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Trial registered on ANZCTR


Registration number
ACTRN12621000799853
Ethics application status
Approved
Date submitted
27/04/2021
Date registered
24/06/2021
Date last updated
23/05/2022
Date data sharing statement initially provided
24/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot testing of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children
Scientific title
Pilot testing of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children
Secondary ID [1] 304067 0
None
Universal Trial Number (UTN)
Trial acronym
DAISY Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurodevelopmental Impairments 321715 0
Post Intensive Care Syndrome - Pediatrics 321716 0
Condition category
Condition code
Neurological 319457 319457 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Collaborative shared care, supported by early, regular e-PROMs with routine outcome monitoring. The following specific components of the intervention are designed to support the collaborative model:

a) Parent Information Booklet on PICS-p: Information regarding what is PICS-p, how common it is, what to be aware of, signs to look out for, and what parents can do to support their child. This booklet will be given to the parents immediately after providing consent to participate in the study (at baseline). Booklet created by the research team and PICOLO network.

b) Collaborative shared care: We define the term ‘collaborative shared care’ as the partnering of care between the PICU team and primary care provider (primarily a general practitioner based in the community). Both the PICU team and the primary care provider maintain ongoing involvement and support in patient care, share information, agree on common processes proactively, and involve the patient throughout. Specifically, the PICU team will phone the parent at 1-, 3-, and 6-months post PICU to provide 1:1 support and anticipatory education around the care of a child post-PICU. The phone calls will take between 30-45minutes. In addition, the PICU team will send an email link to the parents to complete a neurodevelopmental screening assessment of their child and an emotional wellbeing assessment of themselves (e-PROMs). GPs will be provided with a copy of the Act Now for kids 2morrow book, developed by the Queensland Child and Youth Clinical Network, which supports understanding of child development and the multidisciplinary approach to assessment, diagnosis, intervention and support.

c) e-PROMs: Parents/guardians will receive invitations for regular online screening at 1-, 3- and 6-months post PICU. The online screening module consists of a battery of well validated parent completed PICS-p outcome measures and takes approximately 45 minutes to complete. For ease, parents can complete the questionnaire on various devices, including smart phones, and over multiple sessions.

d) Reporting of results: The study team will develop Python scripts to automate the processes of exporting the data from REDCap into Stata processing the data and generating the feedback report. The feedback report (co-designed with parents and GPs in a co-design phase pre-implementation) will be provided to GP and parents at each timepoint. Following each screening-PROM assessment, a reminder text message or phone call will be sent by the PICU follow-up team to the parent to attend a follow-up appointment at the GP practice. The feedback is intended to flag whether a patient needs further follow up, and to act as a stimulus to discuss ongoing management, with potential referral to allied healthcare services, such as psychology, occupational therapy, physiotherapy or speech therapy. GP expertise and autonomy will not be questioned, not will judgements be made about the likelihood of non-beneficial treatment.

Intervention code [1] 320393 0
Early detection / Screening
Intervention code [2] 320394 0
Prevention
Comparator / control treatment
Active Control: Self-directed screening, education and activities

The use of an active control group has been made on the basis that, whilst there is no current follow-up standard of care following PICU in Australia, combined with belief, preliminary evidence suggests that doing something may be better than doing nothing. Therefore, participants allocated to the active control group will receive:

1) Parent information booklet on PICS-p, as above, including suggestions for who to contact if they are concerned, and,

2) routine updates on appropriate developmental milestones and activities via freely available mobile health applications: Centre for Disease Control Developmental Milestone-Tracker App and Telethon Kids Institute Bright Tomorrows App. Parents will be encouraged to complete developmental checks, participate in child play-based activities to develop essential child-life skills, and modules to support parent-life skills.

This simple and inexpensive active control group will inform whether the benefit of the more intensive intervention is worth the additional cost (or not) in terms of relevant patient clinical outcomes. Attention and time given from study staff will be the same as the intervention group, with phone calls to parents made prior to developmental milestones. An active control group also assists with recruitment and retention by increasing the attractiveness of the comparison group. With an increased understanding of PICS-p and appropriate developmental milestones, parents are free to follow up on their concerns with GPs or other primary care providers when they have concerns.
Control group
Active

Outcomes
Primary outcome [1] 327334 0
Feasibility
Eligibility: > or = 80% of potentially eligible patients will be screened. This outcome will be assessed by auditing the screening log and the participant contact attempt and search log.

Timepoint [1] 327334 0
At the conclusion of the study
Primary outcome [2] 327335 0
Feasibility
Recruitment: > or = 80% of eligible patients’ parents will consent to participate. This outcome will be assessed by auditing the screening log and the participant contact attempt and search log.
Timepoint [2] 327335 0
At the conclusion of the study
Primary outcome [3] 327336 0
Feasibility
Retention: < 20% of patients will be lost to follow-up. This outcome will be assessed by auditing the study database and the participant contact attempt and search log.
Timepoint [3] 327336 0
At the conclusion of the study
Secondary outcome [1] 394638 0
Parent Feedback: Parents who have participated in the study will be invited to provide feedback regarding their perceptions of follow-up and ease of use through a specifically designed online survey.
Timepoint [1] 394638 0
Six months after PICU discharge
Secondary outcome [2] 394639 0
Composite neurodevelopmental vulnerability at 6-months post PICU (yes/no), defined as a score in each online screening domain > 1 SD below the mean, or cut-off points defined by the test manuals, on any of the domains; both commonly accepted to define vulnerability. Ages and Stages Questionnaire (ASQ-3), ASQ Social-Emotional screener (ASQ:SE-2), Pediatric Emotional Distress Scale (Child Distress).
Timepoint [2] 394639 0
Six months after PICU discharge
Secondary outcome [3] 396345 0
Feasibility
Protocol fidelity: > or = 90% of participants will receive the prescribed screening and shared care protocol (This is a primary outcome)
Timepoint [3] 396345 0
At the conclusion of the study
Secondary outcome [4] 396346 0
GP Feedback: GPs who have participated in the study will be invited to provide feedback regarding their perceptions of follow-up and ease of use through a specifically designed online survey.
Timepoint [4] 396346 0
Six months after PICU discharge
Secondary outcome [5] 409934 0
Parent stress, defined as the mean total stress score of the Parenting Stress Index (PSI-4-SF)
Timepoint [5] 409934 0
Baseline and 1,-2,-3 months follow up.
Secondary outcome [6] 409935 0
Parent Resilience: The Connor-Davidson Resilience Scale (CD-RISC-10)
Timepoint [6] 409935 0
Baseline and 6 months post PICU
Secondary outcome [7] 409936 0
Parent Self-efficacy:
The Parenting Sense of Competency Scale (PSOC)
Timepoint [7] 409936 0
Baseline and 6 months post PICU discharge
Secondary outcome [8] 409937 0
Child Temperament:
The Short Temperament Scales (STS)
Timepoint [8] 409937 0
Baseline and 6 months post PICU discharge
Secondary outcome [9] 409938 0
Primary Care Giver Post Traumatic Stress (PC-PTSD)
Timepoint [9] 409938 0
Baseline and 1,-3,-6 months follow up.
Secondary outcome [10] 409939 0
Paediatric Quality of life Inventory (PedsQL)
Timepoint [10] 409939 0
Baseline and 1,-3,-6 months follow up.
Secondary outcome [11] 409940 0
Parental distress assessed by the Kessler Psychological Distress Scale (K6).
Timepoint [11] 409940 0
Baseline and 1,-2,-3 months follow up.

Eligibility
Key inclusion criteria
All infants and children discharged alive from PICU aged > or = 2 months and < 4 years and expected to survive hospital admission.

Parent inclusion criteria:
- Able to speak and read English
- Aged 18 years old or older

Minimum age
2 Months
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children born at gestation < 37 weeks, or with congenital heart disease or oncology diagnosis; known high-risk cohorts already in well-established follow-up program through NICU, cardiology or oncology services; cognitive impairment; non-English speaking caregiver.

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)
Children who meet the eligibility criteria and whose parents consent to participate will be randomised 1:1 to either GP shared care, supported by e-PROMs, and feedback of results (intervention arm) or PICS-p informational brochure and links to developmental milestones and activities (active control arm). Randomisation will be performed by the research team using a centralised web-based randomisation system managed by Queensland University of Technology (REDCap).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratifying variables for randomisation will be age: greater than or equal to 2 months to less than 12 months; and 12 to less than 24 months; 24 to 48 months and pre-morbid neurodevelopmental impairment (defined as Ages and Stages Questionnaire score at baseline less than 2 SD below mean on 1 or more domains).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis
Descriptive statistics will be used to report baseline characteristics of the study cohort. It is anticipated that there will be a degree of loss-to-follow up; all available data will be included for these children. Feasibility outcomes will be reported descriptively and compared against a-priori-determined feasibility thresholds of eligibility 80%; recruitment 80%; protocol fidelity greater than or equal to 90%; and retention less than 20% lost to follow-up at 6 months. Neurodevelopmental vulnerability at 6 months post PICU will be presented as counts and percentages. Difference between groups will be analysed using logistic regression including the age-group stratification variable as a fixed effect; odds ratio along with 95% confidence interval (CI) and p-value will be presented. Unadjusted difference and chi-squared p-value will also be presented. Subgroup analyses. The following pre-planned sub-group analyses will be performed: age at enrolment, specific diagnostic groups (e.g. respiratory, neurological), and severity of organ dysfunction. Parent and GP feedback will be reported using counts and percentages (quantitative data), and thematic analysis (qualitative data) Synthesised to produce a narrative account of the process of implementation in relation to the observed outcomes. For incomplete data or withdrawal of consent, the intention to treat principle will be applied.

Sample Size
We will screen 233 children; assuming 80% are eligible and we further recruit 80% of eligible participants, we will be able to accurately report on the eligibility rate and recruitment rate with a 95% confidence interval that has a maximum half-width of 6%. The anticipated recruitment sample size (n=149) will also be sufficient to estimate our protocol fidelity and loss to follow-up rates.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2021
Actual
11/10/2021
Date of last participant enrolment
Anticipated
30/09/2022
Actual
Date of last data collection
Anticipated
31/03/2023
Actual
Sample size
Target
149
Accrual to date
74
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19212 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [2] 22426 0
Sunshine Coast University Hospital - Birtinya
Recruitment postcode(s) [1] 33784 0
4101 - South Brisbane
Recruitment postcode(s) [2] 37590 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 308451 0
Charities/Societies/Foundations
Name [1] 308451 0
Children's Hospital Foundation
Country [1] 308451 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
149 Victoria Park Road
Kelvin Grove QLD 4059
Australia
Country
Australia
Secondary sponsor category [1] 309289 0
None
Name [1] 309289 0
Address [1] 309289 0
Country [1] 309289 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308405 0
Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 308405 0
Ethics committee country [1] 308405 0
Australia
Date submitted for ethics approval [1] 308405 0
Approval date [1] 308405 0
24/03/2021
Ethics approval number [1] 308405 0
HREC/21/QCHQ/73086
Ethics committee name [2] 308407 0
Queensland University of Technology - Human Research Ethics Committee
Ethics committee address [2] 308407 0
Ethics committee country [2] 308407 0
Australia
Date submitted for ethics approval [2] 308407 0
09/04/2021
Approval date [2] 308407 0
23/04/2021
Ethics approval number [2] 308407 0
110264

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

Contacts
Principal investigator
Name 110602 0
A/Prof Debbie Long
Address 110602 0
N Block Level 3, room 341
Queensland University of Technology
149 Victoria Park Road
Kelvin Grove QLD 4059
Brisbane
Country 110602 0
Australia
Phone 110602 0
+61 7 31383834
Fax 110602 0
Email 110602 0
[email protected]
Contact person for public queries
Name 110603 0
Isabel Castillo
Address 110603 0
N Block Level 3, room 311
Queensland University of Technology
149 Victoria Park Road
Kelvin Grove QLD 4059
Brisbane
Country 110603 0
Australia
Phone 110603 0
+61 7 3138 0558
Fax 110603 0
Email 110603 0
[email protected]
Contact person for scientific queries
Name 110604 0
Isabel Castillo
Address 110604 0
N Block Level 3, room 311
Queensland University of Technology
149 Victoria Park Road
Kelvin Grove QLD 4059
Brisbane
Country 110604 0
Australia
Phone 110604 0
+61 7 3138 0558
Fax 110604 0
Email 110604 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification.
When will data be available (start and end dates)?
Immediately following publication and ending 5 years following main results publication.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator

A/Professor Debbie Long
N Block Level 3, room 341
149 Victoria Park Road
Kelvin Grove QLD 4059
+61 7 31383834
[email protected]


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-implementation hybrid-2 randomised trial of a collaborative Shared Care Model for Detecting Neurodevelopmental Impairments after Critical Illness in Young Children (DAISY): pilot study protocol.2022https://dx.doi.org/10.1136/bmjopen-2021-060714
N.B. These documents automatically identified may not have been verified by the study sponsor.