Condition category
Mental and Behavioural Disorders
Date applied
13/03/2014
Date assigned
13/03/2014
Last edited
05/05/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Delirium is also known as acute confusion. Someone with delirium can become confused, have difficulty understanding things, and have poor concentration and memory. These problems can come and go throughout the day. Delirium can last for a short time but it can be a serious illness. Although delirium cannot always be prevented, much can be done to reduce the possibility of it happening in hospitalised older patients. The best way is by making sure patients: have enough food and fluid, keep as mentally and physically active as possible, wear their glasses and hearing aids (if they have them), get enough sleep, do not have infections or low oxygen in their blood, are not on too many medications, and are not in pain. We have designed a system of care to help staff to be able to do this. We have called this the Prevention of Delirium (POD) Programme. We don't yet know if using the POD Programme will help staff to stop their patients getting delirium. In order to find this out, we are doing this study. At the end of the study the results will be compared to see if one way of caring for patients is better than the other at preventing delirium.

Who can participate?
All patients aged 65 years or older who do not have delirium when admitted to elderly care/geriatric medicine or orthopaedic trauma/orthopaedic surgery wards.

What does the study involve?
Sixteen wards in eight hospitals across the UK are taking part in this study. Each ward has been put into a group randomly selected by a computer. Eight wards will use the POD Programme system of care and eight will continue to provide their usual care. Recruited patients will have a delirium test daily for up to 10 days, and then at 30 days. Each test will take less than 10 minutes. Patients will also be asked to complete some questionnaires about their general health, what they are able to do and their thoughts on their experience of hospital care. All these questions should take less than 30 minutes each to complete. There will be three questionnaires in total to be completed when they are asked to join the study, and then at 30 days and 3 months after admission. In addition, the study team will also review hospital and social records of recruited patients to work out how much it costs to stop delirium for patients in hospital. Patients will be involved in the study for around 3 months.

What are the possible benefits and risks of participating?
The benefit of taking part would be the early detection and monitoring of delirium and speedier treatment of the causes. As patients' treatment will be the same whether they take part or not there are no extra risks. The daily visits from the researcher and completion of questions may be a little inconvenient.

Where is the study run from?
Sixteen wards in eight hospitals across the UK are taking part in this study:
University Hospitals South Manchester, Nottingham University Hospitals NHS Trust, Poole Hospital NHS Foundation Trust, St Helens & Knowsley NHS Teaching Hospitals Trust - Whiston Hospital, Queen Elizabeth Hospital, University Hospitals Birmingham, York Teaching Hospitals NHS Foundation Trust, Wales (Bangor) and Ipswich Hospital NHS Trust.

When is the study starting and how long is it expected to run for?
The study started in October 2013 and will run for two years.

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Dr Shamaila Anwar (s.t.anwar@leeds.ac.uk)
2. Dr John Green (john.green@bthft.nhs.uk)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Marie Fletcher

ORCID ID

Contact details

Leeds Institute of Clinical Trials Research
Clinical Trials Research Unit
University of Leeds
Leeds
LS2 9JT
United Kingdom
-
ctru_podhelp@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

16222

Study information

Scientific title

A cluster randomised feasibility study evaluating the Effectiveness and Cost effectiveness of the System of Care versus standard care practice in older patients at risk of developing delirium who are admitted to hospital

Acronym

POD

Study hypothesis

POD is a cluster randomised feasibility study which seeks to explore the potential clinical and cost-effectiveness of the POD System of Care versus standard care practice in older patients at risk of developing delirium who are admitted to hospital, and to gather data to inform a future larger study. It is the third and final project of a programme of interlinked studies that aims to improve delirium prevention for older people in hospital and reduce the burden of delirium for the NHS through the development of a multi-component delirium prevention system of care (the Prevention of Delirium [POD] Programme).

The primary objectives are to:
1. Provide a preliminary estimate of the effectiveness of POD compared to standard care. as measured by the incidence of new onset delirium within 10 days of hospital admission (anticipated primary outcome for definitive trial)
2. Assess the variability of the incidence of new onset delirium within 10 days of hospital admission in both treatment groups
3. Estimate the Intracluster Correlation Coefficient and likely cluster size
4. Assess barriers to the delivery of the POD system of care (e.g. because of changes to service configuration)
5. Assess compliance with the POD system of care
6. Estimate recruitment and follow-up rates at both patient and cluster levels
7. Assess the degree of contamination at ward level
8. Investigate differences in financial costs and benefits between the POD Programme and standard care practice

Secondary objectives are to: investigate differences in the number, severity and length of delirium episodes (including the presence of persistent delirium [at 30 days post admission to the ward]), length of stay in hospital, in-hospital mortality, destination at discharge, health outcome, physical and social independence, anxiety and depression and patient experience. At 3 months post admission we will also investigate health outcome, physical and social independence and health and social care economic resource use.

Ethics approval

First MREC approval date 22/01/2014, 13/YH/0400

Study design

Randomised; Interventional; Design type: Prevention, Process of Care

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Age and ageing

Intervention

Participants are randomised to two groups:
1. POD System of Care: The POD System of Care is a quality improvement, multi-component delirium prevention intervention which will be delivered by ward staff and volunteers. It targets modifiable clinical risk factors for delirium (such as immobility, sleep deprivation, dehydration and pain) in vulnerable patients
2. Control group: Usual care
Follow Up Length: 3 month(s); Study Entry: Registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Estimate effectiveness through calculating incidence of delirium within 10 days of hospital admission
2. Estimate cost-effectiveness
3. Assess intervention delivery
4. Estimate recruitment uptake and follow-up rates
5. Assess completeness of follow-up data collection
6. Assess degree of contamination
7. Estimate cost-effectiveness

Secondary outcome measures

1. Number, severity and length of delirium episodes (including persistent delirium at 30 days post admission)
2. Length of stay
3. Death
4. Discharge destination
5. Health outcome as measured by the EQ5D at baseline, 30 days and 3 months
6. Physical and social independence as measured by the NEADL at baseline and 3 months
7. Depression as measured by the Geriatric Depression Scale at 30 days
8. Anxiety as measured by the Clincial Anxiety Scale at 30 days
9. Patient experience as measured by the Patient Reported Experience Measure from the National Audit of Intermediate Care at 30 days
10. Health and social care economic resource as measured by the trial-specific Health Economic resource use questionnaire at 30 days

Overall trial start date

10/02/2014

Overall trial end date

03/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

All patients aged 65 years or older who do not have delirium when admitted to any elderly care/geriatric medicine or orthopaedic trauma/orthopaedic surgery wards taking part in the study will be assessed and given the opportunity to join.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

Planned Sample Size: 720; UK Sample Size: 720

Participant exclusion criteria

1. Patients with prevalent delirium diagnosed by completion of the Confusion Assessment Method
2. Patients with a planned discharged from hospital within 48 hours of admission (established from information provided by the ward staff)
3. Patients where a delirium assessment (i.e. CAM) has not been performed within 24 hours of admission to the ward (for elderly care patients) or pre-operatively (e.g. fracture patients)
4. Patients who have not provided consent or consultee declaration for trial participation within 48 hours of admission to the ward
5. Patients receiving end of life care (because it is unlikely follow-up data will be available for these patients)

Recruitment start date

01/08/2014

Recruitment end date

28/02/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospitals South Manchester
Manchester
M23 9LT
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Nottingham
NG5 1PB
United Kingdom

Trial participating centre

Poole Hospital NHS Foundation Trust
Poole
BH15 2JB
United Kingdom

Trial participating centre

St Helens & Knowsley NHS Teaching Hospitals Trust - Whiston Hospital
Prescot
L35 5DR
United Kingdom

Trial participating centre

Queen Elizabeth Hospital, University Hospitals Birmingham
Birmingham
B15 2GW
United Kingdom

Trial participating centre

York Teaching Hospitals NHS Foundation Trust
York
YO31 8HE
United Kingdom

Trial participating centre

Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom

Trial participating centre

Ipswich Hospital NHS Trust
Ipswich
IP4 5PD
United Kingdom

Sponsor information

Organisation

Bradford Institute for Health Research (UK)

Sponsor details

Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Government

Funder name

NIHR Programme Grants for Applied Research; Grant Codes: RP-PG-0108-10037

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26253332

Publication citations

Additional files

Editorial Notes

05/05/2016: Publication reference added. 21/07/2015: the overall trial end date was changed from 31/05/2015 to 03/07/2015. 05/03/2015: the overall trial end date was changed from 31/01/2015 to 31/05/2015.