Complex Care for Kids Ontario (CCKO)

September 6, 2022 updated by: Eyal Cohen, The Hospital for Sick Children

Complex Care for Kids Ontario (CCKO): A Patient- and Family-centred Implementation and Evaluation of Care Coordination for Children With Medical Complexity

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Hamilton Health Sciences
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 second to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
Time Frame: 6 months
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
Time Frame: 12 months
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
Time Frame: 24 months
These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.
24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
6 months
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.
12 months
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.
24 months
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).
Baseline
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).
6 months
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).
12 months
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).
24 months
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.
Baseline
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.
Baseline
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.
6 months
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.
6 months
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.
12 months
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.
24 months
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.
12 months
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.
24 months
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).
Baseline
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).
6 months
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).
12 months
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).
24 months
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.
Baseline
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.
6 months
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.
12 months
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.
24 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
6 months
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.
12 months
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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hamilton Health Sciences Corporation
London Health Sciences Centre
Children's Hospital of Eastern Ontario

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eyal Cohen, MD, MSc, The Hospital for Sick Children

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 5, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 10, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000053509

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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