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Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care
Julia Orkin1,2, Carol Y Chan3, Nora Fayed4
1Division of Pediatric Medicine, The Hospital for Sick Children, Toronto, Ontario, Canada.
Insights
This study evaluated the Complex Care for Kids Ontario (CCKO) intervention for children with medical complexity (CMC). The intervention, featuring key workers and shared care plans, aims to improve care coordination and quality of life for these children and their families.
Area of Science:
- Pediatric Healthcare
- Health Services Research
- Complex Care Management
Background:
- Children with medical complexity (CMC) have substantial needs and high healthcare utilization.
- Families of CMC face significant financial burdens and stress due to fragmented care.
- Coordinated care is essential to optimize health outcomes for CMC.
Purpose of the Study:
- To evaluate the Complex Care for Kids Ontario (CCKO) intervention for children with medical complexity (CMC).
- To assess the impact of dedicated key workers and coordinated shared care plans on service delivery and quality of life.
- To determine the effectiveness of a population-level complex care intervention using a randomized controlled trial (RCT).
Main Methods:
- A randomized waitlist control trial design was employed.
- Participants were randomized into two groups (A and B) for staggered intervention rollout.
- The primary outcome was the Family Experiences with Coordination of Care (FECC) survey at 12 months, with secondary outcomes including child/parent health and healthcare utilization.
Main Results:
- The study is designed to assess the impact of the CCKO intervention.
- Analysis will compare the FECC survey scores between groups using ANCOVA.
- Secondary outcomes will provide further insights into the intervention's effects on health and service utilization.
Conclusions:
- The CCKO intervention, with key workers and shared care plans, has the potential to improve care for CMC.
- This RCT will provide evidence on the effectiveness of a population-level approach to complex care.
- Findings will inform strategies for optimizing care delivery and quality of life for CMC and their families.
Introduction:
Technological and medical advances have led to a growing population of children with medical complexity (CMC) defined by substantial medical needs, healthcare utilisation and morbidity. These children are at a high risk of missed, fragmented and/or inappropriate care, and families bear extraordinary financial burden and stress. While small in number (<1% of children), this group uses ~1/3 of all child healthcare resources, and need coordinated care to optimise their health. Complex care for kids Ontario (CCKO) brings researchers, families and healthcare providers together to develop, implement and evaluate a population-level roll-out of care for CMC in Ontario, Canada through a randomised controlled trial (RCT) design. The intervention includes dedicated key workers and the utilisation of coordinated shared care plans.
Methods And Analysis:
Our primary objective is to evaluate the CCKO intervention using a randomised waitlist control design. The waitlist approach involves rolling out an intervention over time, whereby all participants are randomised into two groups (A and B) to receive the intervention at different time points determined at random. Baseline measurements are collected at month 0, and groups A and B are compared at months 6 and 12. The primary outcome is the family-prioritized Family Experiences with Coordination of Care (FECC) survey at 12 months. The FECC will be compared between groups using an analysis of covariance with the corresponding baseline score as the covariate. Secondary outcomes include reports of child and parent health outcomes, health system utilisation and process outcomes.
Ethics And Dissemination:
Research ethics approval has been obtained for this multicentre RCT. This trial will assess the effect of a large population-level complex care intervention to determine whether dedicated key workers and coordinated care plans have an impact on improving service delivery and quality of life for CMC and their families.
Trial Registration Number:
NCT02928757.
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