title: COSMOS--improving the quality of life in nursing home patients: protocol for an effectiveness-implementation cluster randomized clinical hybrid trial.
abstract: BACKGROUND
  Nursing 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
  COSMOS 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.
  
  
  CONCLUSIONS
  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. 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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02238652.
authors.affiliation: Department of Global Public Health and Primary Care, Centre for Elderly - and Nursing Home Medicine, University of Bergen, Kalfarveien 31, N-5020, Bergen, Norway. Bettina.Husebo@uib.no.|Centre for Elderly and Nursing Home Medicine, Stavanger University Hospital, Stavanger, Norway. Bettina.Husebo@uib.no.
authors.forename: Bettina S
authors.initials: BS
authors.lastname: Husebo
authors.affiliation: Department of Global Public Health and Primary Care, Centre for Elderly - and Nursing Home Medicine, University of Bergen, Kalfarveien 31, N-5020, Bergen, Norway. elisabeth.flo@uib.no.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Flo
authors.affiliation: Centre for Elderly and Nursing Home Medicine, Stavanger University Hospital, Stavanger, Norway. daarsland@gmail.com.|Karolinska Institutet (KI), Department of Neurobiology, Care Sciences and Society, KI-Alzheimer Disease Research Center, Stockholm, Sweden. daarsland@gmail.com.
authors.forename: Dag
authors.initials: D
authors.lastname: Aarsland
authors.affiliation: Norwegian National Advisory Unit of Ageing and Health, Vestfold Hospital Trust, Tønsberg, Norway. geir.selbaek@aldringoghelse.no.|Centre for Old Age Psychiatry Research, Innlandet Hospital Trust, Ottestad, Norway. geir.selbaek@aldringoghelse.no.|Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway. geir.selbaek@aldringoghelse.no.
authors.forename: Geir
authors.initials: G
authors.lastname: Selbaek
authors.affiliation: Centre for Elderly and Nursing Home Medicine, Stavanger University Hospital, Stavanger, Norway. itestad@gmail.com.
authors.forename: Ingelin
authors.initials: I
authors.lastname: Testad
authors.affiliation: Department of Global Public Health and Primary Care, Centre for Elderly - and Nursing Home Medicine, University of Bergen, Kalfarveien 31, N-5020, Bergen, Norway. Christine.Gulla@uib.no.
authors.forename: Christine
authors.initials: C
authors.lastname: Gulla
authors.affiliation: Department of Global Public Health and Primary Care, Centre for Elderly - and Nursing Home Medicine, University of Bergen, Kalfarveien 31, N-5020, Bergen, Norway. Irene.Aasmul@uib.no.
authors.forename: Irene
authors.initials: I
authors.lastname: Aasmul
authors.affiliation: Centre for Elderly and Nursing Home Medicine, Stavanger University Hospital, Stavanger, Norway. clive.ballard@kcl.ac.uk.|The Wolfson Wing & Hodgkin Building Guys Campus, Kings College, London, SE1 1UL, UK. clive.ballard@kcl.ac.uk.
authors.forename: Clive
authors.initials: C
authors.lastname: Ballard
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D003142:Communication; D003362:Cost-Benefit Analysis; D003863:Depression / Q000188:drug therapy / Q000453:epidemiology; D055317:Evidence-Based Practice; D006707:Homes for the Aged / Q000458:organization & administration* / Q000592:standards; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D007318:Inservice Training; D007398:Interpersonal Relations; D054539:Medication Therapy Management / Q000458:organization & administration; D008603:Mental Health; D009664:Norway; D009735:Nursing Homes / Q000458:organization & administration* / Q000592:standards; D009788:Occupational Therapy / Q000458:organization & administration; D059408:Pain Management / Q000379:methods; D061214:Patient Safety; D010865:Pilot Projects; D017410:Practice Guidelines as Topic; D011787:Quality of Health Care / Q000458:organization & administration* / Q000592:standards; D011788:Quality of Life; D012107:Research Design