ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Unmet social needs

Condition category

Condition code

Public Health

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]

Treatment: Other

Comparator / control treatment

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Our primary outcome is intervention feasibility and acceptability, which will be assessed as a composite outcome.

Timepoint [1]

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]

Unmet social needs

Timepoint [1]

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]

Satisfaction with the HN service

Timepoint [2]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

The Hospital Research Foundation

Address [1]

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

The Hospital Research Foundation

Address

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

The Hospital Research Foundation

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network HREC

Ethics committee address [1]

https://www.rah.sa.gov.au/research/for-researchers/central-adelaide-local-health-network-human-research-ethics-committee

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/01/2024

Approval date [1]

31/01/2024

Ethics approval number [1]

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

Prof Mark Boyd

Address

Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112

Country

Australia

Phone

+61 8 8182 9653

Fax

mark.boyd@adelaide.edu.au

Contact person for public queries

Name

Mark Boyd

Address

Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112

Country

Australia

Phone

+61 8 8182 9653

Fax

mark.boyd@adelaide.edu.au

Contact person for scientific queries

Name

Mark Boyd

Address

Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, SA 5112

Country

Australia

Phone

+61 8 8182 9653

Fax

mark.boyd@adelaide.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

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.

Trial Review

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