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Trial registered on ANZCTR


Registration number
ACTRN12624000494538
Ethics application status
Approved
Date submitted
4/04/2024
Date registered
22/04/2024
Date last updated
22/04/2024
Date data sharing statement initially provided
22/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Addressing the unmet social needs of parents/caregivers of children: a mixed-methods pilot study of Health Navigators in the Children’s Ward at the Lyell McEwin Hospital
Scientific title
Addressing the unmet social needs of parents/caregivers of children: a mixed-methods pilot study of Health Navigators in the Children’s Ward at the Lyell McEwin Hospital
Secondary ID [1] 311584 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unmet social needs 332966 0
Condition category
Condition code
Public Health 329678 329678 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A screening and referral intervention for unmet social needs will be integrated into the Children's Ward, with the assistance of Health Navigators (HNs) to provide participants appropriate referrals to services and advocacy throughout the follow-up period. This screening and referral interventions comprise three phases: 1) identifying participants' unmet social needs (e.g. housing and financial instability, food insecurity, transportation) using a dedicated screening tool, and 2) an initial meeting with the participant to understand their situation, help prioritise needs and develop an action plan for referrals, and 3) provide follow-up and ongoing support for participants to help them access resources. The HN-participant initial meeting will require approximately one hour and will take place either in the Ward or in the community. The total duration of the intervention is seven months, with a three month recruitment period and four months of follow-up, with a minimum of one HN-participant contact per month. During follow-up, HNs will provide participants support contacting relevant community organisations, assisting with paperwork and attending appointments to provide participants advocacy as required. From our experience in previous HN studies, we anticipate follow-up frequency and duration will vary with case complexity, ranging from quick 10 minute phone calls to over an hour supporting participants in the community while attending appointments. HNs will undertake four full days of face-to-face training prior to intervention commencement, and will be provided a minimum of one hour of supervision and debriefing by a qualified, senior Social Worker to assist with queries and ethical decision-making throughout the intervention period.
Intervention code [1] 328037 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337461 0
Our primary outcome is intervention feasibility and acceptability, which will be assessed as a composite outcome.
Timepoint [1] 337461 0
Feasibility and acceptability outcomes will be assessed at study completion (i.e. 7 months post-enrollment), with the exception of clinician surveys. Clinician surveys will be administered two weeks pre-intervention to obtain baseline measures of intervention feasibility, again at the end of recruitment (i.e. three months into the intervention, when clinicians have access to the HN) and finally post-intervention (i.e. seven months post-enrollment, once the HN is no longer on the Ward).
Secondary outcome [1] 431958 0
Unmet social needs
Timepoint [1] 431958 0
Unmet social needs will be measured at baseline and after follow-up completion (four months duration), i.e. pre/post HN intervention.
Secondary outcome [2] 431959 0
Satisfaction with the HN service
Timepoint [2] 431959 0
Data will be collected at the end of follow-up with the HN, i.e. after four months in active follow-up.

Eligibility
Key inclusion criteria
Parent(s)/caregiver(s) of children (0 to <18 years) admitted to the Children’s Ward
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Parent(s)/caregiver(s) of children readmitted to the Ward that have previously been recruited to the HN intervention
• Parent(s)/caregiver(s) <18 years
• Limited English proficiency
• Families with current safety plans in place or actively involved with intensive family support services.

Study design
Purpose of the study
Treatment
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 design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2024
Actual
Date of last participant enrolment
Anticipated
30/08/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 315890 0
Charities/Societies/Foundations
Name [1] 315890 0
The Hospital Research Foundation
Country [1] 315890 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Hospital Research Foundation
Address
Country
Australia
Secondary sponsor category [1] 318033 0
Charities/Societies/Foundations
Name [1] 318033 0
The Hospital Research Foundation
Address [1] 318033 0
Country [1] 318033 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314732 0
Central Adelaide Local Health Network HREC
Ethics committee address [1] 314732 0
https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
Ethics committee country [1] 314732 0
Australia
Date submitted for ethics approval [1] 314732 0
12/01/2024
Approval date [1] 314732 0
31/01/2024
Ethics approval number [1] 314732 0

Summary
Brief summary
The purpose of this study is to examine the feasibility and acceptability of an intervention that identifies the unmet social needs (e.g. housing and financial insecurity) of vulnerable caregivers and employs Health Navigators (HNs) to provide appropriate referrals to government and community resources and ongoing advocacy over a four-month follow-up period. HNs are non-medical workers who have experience with the community service sector who practice strengths-based approaches to understand participants' situations and be led by them in designing an action plan for their needs. We hypothesise that HNs may be able to engage participants with services and may be able to resolve some of their needs. Our primary outcome of interest is the feasibility and acceptability of the intervention for both participants and clinicians working in the Children's Ward. These will be assessed using mixed-methods methodology, i.e. focus groups with participants and clinicians, and objective feasibility criteria such as rate of intervention recruitment and retention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132558 0
Prof Mark Boyd
Address 132558 0
Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
Country 132558 0
Australia
Phone 132558 0
+61 8 8182 9653
Fax 132558 0
Email 132558 0
[email protected]
Contact person for public queries
Name 132559 0
Mark Boyd
Address 132559 0
Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
Country 132559 0
Australia
Phone 132559 0
+61 8 8182 9653
Fax 132559 0
Email 132559 0
[email protected]
Contact person for scientific queries
Name 132560 0
Mark Boyd
Address 132560 0
Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
Country 132560 0
Australia
Phone 132560 0
+61 8 8182 9653
Fax 132560 0
Email 132560 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21699Study protocol    387375-(Uploaded-21-02-2024-15-18-34)-Study-related document.docx
21700Ethical approval    387375-(Uploaded-21-02-2024-15-19-00)-Study-related document.pdf



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.