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

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 type of disease. Understanding peoples' behaviors is the basis for the initiation of targeted interventions to 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 conducting case conferences include the following: A) using a structured assessment instrument, which staff in understanding the residents' behaviors and B) using a narrative approach in which the staff must the reasons for the residents' behaviors in an unstructured manner. Case conferences are a complex and evaluating their multiple effects is challenging. The aim of this study protocol was to describe a likely 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 every three months in a group of 12 nursing homes (clusters) with a minimum of 360 residents over 19 (7 months of intervention for each cluster and follow-up). The primary outcome is the reduction of behavior (measured with the neuropsychiatric inventory-nursing home version [NPI-NH]). Secondary outcomes residents' quality of life, prescription of psychotropic medications, staff burnout, dementia-related stress, and action competence. The effectiveness of the study will be accompanied by a process evaluation. The primary be analyzed using a Bayesian mixed effect model; the secondary data will be analyzed using descriptive statistics mixed effects models. Discussion: The implementation and effect measurement of complex interventions such as case conferences cluster randomized trial are challenging (e.g., complex and intensive training, delayed treatment effect). In this protocol, the methodological advantages and disadvantages of using the stepped wedge design to answer the research questions are discussed.