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.


Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
13 Jul 2024
Historique:
medline: 14 7 2024
pubmed: 14 7 2024
entrez: 13 7 2024
Statut: epublish

Résumé

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. 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. 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. Australia New Zealand Clinical Trials Registry: 12622001459718.

Identifiants

pubmed: 39002958
pii: bmjopen-2023-076304
doi: 10.1136/bmjopen-2023-076304
doi:

Types de publication

Journal Article Clinical Trial Protocol

Langues

eng

Sous-ensembles de citation

IM

Pagination

e076304

Investigateurs

Sheikh Azmatullah (S)
Alison Berg (A)
Heather Burnett (H)
Mariyam Cadiri (M)
Jack Calderan (J)
Georgina Chambers (G)
Russell Dale (R)
Betty-Jean Dee-Price (BJ)
Delfina Diaz Rojas (DD)
Valsamma Eapen (V)
Georgina Henry (G)
Isra Karem (I)
Raghu Lingam (R)
Tanya Martin (T)
Anne Masi (A)
Sarah McIntyre (S)
Laurel Mimmo (L)
Masyitah Mohamed (M)
Anne Olaso (A)
Katarina Ostojic (K)
Simon Paget (S)
Mick Scarcella (M)
Timothy Scott (T)
Shaini Shiva (S)
Hayley Smithers-Sheedy (H)
Vesna Stojanovic (V)
Iva Strnadová (I)
Debbie van Hoek (DV)
Matthew van Hoek (MV)
Joyce Vasquez (J)
Alunya Wilkinson (A)
Mackenzie Woodbury (M)
Sue Woolfenden (S)
Janet Zacharko (J)
Karen Zwi (K)
Seaneen Wallace (S)

Informations de copyright

© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Auteurs

Katarina Ostojic (K)

Community Paediatrics Research Group, Central Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia katarina.ostojic@sydney.edu.au.
Population Child Health Clinical Research Group, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia.

Isra Karem (I)

Community Paediatrics Research Group, Central Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia.
Population Child Health Clinical Research Group, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia.

Simon Paget (S)

The Children's Hospital at Westmead Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia.
The Children's Hospital at Westmead, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.

Alison Berg (A)

The Children's Hospital at Westmead, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.

Heather Burnett (H)

HNEkidsRehab, John Hunter Children's Hospital, Hunter New England Local Health District, Newcastle, New South Wales, Australia.

Timothy Scott (T)

Sydney Children's Hospital Randwick, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.

Tanya Martin (T)

Sydney Medical School, University of Sydney Poche Centre for Indigenous Health, Camperdown, New South Wales, Australia.

Betty-Jean Dee-Price (BJ)

Southgate Institute for Health, Society and Equity, Flinders University, Adelaide, South Australia, Australia.

Sarah McIntyre (S)

Cerebral Palsy Alliance Research Institute, The University of Sydney, Sydney Medical School, Sydney, New South Wales, Australia.

Hayley Smithers-Sheedy (H)

Population Child Health Clinical Research Group, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia.
Cerebral Palsy Alliance Research Institute, The University of Sydney, Sydney Medical School, Sydney, New South Wales, Australia.

Laurel Mimmo (L)

The Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.

Anne Masi (A)

Discipline of Psychiatry and Mental Health, University of New South Wales School of Clinical Medicine, Sydney, New South Wales, Australia.

Michele Scarcella (M)

The Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.

Sheikh Azmatullah (S)

EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.

Jack Calderan (J)

EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.

Masyitah Mohamed (M)

EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.

Anne Olaso (A)

EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.

Matthew van Hoek (M)

EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.

Debbie van Hoek (D)

EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.

Mackenzie Woodbury (M)

EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.

Alunya Wilkinson (A)

EPIC-CP Research Group, The University of Sydney, Sydney, New South Wales, Australia.

Georgina Chambers (G)

National Perinatal Epidemiology and Statistics Unit, University of New South Wales Centre for Big Data Research in Health, Sydney, New South Wales, Australia.

Karen Zwi (K)

Population Child Health Clinical Research Group, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia.
Community Child Health, The Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.

Russell Dale (R)

The Children's Hospital at Westmead Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia.
The Children's Hospital at Westmead, Sydney Children's Hospitals Network, Sydney, New South Wales, Australia.

Valsamma Eapen (V)

Discipline of Psychiatry and Mental Health, University of New South Wales School of Clinical Medicine, Sydney, New South Wales, Australia.

Raghu Lingam (R)

Population Child Health Clinical Research Group, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia.

Iva Strnadová (I)

School of Education, Faculty of Arts, Design and Architecture, University of New South Wales, Sydney, New South Wales, Australia.

Susan Woolfenden (S)

Community Paediatrics Research Group, Central Clinical School, The University of Sydney, Faculty of Medicine and Health, Sydney, New South Wales, Australia.
Population Child Health Clinical Research Group, University of New South Wales Medicine & Health, Sydney, New South Wales, Australia.
Sydney Institute for Women, Children and their Families, Sydney Local Health District, Camperdown, New South Wales, Australia.

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