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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 information initially 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] 294251 0
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 306933 0
Condition category
Condition code
Neurological 306033 306033 0 0
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] 300551 0
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] 305063 0
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] 305063 0
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] 344045 0
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] 344045 0
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?
No
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] 10311 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 10312 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [3] 10313 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 10314 0
Fairfield Hospital - Prairiewood
Recruitment postcode(s) [1] 21979 0
2170 - Liverpool
Recruitment postcode(s) [2] 21980 0
2200 - Bankstown
Recruitment postcode(s) [3] 21981 0
2560 - Campbelltown
Recruitment postcode(s) [4] 21982 0
2176 - Prairiewood

Funding & Sponsors
Funding source category [1] 298890 0
Hospital
Name [1] 298890 0
Liverpool Hospital SWSLHD
Country [1] 298890 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Locked Bag 7103
Liverpool BC
NSW 1871
Country
Australia
Secondary sponsor category [1] 298104 0
University
Name [1] 298104 0
Western Sydney University
Address [1] 298104 0
Centre for Applied Nursing Research
Locked Bag 7103
Liverpool BC
NSW 1871
Country [1] 298104 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299834 0
SWSLHD HREC
Ethics committee address [1] 299834 0
Liverpool Hospital, Elizabeth St, Liverpool, NSW, Australia. 2170
Ethics committee country [1] 299834 0
Australia
Date submitted for ethics approval [1] 299834 0
30/03/2018
Approval date [1] 299834 0
07/11/2018
Ethics approval number [1] 299834 0
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 81706 0
Dr Steve Frost
Address 81706 0
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 81706 0
Australia
Phone 81706 0
+61 2 87389360
Fax 81706 0
+61 2 87389206
Email 81706 0
[email protected]
Contact person for public queries
Name 81707 0
Steve Frost
Address 81707 0
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 81707 0
Australia
Phone 81707 0
+61 2 87389360
Fax 81707 0
+61 2 87389206
Email 81707 0
[email protected]
Contact person for scientific queries
Name 81708 0
Steve Frost
Address 81708 0
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 81708 0
Australia
Phone 81708 0
+61 2 87389360
Fax 81708 0
+61 2 87389206
Email 81708 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No planned availability of individual records.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15840Study protocol    374662-(Uploaded-25-03-2022-09-49-29)-Study-related document.pdf
15841Ethical approval    374662-(Uploaded-25-03-2022-09-48-35)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Delirium is an acute change in behaviour character... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseDelirium 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).2020https://dx.doi.org/10.1016/j.aucc.2019.12.003
EmbaseFrailty, delirium and hospital mortality of older adults admitted to intensive care: the Delirium (Deli) in ICU study.2020https://dx.doi.org/10.1186/s13054-020-03318-2
N.B. These documents automatically identified may not have been verified by the study sponsor.