title: Effect evaluation of two types of dementia-specific case conferences in German nursing homes (FallDem) using a stepped-wedge design: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Case conferences for people with dementia and challenging behaviors (e.g., apathy) are recommended as useful tools that enable staff in nursing homes to understand the behavior of people with this type of disease. Understanding peoples' behaviors is the basis for the initiation of targeted interventions to improve the quality of care for people with dementia. Furthermore, case conferences demonstrate positive effects on burnout, dementia-specific burden, and vocational action competence of the staff. The two likely approaches for conducting case conferences include the following: A) using a structured assessment instrument, which guides the staff in understanding the residents' behaviors and B) using a narrative approach in which the staff must identify the reasons for the residents' behaviors in an unstructured manner. Case conferences are a complex intervention, and evaluating their multiple effects is challenging. The aim of this study protocol was to describe a likely solution for evaluating this type of complex intervention using a special cluster randomized trial.
  
  
  METHODS
  In this stepped-wedged cluster randomized trial, the two interventions will be sequentially implemented every three months in a group of 12 nursing homes (clusters) with a minimum of 360 residents over 19 months (7 months of intervention for each cluster and follow-up). The primary outcome is the reduction of challenging behavior (measured with the neuropsychiatric inventory-nursing home version [NPI-NH]). Secondary outcomes are residents' quality of life, prescription of psychotropic medications, staff burnout, dementia-related stress, and vocational action competence. The effectiveness of the study will be accompanied by a process evaluation. The primary data will be analyzed using a Bayesian mixed effect model; the secondary data will be analyzed using descriptive statistics and mixed effects models.
  
  
  CONCLUSIONS
  The implementation and effect measurement of complex interventions such as case conferences within a cluster randomized trial are challenging (e.g., complex and intensive training, delayed treatment effect). In this study protocol, the methodological advantages and disadvantages of using the stepped wedge design to answer the research questions are discussed.
  
  
  BACKGROUND
  http://www.controlled-trials.com/ISRCTN20203855; registered 10 July 2013.
authors.affiliation: German Center for Neurodegenerative Diseases (DZNE), Witten, Stockumer Str, 12, 58453 Witten, Germany. sven.reuther@dzne.de.
authors.forename: Sven
authors.initials: S
authors.lastname: Reuther
authors.forename: Daniela
authors.initials: D
authors.lastname: Holle
authors.forename: Ines
authors.initials: I
authors.lastname: Buscher
authors.forename: Olga
authors.initials: O
authors.lastname: Dortmann
authors.forename: René
authors.initials: R
authors.lastname: Müller
authors.forename: Sabine
authors.initials: S
authors.lastname: Bartholomeyczik
authors.forename: Margareta
authors.initials: M
authors.lastname: Halek
mesh_terms: D001499:Bayes Theorem; D002985:Clinical Protocols; D003625:Data Collection; D003704:Dementia / Q000628:therapy*; D006801:Humans; D009735:Nursing Homes; D017063:Outcome Assessment, Health Care; D018579:Patient Selection; D012107:Research Design; D018401:Sample Size; D013223:Statistics as Topic