Clinical trial NCT02928757: Complex Care for Kids Ontario (CCKO)
Official title: Complex Care for Kids Ontario (CCKO): A Patient- and Family-centred Implementation and Evaluation of Care Coordination for Children With Medical Complexity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Medical Complexity
Keywords: Care coordination
Complex care kids Ontario
Technology-dependent
Quality of life
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Eastern Ontario
name: London Health Sciences Centre
name: Hamilton Health Sciences Corporation
First posted: 2016-10-10
Enrollment: 160
Sex: ALL
Minimum age (years): 0
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There are \~6,200 children in Ontario with special and complex healthcare needs requiring multiple services from many different doctors and other healthcare providers. These children are at a high risk of missed, duplicated or inappropriate care, and extraordinary financial burden and stress on families. While small in number (\<1% of Ontario kids), these children use 1/3 of all child healthcare resources, and are known to desperately need coordinated care to optimize their health. Complex Care Kids Ontario (CCKO) brings together researchers, children and families, and healthcare providers from across Ontario to develop, implement and evaluate an evidence-based and coordinated model of care for every child with medical complexity in Ontario.


Eligibility criteria: Inclusion Criteria (Meets at least ONE criterion from EACH of the following four conditions):

* Technology dependent and/or users of high intensity care
* Child is dependent on mechanical ventilators, and/or requires prolonged IV administration of nutritional substances or drugs and/or is to have prolonged dependence on other device-based support. For example: tracheostomy tube care/ artificial airway, suctioning, oxygen support, or tube feeding
* Child has prolonged dependence on medical devices to compensate for vital bodily functions, and requires daily/ near daily nursing care, e.g., cardiorespiratory monitors; renal dialysis due to kidney failure
* Fragility
* The child has severe and/or life-threatening condition
* Lack of availability and/or failure of equipment/technology or treatment places the child at immediate risk resulting in a negative health outcome
* Short-term changes in the child's health status (e.g., an intercurrent illness) put them at immediate serious health risk
* Chronicity
* The child's condition is expected to last at least six more months
* The child's life expectancy is less than six months
* Complexity
* Involvement of at least five healthcare practitioners/ teams and healthcare services are delivered in at least three of the following locations: Home, School/Nursing school, Hospital, Children's Treatment Centre, Community-based clinic (e.g. doctor's office), Other (at clinician's discretion)

Exclusion Criteria:

* High Utilization of hospital level care
* ≥ 3 hospitalizations, ≥ 2 ICU admissions, ≥ 30 days of total hospitalization in previous 3 months, excluding newborn admission
* Patient with tracheostomy and home ventilation
* Medical Status is deemed highly fragile and the need for close follow-up is deemed essential by both referring and triaging team
* Already followed by a complex care team
* \>16.0 years of age
* Inadequate English language skills to comprehend study questionnaires

Primary outcomes:
measure: Service delivery outcomes: coordination of care among health providers and families, coordination of care between health providers and families, utility of follow-up planning tools
timeFrame: Baseline
measure: Service delivery outcomes: coordination of care among health providers and families, coordination of care between health providers and families, utility of follow-up planning tools
timeFrame: 6 months
measure: Service delivery outcomes: coordination of care among health providers and families, coordination of care between health providers and families, utility of follow-up planning tools
timeFrame: 12 months
measure: Service delivery outcomes: coordination of care among health providers and families, coordination of care between health providers and families, utility of follow-up planning tools
timeFrame: 24 months
Secondary outcomes:
measure: Child quality of life & overall emotional health
timeFrame: Baseline
measure: Child quality of life & overall emotional health
timeFrame: 6 months
measure: Child quality of life & overall emotional health
timeFrame: 12 months
measure: Child quality of life & overall emotional health
timeFrame: 24 months
measure: Child physical pain
timeFrame: Baseline
measure: Child physical pain
timeFrame: 6 months
measure: Child physical pain
timeFrame: 12 months
measure: Child physical pain
timeFrame: 24 months
measure: Parents' Quality of Life
timeFrame: Baseline
measure: Parents' Quality of Life
timeFrame: Baseline
measure: Parents' Quality of Life
timeFrame: 6 months
measure: Parents' Quality of Life
timeFrame: 6 months
measure: Parents' Quality of Life
timeFrame: 12 months
measure: Parents' Quality of Life
timeFrame: 24 months
measure: Parents' Quality of Life
timeFrame: 12 months
measure: Parents' Quality of Life
timeFrame: 24 months
measure: Parents' Perceived Emotional and Physical Health
timeFrame: Baseline
measure: Parents' Perceived Emotional and Physical Health
timeFrame: 6 months
measure: Parents' Perceived Emotional and Physical Health
timeFrame: 12 months
measure: Parents' Perceived Emotional and Physical Health
timeFrame: 24 months
measure: Effects of Child's Condition on Parents' Finances and Ability to Work
timeFrame: Baseline
measure: Effects of Child's Condition on Parents' Finances and Ability to Work
timeFrame: 6 months
measure: Effects of Child's Condition on Parents' Finances and Ability to Work
timeFrame: 12 months
measure: Effects of Child's Condition on Parents' Finances and Ability to Work
timeFrame: 24 months
Other outcomes:
measure: Health systems outcomes
timeFrame: Baseline
measure: Health systems outcomes
timeFrame: 6 months
measure: Health systems outcomes
timeFrame: 12 months
measure: Health systems outcomes
timeFrame: 24 months
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Eyal Cohen, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orkin J, Chan CY, Fayed N, Lin JLL, Major N, Lim A, Peebles ER, Moretti ME, Soscia J, Sultan R, Willan AR, Offringa M, Guttmann A, Bartlett L, Kanani R, Culbert E, Hardy-Brown K, Gordon M, Perlmutar M, Cohen E. Complex care for kids Ontario: protocol for a mixed-methods randomised controlled trial of a population-level care coordination initiative for children with medical complexity. BMJ Open. 2019 Aug 1;9(8):e028121. doi: 10.1136/bmjopen-2018-028121.