ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617001188325

Ethics application status

Approved

Date submitted

8/08/2017

Date registered

14/08/2017

Date last updated

7/10/2021

Date data sharing statement initially provided

10/07/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Healthcare Pathways for Children with Chronic Conditions

Scientific title

A randomised controlled study to evaluate an the effect of an integrated care pathway on quality of life for children with chronic disease – connecting the dots in healthcare provision

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Developmental chronic condition

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Human Genetics and Inherited Disorders

Other human genetics and inherited disorders

Public Health

Health service research

Mental Health

Autistic spectrum disorders

Neurological

Other neurological disorders

Mental Health

Learning disabilities

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Children in the intervention group (e.g. integrated care pathway) will have access to an allied health liaison officer (AHLO). The AHLO qualification will be from an allied health background (e.g. speech pathologist, social worker, dietician, physiotherapist, psychologist, music therapist, occupational therapist). The AHLO will facilitate care coordination across hospital, primary, community and educational settings at 1 week, 3 months, 6 months and
12 months post diagnosis via a combination of face-to-face sessions and telephone consults, as clinically required by the family. The duration of face-to-face and telephone consults will range between 10 minutes (if caregiver reports no concerns) to a maximum of 60 minutes (if caregiver has concerns/needs requiring attention). For children <8 years, face-to-face and telephone sessions will occur with the caregiver only. For children >8 years, face-to-face and telephone sessions will occur with both the caregiver and child present.

Frequency: caregivers will be asked to fill in questionnaires either in face to face or via phone (depending on caregiver preferences) at 1 week, 3 months, 6 months and 12 months after their appointment with the Paediatrician. Please note that care coordination tasks will be completed and/or new care coordination tasks identified at the above timepoints. Duration: It is anticipated that the questionnaires will take about 1 hour or so to complete. Appointments with General Practitioners, schools, service providers may also be arranged for children in the integrated care pathway group to help manage their chronic condition. The frequency of contact with other professionals will be dependent on the individual needs of the child and caregiver.

Location: The AHLO will complete contact with the child and caregiver at various locations throughout the care pathway, pending the support requirements of each individual participant. This can include phone calls or face to face appointments at GP clinics and/or in school settings with other professionals.

The AHLO will go through the following checklist to ensure appropriate care coordination. Please note, liaison with other professionals and agencies will occur, as appropriate throughout the duration of the study. Each process used and outcome will be documented to guide process evaluation for the AHLO role. Examples of care coordination tasks include:
• Completion of forms – literacy assistance
• Identification and acceptance to community agencies. Where there is a delay in acceptance, the AHLO will contact the relevant agency to determine what additional information is required and help facilitate the process (e.g. agency may be awaiting documentation from caregiver or letter from hospital provider)
o Disability Services Queensland (DSQ), Child Development Services (CDS), Autism Queensland, Cerebral Palsy League of Queensland (CPLQ), Special Education Unit (SEU)
• Check progress of financial assistance with Centrelink or similar agency
o Carer’s Allowance
• Organising school supports by providing hospital reports; connecting professionals from community agencies to the child's school case worker to develop an individualised education plan.
• Navigation on use of eligible initiatives (Better Start, Chronic Disease Management Plan, Mental Health Care Plan, ATSI Plan)
•Organising multidisciplinary team meetings for the child and caregiver at school or with the treating GP. This can involve other professionals currently providing educational and/or healthcare support for the child.

Intervention code [1]

Treatment: Other

Comparator / control treatment

Control group (no treatment/access to AHLO): self-directed care pathway involves the caregiver being the primary advocate and liaison for their child post medical review with the Paediatrician. This means that they will coordinate and organise all of their child's appointments with other professionals in the school, primary care and community sectors. No additional support will be provided to the child and caregiver to coordinate their care pathway after their medical review with the Paediatrician.

The caregivers will be asked to fill in questionnaires either in person or via phone at 1 week, 3 months, 6 months and 12 months after their appointment with the Paediatrician. The questionnaires will take about 1 hour or so to complete.

Control group

Active

Outcomes

Primary outcome [1]

Pediatric Quality of Life (PedQOL) Child - Score 0 to 100. (Parent or child completed)

Timepoint [1]

1 week, 6 months, 12 months post (endpoint) medical review with Paediatrician

Primary outcome [2]

PedQOL Family Impact - Score 0 to 100. (Parent completed)

Timepoint [2]

1 week, 6 months and 12 months (endpoint) post medical review with Paediatrician

Primary outcome [3]

Subjective Units of Distress Scale (SUDS) - Score 0 to 100. (Parent completed)

Timepoint [3]

1 week, 6 months and 12 months post (end point) medical review with Paediatrician

Secondary outcome [1]

Primary outcome measure: Child Behaviour Checklist (CBCL) – Percentiles. (Parent completed).

Timepoint [1]

3 months, 6 months and 12 months post (end point) medical review with Paediatrician

Secondary outcome [2]

Primary outcome measure: Rotter’s Locus of Control Scale - Score 0 to 23 (Parent completed)

Timepoint [2]

1 week, 6 months and 12 months post (end point) medical review with Paediatrician

Secondary outcome [3]

Number of GP visits, accessed via Medicare data

Timepoint [3]