Feeding in Elderly Late-Stage Dementia: The FIELD Trial

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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.