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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial

Authors: John Young, Francine Cheater, Michelle Collinson, Marie Fletcher, Anne Forster, Mary Godfrey, John Green, Shamaila Anwar, Suzanne Hartley, Claire Hulme, Sharon K Inouye, David Meads, Gillian Santorelli, Najma Siddiqi, Jane Smith, Elizabeth Teale, Amanda J Farrin

Published in: Trials | Issue 1/2015

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Abstract

Background

Delirium is the most frequent complication among older people following hospitalisation. Delirium may be prevented in about one-third of patients using a multicomponent intervention. However, in the United Kingdom, the National Health Service has no routine delirium prevention care systems. We have developed the Prevention of Delirium Programme, a multicomponent delirium prevention intervention and implementation process. We have successfully carried out a pilot study to test the feasibility and acceptability of implementation of the programme. We are now undertaking preliminary testing of the programme.

Methods/Design

The Prevention of Delirium Study is a multicentre, cluster randomised feasibility study designed to explore the potential effectiveness and cost-effectiveness of the Prevention of Delirium Programme. Sixteen elderly care medicine and orthopaedic/trauma wards in eight National Health Service acute hospitals will be randomised to receive the Prevention of Delirium Programme or usual care. Patients will be eligible for the trial if they have been admitted to a participating ward and are aged 65 years or over. The primary objectives of the study are to provide a preliminary estimate of the effectiveness of the Prevention of Delirium Programme as measured by the incidence of new onset delirium, assess the variability of the incidence of new-onset delirium, estimate the intracluster correlation coefficient and likely cluster size, assess barriers to the delivery of the Prevention of Delirium Programme system of care, assess compliance with the Prevention of Delirium Programme system of care, estimate recruitment and follow-up rates, assess the degree of contamination due to between-ward staff movements, and investigate differences in financial costs and benefits between the Prevention of Delirium Programme system of care and standard practice. Secondary objectives are to investigate differences in the number, severity and length of delirium episodes (including persistent delirium); length of stay in hospital; in-hospital mortality; destination at discharge; health-related quality of life and health resource use; physical and social independence; anxiety and depression; and patient experience.

Discussion

This feasibility study will be used to gather data to inform the design of a future definitive randomised controlled trial.

Trial registration

ISRCTN01187372. Registered 13 March 2014.
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Metadata
Title
Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial
Authors
John Young
Francine Cheater
Michelle Collinson
Marie Fletcher
Anne Forster
Mary Godfrey
John Green
Shamaila Anwar
Suzanne Hartley
Claire Hulme
Sharon K Inouye
David Meads
Gillian Santorelli
Najma Siddiqi
Jane Smith
Elizabeth Teale
Amanda J Farrin
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0847-2

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