Complex Care for Kids Ontario (CCKO)

Not Applicable

Completed

• Conditions: Children With Medical Complexity
• Interventions: Other: Complex care clinic as part of the CCKO initiative

• Registration Number: NCT02928757
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-07
• Study First Posted: 2016-10-10
• Study Start: 2016-12
• Primary Completion: 2021-01
• Study Completion: 2021-05
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-06
• Last Update Posted: 2022-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	Complex care clinic as part of the CCKO initiative	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.

Primary Outcome Measures

Name	Time	Method
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	24 months	These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.

Secondary Outcome Measures

Name	Time	Method
Parents' Quality of Life	24 months	Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.
Parents' Perceived Emotional and Physical Health	24 months	Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).
Child physical pain	24 months	Children's physical pain will be measured using only self or proxy reports of pain according to a 10 cm linear Visual Analog Scale (VAS).
Effects of Child's Condition on Parents' Finances and Ability to Work	24 months	Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.
Child quality of life & overall emotional health	24 months	These outcomes will be assessed using the using the "Feelings" subscale from the KIDSCREEN-52 (6 items), used in over 250 studies in the child health services literature since its publication in 2005.

Trial Locations

Locations (4)

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada