Cost-Effectiveness of Weight Loss Prevention in Nursing Homes: A Controlled Trial

描述（由PI提供）：食物和液体摄入不足是疗养院（NH）居民的常见问题，可能导致营养不良、脱水、体重减轻、住院甚至死亡。对高危NH居民最常见的营养干预是口服液体营养补充剂（ONS），尽管补充剂在促进NH居民体重增加方面的有效性的对照证据有限。此外，研究表明，补充剂的提供与订单不一致，居民在日常NH护理实践中几乎没有得到工作人员的帮助或鼓励，以促进消费。结果是，营养风险的NH居民与ONS订单从补充剂中获得的额外每日卡路里很少。最近的证据表明，每天在两餐之间多次为居民提供各种食物和液体的选择，再加上帮助和鼓励促进消费，可以有效地增加每日总热量摄入和促进体重增加。然而，根据迄今为止的研究，我们不知道居民是否更喜欢其他食物和液体而不是补充剂，或者是否是提供的一致性，援助的充分性和/或选择的可用性代表了关键的干预成分。我们也不知道哪种干预措施，传统的啜食补充剂或选择，在增加NH居民的每日热量摄入和促进体重增加方面更具成本效益。成本效益部分是进一步评估研究的关键，因为补充剂是NH设施的重要财务成本。拟议的研究将使用一种对照的干预设计来确定ONS的成本效益，并采用替代营养干预，为居民提供补充剂和其他食物和液体（即，在4个NH站点的250名居民中，有补充医嘱的住院医师将被纳入本研究，并随机分为三组：（1）常规护理对照组;（2）口服液体营养补充剂（ONS）干预组;或（3）选择性干预组。常规护理对照组将继续接受标准的NH护理，以补充或提供零食。研究人员将提供NH使用的相同补充剂（第二组）或补充剂和其他食物和液体（第三组）之间的选择，每天两次，每周五天，持续24周，并记录干预实施的每日成本，同时还提供已知的提示协议，以改善摄入量并提高饮食的独立性。根据广泛的初步数据，预计第二组和第三组将需要比常规护理（第一组）更多的工作人员时间。因此，将记录这些干预措施的劳动力成本，并与有效性措施进行比较。有效性措施包括以下居民结果：每日总热量摄入、体重、营养和水合状态以及生活质量的改善。这些结果将由经过培训的研究人员使用标准化，验证的方案在24周内对所有三组进行独立监测。

DESCRIPTION (provided by the PI): Inadequate food and fluid intake is a common problem among nursing home (NH) residents and one that can lead to under-nutrition, dehydration, weight loss, hospitalization, and even death. The most common nutrition intervention for at-risk NH residents is oral liquid nutrition supplementation (ONS), although, there is limited controlled evidence of the efficacy of supplements in promoting weight gain in NH residents. Moreover, studies show that supplements are not provided consistent with orders and residents receive little to no staff assistance or encouragement to promote consumption in daily NH care practice. The result is that nutritionally at-risk NH residents with ONS orders receive few additional daily calories from supplements. Recent evidence suggests that offering residents a choice among a variety of foods and fluids multiple times per day between meals coupled with assistance and encouragement to promote consumption is effective in increasing total daily caloric intake and promoting weight gain. However, based on the research to date, we do not know if residents' prefer other foods and fluids instead of supplements or if it is the consistency of delivery, adequacy of assistance and/or the availability of choice that represent the critical intervention components. We also do not know which intervention, traditional sip-feed supplements or choice, is more cost-effective in increasing daily caloric intake and promoting weight gain among NH residents. The cost-effectiveness component is key to further evaluation studies because supplements represent a significant financial cost to NH facilities. The proposed study will use a controlled, intervention design to determine the cost-effectiveness of ONS with an alternative nutrition intervention that offers residents a choice between supplements and other foods and fluids (i.e., snacks) between meals in a group of 250 residents across 4 NH sites. Residents with an order for supplementation will be included in this study and randomized into one of three groups: (1) usual care control; (2) oral liquid nutrition supplementation (ONS) intervention; or (3) choice intervention. The usual care control group will continue to receive standard NH care for supplement or snack delivery. Research staff will provide the same supplements used by the NH (group two) or a choice between supplements and other foods and fluids (group three) twice daily, five days per week, for 24 weeks and document the daily costs of intervention implementation when also providing a prompting protocol known to improve intake and enhance independence in eating. Based on extensive preliminary data, it is anticipated that both groups two and three will require significantly more staff time than usual care (group one). Thus, the labor costs of these interventions will be documented and compared to effectiveness measures. Effectiveness measures include the following resident outcomes: improvements in total daily caloric intake, weight, nutrition and hydration status and quality of life. These outcomes will be independently monitored for all three groups across 24-weeks by trained research staff using standardized, validated protocols.