Improving quality of life (QoL) in residents of nursing homes:

A cluster randomized clinical trial of efficacy - The KOSMOS study.

COSMOS (COmmunication (Advance Care Planning - ACP), Systematic pain assessment and treatment, Medication review, Occupational therapy, and Safety) is a practical intervention aimed to improve clinical and psychiatric challenges in NH patients. The COSMOS intervention combines the most effective research results to improve staff competence and patients' mental health, safety, QoL. We also aim to reduce psychotropic drug use and costs.

Background: Nursing home (NH) patients have complex mental health problems, disabilities and social needs, compounded by widespread prescription of psychotropic drugs. To preserve their dignity and quality of life is an important goal of our society. This can only be achieved within NHs that offer high competent conditions of treatment and care.

Research questions and hypotheses:

1. Will the implementation of a communication and end-of-life decision making process have impact on interactions between patients, staff and family? We hypothesize that ACP will improve the interactions between patients, staff and family, and satisfaction in relatives and thereby improve the quality of life NH patients.
2. Is the KOSMOS capable to affect agitation and aggression and reduce medication e.g. psychotropics in NH patient? We hypothesize that KOSMOS will significantly reduce agitation and aggression, the total amount of medication, and psychotropic drug use.
3. What combination of interventions will give the broadest benefit, and could be delivered as a routine intervention as part of NH practice? We hypothesize that the comprehensive KOSMOS approach improves QoL and makes positive changes in NH practice.
4. What other types of advantages are expected? We hypothesize that KOSMOS is a cost-effective approach, with potential to increase the safety and reduce mortality in NH patients.

Method: The KOSMOS intervention combines the most effective research results to improve staff competence, and patients' mental health, safety, QoL, and to reduce psychotropic drug use and costs. The efficacy testing of KOSMOS includes systematic literature review, a pilot study, a 9-month randomized control trial (RCT), and a dissemination plan. Data collection will take place at baseline, months 4, and 9. The intervention entails provision of staff training, study guidelines and manuals. NHs will be randomized to either KOSMOS or current best practice. We will include 38 NH long-term-care (LTC) wards (normally just one ward per NH) in Bergen, Stavanger, Oslo/Bærum, Sarpsborg and Sogn and Fjordane. In total 310 patients ≥65 years will be recruited from these wards

Primary and secondary outcome measures: Quality of life in late stage dementia (QUALID), QUALIDEM, EQ-5-D; Neuropsychiatric Inventory - NH edition (NPI-NH); Activities of Daily Living (ADL); Cornell; Mobilization - Observation - Behaviour - Intensity - Dementia 2 (MOBID-2); drug use; drug-related problems, START; STOP; cost-utility analysis (RUD-FOCA); hospital admission; and mortality, ActiWatch; Log registration of NH activities; Relatives satisfaction with conducted KOSMOS elements

Statistical analyses: include characteristics between 2 groups (Chi square, Mann-Whitney U), ANCOVA, ICC and p-values for each time-point and outcomes.

National and international collaboration: National collaboration between researchers at the Universities of Bergen, Oslo, and Stavanger is established. Internationally, colleagues from the EU COST-Action TD1005, Karolinska University, Stockholm and Kings College, London are engaged in this RCT.

Funding: The employment of two PhD-candidates (100%) and one post-doctoral fellow (50%) received funding by the Norwegian Research Council (Sponsor's Protocol Code: 222113) in 2012.

Inclusion Criteria:

• Resident in long time care ward in Bergen, Bærum, Sarpsborg, Kvam, Fjell, Sund, Askøy and Øygarden

Exclusion Criteria:

• Dying patients with reduced consciousness at baseline
• Active Schizophrenia