ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618000411246

Ethics application status

Approved

Date submitted

7/03/2018

Date registered

21/03/2018

Date last updated

1/10/2023

Date data sharing statement initially provided

21/04/2022

Date results provided

21/04/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

A nurse led intervention to prevent delirium among adults admitted to Intensive Care,

Scientific title

A nurse lead intervention to reduce delirium among adults admitted to intensive care: a randomised multi-centre step-wedged study.

Secondary ID [1]

None

Universal Trial Number (UTN)

u1111-1210-3726

Trial acronym

DeLI Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Delirium

Condition category

Condition code

Neurological

Other neurological disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will incorporate a nurse led delirium prevention protocol, targeting risk factors for delirium: (1) visual and hearing impairment - nurses will ensure that all patient who usually need glasses, or hearing aids will use them during their ICU stay; (2) to prevent and treat sensory deprivation, cognitive impairment, and loss of orientation - all patients will be re-orientated to place, person, and time at the start of nursing shift and during the daily medical round; (3) Sleep deprivation will be minimised, and avoided where possible by ensuring minimal nursing care during the night shift (between 10pm and 6am in the morning), and overnight use of lights will be minimised, and noise kept to a level to facilitate/optimise sleeping; and, (4) lack of mobility - staff will attempt to improve functional mobility while in the intensive care, and also stimulate cognition, this will be undertaken in collaboration with the physiotherapy and occupational therapy teams to ensure patient (when able), will sit out of bed and mobilise within the ICU. Nursing staff will use checklists to direct interventions, and regular delirium prevention rounds (one per shift) will be undertaken to ensure application of interventions to reduce the risk of delirium.

Intervention code [1]

Prevention

Comparator / control treatment

Current nursing practice, which does not include any system approaches to prevent delirium, any measures currently implemented are usually ad hoc, and only implemented once a patient has delirium.

Control group

Active

Outcomes

Primary outcome [1]

Incidence of delirium will assessed using the ICU-CAM scale, which categorising patients as CAM +ve, CAM -ve for delirium, or un-assessable due to coma.

Timepoint [1]

within first 28-days in the intensive care, each patient will be assigned CAM -ve or CAM +ve for delirium during the daily morning medical round.

Secondary outcome [1]

Along with the identification of the primary outcomes of the incidence of delirium during first 28-days in the intensive car, each patient's daily CAM result will determine a delirium or delirium free day.

Timepoint [1]

The calculation of cumulative delirium free days for each patient will be undertaken at the time of discharge.

Eligibility

Key inclusion criteria

All adults aged 18 years or more admitted to the intensive care during the study period.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

(1) patients at the end-of-life, and not expected to survive 24 hours; (2) patients not expected to stay in the ICU for at least 24 hours; (3) patients with acute or chronic neurological conditions that prevented assessment of delirium (traumatic brain injury, intra-cerebral hemorrhage, ischaemic stroke, CNS infection, hypoxic brain injury, hepatic encephalopathy, severe mental disability, serious receptive aphasia, dementia).

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is not concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

After an initial three months of baseline measurement of delirium rates, and delirium free days, each month a single ICU will randomly cross-over into the intervention period of the trial (5 ICUs, and therefore, 5-months). The random selection of each unit's cross-over time will be undertaken using R statistical software, with the starting random seed being obtained from an external colleague to the project.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Crossover

Other design features

Stepped Wedge

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Descriptive statistics will describe the characteristics of each ICU at baseline and after the introduction of the intervention. Characteristics the patients populations before and after the introduction of the intervention will compared using appropriate statistical tests of significance for count or continuous data.

Formal tests of changes between baseline and following the introduction of the intervention, for the two main outcomes of interest: (1) rates of delirium; and (2) delirium free days, will undertaken using a generalised linear mixed model (poisson for rates of delirium), and a linear mixed model for delirium free days, taking into account the repeat measurements of each intensive care unit during the 12-month study period.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2018

Actual

1/05/2019

Date of last participant enrolment

Anticipated

30/06/2019

Actual

29/02/2020

Date of last data collection

Anticipated

28/07/2019

Actual

29/02/2020

Sample size

Target

3000

Accrual to date

Final

2618

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Liverpool Hospital - Liverpool

Recruitment hospital [2]

Bankstown-Lidcombe Hospital - Bankstown

Recruitment hospital [3]

Campbelltown Hospital - Campbelltown

Recruitment hospital [4]

Fairfield Hospital - Prairiewood

Recruitment postcode(s) [1]

2170 - Liverpool

Recruitment postcode(s) [2]

2200 - Bankstown

Recruitment postcode(s) [3]

2560 - Campbelltown

Recruitment postcode(s) [4]

2176 - Prairiewood

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Liverpool Hospital SWSLHD

Address [1]

Locked Bag 7103
Liverpool BC
NSW 1871

Country [1]

Australia

Primary sponsor type

Hospital

Name

Liverpool Hospital

Address

Locked Bag 7103
Liverpool BC
NSW 1871

Country

Australia

Secondary sponsor category [1]

University

Name [1]

Western Sydney University

Address [1]

Centre for Applied Nursing Research
Locked Bag 7103
Liverpool BC
NSW 1871

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SWSLHD HREC

Ethics committee address [1]

Liverpool Hospital, Elizabeth St, Liverpool, NSW, Australia. 2170

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/03/2018

Approval date [1]

07/11/2018

Ethics approval number [1]

HE18/169

Summary

Brief summary

Delirium is an acute neurocognitive disorder that is characterised by a fluctuating level of consciousness with impaired attention and cognition. Delirium has been estimated to occur in approximately 30% of adults admitted the intensive care. Delirium is associated with poor outcomes which include longer stay in intensive care unit, longer stay in hospital by 10 days and experience a prolonged duration of mechanical ventilation. The longer-term outcomes include long-term cognitive impairment, dependency in activities of daily living and 2-3 times higher mortality rates. The restlessness and agitation experienced by patients leads to increasing workload of ICU nurses who need to stay continually by the bedside to ensure the patients safety, thereby requiring one-to-one nursing care. This increases the financial burden of delirium on the Intensive Care unit as well as the hospital.  

This study will evaluate the impact of a nursing-led delirium-prevention protocol (‘the intervention’) that is aimed at reducing the incidence, severity, and duration of delirium among adults admitted to ICU. The Delirium Prevention Nursing Protocol targets the risk factors for delirium which includes visual and hearing impairment, to prevent or treat sensory deprivation and ultimately the loss of orientation; sleep deprivation, cognitive impairment to (re)orientate patients with regard to time, place and person to prevent or minimize decline; and immobility, to improve patients’ functional mobility in the ICU and to stimulate patients’ cognition.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Steve Frost

Address

Centre for Applied Nursing Research
Ingham Institute of Applied Medical Research
South Western Sydney Local Health District
Level 3, room 3.45
1-3 Campbell St Liverpool 2170
Locked Bag 7103
Liverpool BC NSW 1871

Country

Australia

Phone

+61 2 87389360

Fax

+61 2 87389206

[email protected]

Contact person for public queries

Name

Steve Frost

Address

Country

Australia

Phone

+61 2 87389360

Fax

+61 2 87389206

[email protected]

Contact person for scientific queries

Name

Steve Frost

Address

Country

Australia

Phone

+61 2 87389360

Fax

+61 2 87389206

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

No planned availability of individual records.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15840	Study protocol					374662-(Uploaded-25-03-2022-09-49-29)-Study-related document.pdf
15841	Ethical approval					374662-(Uploaded-25-03-2022-09-48-35)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Delirium in intensive care: A stepped-wedge cluster randomised controlled trial for a nurse-led intervention to reduce the incidence and duration of delirium among adults admitted to the intensive care unit (protocol).	2020	https://dx.doi.org/10.1016/j.aucc.2019.12.003
Embase	Frailty, delirium and hospital mortality of older adults admitted to intensive care: the Delirium (Deli) in ICU study.	2020	https://dx.doi.org/10.1186/s13054-020-03318-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically