Complex Care for Kids Ontario (CCKO)

Children With Medical Complexity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928757
• Other study ID #: 1000053509
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: May 2021

Study information

• Verified date: September 2022
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: May 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Children With Medical Complexity

Intervention

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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Children's Hospital of Eastern Ontario, Hamilton Health Sciences Corporation, London Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health systems outcomes	The investigators will link the patient-reported evaluation of the CCKO initiative with encoded health administrative data housed at ICES for consenting participants.	Baseline
Other	Health systems outcomes	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
Other	Health systems outcomes	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
Other	Health systems outcomes	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	24 months
Secondary	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.	Baseline
Secondary	Parents' Quality of Life	Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.	Baseline
Secondary	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.	6 months
Secondary	Parents' Quality of Life	Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.	6 months
Secondary	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.	12 months
Secondary	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.	24 months
Secondary	Parents' Quality of Life	Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.	12 months
Secondary	Parents' Quality of Life	Parents' quality of life will also be measured with an adapted version of the KIDSCREEN survey subscale for Feelings.	24 months
Secondary	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).	Baseline
Secondary	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).	6 months
Secondary	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).	12 months
Secondary	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).	24 months
Secondary	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.	Baseline
Secondary	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.	6 months
Secondary	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.	12 months
Secondary	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.	24 months