secondary data analyses report that tube-feeding in persons with late-stage dementia is common practice. However, the extant literature suggests that tube-feeding does not improve nutritional outcomes, decrease complications or increase survival. Descriptive studies report that dedicated hand-feeding in this population maintains quality-of-life and preserves caregiver interaction. Tube-feeding has not been subjected to a randomized efficacy trial versus other feeding methods such as dedicated hand-feeding, thus leaving providers without a solid evidence base for practice. Yet, even with this lack of evidence, tube-feeding persons with late-stage dementia is a common practice for many providers and institutions. Physicians acknowledge the difficulty in making recommendations and decisions regarding the feeding of persons with late-stage dementia. Consequently, caregivers lack guidance and information to make informed decisions for their loved ones. Because of these many issues, we seek to compare tube-feeding versus hand-feeding in a randomized and controlled setting to determine efficacy. The primary objective of this R21 grant is to provide support to conduct a pilot study regarding the feasibility of randomizing subjects with late-stage dementia to two different modalities of feeding: deliberate hand-feeding versus enteral tube-feeding. In addition, we will determine the ability of both caregivers and physicians to participate in shared and informed decision-making regarding the process of informed consent for participation in a randomized feeding trial. Also, we will determine the practicability of our hand-feeding and tube-feeding protocols. Further we will determine willingness and feasibility of all data collection (staff and caregiver) and estimate completion and attrition rates and reasons for them. This issue greatly affects the public health of the United States, as thousand of feeding tubes are placed each year in late-stage dementia patients without the necessary supporting evidence for improved outcomes. The retrospective literature suggests that the placement of feeding tubes in this vulnerable population does not improve survival or other measurable clinical outcomes. We intend to utilize the lessons learned from this pilot project to develop an RO1 NIH grant for a multi-center randomized prospective trial comparing tube-feedin versus hand-feeding, evaluating a number of clinical outcomes including survival. PUBLIC HEALTH RELEVANCE: Feeding issues are critical for persons with late-stage dementia as these individuals become dependent on others to assist with meals. In some case tube-feeding is instituted, despite literature showing no improvement in clinical outcomes for this vulnerable group. Before a multi-site study is undertaken to establish the standard of practice, formative issues will need to be resolved regarding the willingness of physicians to refer patients and caregivers to give consent. We propose to develop these materials and test protocols in this pilot study.