Complex Care for Kids Ontario (CCKO)

The Hospital for Sick Children

Status: Completed

Conditions: Children With Medical Complexity

Treatments: Other: Complex care clinic as part of the CCKO initiative

Study type: Interventional

Funder types: Other

Identifiers

NCT02928757

1000053509

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Intervention Group

Experimental group

Description:

In addition to standard medical care, participants will be enrolled to be seen as soon as possible in a complex care clinic as part of the CCKO initiative.

Treatment:

Other: Complex care clinic as part of the CCKO initiative

Wait-list Group

No Intervention group

Description:

The control group will receive usual care, but will be wait-listed for 1 year to be seen in a complex care clinic as part of the CCKO initiative.