Background
Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet, nursing home routines frequently disturb residentsā sleep through use of noise, light, or efforts to reduce incontinence. Nursing home residents with Alzheimerās disease and or related dementiasāalmost two-thirds of long-stay nursing home residentsāare likely to be particularly affected by sleep disturbance. Addressing these issues, this study protocol implements an evidence-based intervention to improve sleep: a nursing home 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.
Methods
This study protocol outlines a NIH Stage III, real-world hybrid efficacy-effectiveness pragmatic trial of the LOCK sleep intervention. Over two phases, in a total of 27 non-VA nursing homes from 3 corporations, the study will (1) refine the LOCK program to focus on sleep for residents with dementia, (2) test the impact of the LOCK sleep intervention for nursing home residents with dementia, and (3) evaluate the interventionās sustainability. Phase 1 (1 year; nā=ā3 nursing homes; 1 per corporation) will refine the intervention and train-the-trainer protocol and pilot-tests all study methods. Phase 2 (4 years; nā=ā24 nursing homes; 8 per corporation) will use the refined intervention to conduct a wedge-design randomized, controlled, clinical trial. Phase 2 results will measure the LOCK sleep interventionās impact on sleep (primary outcome) and on psychotropic medication use, pain and analgesic medication use, and activities of daily living decline (secondary outcomes). Findings will point to inter-facility variation in the programās implementation and sustainability.
Discussion
This is the first study to our knowledge that applies a dementia sleep intervention to systematically address known barriers to nursing home quality improvement efforts. This innovative study has future potential to address clinical issues beyond sleep (safety, infection control) and expand to other settings (assisted living, inpatient mental health). The studyās strong team, careful consideration of design challenges, and resulting rigorous, pragmatic approach will ensure success of this promising intervention for nursing home residents with dementia.
Trial registration:
NCT04533815, ClinicalTrials.gov, August 20, 2020.