ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001326987

Ethics application status

Approved

Date submitted

2/10/2020

Date registered

8/12/2020

Date last updated

8/12/2020

Date data sharing statement initially provided

8/12/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Social determinants of health: A new social health screening tool to identify social needs of parents/legal guardians of children admitted to the Children's Ward at the Lyell McEwin Hospital

Scientific title

Social determinants of health: Investigating the efficacy of a new social health screening tool to identify social needs of parents/legal guardians of children admitted to the Children's Ward at the Lyell McEwin Hospital

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1258-5205

Trial acronym

Linked study record

Health condition

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

Social disadvantage

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Caregivers of children admitted to the Lyell McEwin Hospital's Children's Ward will be invited to complete a screening tool on social needs. The tool takes approximately 10 minutes to complete. Caregivers randomly assigned to the intervention group will be asked to self-complete the screening tool on an iPad. Non-response to any questions will be captured as part of the completion.

Intervention code [1]

Early detection / Screening

Comparator / control treatment

For caregivers randomly assigned to the comparator group, the tool will be completed by health workers with the caregiver. Non-response to any questions will be captured as part of the completion.

Control group

Active

Outcomes

Primary outcome [1]

Disclosure rates of social needs determined using the study-specific social health screening tool.
In addition, we will examine the rates of individual social needs as well as the total number of social needs.

Timepoint [1]

Completion of the screening tool.
Outcomes will be assessed after the last participant has completed the study.

Secondary outcome [1]

To determine if a social needs screening tool can successfully be implemented in a hospital setting.
Successful implementation will be indicated by the proportion of complete responses combined with respondents qualitative perceptions of screening for social needs in hospital settings.
Qualitative perceptions will be assessed in a one-on-one audio-recorded phone interview and thematic analysis applied to responses.

Timepoint [1]

Completion of the screening tool.
Outcomes will be assessed after the last participant has completed the study.

Secondary outcome [2]

To determine reasons for non-participation in the trial.
Study-specific questions will be used to determine reasons for non-participation.

Timepoint [2]

When discussing the trial with eligible caregivers who decline to participate, we will ask eligible caregivers their reasons for non-participation.

Eligibility

Key inclusion criteria

Adult parent/legal guardian of a child aged 0-5 years (inclusive) hospitalised at Lyell McEwin Hospital.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

• Unable to give consent
• Unable to complete questionnaire due to language barrier

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomisation by computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation: balanced variable blocks ranging in size from 2 to 8

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Sample size: There are no trials of social screening tools based in Australia from which to inform sample size estimates. Therefore we have used applied a combination of data from a randomised trial of a screening tool used in paediatric settings in the USA with observational data collected from adults with chronic conditions who sought treatment at the Lyell McEwin Hospital Emergency Department. Data specific to the Lyell McEwin Hospital provides some indication of the prevalence of social hardship. In the USA, electronic screening resulted in approximately 10% higher disclosure of sensitive questions (domestic violence, drug use) than face-to-face screening. Thus, we require 200 participants per group (400 total) to detect a 10% difference in disclosure (80% power and alpha 0.05). The sample size estimates are increased by 10% for item non-response and therefore we require 222 participants per group (444 total).

Statistical analysis: We will conduct descriptive analyses of participant characteristics according to group allocation. This will include means and standard deviations, frequencies and proportions. The primary trial analysis will adhere to intention-to-treat principles (according to group allocation). A statistical analysis plan will be written a priori. Treatment effects will be presented as the absolute difference in disclosure of social hardship for each individual item and for the total number of hardships by group. As the duration of the study is very short we do not anticipate many ‘drop outs’. However some participants may decline to answer some sensitive questions. We will examine the extent of non-response to each question, and if appropriate, use multiple imputation for missing information. This is likely to proceed by multiple imputation by chain equations but if the missing at random assumption seems untenable we may proceed with alternative imputation methods.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

14/12/2020

Actual

Date of last participant enrolment

Anticipated

31/12/2021

Actual

Date of last data collection

Anticipated

31/12/2021

Actual

Sample size

Target

444

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Lyell McEwin Hospital - Elizabeth Vale

Recruitment postcode(s) [1]

5112 - Elizabeth Vale

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Adelaide

Address [1]

The University of Adelaide
Adelaide
SA
5005

Country [1]

Australia

Primary sponsor type

University

Name

The University of Adelaide

Address

The University of Adelaide
Adelaide
SA
5005

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Lyell McEwin Hospital

Address [1]

Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale
SA
5112

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

PO Box 287
Rundle Mall
Adelaide  SA  5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/09/2020

Approval date [1]

20/11/2020

Ethics approval number [1]

13717

Summary

Brief summary

There is overwhelming evidence that adverse social and economic conditions have a negative impact on the health, welfare and development of children.  Poor education,  unemployment, financial and food insecurity and housing instability are linked with poor nutrition, developmental problems, increased risk of dysfunctional psychosocial behaviour and short- and long-term diseases of childhood and into adulthood. 

The American Academy of Pediatrics recommends that healthcare providers should routinely screen for and adopt interventions that address social risks as a mandatory aspect of healthcare. Innovative multidisciplinary team-based approaches are critical in hospital systems to identify social risk factors, and to refer families with unmet needs to community-based resources. 

The Lyell McEwin Hospital is the principal tertiary hospital serving a substantially disadvantaged community, with several suburbs in its catchment having significant relative disadvantage across a number of indicators. Australian Bureau of Statistics data show that families living in this catchment area have poorer educational achievement, greater unemployment, lower income and greater mortgage or rental stress compared with other areas. 

This is a 2-arm randomised control trial that will test electronic collection of a new social needs screening tool that will be adminstered either face-to-face with a health worker/researcher or be self-completed.  The study will be conducted at the Lyell McEwin Hospital. The proposed study population includes adult parents/legal guardian(s) of children aged 0-5 years admitted to the Children’s Ward. Currently, there is no screening tool used in the Children’s Ward to identify social needs of families and this study will help determine the acceptability and feasibility of implementing such a tool.

Trial website

None.

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Lisa Smithers

Address

School of Public Health
The University of Adelaide
Adelaide SA 5005

Country

Australia

Phone

+61 8 83130546

Fax

lisa.smithers@adelaide.edu.au

Contact person for public queries

Name

Lisa Smithers

Address

School of Public Health
The University of Adelaide
Adelaide SA 5005

Country

Australia

Phone

+61242215435

Fax

lisa.smithers@adelaide.edu.au

Contact person for scientific queries

Name

Lisa Smithers

Address

School of Public Health
The University of Adelaide
Adelaide SA 5005

Country

Australia

Phone

+61242215435

Fax

lisa.smithers@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

We will not have ethical approval nor consent from carers to share IPD. We will be able to share data dictionaries.

What supporting documents are/will be available?

Doc. No.	Type	Email	Other Details
9225	Study protocol	lisa.smithers@adelaide.edu.au	Once approved by ethics and governance, the study ... [More Details]
9226	Informed consent form	lisa.smithers@adelaide.edu.au	Once approved by ethics and governance, the consen... [More Details]
9227	Ethical approval	lisa.smithers@adelaide.edu.au	Once approved, a copy of the letter from the Human... [More Details]
9234	Statistical analysis plan	lisa.smithers@adelaide.edu.au	Once approved by the study investigators, the Stat... [More Details]
9601	Other	lisa.smithers@adelaide.edu.au	We will include a link to the data dictionary whic... [More Details]

Results publications and other study-related documents

Documents added manually

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No additional documents have been identified.

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