Complex Care for Kids Ontario (CCKO)

NCT02928757 | Completed DMC

• 1 other identifier: 1000053509
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 4

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.

Conditions

Children With Medical Complexity

Keywords

Care coordination; Complex care kids Ontario; Technology-dependent; Quality of life

Outcome Measures

Primary Outcomes (4)

• 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

  These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.

  Baseline

• 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

  These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.

  6 months

• 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

  These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.

  12 months

• 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

  These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.

  24 months

Secondary Outcomes (24)

• Child quality of life & overall emotional health

  Baseline

• Child quality of life & overall emotional health

  6 months

• Child quality of life & overall emotional health

  12 months

• Child quality of life & overall emotional health

  24 months

• Child physical pain

  Baseline

Other Outcomes (4)

• Health systems outcomes

  Baseline

• Health systems outcomes

  6 months

• Health systems outcomes

  12 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Other: Complex care clinic as part of the CCKO initiative

Wait-list Group

NO INTERVENTION

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.

Interventions

Complex care clinic as part of the CCKO initiative OTHER

The CCKO intervention involves intensive care coordination, defined as: "deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient's care to facilitate the appropriate delivery of health care services. Organizing care involves marshaling of personnel and other resources needed to carry out all required patient care activities and is often managed by the exchange of information among participants responsible for different aspects of care". Within CCKO, intensive care coordination will specifically include: 1) the tailored, family/health care provider co-creation and regular updating of care coordination plans for each child which will be 2) facilitated and accounted for by key workers partnering with families.

Intervention Group

Eligibility Criteria

• Age: 0 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Children's Hospital of Eastern Ontario: collaborator
• London Health Sciences Centre: collaborator
• Hamilton Health Sciences Corporation: collaborator

Study Sites (4)

Hamilton Health Sciences

Hamilton, Ontario, L8N 3Z5, Canada

Location

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

Location

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (3)

• Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

  PMID: 39382077 DERIVED

• Cohen E, Quartarone S, Orkin J, Moretti ME, Emdin A, Guttmann A, Willan AR, Major N, Lim A, Diaz S, Osqui L, Soscia J, Fu L, Gandhi S, Heath A, Fayed N. Effectiveness of Structured Care Coordination for Children With Medical Complexity: The Complex Care for Kids Ontario (CCKO) Randomized Clinical Trial. JAMA Pediatr. 2023 May 1;177(5):461-471. doi: 10.1001/jamapediatrics.2023.0115.

  PMID: 36939728 DERIVED

• 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.

  PMID: 31375613 DERIVED

Study Officials

• Eyal Cohen, MD, MSc

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: October 5, 2016
• First Posted: October 10, 2016
• Study Start: December 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

CA (4)