EPIC-CP pilot trial study protocol: a multicentre, randomised controlled trial investigating the feasibility and acceptability of social prescribing for Australian children with cerebral palsy

Katarina Ostojic; Isra Karem; Simon Paget; Alison Berg; Heather Burnett; Timothy Scott; Tanya Martin; Betty-Jean Dee-Price; Sarah McIntyre; Hayley Smithers-Sheedy; Laurel Mimmo; Anne Masi; Michele Scarcella; Sheikh Azmatullah; Jack Calderan; Masyitah Mohamed; Anne Olaso; Matthew van Hoek; Debbie van Hoek; Mackenzie Woodbury; Alunya Wilkinson; Georgina Chambers; Karen Zwi; Russell Dale; Valsamma Eapen; Raghu Lingam; Iva Strnadová; Susan Woolfenden; EPIC-CP Group

doi:10.1136/bmjopen-2023-076304

EPIC-CP pilot trial study protocol: a multicentre, randomised controlled trial investigating the feasibility and acceptability of social prescribing for Australian children with cerebral palsy

BMJ Open. 2024 Jul 13;14(7):e076304. doi: 10.1136/bmjopen-2023-076304.

Authors

Katarina Ostojic^{1

2}, Isra Karem^{3

2}, Simon Paget^{4

5}, Alison Berg⁵, Heather Burnett⁶, Timothy Scott⁷, Tanya Martin⁸, Betty-Jean Dee-Price⁹, Sarah McIntyre¹⁰, Hayley Smithers-Sheedy^{2

10}, Laurel Mimmo¹¹, Anne Masi¹², Michele Scarcella¹¹, Sheikh Azmatullah¹³, Jack Calderan¹³, Masyitah Mohamed¹³, Anne Olaso¹³, Matthew van Hoek¹³, Debbie van Hoek¹³, Mackenzie Woodbury¹³, Alunya Wilkinson¹³, Georgina Chambers¹⁴, Karen Zwi^{2

15}, Russell Dale^{4

5}, Valsamma Eapen¹², Raghu Lingam², Iva Strnadová¹⁶, Susan Woolfenden^{3

2

17}; EPIC-CP Group

Collaborators

Affiliations

¹ Community Paediatrics Research Group, Central Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia [email protected].
² Population Child Health Clinical Research Group, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia.
³ Community Paediatrics Research Group, Central Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia.
⁴ The Children's Hospital at Westmead Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia.
⁵ The Children's Hospital at Westmead, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
⁶ HNEkidsRehab, John Hunter Children's Hospital, Hunter New England Local Health District, Newcastle, New South Wales, Australia.
⁷ Sydney Children's Hospital Randwick, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
⁸ Sydney Medical School, University of Sydney Poche Centre for Indigenous Health, Camperdown, New South Wales, Australia.
⁹ Southgate Institute for Health, Society and Equity, Flinders University, Adelaide, South Australia, Australia.
¹⁰ Cerebral Palsy Alliance Research Institute, The University of Sydney, Sydney Medical School, Sydney, New South Wales, Australia.
¹¹ The Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
¹² Discipline of Psychiatry and Mental Health, University of New South Wales School of Clinical Medicine, Sydney, New South Wales, Australia.
¹³ EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.
¹⁴ National Perinatal Epidemiology and Statistics Unit, University of New South Wales Centre for Big Data Research in Health, Sydney, New South Wales, Australia.
¹⁵ Community Child Health, The Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.
¹⁶ School of Education, Faculty of Arts, Design and Architecture, University of New South Wales, Sydney, New South Wales, Australia.
¹⁷ Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia.

Abstract

Introduction: The social determinants of health contribute to poorer health outcomes for children with cerebral palsy (CP) and are barriers to families accessing health services. At an individual level, social determinants of health are experienced as unmet social needs, for example, unsafe housing conditions. There is emerging evidence that clinical pathways for the systematic identification and referral to services for unmet social needs can support families to address these needs. These clinical pathways have not been implemented for children with CP. The objectives are to investigate the feasibility and acceptability of two co-designed social needs clinical pathways for parents/caregivers of children with CP-social prescribing (ie, Community Linker plus resource pack) compared with resource pack only.

Methods and analysis: This pilot randomised controlled trial will run at the three tertiary paediatric rehabilitation services in New South Wales, Australia. A total of 120 participants will be recruited, with randomisation stratified by study site. A survey tool will be used to identify families experiencing unmet social needs. Parents/caregivers who report one or more unmet social need/s and consent will be eligible. The active control group will receive a resource pack containing information on community services to support unmet social needs. The social prescribing intervention group will receive one-on-one Community Linker support, in addition to the resource pack. The survey tool, intervention, logic model, and resource pack were co-designed with patient families and their healthcare workers. Feasibility of the research design and the clinical pathways will be evaluated using the number/proportion of parents/caregivers who complete the survey tool, consent, engage with the intervention, and complete research measures. Acceptability will be evaluated using questionnaires and qualitative interviews.

Ethics and dissemination: Human research ethics approval was granted by the Sydney Children's Hospitals Network Human Research Ethics Committee (2022/ETH01688). Participants and stakeholders will receive updates and findings via regular communication channels including meetings, presentations, and publications.

Trial registration number: Australia New Zealand Clinical Trials Registry: 12622001459718.

Keywords: Health Equity; Health Services Accessibility; PAEDIATRICS.

Publication types

Clinical Trial Protocol

MeSH terms

Australia
Caregivers / psychology
Cerebral Palsy* / rehabilitation
Cerebral Palsy* / therapy
Child
Feasibility Studies*
Humans
Multicenter Studies as Topic
New South Wales
Parents / psychology
Patient Acceptance of Health Care
Pilot Projects
Randomized Controlled Trials as Topic
Social Determinants of Health