Study Protocol of a Randomised Controlled Group Trial of Client and Care Outcomes in the Residential Dementia Care Setting

Purpose: Literature suggests that quality of life (QOL), quality of care (QOC) and Behavioural and Psychological Symptoms of Dementia (BPSD) can be improved by relatively simple and inexpensive person-centred approaches to nursing care practices (PCC) and modifications to physical environment (PCE). Most research on this topic is observational and few randomised controlled trials have included an economic evaluation of PCC and PCE together. The PerCEN study aims to confirm the value of evidence-based nursing by evaluating the efficacy and cost effectiveness of implementing PCC and PCE in residential dementia care services. This article describes the PerCEN study protocol (ANZCTR 12608000095369). Design/Methods: The 3-year study commenced in 2009 in 38 eligible government-accredited residential dementia care homes in New South Wales, Australia. Study participants include 605 consented residents over 60 years of age with dementia and 380 consenting permanent direct-care staff. The study employs a factorial, group-randomised, cohort design with stratification to evaluate the main effects of PCC and PCE and their joint effects (PCC + PCE), compared with Usual Care (UC) and Usual Environment (UE) on QOL, QOC and BPSD in dementia. Results: The primary outcomes analysis will use a mixed-model analysis of covariance to determine the effects of PCC and PCE on resident QOL and BPSD, and QOC, adjusting for stratification and other potential confounders. The incremental cost of providing PCE and PCC over UC and UE will be calculated; costs and outcomes will be presented as a cost-consequence analysis and cost-effectiveness ratios will be estimated as a cost per unit change in resident QOL and BPSD. Implications: This cluster-randomised trial will rigorously test Kitwood's Social-Psychological Theory of Personhood in Dementia (Kitwood & Bredin 1992). The results will provide timely and solid evidence that can inform policy and nursing practice development in improving the person's QOL and QOC, and reducing BPSD.