ISRCTN - ISRCTN27972532: Pilot Trial of "Stop Delirium!"

Plain English Summary

Background and study aims
Delirium (or acute confusion) is a serious illness, common in older people, in which a persons thinking and perceptions may be affected. Reducing delirium is important both because of the considerable distress it causes and poor outcomes associated with it, such as falls, hospital admissions, deaths and costs to the NHS.

Preventing delirium is possible; successful interventions in hospitals have reduced it by a third. However, there is little research to guide practice in care homes, where it is likely to be common.

In previous research, we developed and tested an intervention, which we called Stop Delirium!. The intervention was based on what is known from the research literature on preventing delirium and on strategies to change professionals practice. We found Stop Delirium! was acceptable to care home staff and had potential to improve care and to improve outcomes for residents. We have yet to find out if it can prevent delirium and whether the additional costs are justified. Before starting on a large (costly) trial to test this, we wish to carry out a pilot study that will test and help improve the design of the main trial.

This pilot study will help to address a major gap in the evidence for delirium prevention by providing information that will allow a full trial. It will also help implement recent national (NICE) delirium guidelines, and for intervention homes, increase staff confidence and self-esteem, which is known to be associated with raising quality of care.

If shown to be effective in a future trial, Stop Delirium! has the potential to deliver substantial benefits for residents, staff and the NHS.

Who can participate?
All care home residents aged over 60 are eligible unless they are receiving end of life care or have severe communication difficulties. Residents who do not have English as a first language will also be ineligible in this pilot.

What does the study involve?
Twelve care homes (with nursing) will be randomly allocated to receive either Stop Delirium! over 16 months or usual care. We will collect data by administering tests to residents, examining health records and interviewing staff to obtain key information such as how many residents agree to take part and can be followed up and the appropriateness of proposed methods to measure impact and costs.

What are the possible benefits and risks of participating?
Residents may benefit from earlier detection of delirium through the assessments. This would mean the underlying causes could be treated earlier. If a resident is found to have delirium during the assessments the researcher will, with prior consent, alert the care home manager. It is possible that residents may be distressed by the assessment process. We will not undertake any assessments of individuals where they appear at all reluctant, even if they have formerly consented.

Where is the study run from?
The study is a collaboration between the University of Leeds and Bradford District Care Trust (BDCT) (UK).

When is the study starting and how long is it expected to run for?
The study started in March 2012 and is expected to run until March 2014.

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

Who is the main contact?
Anne Heaven (Research Fellow)
Tel: (01274) 383931
anne.heaven@bthft.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Najma Siddiqi

ORCID ID

Contact details

University of Leeds
Institute of Health Sciences
Leeds
LS2 9JT
United Kingdom
n.siddiqi@leeds.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12105

Study information

Scientific title

A cluster randomised controlled pilot trial of 'Stop Delirium!' a complex intervention to prevent delirium in care homes for older people

Acronym

PiTSTOP

Study hypothesis

Does a multicomponent intervention Stop Delirium!' Prevent Delirium in Care Homes for Older People?

Delirium (or acute confusion) is a serious illness common in older people, in which a persons thinking and perceptions may be affected. Reducing delirium is important because of the considerable distress it causes and the poor outcomes associated with it e.g. falls, hospital admissions, mortality and costs to the NHS. Preventing delirium is possible using multi-component interventions; successful interventions in hospitals have reduced it by one third. However, there is little research to guide practice in care homes.

In previous work we developed a multi-component intervention, called "Stop Delirium!", based on what is already known.

from the research literature on preventing delirium; and on strategies to change professionals practice. We found Stop Delirium! was acceptable to care home staff and had potential to improve care and to improve outcomes for residents.

We have yet to find out if it can prevent delirium and whether the additional costs are justified. Before starting on a large costly trial of Stop Delirium!, we plan to carry out a pilot that will test and help improve the design of the main trial.

We will select 12 care homes; 6 will be randomised to receive Stop Delirium! over 16 months and 6 to usual care. We will collect data by administering tests to residents, examining their health records and interviewing staff. We will obtain key information e.g rates of recruitment to the study, appropriateness of our proposed methods to measure outcomes, burden of assessments for residents, that will help to plan the main study.

This pilot study will provide information that will allow a full trial. It will also help implement recent national (NICE) delirium guidelines, which recommend multi-component interventions for delirium prevention in care homes.

More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12105

Ethics approval

ref: 12/YH/0018

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Delirium

Intervention

Input from a Specialist Delirium Practitioner over a 16 month period comprised 3x education sessions and monthly working groups.
Delirium Practitioner work is supported by a Toolkit, Manual and learning resources i.e. 'Delirium box'
The development of a Delirium Champion in the care home.

The methodology for the control arm is care as usual.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

Presence of delirium on any day during a 1 month post intervention period. Researchers will examine residents on alternate days (except Sundays).

Secondary outcome measures

Delirium severity (proportion of residents with DRS-R-98 severity scale score >15.25 at any assessment) during the 1 month post intervention period

Overall trial start date

26/03/2012

Overall trial end date

31/03/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Care Homes
1. Care homes for older people in Bradford
2. Run by an independent provider (private, voluntary or non profit-making)
3. Managers expressing an interest for their care home to participate in the study
4. Providing nursing care
5. Within catchment area for the City and North Bradford District NHS Care Trust Older Peoples Community Mental Health Teams.

Residents:
1. All people resident in the 12 study care homes during recruitment period recruitment
2. Male and female participants
3. Lower Age Limit 60 years

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

UK Sample Size: 288;

Participant exclusion criteria

Care Homes:
1. Local Authority homes
2. Residential homes
3. Specialist homes, except those specialising in providing dementia care
4. Care homes involved in other projects likely to impact on study e.g initiatives to reduce hospital admissions

Residents
1. Unable to participate in assessments because of severe communication difficulties or severe dementia.
2. Receiving end of life care
3. Non-English speakers

Recruitment start date

26/03/2012

Recruitment end date

31/03/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Leeds
Leeds
LS2 9JT
United Kingdom

Sponsor information

Organisation

Bradford District Care Trust (UK)

Sponsor details

Lynfield Mount Hospital
Heights Lane
Bradford
BD9 6DP
United Kingdom
+44 (0)1274 408600

Sponsor type

Hospital/treatment centre

Website

http://www.bdct.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-0610-22068

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data