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 trialReport as inadecuate




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 - Download this document for free, or read online. Document in PDF available to download.

Trials

, 15:47

First Online: 05 February 2014Received: 23 August 2013Accepted: 20 January 2014DOI: 10.1186-1745-6215-15-47

Cite this article as: Heaven, A., Cheater, F., Clegg, A. et al. Trials 2014 15: 47. doi:10.1186-1745-6215-15-47

Abstract

BackgroundDelirium 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-DesignWe 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.

DiscussionThis 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 registrationISRCTN27972532.

KeywordsPilot Feasibility RCT Complex intervention Older people Delirium Care home AbbreviationsCAMConfusion Assessment Method

CQCCare Quality Commission

CTRULeeds Clinical Trials Research Unit

DPdelirium practitioner

DRS-R-98Delirium Rating Scale Revised-98

EOIexpression of interest

GPgeneral practitioner

ICCintraclass coefficient

ITTintention-to treat analysis

MRCMedical Research Council

NHSNational Health Service

NICENational Institute for Health and Clinical Excellence

NIHRNational Institute for Health Research

RCTrandomised controlled trial

RfPBresearch for patient benefit

6-CITSix Item Cognitive Impairment Test.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-15-47 contains supplementary material, which is available to authorized users.

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Author: Anne Heaven - Francine Cheater - Andrew Clegg - Michelle Collinson - Amanda Farrin - Anne Forster - Mary Godfrey - Liz Gra

Source: https://link.springer.com/







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