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Complex Care for Kids Ontario (CCKO)

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ClinicalTrials.gov Identifier: NCT02928757
Recruitment Status : Completed
First Posted : October 10, 2016
Last Update Posted : September 8, 2022
Sponsor:
Collaborators:
Children's Hospital of Eastern Ontario
London Health Sciences Centre
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Eyal Cohen, The Hospital for Sick Children

Study Description
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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.

Condition or disease Intervention/treatment Phase
Children With Medical Complexity Other: Complex care clinic as part of the CCKO initiative Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2016
Actual Primary Completion Date : January 2021
Actual Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Family Issues

Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention Group
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
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.
No Intervention: Wait-list Group
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline ]
    These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.

  2. 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 [ Time Frame: 6 months ]
    These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.

  3. 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 [ Time Frame: 12 months ]
    These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.

  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 [ Time Frame: 24 months ]
    These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.


Secondary Outcome Measures :
  1. Child quality of life & overall emotional health [ Time Frame: Baseline ]
    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.

  2. Child quality of life & overall emotional health [ Time Frame: 6 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.

  3. Child quality of life & overall emotional health [ Time Frame: 12 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.

  4. Child quality of life & overall emotional health [ Time Frame: 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.

  5. Child physical pain [ Time Frame: Baseline ]
    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).

  6. Child physical pain [ Time Frame: 6 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).

  7. Child physical pain [ Time Frame: 12 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).

  8. Child physical pain [ Time Frame: 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).

  9. Parents' Quality of Life [ Time Frame: Baseline ]
    Parents' quality of life will be measured according to a subjective life appraisal definition with Diener's highly validated Satisfaction with Life Scale (SWLS) (5 items) which is the most validated life satisfaction scale in health and social sciences literature.

  10. Parents' Quality of Life [ Time Frame: Baseline ]
    Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.

  11. Parents' Quality of Life [ Time Frame: 6 months ]
    Parents' quality of life will be measured according to a subjective life appraisal definition with Diener's highly validated Satisfaction with Life Scale (SWLS) (5 items) which is the most validated life satisfaction scale in health and social sciences literature.

  12. Parents' Quality of Life [ Time Frame: 6 months ]
    Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.

  13. Parents' Quality of Life [ Time Frame: 12 months ]
    Parents' quality of life will be measured according to a subjective life appraisal definition with Diener's highly validated Satisfaction with Life Scale (SWLS) (5 items) which is the most validated life satisfaction scale in health and social sciences literature.

  14. Parents' Quality of Life [ Time Frame: 24 months ]
    Parents' quality of life will be measured according to a subjective life appraisal definition with Diener's highly validated Satisfaction with Life Scale (SWLS) (5 items) which is the most validated life satisfaction scale in health and social sciences literature.

  15. Parents' Quality of Life [ Time Frame: 12 months ]
    Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.

  16. Parents' Quality of Life [ Time Frame: 24 months ]
    Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.

  17. Parents' Perceived Emotional and Physical Health [ Time Frame: Baseline ]
    Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).

  18. Parents' Perceived Emotional and Physical Health [ Time Frame: 6 months ]
    Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).

  19. Parents' Perceived Emotional and Physical Health [ Time Frame: 12 months ]
    Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).

  20. Parents' Perceived Emotional and Physical Health [ Time Frame: 24 months ]
    Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).

  21. Effects of Child's Condition on Parents' Finances and Ability to Work [ Time Frame: Baseline ]
    Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.

  22. Effects of Child's Condition on Parents' Finances and Ability to Work [ Time Frame: 6 months ]
    Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.

  23. Effects of Child's Condition on Parents' Finances and Ability to Work [ Time Frame: 12 months ]
    Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.

  24. Effects of Child's Condition on Parents' Finances and Ability to Work [ Time Frame: 24 months ]
    Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.


Other Outcome Measures:
  1. Health systems outcomes [ Time Frame: Baseline ]
    The investigators will link the patient-reported evaluation of the CCKO initiative with encoded health administrative data housed at ICES for consenting participants.

  2. Health systems outcomes [ Time Frame: 6 months ]
    The investigators will link the patient-reported evaluation of the CCKO initiative with encoded health administrative data housed at ICES for consenting participants.

  3. Health systems outcomes [ Time Frame: 12 months ]
    The investigators will link the patient-reported evaluation of the CCKO initiative with encoded health administrative data housed at ICES for consenting participants.

  4. Health systems outcomes [ Time Frame: 24 months ]
    The investigators will link the patient-reported evaluation of the CCKO initiative with encoded health administrative data housed at ICES for consenting participants.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928757


Locations
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Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
London Health Sciences Centre
London, Ontario, Canada, N6A 5A5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Children's Hospital of Eastern Ontario
London Health Sciences Centre
Hamilton Health Sciences Corporation
Investigators
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Principal Investigator: Eyal Cohen, MD, MSc The Hospital for Sick Children
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Eyal Cohen, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02928757    
Other Study ID Numbers: 1000053509
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Eyal Cohen, The Hospital for Sick Children:
Care coordination
Complex care kids Ontario
Technology-dependent
Quality of life