title: TIME - Targeted interdisciplinary model for evaluation and treatment of neuropsychiatric symptoms: protocol for an effectiveness-implementation cluster randomized hybrid trial.
abstract: Nearly all persons with dementia will experience neuropsychiatric symptoms (NPS) during the course of their disease. Clinicians and researchers emphasize the need for an evidence-informed standardized approach to managing NPS that integrates pharmacological and nonpharmacological treatments for real-world implementation. The Targeted Interdisciplinary Model for Evaluation and Treatment of Neuropsychiatric Symptoms (TIME) represents such an approach and is a multicomponent intervention based on the theoretical framework of cognitive behavioural therapy.
  
  
  
  The trial is a 3-month cluster randomized trial conducted in 30 nursing homes including 168 participants with dementia and a high level of agitation. Each nursing home defined as a cluster will be randomized to receive either the TIME intervention (the intervention group) or a brief education-only intervention regarding dementia and NPS (the control group). TIME is a manual-based, multicomponent programme that includes a rigorous assessment, one or more case conferences and the treatment and evaluation of NPS. Patient-level measurements are taken at baseline (prior to randomization) and 8 and 12 weeks later. The primary outcome measure is the change in agitation, as defined by the Neuropsychiatric Inventory-Nursing Home Version, at 8 weeks from baseline. Secondary outcome measures include change in agitation at 12 weeks from baseline, and change from baseline at 8 and 12 weeks in other NPS, quality of life, and the use of psychotropic and analgesic medications. Mixed methods will be used to follow, measure and explore the implementation process and the effect of the intervention at the individual staff level and the organization level. Combining measurements of clinical effectiveness and implementation outcomes define this trial as an effectiveness-implementation hybrid trial.
  
  
  
  Measuring the implementation and effect of complex interventions aimed at reducing NPS in nursing homes is challenging. In this study protocol, we describe a multicomponent program, TIME, and discuss how an effectiveness-implementation cluster randomized hybrid trial can meet these challenges.
  
  
  
  ClinicalTrials.gov identifier NCT02655003 . Registered 6 January 2016.
authors.affiliation: Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, Ottestad, Norway. bjorn.lichtwarck@sykehuset-innlandet.no.|Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway. bjorn.lichtwarck@sykehuset-innlandet.no.
authors.forename: Bjørn
authors.identifier: 0000-0002-3763-8134
authors.initials: B
authors.lastname: Lichtwarck
authors.affiliation: Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, Ottestad, Norway.|Institute of Health and Society, Faculty of Medicine, University of Oslo, Oslo, Norway.|Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Vestfold, Norway.
authors.forename: Geir
authors.initials: G
authors.lastname: Selbaek
authors.affiliation: Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, Ottestad, Norway.|Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Vestfold, Norway.|Departement of Health, Care and Nursing, Faculty of medicine NTNU, Norwegian University of Science and Technology, Gjøvik, Norway.
authors.forename: Øyvind
authors.initials: Ø
authors.lastname: Kirkevold
authors.affiliation: Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Vestfold, Norway.|Molde University College, Faculty of Health Sciences and Social Care, Molde, Norway.
authors.forename: Anne Marie Mork
authors.initials: AM
authors.lastname: Rokstad
authors.affiliation: Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, Ottestad, Norway.|Institute of Clinical Medicine, Campus Ahus, University of Oslo, Oslo, Norway.|HØKH, Research Centre, Akershus University Hospital, Lørenskog, Norway.
authors.forename: Jūratė Šaltytė
authors.initials: JŠ
authors.lastname: Benth
authors.affiliation: Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, Ottestad, Norway.
authors.forename: Janne
authors.initials: J
authors.lastname: Myhre
authors.affiliation: Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, Ottestad, Norway.
authors.forename: Solvor
authors.initials: S
authors.lastname: Nybakken
authors.affiliation: Centre for Old Age Psychiatric Research, Innlandet Hospital Trust, Ottestad, Norway.|Norwegian National Advisory Unit on Ageing and Health, Vestfold Hospital Trust, Vestfold, Norway.
authors.forename: Sverre
authors.initials: S
authors.lastname: Bergh
mesh_terms: D000700:Analgesics / Q000009:adverse effects / Q000627:therapeutic use; D016000:Cluster Analysis; D003704:Dementia / Q000175:diagnosis* / Q000453:epidemiology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D008960:Models, Psychological; D009664:Norway / Q000453:epidemiology; D009735:Nursing Homes / Q000639:trends; D011595:Psychomotor Agitation / Q000175:diagnosis / Q000453:epidemiology / Q000628:therapy; D011619:Psychotropic Drugs / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life / Q000523:psychology; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D011619:Psychotropic Drugs
keywords: Behavioural and psychological Symptoms of dementia (BPSD); Case conference; Dementia; Neuropsychiatric symptoms; Nursing home; Psychosocial interventions