Title: Pilot trial of Stop Delirium! A complex intervention to prevent delirium in care homes for older people
Funder: Department of Health (England)

Abstract: Background Delirium is a common acute illness in the elderly associated with considerable distress, hospitalisation & mortality(1). Evidence suggests that delirium can be prevented in 1/3 of hospital patients(2, 3), but there is little research to guide practice in care homes, where it is likely to be common(4). Delirium prevention is predicated on providing good quality care & effective interventions have potential to deliver significant benefits for care home residents & health services(5). Recent NICE guidelines(6) include a research recommendation to investigate effectiveness of multi-component interventions in preventing delirium in long-term care (LTC). In previous work, using the MRC framework(7), we developed & established feasibility of such an intervention, termed Stop Delirium!(5) Aims The overall aim of this research is to prevent delirium in residents of care homes for older people. Having established the feasibility of Stop Delirium! we need a cluster randomised trial to investigate its clinical and cost effectiveness. Before embarking on a large (& expensive) trial we now plan to carry out a pilot that will allow us to optimise the trial protocol & specifically to: A: Determine intra-class coefficients and recruitment & attrition rates to inform an estimate of the number of clusters required. B: Establish feasibility of outcomes measurements, including measures for a future cost-effectiveness analysis & estimate costs associated with delirium & Stop Delirium! C: Examine adherence to the various components of the intervention and investigate its sustainability. Plan of Investigation We propose to conduct a pilot cluster randomised controlled trial in 12 care homes. Stop Delirium! will be delivered to intervention homes over 16 months with controls receiving usual care. We will collect data to determine recruitment & attrition rates; feasibility of determining various outcomes measurements using validated instruments and through examining health records; and the between cluster variation for the primary outcome, delirium occurrence. We will test feasibility of capturing resource use through resident diaries to inform future cost-effectiveness analyses & use data from diaries to estimate costs associated with delirium & with the intervention. We will also conduct interviews with staff to examine sustainability of the intervention & its integration into routine care. Potential Impact This work will help address a major evidence gap through optimising parameters for future definitive trials of interventions to prevent delirium in LTC- a key NICE research recommendation. It will raise delirium awareness locally & internationally; help implement NICE guidelines for delirium in care homes; and promote partnership working between the NHS & care home sector. If shown to be effective in a future trial the intervention would not only reduce delirium (important in itself because of the distress, morbidity & mortality associated with the condition) but also have potential to reduce its adverse outcomes (e.g. hospital admissions & falls), empower care home staff (known to be associated with better care), improve quality of care for residents and reduce health & social care costs.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;7.1 INDIVIDUAL CARE NEEDS
Health categories: MENTAL HEALTH