Department of Medicine, New York University Grossman School of Medicine, New York City, NY, United States of America; Medicine Service, VA New York Harbor Healthcare System, New York City, NY, United States of America.
Geriatric Research, Education, and Clinical Center, VA Greater Los Angeles Healthcare System, CA, United States of America.
Contemp Clin Trials. 2023 Mar;126:107107. doi: 10.1016/j.cct.2023.107107. Epub 2023 Jan 27.
Poor sleep is ubiquitous in skilled nursing facilities (SNFs) and is associated with a myriad of negative symptoms. Non-pharmacological interventions can improve sleep, yet sustainability has not been demonstrated. The Improving Sleep Using Mentored Behavioral and Environmental Restructuring (SLUMBER) trial will test whether a staff mentoring approach to address resident sleep issues positively impacts sleep quality and whether improved sleep benefits mood, cognitive performance, and activity engagement for residents living in SNFs.
This is a four-year hybrid type I effectiveness/implementation randomized stepped-wedge trial using a comprehensive sleep improvement program conducted in three urban SNFs.
We will provide SNF staff with sleep promotion strategies over a four-month intervention. Staff will have access to in-person workshops, webinars, weekly sleep pearls via text messaging, environmental data, and expert program mentors. We will consent residents for data collection (at baseline, end of intervention, and three- and six-months post-intervention) including resident observations, questionnaires, and wrist actigraphy (to objectively measure sleep). We will also use selected Minimum Data Set 3.0 (MDS) measures.
SLUMBER uses a unique strategy to iteratively improve sleep interventions through SNF staff buy-in, expert mentoring, and technological supports within a quality improvement framework. As a stepped-wedge trial, the initial SNF units provide opportunities for program improvement in subsequent units, accounting for variation across resident populations at different sites. Protocol limitations include strategies which may require substantial customization for greater spread. A comprehensive staff training program that addresses both sleep quality and related symptoms has the opportunity for considerable dissemination.
USGOV Clinical Trials ID: NCT03327324.
在熟练护理机构（SNF）中，睡眠质量差普遍存在，并与许多负面症状有关。非药物干预可以改善睡眠，但可持续性尚未得到证明。使用有指导的行为和环境重构改善睡眠（SLUMBER）试验将测试以员工指导的方式解决居民睡眠问题是否会对睡眠质量产生积极影响，以及改善睡眠是否会对居住在 SNF 的居民的情绪、认知表现和活动参与产生有益影响。
这是一项为期四年的混合 I 型有效性/实施随机阶梯式试验，使用全面的睡眠改善计划在三个城市的 SNF 中进行。
我们将在四个月的干预期内为 SNF 员工提供促进睡眠的策略。员工将可以参加面对面的研讨会、网络研讨会、每周通过短信发送的睡眠精华、环境数据和专家计划导师。我们将征得居民的数据收集同意（在基线、干预结束时以及干预后三个月和六个月），包括居民观察、问卷调查和腕部活动记录仪（客观测量睡眠）。我们还将使用选定的最低数据集 3.0（MDS）措施。
SLUMBER 使用一种独特的策略，通过 SNF 员工的参与、专家指导和质量改进框架内的技术支持，逐步改进睡眠干预措施。作为一个阶梯式试验，最初的 SNF 单位为后续单位提供了改进计划的机会，考虑了不同地点不同居民群体的差异。方案限制包括可能需要大量定制以扩大推广的策略。一个全面的员工培训计划，既解决睡眠质量问题，又解决相关症状问题，有机会得到广泛传播。
美国政府临床试验 ID：NCT03327324。
