Background: Disturbed sleep places older adults at higher risk for frailty, morbidity, and even mortality. Yet, nursing home routines frequently disturb residents' sleep through use of noise, light, or efforts to reduce incontinence. Nursing home residents with Alzheimer's disease and or related dementias-almost two-thirds of long-stay nursing home residents-are 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 intervention's sustainability. Phase 1 (1 year; n = 3 nursing homes; 1 per corporation) will refine the intervention and train-the-trainer protocol and pilot-tests all study methods. Phase 2 (4 years; n = 24 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 intervention's 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 program's 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 study's 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.
Keywords: Alzheimer’s disease; Dementia; Front line staff; Health care; Long term care; Mental health; Nursing homes; Program development; Quality improvement; Quality indicators; Sleep.