Complex Care for Kids Ontario (CCKO): A Patient- and Family-centred Implementation and Evaluation of Care Coordination for Children With Medical Complexity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Complex care clinic as part of the CCKO initiative (Other)
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.
结局指标
主要结局
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
时间窗: 24 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
时间窗: 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
时间窗: 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
时间窗: 12 months
These outcomes will be assessed with the Family Experiences with Coordination of Care (FECC) survey.
次要结局
- Parents' Quality of Life(24 months)
- Parents' Perceived Emotional and Physical Health(24 months)
- Child physical pain(24 months)
- Effects of Child's Condition on Parents' Finances and Ability to Work(24 months)
- Child quality of life & overall emotional health(24 months)
- 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 physical pain(Baseline)
- Child physical pain(6 months)
- Child physical pain(12 months)
- Parents' Quality of Life(Baseline)
- Parents' Quality of Life(6 months)
- Parents' Quality of Life(12 months)
- Parents' Perceived Emotional and Physical Health(Baseline)
- Parents' Perceived Emotional and Physical Health(6 months)
- Parents' Perceived Emotional and Physical Health(12 months)
- Effects of Child's Condition on Parents' Finances and Ability to Work(Baseline)
- Effects of Child's Condition on Parents' Finances and Ability to Work(6 months)
- Effects of Child's Condition on Parents' Finances and Ability to Work(12 months)
研究者
Eyal Cohen
Staff Physician
The Hospital for Sick Children