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

Chronic health conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and intellectual impairment (II), have prevalence rates of approximately 5% [1] and 1–3% [2] in the population, respectively. Such a demand has led to longer waitlist times to see a specialist and access appropriate services within the public health sector in Australia. In addition, poorer short-term (e.g. increased risk of mental health, social difficulties) and long-term (e.g. convictions, arrests) outcomes have been reported for vulnerable children with multiple risk factors (i.e. income, education, social support) [3]. Traditional approaches to increasing frequency and service of healthcare delivery are expensive and have been shown to have minimal impact on caregiver burden [4] and changes to caregiver perception of their reduced influence over their current circumstances, including behavioural issues and overall well-being of their children [5, 6]. Research has shown that caregivers who have higher levels of external locus-of-control may be more likely to have issues with taking action to influence their children’s behaviours [5]. There is also emerging literature that suggests that locus-of-control may act as a mediator in the relationship between parenting and the caregivers’ mental health [6]. These findings suggest that a caregivers’ locus-of-control may influence their ability to undertake services and therapies which require regular and active involvement in the management of their child’s chronic health condition and well-being. Given this context, a different approach to health care systems in the management of chronic health condition in children which includes caregiver/family involvement will likely improve both child and caregiver health and social outcomes [7].

Children with chronic health conditions have better health-related outcomes when their care is managed in a coordinated way [8]. Specifically for children with ADHD there are improvements in functional outcomes when families receive more personalized and coordinated care [9] .The Chronic Care Model [10] is the most well-known model used to address healthcare systems in the management of chronic health conditions. Improved quality of life, clinical outcomes and a reduction in health costs have been seen in adults with chronic health conditions (e.g. diabetes, heart disease, chronic obstructive pulmonary disease) when the Chronic Care Model [10] was utilised. Different components (e.g. care coordination) of the Chronic Care Model [10] have been successfully used in the management of children with asthma and ADHD [1, 11, 12]. However, further research utilising the Chronic Care Model [10] to address health care outcomes in vulnerable children with other types of developmental chronic health conditions is required.

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. Similar to features of the Chronic Care Model, [10] community based service-integration approaches have been shown to reduce neonatal and maternal morbidity in developing countries [13] and increase the number of service linkages for low income families in a developing country. [14] Features of community based service integration approaches include health worker visits in the community, training of community staff, health promotion, availability of resources to link into existing community services and the allocation of a case manager to the child and family. However, despite reported success in reducing morbidity and increasing access for vulnerable children in developing or low-income families, cost-effectiveness data on the community service-integration models used has not been included in study designs. Nevertheless, reduced health care system costs (e.g. reduced inpatient days, reduced out of pocket expenses) has been shown when care coordination between community and tertiary care providers is provided to children with medically complex conditions [15]. No such information is available for children with chronic health conditions. Further short and long-term health economics information, which includes financial impacts within the school, family and health care environments are required, particularly for children with chronic health conditions. Such health economics information is a gap in current literature and needs to be addressed to ensure publicly funded community service-integrated models of care are cost-effective and sustainable in the long-term.

Based on available literature and increasing financial pressures to cost-effectively sustain a public health care system for children with chronic health conditions, an integrated health care pathway which incorporates the care coordination features of the Chronic Care Model [10] and includes caregiver involvement as an essential component has the potential to improve health and social benefits in an already at risk population. The development of an Integrated Children’s Clinic Care (ICCC) pathway which incorporates features of the Chronic Care Model [10] and involvement of caregivers was developed to improve health and social benefits for children with chronic health conditions. This protocol paper outlines a randomised control trial evaluating the cost-effectiveness of the ICCC pathway. The ICCC centres around an allied health liaison officer (AHLO) facilitating key components of the Chronic Care Model [10] in primary, community and acute care facilities across two Australian health districts of varying socioeconomic status’.

In our paediatric clinics across hospital sites, it is anticipated that a majority of recruited participants will be under 8 years old. A limitation of this study protocol includes the reliance of parental reported outcome measures for child behavioural and quality of life measures, particularly for children under 8 years old. Nevertheless, obtaining information from multiple sources aside from the child in the assessment of behaviours for school-aged children has previously been recommended in reducing reporting bias [25]. Other studies have also suggested that parents are much better at reporting on their children’s externalising, as opposed to internalising behaviours [26]. There is also a large body of research that suggest that there is a low to moderate relationship between parent and teacher’s reports of the child’s behaviours [27, 28]. In most studies, parents tend to have much higher scores of children’s misbehaviours, as compared with, the teachers [29]. As a result, many studies on school-aged children include measures which require parents to report on their child’s perceived emotional and behavioural states. It must be noted; however, that the current study will also attempt to obtain some self-reported data from children over 8 years old via the Peds QOL [20] and the SUDS [30]. Self-reported data for children older than 8 years old is generally regarded as the minimum age for reliable completion of questionnaires, as most will have mastered the basics of reading, writing and arithmetic skills commensurate with year levels 3 to 4 [31]. Based on available literature, this study proposes to focus on data based on a combination of parental and child self-reporting, dependent on the child’s age, developmental and cognitive levels.

In Australia, a National Disability Insurance Scheme (NDIS) [32] is being introduced progressively across the country from July 2016 onwards. The NDIS aims to provide support to all Australians under 65 years with a permanent disability to assist in planning their individual healthcare pathway [32]. A main component of the NDIS provides individuals with further information on their disability and referral options to existing support services available in the community. However, without strong empirical evidence and supporting frameworks, such an approach may provide significant challenges for families to navigate the health system to achieve appropriate coordinated and timely care for their child’s needs. It is anticipated that factors such as lower education, health literacy, socioeconomic status and knowledge of treatment/service options may impact on the successful uptake of available services via the NDIS [33‐36]. Lack of resilience and networking may also impact on negotiating beauacratic road blocks and mis-information about to access care. Thankfully, the role out of the NDIS will not impact on the recruitment of participants for this study, as implementation dates at both sites for NDIS occur after this study’s planned recruitment timeframe: July 2018 (Gold Coast) and January 2019 (Moreton Bay, Caboolture), respectively. Nevertheless, outcomes from this study will help provide Australian healthcare system providers and policy makers on which types of families can successfully navigate the healthcare system themselves and which families need additional support. In particular, key resources and activities utilised within the ICCC pathway which provide the greatest health outcomes for participants in study may help guide care coordination frameworks for children with developmental chronic health conditions.