Abstract
BackgroundNursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients’ quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial.Methods/DesignCOSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality.DiscussionDespite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover. Implementation of a research-based multicomponent intervention may improve staff’s knowledge and competence and consequently the quality of life of nursing home patients in general and people with dementia in particular.Trial registrationClinicalTrials.gov NCT02238652
Highlights
Nursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs
Despite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover
COSMOS intends to improve the quality of life (QoL) in nursing home (NH) patients by enhanced communication and advance care planning (ACP), systematic assessment and treatment of pain, medication review and organization of meaningful activities provided by educated NH staff
Summary
COSMOS intends to improve the QoL in NH patients by enhanced communication and ACP, systematic assessment and treatment of pain, medication review and organization of meaningful activities provided by educated NH staff. It has previously been described that the complexity resulting from interactions among many component parts decreases the predictability of effects [66] Despite this limitation, we argue that the combination of several components to a multifaceted intervention is necessary to cover a larger area of unmet needs in NH patients and people with dementia. To avoid study complexity and unpredictability, researchers usually reduce study designs to one of the most essential parts in order to fulfill strict RCT requirements [67]. We expect to contribute to further development of implementation research in the NH setting It is widely recognized [47] that RCTs are less efficient, in a statistical sense; compounded by the effect of personal interactions among cluster members who receive the same intervention. Research is imperative to understand and evaluate potential obstacles to refine interventions and competence improving programs through extensive field testing
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