Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000736943p
Ethics application status
Submitted, not yet approved
Date submitted
10/05/2020
Date registered
14/07/2020
Date last updated
14/07/2020
Date data sharing statement initially provided
14/07/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of the ABCDEF bundle on delirium, functional outcomes and quality of life in critically ill patients - a randomised controlled trial with embedded process evaluation
Scientific title
The effect of the ABCDEF bundle on delirium, functional outcomes and quality of life in critically ill patients - a randomised controlled trial with embedded process evaluation
Secondary ID [1] 300759 0
Nil Known
Universal Trial Number (UTN)
U1111-1249-4979
Trial acronym
Linked study record
ACTRN 12614000763640 was the feasibility study of this RCT and was designed to test important aspects of our research methodology to ensure this RCT would be robust.

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 316608 0
Delirium 316609 0
Condition category
Condition code
Physical Medicine / Rehabilitation 314837 314837 0 0
Other physical medicine / rehabilitation
Neurological 315688 315688 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive the protocolised ABCDEF bundle of cares which is outlined below:
A: - Assess, prevent and manage pain: Pain will be assessed every 2 hours and when necessary using the Numeric Rating Scale (NRS) if the patient is conscious or the Critical Care Observation Tool (CCOT) if unconscious. Significant pain will be assumed if the NRS is greater than 4 or the CCOT is greater than 3. Pre-procedural analgesia will be administered as per medical officer's prescription. “Treat pain first, then sedate” will be emphasised.
B: - Both Spontaneous awakening trial (SAT) and spontaneous breathing trial (SBT)
This component relates to mechanically ventilated patients. Sedative medications will be ceased daily, the patient will be orientated to time and day, and an SBT will be conducted to liberate the patient from the ventilator. A safety screen within the CIS will be completed by the RN every morning to determine whether it is safe to interrupt sedation and commence a SAT. The Consultant must agree to both the SAT and SBT before progressing.
C: - Choice of analgesia and sedation. Level of alertness will be monitored every 4 hours with the Richmond Agitation and Sedation Scale (RASS). ICU nursing and medical staff will optimise sedation by keeping the RASS between light sedation (-2) to restless (+1) for mechanically ventilated patients unless it is deemed not appropriate by the treating consultant.
D: - Delirium: assess, prevent and manage. The CAM-ICU will be performed every 12 hours (8am and 8pm) on patients with a RASS score of -2 or higher to determine if the patient is delirious. Reorientation and cognitive stimulation activities will be performed by the occupational therapist and nursing staff. Patients will be provided their glasses and hearing aids throughout the day. Shower and bed bath will be considered once the patient is conscious and haemodynamically stable. The use of physical restraints will be avoided. Patients will be taken outside to the courtyard each day- weather permitting. Patients will receive a sleep hygiene program that will occur from 11 pm to 5 am and will include the use of earplugs, reduction in light and noise, and organisation of care activities to provide maximum uninterrupted sleep.
E: - Early mobility and exercise. The physiotherapist and nursing staff will ensure the early mobility and exercise program is incorporated into patient care. The completion of a screen within the Clinical Information System (CIS) will ensure the patient meets safety criteria. The patient will progress through four levels of progressive activity, receiving the highest level they can manage. Level 1: If the patient does not pass the safety screen, they will receive passive range of motion exercise and sitting position three times a day in bed. Level 2: If the patient can lift their arm on request, they will receive active resistance exercises, will sit in bed at a sitting position three times per day, and will sit on the edge of the bed daily. Level 3: If able to lift their leg on request, the patient will receive level 2 exercises and will also trial a stand once per day. Level 4: If the patient can lift their leg and managed level 3 the previous day, they will receive level 3 exercises and will be encouraged to ambulate- march in place, or take a few steps, or walk with assistance.
F: - Family engagement and empowerment. The F component of the bundle focuses on strategies that are respectful of and responsive to patient and family needs and values, enhance family satisfaction with patient care, enhance decision-making, and acknowledge that delirious patients often feel greater trust toward family members versus staff. Families within the intervention group will be offered the following: face to face meeting with a member of the medical team (Monday - Sunday) or with the social worker (Monday – Friday). At this meeting, the family will be provided an update on the patient's status. The family will be given the opportunity to have questions answered and concerns addressed. Family members will receive an information brochure related to delirium on admission to the ward (Delirium in the Intensive Care Unit - A guide for Families and Patients developed by Critical Illness, Brain Dysfuction, and Survivorship (CIBS) Center, Nashville USA.) Family members will be encouraged to be actively involved in delirium management and exercise components of the protocol under supervision of the treating team. This involvement may include bringing in photos and personal items from home, ensuring hearing aids and glasses are used, re-orientating the patient, reading to and talking to the patient, bringing in favorite music, spreading out visits throughout the day, assisting the patient with Level 1 and 2 exercise as described in component E.
Data related to adherence to each component of the ABCDEF protocol will be collected. The bed-side Registered Nurse will record each component of the ABCDEF bundle as it is delivered within the ICU clinical information system. The Principal Investigator will retrospectively record this data on a case report form. Reasons for not completing components of the ABCDEF bundle will be recorded by the bedside nurse.
The intervention will continue until the patient is considered suitable to transfer to a ward.
Intervention code [1] 317513 0
Prevention
Comparator / control treatment
Participants in the control group will receive standard medical, nursing, and allied health care. Standard care includes decisions made on a daily basis with no use of protocols: spontaneous breathing and awakening trials as determined by the Consultant Intensivist on duty; ad hoc management of pain and delirium; once or twice daily passive and active exercise as determined by the physiotherapist of the day with patients generally remaining in bed if they are ventilated.
Potential contamination of the control group has been considered. The intervention group will receive the protocolised ABCDEF bundle via a prescription within the CIS. The control group will not have access to the ABCDEF protocols as they will not be available in any other format. Variation in the control group will relate to different clinical practice and effort of individuals
Control group
Active

Outcomes
Primary outcome [1] 323712 0
The incidence of delirium as measured by the Confusion Assessment Method - Intensive Care Unit (CAM-ICU). The incidence of delirium will be defined as a positive CAM-ICU on any day.
Timepoint [1] 323712 0
Delirium will be measured every 12 hours (8 am and 8 pm) on patients with a Richmond Agitation Sedation Scale (RASS) score of -2 or higher until the patient is considered to be suitable for transfer to the ward.
Primary outcome [2] 323987 0
The duration of delirium as measured by the Confusion Assessment Method - Intensive Care Unit (CAM-ICU). Duration of delirium will be defined as the number of ICU days in which patients were CAM-ICU positive.
Timepoint [2] 323987 0
Delirium will be measured every 12 hours (8 am and 8 pm) on patients with a Richmond Agitation Sedation Scale (RASS) score of -2 or higher until the patient is considered to be suitable for transfer to the ward.
Secondary outcome [1] 382695 0
Functional ability as measured by the Functional Independence Measure (FIM)
Timepoint [1] 382695 0
The FIM will be measured within 24 hours of the expected ICU discharge and within 24 hours of the expected hospital discharge or on Friday before the expected discharge if it is likely to be over the weekend.
Secondary outcome [2] 382696 0
Health-Related Quality of Life (HRQOL) as measured by the EuroQol- 5 Dimension (EQ-5D).
Timepoint [2] 382696 0
HRQOL will be measured at baseline, 90 days post-discharge from ICU, and 12 months post-discharge from ICU.
Secondary outcome [3] 383497 0
Sedation using the validated Richmond Agitation Sedation Scale (RASS).
Timepoint [3] 383497 0
Sedation will be monitored every 4 hours with the Richmond Agitation and Sedation Scale (RASS) throughout the ICU admission and will continue until the patient is considered suitable for transfer to the ward.
Secondary outcome [4] 383498 0
Pain scores using the Pain Numeric Score or the CPOT
Timepoint [4] 383498 0
Pain will be monitored every 4 hours throughout the ICU admission and will continue until the patient is considered suitable for transfer to the ward.
Secondary outcome [5] 383499 0
Ventilator free days. Data will be collected from the patient medical record.
Timepoint [5] 383499 0
From randomisation to day 28
Secondary outcome [6] 383500 0
All cause mortality
Timepoint [6] 383500 0
From randomisation to 90 days
Secondary outcome [7] 383501 0
ICU free days. Data will be collected from the patient medical record.
Timepoint [7] 383501 0
From randomisation to day 28
Secondary outcome [8] 383502 0
Hospital free days. Data will be collected from the patient medical record.
Timepoint [8] 383502 0
From randomisation to day 90
Secondary outcome [9] 383503 0
ICU readmissions rates. Data will be collected from the patient medical record.
Timepoint [9] 383503 0
Throughout the initial hospital stay whilst a participant of the study.
Secondary outcome [10] 383504 0
Discharge destination. Data will be collected from the patient medical record.
Timepoint [10] 383504 0
Following discharge from the hospital..
Secondary outcome [11] 383505 0
Compliance with the ABCDEF bundle. Data will be collected from the patient medical record.
Timepoint [11] 383505 0
During the ICU admission and will continue until the patient is considered suitable for transfer to the ward.
Secondary outcome [12] 383506 0
Adverse events including falls, slips, self-extubation. Data will be collected from the patient medical record.
Timepoint [12] 383506 0
During the ICU admission and will continue until deemed suitable for transfer to the ward.

Eligibility
Key inclusion criteria
All adult patients admitted to the ICU who are expected to remain in the ICU for at least 48 hours.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have been readmitted to ICU within the current hospitalisation, are not predicted to survive the admission to ICU, or are receiving end of life care.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment is guaranteed as a secure web-based randomisation system from Griffith University will be used and will only release a randomisation code once the patient has completed screening procedures and has been formally consented.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to the intervention group who will receive the protocolised bundle of ABCDEF cares or the control group who will receive standard medical, nursing and physiotherapy care using a secure web-based randomisation system from Griffith University. The allocation sequence will be computer-generated in a ratio of 1:1, using randomly varied block sized of 2 and 4 to avoid predictability of allocation and to ensure even groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary outcome measure is incidence and duration of delirium. It is difficult to predict numbers of delirious patients in the ICU as they have been reported to be as low as 19% or as high as 87%. A pre-post study by Balas and colleagues has been used to guide the primary outcome measure to calculate sample size. In order to have 80% power to identify a change in percentage of patients with delirium at any time from 65% to 42.5% or less (i.e. a change of 22.5%), 75 patients will be required in each of the treatment group and control group (total of 150 patients) .
Patients with at least 48 hours in the ICU will be included in the statistical analysis. Descriptive statistics will be used to determine the frequency and percentage of the intervention and the control group participants’ demographic variables. Values will be compared to ascertain mean outcomes and to test whether statistical assumptions for parametric tests are met. Analyses will be performed on a basis of an intention-to-treat and per protocol method. Continuous variables that are normally distributed will be compared using the independent t-test. Non-parametric analysis will be conducted for continuous variables that are not normally distributed. Categorical variables will be tested with the chi-square statistic. Regression models will be used to explain confounders (receipt of certain medications including benzodiazepines and muscle relaxants). Patients who die during the ICU stay will be assigned a score of 0 for ventilator free days, ICU free days, and hospital free days. A p value of p < 0.05 will be considered statistically significant. Where appropriate, analyses will be reported with mean differences and 95% confidence interval (CI). Protocol violations will be noted. Imputation will be used to correct for missing data where appropriate. Statistical analysis will be performed using IBM Statistical Package for Social Sciences (SPSS) software, version 26.0.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 16642 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 30237 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 305219 0
Hospital
Name [1] 305219 0
Metro South Health
Country [1] 305219 0
Australia
Primary sponsor type
Individual
Name
Kellie Sosnowski
Address
Intensive Care Unit
Logan Hospital
Cnr Loganlea and Armstrong Roads
Meadowbrook QLD 4131
Country
Australia
Secondary sponsor category [1] 305578 0
None
Name [1] 305578 0
Address [1] 305578 0
Country [1] 305578 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 305567 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 305567 0
Ethics committee country [1] 305567 0
Australia
Date submitted for ethics approval [1] 305567 0
17/06/2020
Approval date [1] 305567 0
Ethics approval number [1] 305567 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100798 0
Ms Kellie Sosnowski
Address 100798 0
Intensive Care Unit
Logan Hospital
Cnr Loganlea and Armstrong Road
Meadowbrook, QLD, 4131
Country 100798 0
Australia
Phone 100798 0
+61 07 3299 8049
Fax 100798 0
Email 100798 0
[email protected]
Contact person for public queries
Name 100799 0
Kellie Sosnowski
Address 100799 0
Intensive Care Unit
Logan Hospital
Cnr Loganlea and Armstrong Road
Meadowbrook, QLD, 4131
Country 100799 0
Australia
Phone 100799 0
+61 07 3299 8049
Fax 100799 0
Email 100799 0
[email protected]
Contact person for scientific queries
Name 100800 0
Kellie Sosnowski
Address 100800 0
Intensive Care Unit
Logan Hospital
Cnr Loganlea and Armstrong Road
Meadowbrook, QLD, 4131
Country 100800 0
Australia
Phone 100800 0
+61 07 3299 8049
Fax 100800 0
Email 100800 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
Medical data pertaining to an individual will not be made public. Only aggregate summary data will be published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of the ABCDEF bundle on delirium, functional outcomes and quality of life in intensive care patients: A study protocol for a randomised controlled trial with embedded process evaluation.2021https://dx.doi.org/10.1136/bmjopen-2020-044814
N.B. These documents automatically identified may not have been verified by the study sponsor.