Open Access Study protocol

Pilot trial of Stop Delirium! (PiTStop) - a complex intervention to prevent delirium in care homes for older people: study protocol for a cluster randomised controlled trial

Anne Heaven1, Francine Cheater2, Andrew Clegg3, Michelle Collinson4, Amanda Farrin4, Anne Forster3, Mary Godfrey3, Liz Graham4, Anne Grice1, Rachel Holt5, Claire Hulme3, Ernie Lloyd1, David Meads3, Chris North1, John Young3 and Najma Siddiqi16*

Author Affiliations

1 Bradford District Care Trust (R&D Department), Lynfield Mount Hospital, Heights Lane, Bradford, West Yorkshire BD9 6DP, UK

2 School of Nursing Sciences, Faculty of Medicine and Health Sciences, University of East Anglia, Norwich Research Park, Norwich NR4 7TJ, USA

3 Leeds Institute of Health Sciences, Charles Thackrah Building, University of Leeds, 101 Clarendon Road, Leeds LS2 9LJ, UK

4 Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds LS2 9JT, UK

5 Department of Elderly Medicine, Pinderfields Hospital, Mid Yorkshire NHS Trust, Pinderfields Hospital, Aberford Road, Wakefield, West Yorkshire WF1 4DG, UK

6 Bradford District Care Trust, Meridian House, Bradford Road, Keighley BD21 4AD, UK

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Trials 2014, 15:47  doi:10.1186/1745-6215-15-47

Published: 5 February 2014

Abstract

Background

Delirium (or acute confusion) is a serious illness common in older people, in which a person’s thinking and perceptions may be affected. Reducing delirium is important because of the considerable distress it causes, and the poor outcomes associated with it, such as increased admissions to hospital, falls, mortality and costs to the National Health Service (NHS). Preventing delirium is possible using multicomponent interventions; successful interventions in hospitals have reduced it by one-third. However, there is little research to guide practice in care homes, where it is common because of the clustering of known risk factors (older age, frailty, and dementia). In previous work we developed a multicomponent intervention to prevent delirium in care homes, called Stop Delirium! The intervention was based upon evidence from the research literature relating to the prevention of delirium and on strategies to change professional practice. Before starting a large costly trial of Stop Delirium!, this pilot study will test and help improve the design and feasibility of the trial protocol.

Methods/Design

We plan to conduct a cluster randomised pilot trial in 14 care homes (independent residential and nursing). Following recruitment of residents (over 60 years, consenting or with consultee agreement, able to communicate in English, and not in palliative care) participating homes will be randomised, stratified by size of home and proportion of residents with dementia. Stop Delirium! will be delivered to intervention homes over 16 months, with controls receiving usual care. The primary outcome measure will be the presence of delirium on any day during a one-month post-intervention period.

We will collect data to determine 1) recruitment and attrition rates, 2) feasibility of various outcomes measurements, and 3) feasibility of capturing health resource use (resident diaries and by examining health records). We will estimate the between-cluster variation for the primary outcome, delirium occurrence.

Discussion

This pilot study will refine methods for the definitive trial. The lessons learnt will also contribute to implementing National Institute for Health and Clinical Excellence (NICE) delirium guidelines, which recommend multicomponent interventions for delirium prevention.

Trial registration

ISRCTN27972532.

Keywords:
Pilot; Feasibility; RCT; Complex intervention; Older people; Delirium; Care home