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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
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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
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Secondary ID [1]
311584
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Unmet social needs
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Condition category
Condition code
Public Health
329678
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
328037
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Treatment: Other
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Our primary outcome is intervention feasibility and acceptability, which will be assessed as a composite outcome.
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Assessment method [1]
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Intervention feasibility will be assessed through 1) progression criteria, i.e. rates of recruitment, intervention uptake and intervention completion and 2) brief, electronic clinician surveys. Progression criteria data will be collected through audit of recruitment and follow-up records. Clinician surveys are modified from Jean-Pierre 2020
(https://doi.org/10.1007/s00520-019-04833-x), refined with the assistance of Ward clinicians to better suit the local context. Intervention acceptability will be assessed through reasons for non-participation and intervention withdrawal, and through focus groups with clinicians and participants. Reasons for non-participation and withdrawal will be collected by HNs following pre-defined, semi-structured interview questions.
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Timepoint [1]
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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).
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Secondary outcome [1]
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Unmet social needs
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Assessment method [1]
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Change in prevalence of unmet social needs as measured using a modified version of the Unmet Needs Screening Tool. This tool was validated with community and clinicians at the hospital in a previous study, and refined with Children's Ward team members to better reflect the social and cultural context of the population attending the Children's Ward.
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Timepoint [1]
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Unmet social needs will be measured at baseline and after follow-up completion (four months duration), i.e. pre/post HN intervention.
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Secondary outcome [2]
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Satisfaction with the HN service
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Assessment method [2]
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A brief survey comprising five questions about participants experience with the HN will be administered via email or mobile text. Response format uses a 5-point Likert Scale to grade participants satisfaction with the HN.
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Timepoint [2]
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Data will be collected at the end of follow-up with the HN, i.e. after four months in active follow-up.
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Eligibility
Key inclusion criteria
Parent(s)/caregiver(s) of children (0 to <18 years) admitted to the Children’s Ward
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
3/06/2024
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Actual
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Date of last participant enrolment
Anticipated
30/08/2024
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Actual
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Date of last data collection
Anticipated
31/12/2024
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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The Hospital Research Foundation
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
Charities/Societies/Foundations
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Name
The Hospital Research Foundation
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Address
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Country
Australia
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Secondary sponsor category [1]
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Charities/Societies/Foundations
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Name [1]
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The Hospital Research Foundation
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Address [1]
318033
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Country [1]
318033
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Central Adelaide Local Health Network HREC
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Ethics committee address [1]
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https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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12/01/2024
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Approval date [1]
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31/01/2024
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Ethics approval number [1]
314732
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Mark Boyd
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Address
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Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
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Country
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Australia
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Phone
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+61 8 8182 9653
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Mark Boyd
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Address
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Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
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Country
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Australia
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Phone
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+61 8 8182 9653
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Mark Boyd
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Address
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Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112
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Country
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Australia
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Phone
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+61 8 8182 9653
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Fax
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
21699
Study protocol
387375-(Uploaded-21-02-2024-15-18-34)-Study-related document.docx
21700
Ethical 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.
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