Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001459718
Ethics application status
Approved
Date submitted
27/10/2022
Date registered
17/11/2022
Date last updated
17/11/2022
Date data sharing statement initially provided
17/11/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Equity Pathways in Integrated Care in Cerebral Palsy (EPIC-CP): a pilot clinical trial of social prescribing for children and young people with cerebral palsy and their parents/caregivers
Scientific title
Equity Pathways in Integrated Care in Cerebral Palsy (EPIC-CP): a pilot clinical trial of social prescribing for children and young people with cerebral palsy and their parents/caregivers
Secondary ID [1] 308239 0
None
Universal Trial Number (UTN)
Trial acronym
EPIC-CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cerebral palsy 328000 0
unmet social needs 328002 0
Condition category
Condition code
Neurological 325061 325061 0 0
Other neurological disorders
Public Health 325062 325062 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm= social prescribing (resource pack and Community Linker)
The intervention is an adjunct to standard treatment. Participants randomised to the social prescribing group will receive resource pack plus in-person Community Linker. This will be a case-by-case intervention based upon the needs of the family.

After enrolment, baseline assessment, and randomisation, allocated participants receive the resource pack and will be scheduled for an intake appointment to connect with the Community Linker. Participants will also receive the resource pack containing information about supports and services that may help address unmet social needs. The resource pack will be available in hard copy and online. The resource pack has been specifically designed for this study, and is a compilation of helpful links and organisations that can assist families with their unmet needs. Examples of supports and services listed include “Ask Izzy”, “NSW Public School Finder”, information on the National rent affordability scheme and “Secondbite”.

A community Linker is a trained, non-medical personnel who assists parents/caregivers to connect with appropriate services and supports to address their unmet social needs. It is not a therapeutic role. Community Linkers provide practical, hands-on support navigating services e.g., finding an appropriate local community service, making referrals to services, help completing forms, follow-up with services, and booking appointments. Community linkers will be employed under NSWHealth and will thus be required to complete the mandatory online Health Education and Training Institute (HETI) modules (https://www.heti.nsw.gov.au/education-and-training/my-health-learning/mandatory-training). They will also complete additional modules including cultural competence training, family care and support framework training, NSW Health Education Centre Against Violence training and child protecting training. They will also be engaging in regular meetings with the research team, other community linkers and their site-specific social worker and service manager. The community linker will be expected to have extensive knowledge of services and disability to effectively carry out their role in this intervention.

All participants in the intervention arm will have an initial intake appointment with the Community Linker which will be approximately 30-60 minutes in length. Dependent on participant preference, the intake appointment may occur face-to-face at the Rehabilitation Department immediately after randomisation. Alternatively, it may occur via phone, videoconference, or in-person at a different time that suits the participant. All participants will have an intake consultation within 1 week of enrolment and randomisation to the social prescribing arm. During the intake appointment, participants will discuss with the Community Linker their unmet social needs; the current supports and services they are accessing; what they need help with; and their goals for managing their unmet social needs. A personalised care plan will be made together with the parent/caregiver. Parents/caregivers will also elect their preferred mode (e.g., videoconference, phone call, email) and frequency of communication (e.g., once-a-week, once a fortnight) with the Community Linker moving forward which can be revised at any time should the parent/caregiver change their preferences or needs (e.g., require additional/less support).

The Community Linker will provide personalised 1:1 support in-person, via phone call/text message, or via videoconference visit (determined by participant preference) for a period of 3-months. The frequency and length of engagement will depend on participants' preferences and needs. The Community Linker will conduct minimum monthly check-ins in person during clinic, over the phone, email, or videoconference (determined by participant preference). Each Community Linker will keep a logbook of their activities including type of social care navigation activities provided, e.g., advice regarding services, attending services with families, types of services, referrals made to services collected, etc. to monitor adherence to the intervention.
Intervention code [1] 324701 0
Treatment: Other
Comparator / control treatment
Active control arm= resource pack
Participants in the active control arm will receive a resource pack containing information about supports and services that may help address unmet social needs. The resource pack will be available in hard-copy and online.

Participants who enrol, complete baseline assessment, and are randomised in-person will be provided a hard-copy of the resource pack and a project post-card with a QR code to the online version of the resource pack.
Control group
Active

Outcomes
Primary outcome [1] 332889 0
Evaluate the feasibility of delivering a social prescribing intervention (resource pack plus in-person Community Linker) and active control intervention (resource pack) evaluated against the set criteria for success of feasibility, which include recruitment rates, uptake of intervention and follow-up of participants. These will be assessed by an audit of the completed surveys identifying the percentage of completed surveys, percentage of agreeance to be screened and percentage of individuals agreeing to enrolment. Follow-up of participants will be assessed by auditing enrolment logs and surveys idenitfying percentage of completion, and percentage of individuals lost to follow up.
Timepoint [1] 332889 0
Baseline, 3 months post-randomisation (primary) and 6 months post-randomisation follow up
Primary outcome [2] 333017 0
Acceptability of a social delivering a social prescribing intervention (resource pack plus in-person Community Linker) and active control intervention (resource pack) evaluated through surveys and qualitative methods. Surveys will be audited and percentage of satisfaction completing the survey noted, and semi-structured one-on-one interviews of intervention participants will be conducted with a member of the research team. These will be conducted face-to-face or via telehealth dependent on participant preference and explore the participants' experiences, barriers, and enablers to social prescribing.
Timepoint [2] 333017 0
Basline, 3 months post-randomisation (primary) and 6 months post-randomisation
Secondary outcome [1] 414988 0
Intervention fidelity- social prescribing intervention (resource pack plus in-person Community Linker) assessed by auditing community linker logbooks and participant bespoke questionnaires to identify type of social prescribing activities provided e.g. advice regarding services, attending services with families, types of referrals made to services.
Timepoint [1] 414988 0
3 month post-randomisation follow up
Secondary outcome [2] 414989 0
Unmet social needs (parent/caregiver self-report) assess through an adapted WECARE tool
Timepoint [2] 414989 0
Baseline, 3 months post-randomisation and 6 months post-randomisation follow up
Secondary outcome [3] 414990 0
Parent/caregiver distress (parent/caregiver self-report) assessed through the K-6 distress scale
Timepoint [3] 414990 0
Baseline, 3 months post-randomisation and 6 months post-randomisation follow up
Secondary outcome [4] 414991 0
Child/young person global health (parent/caregiver proxy-report or child/young person self-report) assessed through the PROMIS Parent Proxy Scale or the PROMIS Pediatric Scale if the child/young person is >8 years of age and can self report
Timepoint [4] 414991 0
Baseline, 3 months post-randomisation and 6 months post-randomisation follow up
Secondary outcome [5] 414992 0
Parent/caregiver global health (parent/caregiver self-report) assessed through the PROMIS Scale
Timepoint [5] 414992 0
Baseline, 3 months post-randomisation and 6 months post-randomisation follow up

Eligibility
Key inclusion criteria
Parent/caregiver of a child (aged 0-18 years) with a confirmed diagnosis of CP who is patient of the CP Service at one of the following tertiary Paediatric Rehabilitation Departments: Kids Rehab, the Children’s Hospital at Westmead; Rehab2Kids, Sydney Children’s Hospital; HNEkidsRehab, John Hunter Children’s Hospital;

Reside in New South Wales or the Australian Capital Territory;
Provide informed consent;

Report at least one unmet social need from the following six items on the adapted WECARE screening tool: Childcare or schooling; Government benefits and vouchers; Housing; Food; Bills; Transport
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Family already enrolled and assigned a research participant ID e.g. in the instance where a parent/caregiver meets inclusion criteria and has multiple children with a diagnosis of CP (e.g., siblings with CP or twins with CP), the parent/caregiver will only be able to enrol once per family, rather than multiple times for each child with CP.

Have no mechanism for contact (telephone or email).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by REDCap platform
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
As this is a feasibility trial it is not powered to detect changes in the proposed definitive trial outcome measures, rather primary outcomes relate to feasibility and acceptability. The pilot trial will aim to obtain a minimum of 35 respondents in each trial arm at 3 and 6- months follow-up. Assuming a 30% loss to follow in line with previous research, the sample size to be recruited will be 50 parents/caregivers in each arm. A total sample size of 120 parents/caregivers makes it possible to assess feasibility as the relevant primary outcome. Randomisation will be stratified by Rehabilitation Department/study site. Across the entire project (three study sites), 60 parents/caregivers will be randomised to the social prescribing intervention arm (20 per site) and 60 parents/caregivers will be randomised to the active control arm (20 per site).

Qualitative data collection and analysis : Data collected from the semi-structured interviews will be coded using grounded theory according to common themes using thematic analysis.
Initially all coding of the interviews and development of themes will be done by hand. This provides the opportunity to redefine and/or merge themes as analysis proceeds. When no new themes are emerging, data will be managed with the assistance of the qualitative software NVivo 11 software by the principal investigator. Transcription checks against tapes and notes taken, triangulation, feedback, will be employed to ensure rigor (e.g., all interviewees will receive a copy of their interview transcript to check). Comments after reading these will be fed back into the analysis.

Quantitative data analysis: Participant characteristics will be reported using descriptive statistics. The analysis will be according to randomised treatment allocation.

The analysis of primary outcomes- feasibility and acceptability outcomes will be based on descriptive statistics reported as percentage (95% confidence interval). Acceptability will be evaluated through responses on parent/caregiver satisfaction questionnaire. Furthermore, feasibility will be evaluated against the set criteria for success of feasibility, as follows:
Recruitment rates: Recruitment will be successful if 80% of our target sample is met in the 3 months of recruitment.

Uptake of intervention: Will be considered successful if > 70% of families complete the intervention.

Follow-up of participants: Will be considered successful if > 70% of families complete all the study visits.

Analysis of secondary outcomes will be purely exploratory and not powered to detect efficacy, thus we will not perform tests of significance. Secondary outcome measures will be described by intervention allocation using the t-test and non-parametric tests for continuous data and the chi-squared test for categorical data. If suitable, linear and logistic regression modelling will be conducted to test group differences adjusting for basic baseline (where the model allows); for example, gender, and sociodemographic characteristics.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2023
Actual
Date of last participant enrolment
Anticipated
30/04/2023
Actual
Date of last data collection
Anticipated
31/10/2023
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23429 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [2] 23430 0
Sydney Children's Hospital - Randwick
Recruitment hospital [3] 23431 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 38831 0
2305 - New Lambton
Recruitment postcode(s) [2] 38832 0
2031 - Randwick
Recruitment postcode(s) [3] 38833 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 312496 0
Charities/Societies/Foundations
Name [1] 312496 0
Sydney Children's Hospitals Foundation
Country [1] 312496 0
Australia
Funding source category [2] 312497 0
Charities/Societies/Foundations
Name [2] 312497 0
Cerebral Palsy Alliance Research Foundation
Country [2] 312497 0
United States of America
Primary sponsor type
Hospital
Name
Sydney Children's Hospital Network
Address
Corner Hawkesbury Road and, Hainsworth St, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 314134 0
None
Name [1] 314134 0
Address [1] 314134 0
Country [1] 314134 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311831 0
Sydney Children's Hospitals Network (SCHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 311831 0
Ethics committee country [1] 311831 0
Australia
Date submitted for ethics approval [1] 311831 0
29/08/2022
Approval date [1] 311831 0
10/10/2022
Ethics approval number [1] 311831 0
2022/ETH01688

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 122526 0
A/Prof Susan Woolfenden
Address 122526 0
Associate Professor Sue Woolfenden
School of Women and Children’s Health, UNSW Sydney
Level 8 Bright Alliance, High Street, Randwick 2031, NSW Australia
Country 122526 0
Australia
Phone 122526 0
+61 293828183
Fax 122526 0
Email 122526 0
[email protected]
Contact person for public queries
Name 122527 0
Susan Woolfenden
Address 122527 0
Associate Professor Sue Woolfenden
School of Women and Children’s Health, UNSW Sydney
Level 8 Bright Alliance, High Street, Randwick 2031, NSW Australia
Country 122527 0
Australia
Phone 122527 0
+61 293828183
Fax 122527 0
Email 122527 0
[email protected]
Contact person for scientific queries
Name 122528 0
Susan Woolfenden
Address 122528 0
Associate Professor Sue Woolfenden
School of Women and Children’s Health, UNSW Sydney
Level 8 Bright Alliance, High Street, Randwick 2031, NSW Australia
Country 122528 0
Australia
Phone 122528 0
+61 293828183
Fax 122528 0
Email 122528 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
Not approved


What supporting documents are/will be available?

No Supporting Document Provided



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.