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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
10/07/2019
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] 292613 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Developmental chronic condition 304293 0
Condition category
Condition code
Physical Medicine / Rehabilitation 303640 303640 0 0
Other physical medicine / rehabilitation
Human Genetics and Inherited Disorders 303641 303641 0 0
Other human genetics and inherited disorders
Public Health 303679 303679 0 0
Health service research
Mental Health 303680 303680 0 0
Autistic spectrum disorders
Neurological 303681 303681 0 0
Other neurological disorders
Mental Health 303682 303682 0 0
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] 298856 0
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] 303047 0
Pediatric Quality of Life (PedQOL) Child - Score 0 to 100. (Parent or child completed)
Timepoint [1] 303047 0
1 week, 6 months, 12 months post (endpoint) medical review with Paediatrician
Primary outcome [2] 303048 0
PedQOL Family Impact - Score 0 to 100. (Parent completed)
Timepoint [2] 303048 0
1 week, 6 months and 12 months (endpoint) post medical review with Paediatrician
Primary outcome [3] 303049 0
Subjective Units of Distress Scale (SUDS) - Score 0 to 100. (Parent completed)
Timepoint [3] 303049 0
1 week, 6 months and 12 months post (end point) medical review with Paediatrician
Secondary outcome [1] 337768 0
Primary outcome measure: Child Behaviour Checklist (CBCL) – Percentiles. (Parent completed).
Timepoint [1] 337768 0
3 months, 6 months and 12 months post (end point) medical review with Paediatrician
Secondary outcome [2] 337769 0
Primary outcome measure: Rotter’s Locus of Control Scale - Score 0 to 23 (Parent completed)
Timepoint [2] 337769 0
1 week, 6 months and 12 months post (end point) medical review with Paediatrician
Secondary outcome [3] 337770 0
Number of GP visits, accessed via Medicare data
Timepoint [3] 337770 0
1 week, 3 months and 6 months post medical review with Paediatrician
Secondary outcome [4] 337771 0
Number of hospital admissions, accessed via Medicare data
Timepoint [4] 337771 0
1 week, 3 months and 6 months post medical review with Paediatrician
Secondary outcome [5] 337772 0
Number of specialist appointments, accessed via Medicare data
Timepoint [5] 337772 0
1 week, 3 months and 6 months post medical review with Paediatrician
Secondary outcome [6] 337773 0
Number of absent school days, accessed by Education Queensland Central Office records
Timepoint [6] 337773 0
1 week, 3 months and 6 months post medical review with Paediatrician
Secondary outcome [7] 337774 0
Number of caregiver missed employment days based on parental report
Timepoint [7] 337774 0
1 week, 3 months and 6 months post medical review with Paediatrician
Secondary outcome [8] 337775 0
Number of school suspensions, measured in days; accessed by Education Queensland Central Office records
Timepoint [8] 337775 0
1 week, 3 months and 6 months post medical review with Paediatrician
Secondary outcome [9] 337776 0
Number of services accessed at the time, based on parental report
Timepoint [9] 337776 0
1 week, 3 months and 6 months post medical review with Paediatrician

Eligibility
Key inclusion criteria
Children 0 to 16 years seen by Paediatrician at Caboolture Hospital, Gold Coast University Hospital or Queensland Children's Hospital and newly diagnosed with a developmental chronic condition where community based health or family support services are part of the management plan. Chronic conditions are expected to last more than 6 months and to produce consequences that impact on the child’s quality of life.

Examples of developmental chronic conditions include (but are not limited to): Autism Spectrum Disorder (ASD), Attention Deficit Hyperactivity Disorder (ADHD), Intellectual Impairment (II), Specific Language Impairment (SLI), Oppositional Defiance Disorder (ODD), Fetal Alcohol Spectrum Disorder (FASD), Cerebral Palsy (CP).
Minimum age
0 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Children with acute medical conditions requiring urgent intervention where community follow-up is deemed inappropriate by the treating Paediatrician.
• Children with a chronic medical condition primarily managed by medical consultation alone and those conditions where hospital based multidisciplinary teams provide coordinated care.
• Examples of excluded chronic conditions include: cancer, cystic fibrosis, asthma, epilepsy.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
We plan for a total sample size of 112 children (80 % power to detect a mean effect difference of 15 between groups on the quality of life scale) at 0.05 significance level. This sample size has been adjusted for an anticipated high attrition rate of 50%. A 2-sample test of proportions will be used to compare baseline characteristics of both groups.

All analyses will be conducted using an “intention to treat” (ITT) analysis where all subjects will be compared in the groups which they were originally assigned (regardless of withdrawal or lost to follow-up). For our primary objective, Mann Whitney U test will be used to determine if differences in quality of life measures exist between the ICCC versus self-directed care groups.

For our secondary objective, we will perform univariable analysis to determine which health economic parameters (e.g. missed school days, number of hospital admissions) are related to higher quality of life scores. Stepwise regression will then examine the various combinations via of health economic parameters to generate aROC curves to determine a clinical prediction index for higher quality of life scores. Parameters chosen will be based on using factors that were significant plus those with P < .25 level in the univariable analysis and other variables known to have a strong association with poorer health outcomes (e.g. multiple co-morbidities) within the literature. An aROC of =0.75 will be considered a clinically relevant cut-off score.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8698 0
Caboolture Hospital - Caboolture
Recruitment hospital [2] 8699 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 14175 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 16810 0
4510 - Caboolture
Recruitment postcode(s) [2] 16811 0
4215 - Southport
Recruitment postcode(s) [3] 27151 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 297200 0
Government body
Name [1] 297200 0
Allied Health Professions Of Queensland
Address [1] 297200 0
Allied Health Professions' Office of Queensland
PO Box 2368, Fortitude Valley BC,
QLD 4006.
Country [1] 297200 0
Australia
Funding source category [2] 303247 0
Charities/Societies/Foundations
Name [2] 303247 0
Children's Hospital Foundation
Address [2] 303247 0
62 Graham St, South Brisbane, QLD, 4101.
Country [2] 303247 0
Australia
Funding source category [3] 303248 0
Charities/Societies/Foundations
Name [3] 303248 0
The Prince Charles Hospital Foundation
Address [3] 303248 0
Rode Rd, Chermside, QLD, 4032.
Country [3] 303248 0
Australia
Primary sponsor type
Individual
Name
Dr Thuy Frakking
Address
Research Development Unit
Caboolture Hospital
McKean St,
Caboolture,
QLD, 4510.
Country
Australia
Secondary sponsor category [1] 296208 0
None
Name [1] 296208 0
Address [1] 296208 0
Country [1] 296208 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298356 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 298356 0
Level 7, Centre for Children's Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane
QLD 4101.
Ethics committee country [1] 298356 0
Australia
Date submitted for ethics approval [1] 298356 0
14/07/2017
Approval date [1] 298356 0
08/08/2017
Ethics approval number [1] 298356 0
HREC/17/QRCH/159

Summary
Brief summary
Background: Children with chronic health conditions have better health-related outcomes when their care is managed in a personalised and coordinated way. However, increased demand on Australian ambulatory care hospital services has led to longer waitlist times to access specialists and appropriate intervention services; placing vulnerable children at increased risk of poorer short-term (e.g. social difficulties) and long-term (e.g. convictions) health and social outcomes. Traditional approaches to increasing frequency and service of delivery are expensive and can have minimal impact on caregiver burden. A community based service-integration approach, rather than self-directed care is proposed as a better health systems approach, as increased service linkages are more likely to occur thus and improving the health outcomes of children with a chronic health condition resulting in health economic benefits .

Aim:To determine the effectiveness of an integrated care pathway led by an allied health liaison officer in the management of chronic disease in children.


Methods: An open, unblinded, multi-centre randomised controlled trial in two Australian public hospitals. 112 children (0-16 years) fulfilling the inclusion criteria will be randomised to one of two clinical pathways for management of their chronic health condition: (1) integrated children’s care clinic (ICCC) or (2) self-directed care pathway. All children and caregivers will be interviewed at 1 week, 3, 6 and 12 months time intervals. Primary outcome measures include the Pediatric Quality of Life (PedQOL) questionnaire, subjective units of distress scale, child behaviour checklist (CBCL) and Rotter’s locus of control scale. Secondary outcome measures include the total number of medical appointments, school days missed and quantity of services accessed. Our main objectives are to determine if the ICCC results in better health and economics outcomes compared to the self-directed care pathway.

Hypotheses:
a) Children who access the ICCC will have improved quality of life (child and family impact) scores than children who access the self-directed care pathway.
b) The ICCC pathway is more cost-effective than a self-directed care pathway.

Discussion: The success of a health systems approach needs to be balanced against clinical, mortality and cost-effectiveness data for long-term sustainability within a publicly funded health system. A clinical pathway that is sustainable, cost-effective, provides efficient evidence-based care and improves the quality of life outcomes for children with chronic health conditions has the potential to reduce waitlist times to access health services, increase consumer satisfaction; and prevent costs associated with poorly managed chronic health conditions
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1953 1953 0 0
/AnzctrAttachments/373442-HREC approval letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 76826 0
Dr Thuy Frakking
Address 76826 0
Research Development Unit
Executive Building 3
Caboolture Hospital
McKean St,
Caboolture, QLD, 4510.
Country 76826 0
Australia
Phone 76826 0
+61753165972
Fax 76826 0
Email 76826 0
thuy.frakking@health.qld.gov.au
Contact person for public queries
Name 76827 0
Dr Thuy Frakking
Address 76827 0
Research Development Unit
Executive Building 3
Caboolture Hospital
McKean St
Caboolture, QLD, 4510.
Country 76827 0
Australia
Phone 76827 0
+61753165972
Fax 76827 0
Email 76827 0
thuy.frakking@health.qld.gov.au
Contact person for scientific queries
Name 76828 0
Dr Thuy Frakking
Address 76828 0
Research Development Unit
Executive Building 3
McKean St
Caboolture Hospital
Caboolture, QLD, 4510.
Country 76828 0
Australia
Phone 76828 0
+61753165972
Fax 76828 0
Email 76828 0
thuy.frakking@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sharing of IPD was not included in original ethics application.
What supporting documents are/will be available?
Study protocol
How or where can supporting documents be obtained?
Type [1] 2848 0
Study protocol
Citation [1] 2848 0
Frakking TT, Waugh J, Teoh H-J, Ward D, Carter H, David M, Mickan S, Shelton D, Moloney S, Barber M, Weir, KA (2018). Integrated children's clinic care (ICCC) versus a self-directed care pathway for children with a chronic health condition: a multi-centre randomised controlled trial study protocol. BMC Pediatrics; 18(1): 72. doi: 10.1186/s12887-018-1034-x
Link [1] 2848 0
Email [1] 2848 0
Other [1] 2848 0
Summary results
No Results