Enhancing Sleep Quality for Nursing Home Residents with Dementia: Pragmatic Trial

睡眠紊乱使老年人面临更高的虚弱、发病甚至死亡风险。Yet养老院 (NH)日常生活经常干扰居民的睡眠，例如，通过使用噪音和光线或努力， 减少尿失禁。患有阿尔茨海默病或相关痴呆症（ADRD）的NH居民-近三分之二 长期居住的NH居民可能特别受到睡眠障碍的影响。这项研究解决了这些 重要问题，并大大推进国家计划的目标，以解决阿尔茨海默病 2018年更新，建议实施基于证据的干预措施以改善睡眠：NH前线工作人员 一个被称为“秘密行动”的秘密计划。该计划是来自证据支持的优势， 学习、系统观察、基于关系的团队合作和效率。一个以 工作人员与居民的互动使6名退伍军人健康管理局（VA）的NHS能够进行有意义的定量 和质量上的改进。来自全国VA推出的初步定性数据显示，该计划是 在针对住院医师临床结局（如疼痛和压疮）时有效。程序的方法 也改善了非VA NH的临床护理。因此，该提案是NIH第三阶段，真实的世界混合 有效性-有效性实用性试验的睡眠睡眠计划（睡眠计划）。非弗吉尼亚州国家卫生机构 来自3个NH公司，该研究将（1）完善睡眠管理计划，重点关注ADRD居民的睡眠 在R61阶段，（2）在R33阶段测试NH ADRD居民睡眠计划的影响， （3）评估项目的可持续性。R61阶段（1年; n = 3个NH;每个公司1个NH） 以下具体目标：（1）通过实施， （2）完善研究方法，有效识别符合条件的NHS和居民， 同意，从居民和工作人员那里收集原始数据，探索工作人员对额外睡眠的印象 测量设备（Fitbits），将主要和次要数据传输到我们的数据中心，并合并所有数据。 在成功完成指定的R61里程碑和改进干预方法后，我们将 进行一项楔形设计的随机对照试验。R33阶段（4年; n = 24名NHS; 8名NHS/ 公司）有以下具体目标：（1）为居民实施基于LOCK的睡眠计划 使用培训师模型治疗ADRD。(2)评估睡眠质量管理计划对睡眠的影响（主要 结果）和精神药物使用、疼痛和镇痛药物使用以及日常生活活动 下降（次要结局）。(3)使用混合方法检查与 计划的实施和可持续性。这一创新计划也有未来的潜力，以解决 其他重要问题（安全，感染控制），并扩展到其他设置（辅助生活，住院精神 健康）。强大的研究团队，认真考虑设计挑战，并由此产生严谨、务实的 方法将确保成功的这一有前途的干预与ADRD的NH居民。

Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet nursing home (NH) routines frequently disturb residents’ sleep through use of noise and light or efforts, for example, to reduce incontinence. NH residents with Alzheimer’s disease or related dementias (ADRD)—almost two-thirds of long-stay NH residents—are likely to be particularly affected by sleep disturbance. This study tackles these important issues and substantially moves forward goals of the National Plan to Address Alzheimer’s Disease 2018 Update by proposing to implement an evidence-based intervention to improve sleep: a NH frontline staff huddling program known as LOCK. The LOCK program is derived from evidence supporting strengths-based learning, systematic observation, relationship-based teamwork, and efficiency. A LOCK program pilot targeting staff-resident interactions enabled 6 Veterans Health Administration (VA) NHs make meaningful quantitative and qualitative improvements. Preliminary qualitative data from a national VA roll out show that the program is effective when targeting resident clinical outcomes such as pain and pressure ulcers. The program’s methods have also improved clinical care in non-VA NHs. This proposal is therefore an NIH Stage III, real world hybrid efficacy-effectiveness pragmatic trial of the LOCK program for sleep (LOCK sleep program). In non-VA NHs from 3 NH corporations, the study will (1) refine the LOCK program to focus on sleep for residents with ADRD in an R61 phase, (2) test the impact of the LOCK sleep program for NH residents with ADRD in an R33 phase, and (3) evaluate the program’s sustainability. The R61 phase (1 year; n = 3 NHs; 1 NH per corporation) has the following specific aims: (1) Refine the LOCK sleep program train-the-trainer protocol by implementing and pilot-testing it. (2) Refine the research methods to effectively identify eligible NHs and residents, obtain consent, collect primary data from residents and staff, explore staff impressions of additional sleep measurement devices (Fitbits), transfer primary and secondary data to our data center, and merge all data. After successfully completing designated R61 milestones and refining the intervention methods, we will conduct a wedge-design randomized, controlled trial. The R33 phase (4 years; n = 24 NHs; 8 NHs per corporation) has the following specific aims: (1) Implement the LOCK-based sleep program for residents with ADRD using the train-the-trainer model. (2) Estimate impact of the LOCK sleep program on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). (3) Examine factors, using mixed methods, associated with variation in the program’s implementation and its sustainability. This innovative program also has future potential to address other important issues (safety, infection control) and expand to other settings (assisted living, inpatient mental health). The study’s strong team, careful consideration of design challenges, and resulting rigorous, pragmatic approach will ensure success of this promising intervention for NH residents with ADRD.