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Trial registered on ANZCTR

Registration number

ACTRN12625000539437

Ethics application status

Approved

Date submitted

24/04/2025

Date registered

28/05/2025

Date last updated

28/05/2025

Date data sharing statement initially provided

28/05/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

The FOOTPRINTS Project Phase Two: Follow-On Outreach - Psychosocial Support after the Unexpected Death of a Child in a Paediatric Intensive Care Unit (PICU)

Scientific title

The FOOTPRINTS Project Phase Two: Follow-On Outreach - Psychosocial Support after the Unexpected Death of a Child in PICU

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

FOOTPRINTS

Linked study record

ACTRN12623001295639 This record is the first phase of the FOOTPRINTS Project.

Health condition

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

Child sudden and unexpected death

Bereavement

Grief

Condition category

Condition code

Public Health

Health service research

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention will be a PICU bereavement service - the FOOTPRINTS Service - designed in Phase One of the FOOTPRINTS Project. The FOOTPRINTS Service will systematically follow-up and support families of children who have died in PICU from sudden and unexpected causes who are not already linked to specialist palliative care service. The service will be offered by a PICU liaison nurse and critical care social worker who will work together to provide a systematic program of follow-up, with regular contact time-points, focused on transitional support, coordinating elements of bereavement support and linking families to community services. Outreach contact will be offered via telephone, text, or email depending on the preference of participating family members, at the following time-points:
1) In PICU around the time of death
2) 2 weeks post bereavement
3) 3 months post bereavement
4) 6 months post bereavement
5) 12 months post bereavement
* Research measures administered at 13 months post bereavement.
The duration of outreach contact will vary depending on the level of response from participating family members, but is expected to range between 15 - 45 minutes. Families will be offered links to community services relevant to their unique grief circumstances as assessed by the FOOTPRINTS liaison nurse and social worker, such as professional grief counselling services and peer support groups. In addition, all participating families will be able to view links to a wide range of community services available on the FOOTPRINTS Project website, which will go live at the commencement of the service and will be regularly updated to reflect current community bereavement offerings including community-led peer support services in addition to professional service providers. An Intervention Delivery Checklist will be maintained for each service contact time-point to capture the extent the intervention is delivered as planned, along with a Telephone / Contact Log to record the extent to which family members receive contact and interact with the intervention providers. A Resource Utilisation Checklist will also be maintained to record the uptake and utilisation of community resources advised by the intervention providers.
Participants from the FOOTPRINTS Project - Phase One will be invited to be involved in Phase Two as Consumer Advisors but not as participants.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The control group will consist of family members of children who died before the FOOTPRINTS Service commenced and therefore received usual care bereavement support and follow-up. Each site will select a control group identified via review of ANZPIC Registry Data from a 5-year period prior to the commencement of the FOOTPRINTS Service. This period is anticipated to be from 01/07/2020 to 31/06/2025 but may differ site-to-site dependent on the timing of governance approval

Control group

Historical

Outcomes

Primary outcome [1]

Grief Intensity

Timepoint [1]

13 months post bereavement

Secondary outcome [1]

Family functioning

Timepoint [1]

13 months post bereavement

Secondary outcome [2]

Post Traumatic Stress Disorder

Timepoint [2]

13 months post bereavement

Secondary outcome [3]

Implementation: Feasibility

Timepoint [3]

After enrolment of the first five families at each site

Secondary outcome [4]

Implementation: Fidelity

Timepoint [4]

Every service contact timepoint

Secondary outcome [5]

Implementation: Translatability

Timepoint [5]

End of study

Eligibility

Key inclusion criteria

Inclusion Criteria –Baseline Cohort:
Any person who:
a) considers themselves a close family member of a child who has died unexpectedly in PICU within the preceding five years, and
b) has the capacity to complete the study assessments.

Inclusion Criteria – Intervention Cohort:
Any person who:
a) considers themselves a close family member of a child who has died unexpectedly in PICU, and
b) has received contact from the FOOTPRINTS Service, or
c) interacted with the FOOTPRINTS Service materials, or
d) utilised community services facilitated by FOOTPRINTS personnel, and
e) has the capacity to complete the study assessments.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion Criteria – Both cohorts:
Family members of children already receiving pre-existing palliative care services prior to the time of death.

Discretionary Exclusion Criteria:
Situations involving:
a) Inflicted injuries
b) Disputed Custody
c) Active criminal investigations
– as documented in hospital notes from the time of death.

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

Other

Other design features

A historical control will be utilised with each site recruiting their own control group. Controls will be participants who experienced the unexpected death of a child before the introduction of the FOOTPRINTS Service.

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Comparison of the demographic and clinical characteristics of each group (baseline and intervention) will be undertaken using standard approaches (mean/standard deviation; median/interquartile range; number/percentage). Relationships among participants and between participants and child deaths in PICU will be described. Differences in baseline characteristics that may have an association with the primary outcome include relationship of participants to the deceased child, age of the deceased child at the time of death, and presence of complex trauma (including multiple deaths or injuries within the family at the time of the child’s death, or previous child death within the family). Due to the non-randomised nature of the data, exploratory statistical comparisons of the baseline characteristics between the two study groups will be reported to inform the use of covariates in the primary analysis. This will be achieved through multilevel mixed effect regression models (accounting for site and child as clusters) and report effect differences and 95% confidence levels. Should significant imbalance between the two groups exist, the use of propensity score matching will be explored to derive balanced cohorts.

The primary analysis will be conducted on a modified intention-to-treat cohort for the intervention group, i.e. regardless of how much of the intervention bundle is received, the intervention group will be analysed as the intervention cohort. Statistical analysis of the primary outcome will be undertaken using multilevel mixed effects regression, accounting for site and family clustering through random effects, and treatment group as the fixed effects. The effect estimate, 95% confidence interval, and p-value will be reported. A priori planned sensitivity analyses will be undertaken as follows: 1) adjusting for unbalanced characteristics in the cohort; 2) restricting the baseline cohort to participants within the time window of 13 – 15 months post bereavement; and 3) a modified per-protocol analysis including participants in the intervention group who adhered to the intervention as prescribed. Secondary outcomes will be analysed using similar approaches, however p-values will not be reported.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/07/2025

Actual

Date of last participant enrolment

Anticipated

1/07/2027

Actual

Date of last data collection

Anticipated

1/08/2028

Actual

Sample size

Target

106

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA,VIC

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Perth Children's Hospital Foundation

Address [1]

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Stan Perron Charitable Foundation

Address [2]

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Government of Western Australia Department of Health - Futures Health and Research Innovation Fund

Address [3]

Country [3]

Australia

Primary sponsor type

Government body

Name

Child and Adolescent Health Service Western Australia

Address

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Perth Children's Hospital

Address [1]

Country [1]

Australia

Other collaborator category [1]

University

Name [1]

Curtin University

Address [1]

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Monash Children's Hospital

Address [2]

Country [2]

Australia

Other collaborator category [3]

Hospital

Name [3]

John Hunter Children's Hospital

Address [3]

Country [3]

Australia

Other collaborator category [4]

Hospital

Name [4]

Royal Children's Hospital Melbourne

Address [4]

Country [4]

Australia

Other collaborator category [5]

Hospital

Name [5]

Sydney Children's Hospital Westmead

Address [5]

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Child and Adolescent Health Service Human Research Ethics Committee

Ethics committee address [1]

https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

06/11/2023

Approval date [1]

07/12/2023

Ethics approval number [1]

RGS000006539

Summary

Brief summary

Project Summary:
Aim: The aim of this study is to design and measure the effect of a PICU bereavement service to follow-up families of children who died unexpectedly. 
Background: Despite most inpatient paediatric deaths in developed countries occurring in a paediatric intensive care unit (PICU), there is a gap in literature and services on the topic of unexpected bereavement. Unlike patients who have life-limiting conditions and those who die expected deaths, children who present acutely to PICU and subsequently die generally do not fall under the remit of traditional palliative care services, and therefore their families often do not receive structured bereavement follow-up. Due to the rapid and traumatic nature of their child’s death these families have unique and significant grief factors equating to high risk of post-traumatic stress, complicated grief, and poor family functioning. Examining the experience of these families provides an opportunity to design bereavement care targeted to their needs and improve family-centred outcomes including family coping, functioning, well-being, and the family experience of bereavement.  
Methodology: A two-phase project consisting of a design phase followed by an interventional study. Phase One will consist of: 1) an integrative review of the literature on the topic of unexpected death in PICU and practice recommendations for bereavement care, 2) focus groups and interviews with bereaved families to understand what they consider important in a PICU bereavement service, 3) a scoping survey of current bereavement practices in Australian PICUs, and 4) Informed design of a PICU bereavement service (FOOTPRINTS) in collaboration with industry stakeholders and health consumers. Phase Two will be a type 2 hybrid effectiveness-implementation design. Effect of the FOOTPRINTS Service will be measured in a mixed-methods interventional trial, utilising a sequential pre and post design to assess grief severity in bereaved family members as the primary outcome. Implementation measures will assess feasibility, fidelity, and translatability of the FOOTPRINTS Service. Significance: The findings of this project will increase knowledge about unexpected death in PICU, family bereavement care needs, components of a bereavement service and feasibility of intervention delivery. Findings will contribute to establishment of a business case for a PICU bereavement service.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Arielle Jolly

Address

Child and Adolescent Health Service 15 Hospital Ave Nedlands WA 6009

Country

Australia

Phone

+61 401008874

Fax

[email protected]

Contact person for public queries

Name

Arielle Jolly

Address

Child and Adolescent Health Service 15 Hospital Ave Nedlands WA 6009

Country

Australia

Phone

+61 401008874

Fax

[email protected]

Contact person for scientific queries

Name

Arielle Jolly

Address

Child and Adolescent Health Service 15 Hospital Ave Nedlands WA 6009

Country

Australia

Phone

+61 401008874

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically