Children With Medical ComplexityNCT02928757
Complex Care for Kids Ontario (CCKO)
A study testing Complex care clinic as part of the CCKO initiative in people with Children With Medical Complexity, run by The Hospital for Sick Children at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 16 years
- Conditions the study is for
- Children With Medical Complexity
- What is being tested?
- Complex care clinic as part of the CCKO initiative
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesCanada
- Study dates
- Dec 2016to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Canada4 sites
Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
London Health Sciences Centre
London, Ontario, N6A 5A5
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
Official title: 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.
- Conditions
- Children With Medical Complexity
- Being tested
- Complex care clinic as part of the CCKO initiative
- Keywords
- Care coordination, Complex care kids Ontario, Technology-dependent, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex care clinic as part of the CCKO initiativeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Secondary outcomes (24)
Child quality of life & overall emotional health
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.
Measured: Baseline
Child quality of life & overall emotional health
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.
Measured: 6 months
Child quality of life & overall emotional health
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.
Measured: 12 months
Child quality of life & overall emotional health
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.
Measured: 24 months
Child physical pain
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).
Measured: Baseline
Child physical pain
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).
Measured: 6 months
Child physical pain
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).
Measured: 12 months
Child physical pain
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).
Measured: 24 months
Parents' Quality of Life
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.
Measured: Baseline
Parents' Quality of Life
Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.
Measured: Baseline
Parents' Quality of Life
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.
Measured: 6 months
Parents' Quality of Life
Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.
Measured: 6 months
Parents' Quality of Life
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.
Measured: 12 months
Parents' Quality of Life
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.
Measured: 24 months
Parents' Quality of Life
Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.
Measured: 12 months
Parents' Quality of Life
Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.
Measured: 24 months
Parents' Perceived Emotional and Physical Health
Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).
Measured: Baseline
Parents' Perceived Emotional and Physical Health
Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).
Measured: 6 months
Parents' Perceived Emotional and Physical Health
Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).
Measured: 12 months
Parents' Perceived Emotional and Physical Health
Parents' perceived health, energy, and fatigue will be assessed with short forms of the Patient Reported Outcomes Measurement Information System (PROMIS).
Measured: 24 months
Effects of Child's Condition on Parents' Finances and Ability to Work
Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.
Measured: Baseline
Effects of Child's Condition on Parents' Finances and Ability to Work
Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.
Measured: 6 months
Effects of Child's Condition on Parents' Finances and Ability to Work
Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.
Measured: 12 months
Effects of Child's Condition on Parents' Finances and Ability to Work
Financial Impact on Parents' will be measured using an Expense Diary survey created by the co-investigators.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startDec 2016
- Primary completionJan 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Children With Medical ComplexityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario, London Health Sciences Centre, Hamilton Health Sciences Corporation
- Responsible party
- Principal investigator, Eyal Cohen, The Hospital for Sick Children
- Investigators
- Eyal Cohen, MD, MSc, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928757
- Sponsor's protocol ID
- 1000053509
- Status last verified
- Sep 2022
- First submitted
- 5 Oct 2016
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 39382077Cohen 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.
PubMed 36939728Orkin 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.
PubMed 31375613
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Care for Kids Ontario (CCKO): A Patient- and Family-centred Implementation and Evaluation of Care Coordination for Children With Medical Complexity
- ClinicalTrials.gov ID
- NCT02928757
- Acronym / sponsor ID
- 1000053509
- Conditions
- Children With Medical Complexity
- Keywords
- Care coordination, Complex care kids Ontario, Technology-dependent, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Children's Hospital of Eastern Ontario, London Health Sciences Centre, Hamilton Health Sciences Corporation
- Study start
- Dec 2016
- Primary completion
- Jan 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Complex care clinic as part of the CCKO initiativeIn 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. |
| 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. |
Who may qualify
- Ages
- 0 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex care clinic as part of the CCKO initiativeThe 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. | Other | Intervention Group |
Primary outcome
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.
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.
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.
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 secondary outcomes
Child quality of life & overall emotional health
Time frame: Baseline
Child quality of life & overall emotional health
Time frame: 6 months
Child quality of life & overall emotional health
Time frame: 12 months
Child quality of life & overall emotional health
Time frame: 24 months
Child physical pain
Time frame: Baseline
Child physical pain
Time frame: 6 months
Child physical pain
Time frame: 12 months
Child physical pain
Time frame: 24 months
Parents' Quality of Life
Time frame: Baseline
Parents' Quality of Life
Time frame: Baseline
Parents' Quality of Life
Time frame: 6 months
Parents' Quality of Life
Time frame: 6 months
Parents' Quality of Life
Time frame: 12 months
Parents' Quality of Life
Time frame: 24 months
Parents' Quality of Life
Time frame: 12 months
Parents' Quality of Life
Time frame: 24 months
Parents' Perceived Emotional and Physical Health
Time frame: Baseline
Parents' Perceived Emotional and Physical Health
Time frame: 6 months
Parents' Perceived Emotional and Physical Health
Time frame: 12 months
Parents' Perceived Emotional and Physical Health
Time frame: 24 months
Effects of Child's Condition on Parents' Finances and Ability to Work
Time frame: Baseline
Effects of Child's Condition on Parents' Finances and Ability to Work
Time frame: 6 months
Effects of Child's Condition on Parents' Finances and Ability to Work
Time frame: 12 months
Effects of Child's Condition on Parents' Finances and Ability to Work
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Derived from this study: PubMed 39382077Lalji 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.
- Derived from this study: PubMed 36939728Cohen 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.
- Derived from this study: PubMed 31375613Orkin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eyal Cohen, MD, MSc principal investigator
The Hospital for Sick Children
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex care clinic as part of the CCKO initiative in people with Children With Medical Complexity, run by The Hospital for Sick Children at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928757, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.