Introduction
Cerebral palsy (CP) is a lifelong condition and the most common cause of physical disability in childhood, with an estimated prevalence of 1.5 per 1000 live births in high-income countries,1 including Australia.2 It is a diagnostic term describing a heterogenous group of permanent but not unchanging disorders of movement and/or posture, caused by a non-progressive lesion or anomaly to the immature brain.2 Among individuals with CP, the motor disorder/s (spastic, dyskinetic, ataxic, hypotonic) vary and severity of gross motor impairment can range from having a minimal to severe impact on gross motor function.2 People living with CP may also experience other comorbidities including intellectual disability (32.0%), epilepsy (33.5%), hearing (12.8%), vision (36.4%), and speech (62.7%) impairment.2 Many people with CP need long-term, high-quality support from health and social care services to enable management of their chronic health condition/s and promote optimal quality of life.3
There is evidence of health inequities in children with CP.4 5 In Australia, socioeconomic disadvantage at birth is associated with increased severity of CP functional outcomes (more severe gross motor impairment, at least one moderate–severe comorbidity) at age 5 years.4 Health inequities have their origins in the social determinants of health; the non-medical conditions in which people are born, grow, live, work, and age including food, transport, and housing.6 There is increasing recognition of the importance of addressing the social determinants of health to improve health outcomes.7 At a personal level, social determinants of health concerns are experienced as unmet social needs (eg, housing needs).7 8
A recent systematic review explored clinical pathways for the identification and referral of unmet social needs in children attending outpatient community and ambulatory healthcare services.9 Interventions were described as being implemented in one of three ways: (1) identification of unmet social needs with clinician training; (2) identification of unmet social needs with targeted community resources; and (3) identification of unmet social needs with Navigator/Link Worker support.9 The review found positive outcomes, with all pathways leading to an increase in social needs identification and referrals, and reduction in social needs.9 Notably, there was no superior pathway type; though, outcome measures were heterogeneous and not easily comparable.9
In the UK, a formalised scheme for health professionals to identify and refer patients to non-medical community services to target their unmet social needs, using a ‘Link Worker’, is referred to as ‘social prescribing’.10 Individuals living with chronic physical health conditions and multimorbidity have been recognised as a key clinical cohort that may benefit from social prescribing.11 There is also small scale data on a ‘Key Worker’ in the UK, with their involvement associated with better outcomes for families and minor reductions in children unmet needs. Their role, however, is broader than that of a ‘Link Worker’, with less focus on systematic screening.12 To date, social prescribing has not been tested for children with disability, including CP, in the Australian context.
This pilot clinical trial aims to address this critical research gap. It builds on our previous formative research involving people with a lived experience of CP, their families, and health service providers to co-design a social prescribing pathway for children with CP and their families in Australia.13 The objectives of this pilot randomised controlled trial (RCT) are to assess the feasibility and acceptability of two co-designed social needs clinical pathways—social prescribing (ie, Community Linker plus resource pack) compared with resource pack only—for parents/caregivers of children with CP in tertiary paediatric rehabilitation clinic settings.
Methods
Objectives and hypotheses
The primary objectives of this pilot RCT are to evaluate the feasibility and acceptability of implementation and delivery of the co-designed social needs pathways. Secondary objectives include assessment of fidelity and service model variations, to determine the short-term impacts of the intervention at 3- and 6- months post-enrolment and to inform a future, definitive, multicentre, large-scale RCT.
We hypothesise that both the social prescribing intervention (Community Linker plus resource pack) and active control intervention (self-navigation using resource pack) will be feasible and acceptable, according to outcome measures described in sections below.
Co-design of intervention and trial with parents and young people
The intervention was co-designed using a modified Hawkins et al
14 framework. It involved families of children with CP and their healthcare providers. This was to ensure the intervention was responsive to the needs of its end users and was tailored for implementation in the local health setting. A protocol of this co-design approach has been published13 and the findings of the co-design research phase is described in a separate publication, reporting against the Guidance for Reporting Involvement of Patients and the Public guideline.15
Study design
This is a multicentre, unblinded, pilot RCT which will take place from April 2023 to December 2024. The unmet social needs of parents/caregivers of children with CP will be screened during their clinic appointment. Families who self-report experiencing unmet social need/s on the survey tool and consent to the research study are randomised into arms, either (1) social prescribing intervention arm (Community Linker plus resource pack) or (2) active control arm (self-navigation using resource pack). The rationale for this design is that there is evidence to support both pathways (Community Linker; resource pack), and it is unethical to screen for unmet social needs and not provide a response. The trial design is outlined in figure 1.
Study diagram. CP, cerebral palsy; WECARE, Well Child Care, Evaluation, Community Resources, Advocacy, Referral, Education.
Setting
This study is conducted at the rehabilitation departments of the three tertiary paediatric hospitals in New South Wales, Australia: The Children’s Hospital at Westmead; Sydney Children’s Hospital Randwick; and John Hunter Children’s Hospital. The paediatric rehabilitation departments offer a comprehensive CP clinical service staffed by a multidisciplinary team including paediatric rehabilitation medicine physician, nurse, physiotherapist, occupational therapist, and social worker.
Study population
Participants in the RCT must meet the following criteria to be eligible for the study.
Inclusion criteria
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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.
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Parent/caregiver self-report at least one unmet social need from the following six items on the adapted WECARE (Well Child Care, Evaluation, Community Resources, Advocacy, Referral, Education) survey tool: childcare or schooling; government benefits and vouchers; housing; food; bills; transport.
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Reside in New South Wales or Australian Capital Territory.
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Provide informed consent.
Exclusion criteria
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Parent/caregiver have no mechanism for contact (telephone or email).
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Family already enrolled and assigned a research participant ID. In the instance where a parent/caregiver meets inclusion criteria and has multiple children with a diagnosis of CP (eg, siblings with CP or twins with CP), the parent/caregiver will only be able to enrol once for their family.
Service provider participants (qualitative interviews/focus groups)
Service providers working at the rehabilitation departments of the three NSW Children’s Hospitals will be invited to take part in qualitative interviews/focus groups to explore their perspectives of the pilot trial and implementation of social prescribing intervention (Community Linker plus resource pack) and active control intervention (self-navigation using resource pack).
Intervention
The intervention was co-designed with over 200 participants through a rigorous co-design research phase described in detail in separate publications.13 15–17 Research participants codeveloped the programme logic model and prototype of the intervention. Following an intensive qualitative needs assessment, participants codeveloped the intervention including a survey tool for the standardised identification of unmet social needs, community linker role and scope of practice, and resource pack. This process was piloted in research action cycles, with continuous refinement until a consensus was achieved. The finalised logic model is shown in figure 2.
Finalised logic model. CP, cerebral palsy; EPIC-CP, Equitable Pathways and Integrated Care in Cerebral Palsy; KPIs, Key Performance Indicators; NDIS, National Disability Insurance Scheme; WECARE, Well Child Care, Evaluation, Community Resources, Advocacy, Referral, Education.
Active control (self-navigation with resource pack)
Participants randomised to the active control arm will be provided a resource pack containing information on community services to support their unmet social needs. The resource pack was co-designed during the earlier formative research phase and piloted during iterative co-design processes.13 The resource pack will be available in hard copy and online. The online version of the resource pack will be available on a secure website accessible only to individuals provided the QR code to the webpage or direct weblink. The resource pack is an enhancement to usual care, which may involve clinicians recommending these services for unmet needs as part of their care.
Social prescribing intervention arm (Community Linker plus resource pack)
Participants randomised to the social prescribing intervention arm will receive one-on-one Community Linker support, in addition to the resource pack (described above). The Community Linker provides one-on-one support based on the needs of the family, as an extension to usual care, and in addition to the resource pack.
A Community Linker is a trained, non-medical staff member who assists parents/caregivers to connect with appropriate services and supports to address their unmet social needs. Community Linkers provide practical, hands-on support navigating services, for example, finding an appropriate local community service, making referrals to services, helping parents/caregivers complete forms, follow-up with services, booking appointments, assisting in gathering support letters, and submitting paperwork for funding under the National Disability Insurance Scheme. The Community Linker position description including their title, qualifications, and key roles and responsibilities was co-designed with end users during the previous phase of research. Each study site will employ a Community Linker to be supervised by the CP Service Manager and CP Service Social Worker. Community Linkers will follow a co-designed documented standard operating procedure including specific training modules, which includes escalation procedures should concerns be disclosed that are beyond the scope of their role (eg, mental health concerns, domestic violence, clinical concerns).
All participants in the intervention arm will have an intake appointment with the Community Linker at their service. 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 be contacted to have an intake appointment within 1 week of randomisation to the social prescribing arm. During the appointment, participants will discuss their unmet social needs with the Community Linker; 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 and their child/young person with CP (as required). The parent/caregiver will be offered the opportunity to for their child/young person with CP to engage with the Community Linker. Parents/caregivers will also select their preferred mode (eg, videoconference, phone call, email) and frequency of communication (eg, once a week, once a fortnight) with the Community Linker which can be revised at any time as required. The Community Linker will provide support for a period of 3 months. The frequency of engagement will depend on participants preferences and needs. However, the Community Linker will conduct minimum monthly check-ins for all participants.
Sample size
The pilot trial will aim to obtain a minimum of 35 respondents in each trial arm at 3-month and 6-month follow-up. Assuming a 30% loss to follow-up in line with previous research,18 19 a total sample size of 120 families will be recruited—60 in each research arm.20 A total sample size of 120 parents/caregivers makes it possible to assess feasibility as the relevant primary outcome.15 Randomisation will be stratified by rehabilitation department/study site. Thus, at each study site, 20 parents/caregivers will be randomised to each research arm.
Within the prior formative research to co-design the interventions, quality improvement cycles were conducted at one study site piloting the survey tool and pathways.13 During the 12-week testing period, 105 parents/caregivers of children with CP completed the unmet social needs survey tool. Based on this experience, we estimate a recruitment period of 3 months to enrol all participants in the study across three sites. The data from this pilot RCT will form sample size calculations for a potential future RCT of efficacy.
Qualitative data sample size
As this is inductive rather than deductive research, a sample size calculation cannot be done. However, using purposeful sampling, the saturation point will most likely be reached after 10–20 interviews with parents/caregivers. We estimate that 5–10 service providers will take part in an interview/focus group per site, thus 15–30 service provider participants in total.
Screening and recruitment strategy
Parent/caregiver participants
All parents/caregivers of a child with CP attending the participating rehabilitation departments will be asked to complete a paper-based survey tool for standardised identification of unmet social needs during their routine clinic visit (online supplemental file 1). The survey tool includes information about the research study where parents/caregivers can indicate their interest (yes/no) in hearing more and provide contact details if applicable. All survey tools will be distributed and collected by the site Community Linker and project staff. Contact details of interested parents/caregivers will be provided to project staff responsible for enrolment.
Supplemental material
If parents/caregivers screen positive on the tool (self-report one or more unmet social needs) but are not interested in knowing more about the study, they will be advised to discuss their concerns with their clinical team per routine care. If interested parents/caregivers are not eligible for the project, they will be told that they are ineligible for the research project and will be advised to discuss any concerns with their clinical team per routine care. If interested parents/caregivers are eligible for the project, they will be provided a participant information sheet and consent form (PISCF). The PISCF may be provided immediately by the community linker/project staff during the family’s attendance of the clinical appointment in paper form or a REDCap link sent via email, dependent on the family’s preference and availability on the day.
Service provider participants
Service providers will be identified through department meetings and professional networking within the participating study sites. Interested service providers will be given a service provider PISCF either in hard copy version or via recruitment email. They will be given time to think about the project and have the opportunity to ask any questions they may have about their participation in the study to the study coordinator.
Consent
Parent/caregiver and young person participants
Parent/caregiver and young person PISCFs will provide information about the research, the risks/benefits, and its voluntary nature. The parent/caregiver PISCF will be provided to all interested parents/caregivers (online supplemental file 2). Additionally, young people aged 8 years or older who can self-report (determined via parent/caregiver and young person report) will be provided a young person PISCF. If the young person has capacity to provide consent, they will be requested to co-consent along with their parent/caregiver in whatever form of communication suits their preference and needs (eg, in writing, verbal consent, using augmented and alternative communication methods). The approved PISCFs will be translated into other languages based on data pertaining to limited English language proficiency and largest language groups attending the tertiary paediatric rehabilitation departments.
It will be made clear to participants that they can stop participating in the study at any time without consequences to the care or services they receive. If the participant expresses that they are not interested in the study, no further contact will be made in relation to the study. Parents/caregivers will also be free to withdraw their consent if they change their minds at any point during the study. Participants can provide informed consent in several ways: signing the hard copy of the PISCF at a face-to-face visit; signing the online REDCap consent form to be included in the recruitment email21; providing verbal consent via phone call. Participants will be asked to complete a baseline questionnaire immediately after providing consent.
Service provider participants
The service provider PISCF will be distributed as paper-based copy or via recruitment email. The recruitment email will include a link directing potential service provider participants to the online version of the PISCF via the REDcap data link. Service providers will be required to either sign the hard copy consent form and return to study coordinator or sign the online consent form hosted on REDCap.
Randomisation and intervention allocation
Participants will be randomised automatically by the REDCap platform,21 assigning 50% of participants to each group. Randomisation will be conducted by project staff. Randomisation will be stratified by rehabilitation department/study site. Across the entire project, 60 parents/caregivers will be randomised to the social prescribing intervention arm (n=20 at each study site) and 60 parents/caregivers will be randomised to the active control arm (n=20 at each site). The project staff will notify participants of their intervention allocation via one of three methods (face to face, email or phone) dependent on their personal preference and corresponding to chosen method of consent as described above.
Outcome measures
Table 1 offers a summary of the outcome measures.
Summary of study outcome measures
Pilot outcomes: feasibility and acceptability
Feasibility will be evaluated against the stop–go criteria for success of feasibility, as follows:
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Recruitment rates: recruitment will be successful if 80% of our target sample is met in the 3 months of recruitment.
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Uptake of intervention: will be considered successful if >70% of families complete the intervention.
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Follow-up of participants: will be considered successful if >70% of families complete all the study visits.
We will also evaluate feasibility and acceptability via:
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Process measures: non-identifiable data will be recorded on the proportion of families who: complete versus decline the unmet social needs survey tool; positive versus negative unmet social needs screening on survey tool; are interested versus not interested in research participation consent versus do not consent to research study.
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Community Linker logbook: each Community Linker will keep a logbook of their activities including type of social care navigation activities provided, for example, advice regarding services, attending services with families, types of pf services, referrals made to services collected etc.
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Satisfaction and acceptability survey: at 3-months post-enrolment, all participants (social prescribing intervention; active control) will be asked to complete a bespoke questionnaire regarding their satisfaction and acceptability of their allocated intervention.
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Parent/caregiver qualitative interview: at 3-months post-enrolment, participants in the social prescribing group will be invited to complete a qualitative interview to explore their experiences, barriers, and enablers to social prescribing as perceived by parents/caregivers. The interviews will be conducted 1:1 with the project staff and will follow a semi-structured interview guide. Interviews will be conducted face to face, via phone, or teleconference dependent on participants preference.
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Clinician qualitative interview/focus group: clinicians from participating study sites will be invited to take part in interview/focus group exploring the experiences, barriers, and enablers of social prescribing intervention and active control intervention as perceived by clinicians (conducted during trial implementation based on availability and preference of staff at sites).
Secondary outcomes: proposed impacts for future RCT
Secondary outcomes aim to determine short-term impacts of the intervention at 3- and 6-months post-enrolment. This will help inform sample size and outcome measures to be used in future, definitive, multicentre, large-scale RCT. Per table 1, outcomes will be assessed at baseline, 3-month, and 6-month follow-up including:
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Unmet social needs (adapted WECARE survey tool).22
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Parent/caregiver distress (K-6 Distress Scale—Self Administered).23
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Child/young person global health (PROMIS Parent Proxy Scale V.1.0—Global Health 7 (item 1; item 2)24 or PROMIS Pediatric Scale V.1.0—Global Health 7 (item 1; item 2)).24
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Parent/caregiver global health (PROMIS Scale V.1.2—Global Health (item 1; item 2)).25
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Service use captured on bespoke survey.
Furthermore, at baseline, parent/caregivers will be asked to complete a demographic survey. A medical record review of children with CP will be completed for all participants to describe the characteristics of participating children/families and explore any potential association between outcome measures and clinical factors relating to the child with CP and demographic factors related to the parent/caregiver. The feasibility and acceptability and secondary outcome measures will be reviewed and findings will be integrated into an update programme logic model to inform future, definitive multicentre large-scale RCT.
Data collection
All participants will be allocated a unique identifier code that will be used throughout the study. For enrolment and quantitative data collection, the study will prioritise electronic collection procedures. However, participants will be given the option to complete research questionnaires face to face, online via REDCap21, or on the phone with the research staff. All quantitative data, irrespective of initial mode of data collection, will then be entered into a secure password-protected server-based database, REDCap.21 Any hard copies of consent forms and deidentified questionnaires will be stored in a locked cabinet at each study site before being securely transferred to the study team at The University of New South Wales (UNSW). When being stored at the study sites, hard copy materials will be stored in a locked filing cabinet within a locked office, accessible only to the site project staff.
Qualitative interviews with families and qualitative focus groups with health service providers will be conducted face to face, via phone call, or videoconference dependent on participants preference. These will focus on participant’s thoughts on and experiences engaging with the intervention, and clinicians’ views on how well the intervention integrated within the clinics. Interviews and focus groups will be transcribed verbatim, and all data management, storage, and analysis will be done at UNSW. All paper copy and taped data will be deidentified. Coded information will be stored in a locked filing cabinet or on password protected digital media. As soon as interviews have been transcribed, the audio tapes will be erased.
All paper data and questionnaires will be entered into a secure password-protected server-based database, REDCap, hosted at UNSW, and stored for 15 years after the last date of data collection.21 After 15 years, any paper data will be shredded, and the electronic data will be permanently erased and backups destroyed.
Data 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—will be based on descriptive statistics reported as percentage (95% CI). The 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 χ2 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 other sociodemographic characteristics.
Qualitative data collection and analysis
Data collected from the semistructured interviews and semistructured focus groups will be coded according to common themes using a thematic analysis.26 Researcher triangulation will be employed to further substantiate the emerging themes. Data collection and analysis will continue until no new themes or hypotheses emerge, that is, a ‘saturation point’ is reached. 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 V.11 software by the principal investigator. Transcription checks against tapes and notes taken, triangulation, feedback, will be employed to ensure rigour (eg, all interviewees will receive a copy of their interview transcript to check). Comments after reading these will be fed back into the analysis.
Patient and public involvement
The social needs clinical pathways being evaluated in this pilot RCT were co-designed with people with a lived experience of CP, their families, and healthcare professionals in earlier formative research.13 Outcomes to be assessed in this pilot RCT were included as part of the co-design process. This study is overseen by two Research Advisory groups—one group of young adults with CP and one group of parents of a young person with CP. Research Advisors meet with the project officer monthly and provide input into each phase of the study, that is, project conception and planning, data collection and analysis, and dissemination. They have been involved with the project since commencement of earlier formative research to co-design the program and will continue to work together for this pilot RCT.12 Research advisors are paid $A30 per hour.
This project has a governance structure including several subcommittees: Research Operations Committee, Research Advisory Group, Steering Committee, and Knowledge Translation Committee. Each committee meets consistently with the chief investigator and project officer to facilitate information exchange and cooperation between stakeholders.
For completing the study questionnaires at baseline, 3-month, and 6-month follow-up, parent/caregiver research participants will be reimbursed for their time with a $A20 gift voucher for each data collection time point.
Ethics and considerations
Ethics approval for this project was granted by the Sydney Children’s Hospitals Network (SCHN) Human Research Ethics Committee (2022/ETH01688) in October 2022. Site-specific research governance approvals were granted for SCHN and John Hunter Children’s Hospitals. This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN12622001459718).
Where a reportable clinical incident is identified through or during the data collections, an incident report will be lodged in the Incident Investigation and Management System as per the NSW Health Clinical Incident Policy. During the research project, we may identify families where there is domestic violence, financial abuse or imminent risk of homelessness. In this event, families will be referred directly to CP service social worker. Referral to the CP service social worker does not exclude the parent/caregiver from participation in the research project. They will receive support from the site CP service social worker in addition to their allocated intervention. If child protection concerns are raised, the usual mandatory reporting guidelines will apply.
Participants are free to withdraw their consent at any time. Reasons for non-participation will be recorded, and the decision not to participate or to withdraw from the study will not affect the participant’s relationship with study hospitals. In such case, the researchers will not collect additional information from the participant.
Dissemination and policy implications
Research findings will be shared with people living with CP, parents/caregivers of people with CP, family members of people with CP, health professionals, social service professionals, policymakers, and academics via various outputs including a lay summary of research findings, a poster summarising research results displayed at study sites, peer-reviewed publications, conference presentations. These outputs will be developed in collaboration with all project members, including research advisors, to ensure the material is suitable and accessible to the relevant audience.
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