Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001295639
Ethics application status
Approved
Date submitted
6/11/2023
Date registered
12/12/2023
Date last updated
18/07/2024
Date data sharing statement initially provided
12/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The FOOTPRINTS Project : Follow-on Outreach - Bereavement care after the unexpected death of a child in PICU - Phase One
Scientific title
The FOOTPRINTS Project Phase One: Involving Families in the Design of a PICU Bereavement Service using Focus Groups and Family Interviews
Secondary ID [1] 310899 0
None
Universal Trial Number (UTN)
U1111-1299-9327
Trial acronym
FOOTPRINTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Grief 331955 0
Condition category
Condition code
Public Health 328682 328682 0 0
Health service research
Mental Health 328778 328778 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
A combination of focus groups and family interviews with close relatives of children who have died an unexpected death in PICU, to explore qualitative themes relating to their experience of bereavement care, gaps in care they encountered, their perceived bereavement care needs, and their recommendations for a PICU bereavement service.

a) Each participant will attend a single focus group or family interview, depending on preference, lasting approximately 2 hours.

b) Each focus group / family interview will have no more than 12 participants, preferably six to eight.

c) Sessions will be semi-structured, following a facilitation guide that has been developed by the FOOTPRINTS working party and refined with two consumers. Questions will be open-ended, and participants will be provided pen and paper as an alternative option to record answers should they feel uncomfortable answering any questions verbally. A psychological safety plan has been developed by the FOOTPRINTS working party and refined with two consumers, and this will guide the focus group / family interview conduct to protect participant and researcher psychological safety. Participants will also be provided with written resources at the entry / exit to the sessions, with contact details for grief support services and contact details for the research team should they require support after the session.

d) Groups will be convened by two facilitators within the room, and a third outside the room to support any participants who experience distress. Facilitators will be members of the FOOTPRINTS working party, and will include an experienced researcher, a social worker, and a nurse with experience communicating with bereaved families.

Intervention code [1] 327437 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336626 0
Experience of care after losing a child unexpectedly in a PICU.
Timepoint [1] 336626 0
As described by the participant at the time of the focus group / interview.
Primary outcome [2] 336741 0
Gaps in the grief support received.
Timepoint [2] 336741 0
As described by the participant at the time of the focus group / interview.
Primary outcome [3] 336742 0
What the participant considers important in a PICU bereavement service
Timepoint [3] 336742 0
As described by the participant at the time of the focus group / interview.
Secondary outcome [1] 429052 0
Nil
Timepoint [1] 429052 0
Nil

Eligibility
Key inclusion criteria
Any person over the age of 18 who considers themselves a close family member of a child who has:
a) died in PICU during the five years preceding the commencement of this project and
b) who has not received Palliative Care Services.
Non-English-speaking families will be supported to participate using existing professional interpreter services.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
N/A - qualitative research

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2024
Actual
3/05/2024
Date of last participant enrolment
Anticipated
31/05/2024
Actual
31/05/2024
Date of last data collection
Anticipated
31/05/2024
Actual
21/06/2024
Sample size
Target
16
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25874 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 41707 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 315156 0
Charities/Societies/Foundations
Name [1] 315156 0
Perth Children's Hospital Foundation
Country [1] 315156 0
Australia
Primary sponsor type
Individual
Name
Dr Simon Erickson
Address
Perth Children's Hospital - 15 Hospital Ave Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 317176 0
Hospital
Name [1] 317176 0
Perth Children's Hospital
Address [1] 317176 0
15 Hospital Ave Nedlands WA 6009
Country [1] 317176 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314093 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 314093 0
Ethics committee country [1] 314093 0
Australia
Date submitted for ethics approval [1] 314093 0
06/11/2023
Approval date [1] 314093 0
07/12/2023
Ethics approval number [1] 314093 0
RGS0000006539

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

Contacts
Principal investigator
Name 130382 0
Mrs Arielle Jolly
Address 130382 0
Perth Children's Hospital - 15 Hospital Ave Nedlands WA 6009
Country 130382 0
Australia
Phone 130382 0
+61 401008874
Fax 130382 0
Email 130382 0
[email protected]
Contact person for public queries
Name 130383 0
Arielle Jolly
Address 130383 0
Perth Children's Hospital - 15 Hospital Ave Nedlands WA 6009
Country 130383 0
Australia
Phone 130383 0
+61401008874
Fax 130383 0
Email 130383 0
[email protected]
Contact person for scientific queries
Name 130384 0
Arielle Jolly
Address 130384 0
Perth Children's Hospital - 15 Hospital Ave Nedlands WA 6009
Country 130384 0
Australia
Phone 130384 0
+61 401008874
Fax 130384 0
Email 130384 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 will be qualitative in nature and gathered from group sessions and thus will not be individually reflecting of participants, but rather group discussion.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20822Study protocol  [email protected]
20823Informed consent form  [email protected]



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.