Controlled pre-post, mixed-methods study to determine the effectiveness of a national delirium clinical care standard to improve the diagnosis and care of patients with delirium in Australian hospitals: a protocol.

introductionDelirium, an acute confusional state, affects up to 29% of acute inpatients aged 65 years and over. The Australian Delirium Clinical Care Standard (the Standard) contains evidence-based, multicomponent interventions, to identify and reduce delirium. This study aims to: (1) conduct a controlled, before-and-after study to assess the clinical effectiveness of the Standard to improve diagnosis and treatment of delirium; (2) conduct a cost-effectiveness study of implementing the Standard and (3) evaluate the implementation process. METHODS AND ANALYSIS: The study will use a controlled, preimplementation and postimplementation mixed-methods study design, including: medical record reviews, activity-based costing analysis and interviews with staff, patients and their family members. The study population will comprise patients 65 years and over, admitted to surgical, medical and intensive care wards in four intervention hospitals and one control hospital. The primary clinical outcome will be the incidence of delirium. Secondary outcomes include: length of stay, severity and duration of delirium, inhospital mortality rates, readmission rates and use of psychotropic drugs. Cost-effectiveness will be evaluated through activity-based costing analysis and outcome data, and the implementation process appraised through the qualitative results. ETHICS AND DISSEMINATION: Ethics approval has been received for two hospitals. Additional hospitals have been identified and ethics applications will be submitted once the tools in the pilot study have been tested.The results will be submitted for publication in peer-reviewed journals and presented to national and international conferences. Results seminars will provide a quality feedback mechanism for staff and health policy bodies.