Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001624875
Ethics application status
Not required
Date submitted
29/09/2021
Date registered
29/11/2021
Date last updated
29/11/2021
Date data sharing statement initially provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Paediatric Intensive Care Unit (PICU): Every Child, Every Day, Back to Play: the PICUstars protocol
Scientific title
Every Child, Every Day, Back to Play: the PICUstars protocol
Determining the Feasibility of Designing and Implementing a Nurse-Led Paediatric Intensive Care Unit (PICU) Liberation Program
Secondary ID [1] 305431 0
None
Universal Trial Number (UTN)
U1111-1269-8878
Trial acronym
PICUstars
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Post Intensive Care Syndrome (paediatric) 323803 0
Deconditioning 323804 0
Oversedation 323805 0
PICU-related complications 323806 0
Condition category
Condition code
Physical Medicine / Rehabilitation 321309 321309 0 0
Other physical medicine / rehabilitation
Public Health 321603 321603 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1) current practices of care in PICU will be assessed in a prospective baseline measurement to inform the adaptation of the PICU Liberation bundle and the PICU-STARS implementation
2) the implementation process will be evaluated as a longitudinal feasibility study and formative evaluation based on focus groups, interviews, questionnaires, and observations. Barriers and enablers for implementation success will be examined over time with recommendations from “lessons learned”
bundle elements:
A – Optimising analgesia: manage pain first
B – Spontaneous awakening and breathing trials (SABT)/nurse-enabled extubations
C – Choice of sedatives: avoid sedatives with adverse neurodevelopmental effects where possible
D – Early assessment and management of delirium
E – Early mobility and rehabilitation: set daily mobility goals
F – Family engagement and empowerment
G – Good Nutrition
H – Humanism

study phases:
Engage (Phase 1) – 6 months
• Establish the inter-professional team (nursing, medical, allied health).
• Include patient and family representatives, and research team members. Clarify roles and processes.
• Define problems, set goals and timelines.
• Comprehensive assessment of impediments to bundle.
• Assess local practice and resources.
• Systematically assess enablers and barriers to implementation of the bundle using evidence-informed strategies and measures from the Knowledge Translation (KT) literature.
• Develop implementation protocol.
• Tailor PICU Liberation Bundle elements to the needs of the PICU.
• Develop a process for reliable Bundle delivery to all patients.
• Match Liberation interventions and processes to mitigate challenges identified in assessment phase.
• Determine evaluation strategy.
• Using these data, design the protocol.
Educate (Phase 2) – 6 months
• Train operational leads on all intervention activities (face to face and hybrid 1-hour workshops x 3, attendance log).
• Train front line clinicians and stakeholders (face to face by clinical practice facilitators, sign off sheet; monthly 1-hour workshops, attendance sheets).
• Provide self-learning modules and resources (development of 2 x self-learning online modules, example videos, mandatory training checklist).
Execute (Phase 3) – 24 months
• Integrate PICU Liberation into practice.
• Unit wide roll-out, one to three bundle elements at every one time at every 2 - 3 months period (adherence will be monitored utilising the implementation check-list, focus groups and screening of electronic medical records).
A – Instances of Face, Legs, Activity, Cry, Consolability scale (FLACC) assessments/opportunities, Appropriate stepwise use of pain medication as per pain management escalation guideline (percentage), Withdrawal assessment tool (WAT3) assessments/opportunities, Empathic questionnaire results (carer perception of child’s pain management)
B – Instances of spontaneous awakening and breathing trials (SABT) screening performed/opportunities, SABT trials/opportunities, Extubation readiness assessments/opportunity, Instances of nurse-enabled extubation/opportunity, Empathic questionnaire results (carer perception of child’s spontaneous awakening and breathing trials)
C – Richmond Agitation-Sedation Scale (RASS) assessments/ opportunities, Sedation goal set (RASS)/ opportunities, Sedation titration performed appropriately as per sedation guideline to target RASS goal/ opportunities, Number of patients with “deep sedation” (RASS > -2), Sedative use (by number of classes of sedatives used for example: Benzodiazepines, chloralhydrate, ketamine), Empathic questionnaire results (carers perception of child’s sedation management)
D – Cornell Assessment of Pediatric Delirium (CAP-D) assessments/opportunities, Delirium identified (instances), Delirium management guideline followed/opportunities (instances of non-pharmacological interventions targeting delirium, instances of pharmacological interventions targeting delirium), sleep adjuncts utilised (e.g. day/night routine; swaddling/nesting), Empathic questionnaire results (carers perception of child’s delirium prevention management)
E – Graded activity level goals set/opportunity (as daily goal during ward-round), Mobility activities administered per patient per day, Mobility levels achieved (mobility levels are named in ascending order - Lizard, Koala,Wombat, Kangoroo = activity level one to four): Lizard – immobile, routine positioning and range of motion unless contraindications; Koala – in bed activities including sitting; Wombat – in bedspace activities including mobility out of bed/standing; Kangoroo– mobility out of bedspace including ambulatory; Immobility, Deconditioning (assessment of physical function by instances of Children’s Chelsea Critical Care Physical Assessment tool (cCPAx), Empathic questionnaire results (carers perception of child’s mobility management)
F – Tools used to ensure family inclusion (e.g. clear windows goals set, likes/dislikes on “getting to know you” form utilised), Instances of family participation in liberation goal setting, Family participation in liberation goals activity (education provided on PICU liberation, included in cares, neurodevelopmental and early mobility activity, rounds, plan of care including baby liberation flower, instances of therapeutic cuddles, instances of trips outside the patients room), Family communication with healthcare providers “have you been kept up to date?”, empathic questionnaire completion/opportunity
G – patient weight assessed, nutritional goals set/opportunity (during daily wardround), instances of nutritional goals achieved/opportunity, institutional Nutritional assessment tool used, instances of nutrition delivered to goal (defined as 2/3 of requirements reached enterally or parentally from 48 hours post I/V), Nutrition free days, Referrals to speech pathology, Oral feeding readiness assessments, Empathic questionnaire results (carers perception of child’s feeding and nutrition management
H – Family awareness of resources such as children’s book library, photo printing service (and use of same), Completion of “getting to know you” form, Empathic questionnaire results (carers perception of individualised care; use of care planning etc
• Post-marketing and education (newsletter section in PICU wide weekly newsletter, feedback at monthly workshops, focus groups).
Evaluate (Phase 4) – 12 months
• Evaluate Impact of PICU Liberation on practice.
• Regular evaluation (every 2 months in implementation period) - refine implementation and target education in response to feedback and control chart data implementation process and efficacy outcomes measurement.
• Re-measure bundle fidelity over time to determine maintenance of new practices.

3) the department-level implementation team will utilise the Consolidated Framework for Implementation Research (CIFR) and process evaluation (mixed methods) to assess feasibility, implementation outcomes, and intervention effectiveness
Intervention code [1] 321828 0
Prevention
Comparator / control treatment
No control group, but before-after study as part of evaluating impact of intervention on the PICU related complications:
before period has been defined as March 2019 to March 2020
before data will be collected from this 12 month period
Control group
Historical

Outcomes
Primary outcome [1] 329093 0
feasibility of PICUStars implementation “toolkit”
Timepoint [1] 329093 0
Pre-Implementation,
Adaptation will lead to updated versions at 6 months and 24 months of implementation
6 months post-Implementation
Primary outcome [2] 329408 0
barriers and enablers to the implementation of the PICU Liberation program pilot study
determined through focus groups, questionnaires (specifically developed for this study) and audio-recorded one-on-one interviews with PICU staff
Timepoint [2] 329408 0
Pre-Implementation,
Adaptation will lead to updated versions at 6 months and 24 months of implementation
6 months post-Implementation
Primary outcome [3] 329609 0
change in the number of PICU-related complications including ventilator associated pneumonia, accidental extubations requiring re-intubation within 1 hour, central line-associated bloodstream infections (CLABSI), catheter-associated urinary tract infection (CAUTI), delirium instances, withdrawal instances, deconditioning (assessed by Children’s Chelsea Critical Care Physical Assessment tool (cCPAx), malnutrition (as per institutional malnutrition assessment tool) after implementation of the PICU liberation program assessed by data-linkage to medical records
Timepoint [3] 329609 0
at 24 months of implementation
6 months post implementation
Secondary outcome [1] 401433 0
Length of PICU stay determined by data-linkage to medical records
Timepoint [1] 401433 0
at 24 months of Implementation
6 months post Implementation
Secondary outcome [2] 403556 0
Implementation process record ("toolkit") = handbook describing intervention and guide to local adaptation and implementation process
(description will be based on Consolidated Framework for Implementation Research (CFIR) principles and descriptors)
Implementation team will develop this toolkit during all study phases through record keeping of implementation process, focus groups, questionnaires and audio-recorded one-on-one interviews with PICU staff
Timepoint [2] 403556 0
Pre-Implementation,
Adaptation will lead to updated versions at 6 months and 24 months of implementation
6 months post-Implementation

Eligibility
Key inclusion criteria
Admission to study PICU
less than or equal to 18 years of age on admission
PICU LOS greater than or equal to 24 hours
Expected survival greater than or equal to 1 year post PICU admission
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Paediatric Advanced Resuscitation Plan (PARP) actively enacted during admission
Severe chronic disability precluding PICU liberation program participation
Minimally consciousness state on admission

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Single centre before-after hybrid trial-and-implementation study. It is designed to assess both the feasibility of adapting the multifaceted, nurse-led PICU Liberation model of care to PICU and its effectiveness in reducing PICU-related complications in a mixed quaternary PICU. The current practices of care in PICU will be assessed in a prospective baseline measurement to inform the adaptation of the PICU Liberation bundle and the PICU-STARS implementation. The department-level implementation team will utilise the Consolidated Framework for Implementation Research (CIFR) and process evaluation (mixed methods) to assess feasibility, implementation outcomes, and intervention effectiveness. The implementation process will be evaluated as a longitudinal feasibility study and formative evaluation based on focus groups, interviews, questionnaires, and observations. Barriers and enablers for implementation success will be examined over time with recommendations from “lessons learned”.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All outcomes will be examined using standard descriptive statistics and analytical techniques, with appropriate account for patient differentials in severity and relevant characteristics. The results will inform the fine-tune of the Liberation bundle adaptation and PICU-STARS implementation process. The expected primary output is a detailed adaptation and implementation guideline, including clinical resources (and investment) required, to adopt the PICU-STARRS in other children’s hospitals.
We will use Orchestrated Testing to measure implementation success, the impact of the PICU Liberation intervention and to help identify key components for best practice (ref). Requirements of Orchestrated Testing are a clear implementation plan and structure for engagement (generated in study phase 1). A Factorial (or Fractionated factorial) matrix, in our study the number of components of the bundle in phase 1 representing current practice and Phase 4 following bundle implementation, is crucial. Analysis of results will occur in phase 4. Ability to replicate the study findings will be tested internally on repeat plan-do-act cycles and externally as part of the proposed secondary study testing bundle implementation at a different PICU in Australia.
Exposure to the intervention/consistency will be monitored by control charts showing the measures of the PICU Liberation.
Repeated measure analyses for bundle compliance and performance over time will use Control Charts (i.e., time series analysis) as this is an efficient method of measuring practice change in real-time. Education and implementation strategies can be tailored in response to positive or negative change. Improvement will be defined using established control chart rules.
Statistical process control methodology will be used to assess study progress. Process of care outcomes will be measured before and after implementation. Background variables that may be potential confounders to the process outcomes will be tracked (e.g., acuity, staffing ratios). The effects of each factor and relevant interactions will provide preliminary estimates of clinical significance of the PICU Liberation bundle.
Analysis of secondary efficacy outcomes prior to and after implementation of the bundle will be compared by calculating absolute and relative risks followed by logistic regression procedures to adjust for important prognostic risk factors for dichotomous outcomes. For the economic analysis plan we will estimate the incremental cost of PICU related complications and incremental cost effectiveness ratios and corresponding 95% confidence intervals.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/12/2021
Actual
Date of last participant enrolment
Anticipated
1/12/2023
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20641 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 35430 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 309788 0
Hospital
Name [1] 309788 0
Queensland Children's Hospital
Country [1] 309788 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
Stanley Street, South Brisbane, 4101 QLD
Country
Australia
Secondary sponsor category [1] 310827 0
None
Name [1] 310827 0
Address [1] 310827 0
Country [1] 310827 0

Ethics approval
Ethics application status
Not required
Ethics committee name [1] 309539 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 309539 0
Ethics committee country [1] 309539 0
Australia
Date submitted for ethics approval [1] 309539 0
30/07/2019
Approval date [1] 309539 0
Ethics approval number [1] 309539 0
waak310719

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

Contacts
Principal investigator
Name 114510 0
Dr Michaela Waak
Address 114510 0
Queensland Children's Hospital
51 Stanley Street
South Brisbane
4101 QLD
Country 114510 0
Australia
Phone 114510 0
+61730683333
Fax 114510 0
Email 114510 0
[email protected]
Contact person for public queries
Name 114511 0
Michaela Waak
Address 114511 0
Queensland Children's Hospital
51 Stanley Street
South Brisbane
4101 QLD
Country 114511 0
Australia
Phone 114511 0
+61730683333
Fax 114511 0
Email 114511 0
[email protected]
Contact person for scientific queries
Name 114512 0
Michaela Waak
Address 114512 0
Queensland Children's Hospital
51 Stanley Street
South Brisbane
4101 QLD
Country 114512 0
Australia
Phone 114512 0
+61730683333
Fax 114512 0
Email 114512 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
data dictionaries and aggregated data will be available on request
IPD will be available to the research team only


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
No additional documents have been identified.