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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] 302357 0
None
Universal Trial Number (UTN)
U1111-1258-5205
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social disadvantage 319135 0
Condition category
Condition code
Public Health 317099 317099 0 0
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] 318646 0
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] 325184 0
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] 325184 0
Completion of the screening tool.
Outcomes will be assessed after the last participant has completed the study.
Secondary outcome [1] 387107 0
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] 387107 0
Completion of the screening tool.
Outcomes will be assessed after the last participant has completed the study.
Secondary outcome [2] 387108 0
To determine reasons for non-participation in the trial.
Study-specific questions will be used to determine reasons for non-participation.
Timepoint [2] 387108 0
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17588 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 31332 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 306789 0
University
Name [1] 306789 0
University of Adelaide
Address [1] 306789 0
The University of Adelaide
Adelaide
SA
5005
Country [1] 306789 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide
Adelaide
SA
5005
Country
Australia
Secondary sponsor category [1] 307339 0
None
Name [1] 307339 0
Address [1] 307339 0
Country [1] 307339 0
Other collaborator category [1] 281484 0
Hospital
Name [1] 281484 0
Lyell McEwin Hospital
Address [1] 281484 0
Lyell McEwin Hospital
Haydown Rd
Elizabeth Vale
SA
5112
Country [1] 281484 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306948 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306948 0
PO Box 287
Rundle Mall
Adelaide SA 5000
Ethics committee country [1] 306948 0
Australia
Date submitted for ethics approval [1] 306948 0
03/09/2020
Approval date [1] 306948 0
20/11/2020
Ethics approval number [1] 306948 0
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 105550 0
A/Prof Lisa Smithers
Address 105550 0
School of Public Health
The University of Adelaide
Adelaide SA 5005
Country 105550 0
Australia
Phone 105550 0
+61 8 83130546
Fax 105550 0
Email 105550 0
lisa.smithers@adelaide.edu.au
Contact person for public queries
Name 105551 0
A/Prof Lisa Smithers
Address 105551 0
School of Public Health
The University of Adelaide
Adelaide SA 5005
Country 105551 0
Australia
Phone 105551 0
+61242215435
Fax 105551 0
Email 105551 0
lisa.smithers@adelaide.edu.au
Contact person for scientific queries
Name 105552 0
A/Prof Lisa Smithers
Address 105552 0
School of Public Health
The University of Adelaide
Adelaide SA 5005
Country 105552 0
Australia
Phone 105552 0
+61242215435
Fax 105552 0
Email 105552 0
lisa.smithers@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Other
'Other' documents specified
We will include a link to the data dictionary which will be posted on the Open Science Framework website. We will attach the link once the Data Dictionary is uploaded. This can only occur once the data collection and sharing has been approved by the ethics committee.
How or where can supporting documents be obtained?
Type [1] 9225 0
Study protocol
Citation [1] 9225 0
Link [1] 9225 0
Email [1] 9225 0
lisa.smithers@adelaide.edu.au
Other [1] 9225 0
Once approved by ethics and governance, the study protocol will be available by emailing the lead investigator.
Attachment [1] 9225 0
Type [2] 9226 0
Informed consent form
Citation [2] 9226 0
Link [2] 9226 0
Email [2] 9226 0
lisa.smithers@adelaide.edu.au
Other [2] 9226 0
Once approved by ethics and governance, the consent and information sheets will be available by emailing the lead investigator.
Attachment [2] 9226 0
Type [3] 9227 0
Ethical approval
Citation [3] 9227 0
Link [3] 9227 0
Email [3] 9227 0
lisa.smithers@adelaide.edu.au
Other [3] 9227 0
Once approved, a copy of the letter from the Human Research Ethics Committee will be available by emailing the lead investigator.
Attachment [3] 9227 0
Type [4] 9234 0
Statistical analysis plan
Citation [4] 9234 0
Link [4] 9234 0
Email [4] 9234 0
lisa.smithers@adelaide.edu.au
Other [4] 9234 0
Once approved by the study investigators, the Statistical Analysis Plan will be available by emailing the lead investigator.
Attachment [4] 9234 0
Type [5] 9601 0
Other
Citation [5] 9601 0
Link [5] 9601 0
Email [5] 9601 0
lisa.smithers@adelaide.edu.au
Other [5] 9601 0
Attachment [5] 9601 0
Summary results
No Results