Improving Care for Children With Complex Needs (I3CN)
Improving Care for Children With Complex Needs (I3CN) Study
研究概览
地位
条件
- 护理协调
- Medically Complex Children
- 个案经理
- Care Manager
- 协同护理
- 疾病管理
- Patient Care Team or Organization
- Managed Care
- Children With Chronic Conditions
- Children With Special Health Care Needs
- Shared Care Plan
- Patient Care Plan
- Health Care and Resource Utilization
- Adherence to Care
- Functional Status and Productivity
- 与健康相关的生活质量
- Satisfaction With Care
- Care Coordinator
- Family Experience of Care
- Quality Health Care
详细说明
Children with complex health care needs often lack a comprehensive care plan and access to case management. They are at risk for frequent and prolonged hospitalizations, fragmented care, parental stress/burnout and unsafe care. To address this issue, Seattle Children's Hospital developed the Comprehensive Case Management (CCM) program, which includes access to a special clinic at Seattle Children's with case managers and a health care team that works with parents and community physicians to create care plans for children with complex needs.
The investigators goal is to evaluate whether children who participate in the CCM program have better parent reported access to needed care, timeliness of receiving needed services, more coordinated care, improved health status, and higher parent satisfaction with care compared to children who receive care outside the CCM program. In addition, the investigators will examine whether these children experience decreased annual costs of care, emergency department visits, hospital admissions, and hospital lengths of stay compared to children receiving care outside the program. The investigators also want to understand whether community physicians who have patients enrolled in the CCM program are more satisfied with caring for children with complex medical needs than physicians caring for these children outside the program.
The investigators plan to enroll 650 parents of eligible children into the I3CN study. Three hundred twenty five of these parents will have children enrolled in the CCM program and 325 will have children who continue to receive usual care. Enrolled parents complete a survey every 6 months during the study (5 surveys over 2 ½ years) in order to assess study outcomes including parent perceived. Parent participation in the study will be completed 2 ½ years after enrollment.
When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. The CCM team includes physicians, nurse practitioners, social workers, nutritionists, and nurse case managers. This plan will include all of the child's routine health care needs in addition to information about what to do when the child gets sick. Community providers will also be asked to review and provide input on the shared care plan. Once the shared care plan is in place, the parent, primary care provider (PCP), and the CCM clinic will follow the standardized processes established by the program and the shared care plan when the child becomes ill.
During the course of the 2 ½ year study, the investigators will analyze our outcomes of interest every 6 months. If the investigators find that children in the CCM the program are experiencing significantly better outcomes than children receiving care outside the program, they will stop the study and open the program to all eligible children.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Washington
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Seattle、Washington、美国、98105
- Seattle Children's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- between the ages of 3 months and 18 years,
- have at least three chronic medical conditions requiring active management
- were hospitalized or had an emergency department (ED) visit at SCH within the last year
- their PCP is enrolled in the study
Exclusion Criteria:
- had 2+ visits to Pulmonary, Craniofacial, or Rheumatology within the last year
- had 3+ visits to Nephrology, Gastroenterology and has either Short Gut Syndrome or Crohn's Disease, Endocrinology or Neuromuscular Clinic within the last year
- has had 2+ visits to the Neurodevelopmental clinic and is followed by a NDV doctor
- cancer patient
- transplant recipient
- has cystic fibrosis, muscular dystrophy or sickle cell anemia
- has Down Syndrome and does not have any other medical issues aside from developmental delays
- renal patient on dialysis
- had a hospitalization for > 27 days
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
无干预:控制
日常护理组
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实验性的:Comprehensive Care Management Service
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
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When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child.
This plan will include all of the child's routine health care needs and information about what to do when the child gets sick.
The parent will also have 24 hour access to an on-call CCM nurse.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Cost of Care
大体时间:Baseline, 12 month, 18 month
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The investigators will examine whether the children in the CCM group experience decreased annual costs of care.
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Baseline, 12 month, 18 month
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Health Care Quality Ranking
大体时间:Baseline, 12-months, 18-months
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For Healthcare Quality Rating, the construct is Parent Satisfaction.
Parents were asked to rate the quality of the health care their child received.
Overall range is 0-100.
Higher values equal a better outcome or more satisfaction.
Sub scales are not combined.
The scale is considered continuous.
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Baseline, 12-months, 18-months
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ED Visits Per Child
大体时间:Baseline, 12-month, 18-month
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Baseline, 12-month, 18-month
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Inpatient Admissions Per Child
大体时间:Baseline, 12 month, 18 month
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Baseline, 12 month, 18 month
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Hospital Days Per Child
大体时间:Baseline, 12-Month, 18-Month
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Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data
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Baseline, 12-Month, 18-Month
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Physician Satisfaction
大体时间:Baseline, 12 Months, 18 months
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Primary care provider (PCP)'s satisfaction with the care coordination program was measured on a scale of 0-100, where the higher number indicates more satisfaction.
This variable was collected at baseline and 12-months but was dropped from the 18 month follow-up as previous analysis suggested it was not relevant to the stated objective.
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Baseline, 12 Months, 18 months
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合作者和调查者
调查人员
- 首席研究员:Rita Mangione-Smith, MD, MPH、Seattle Children's Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- CCMS
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护理协调的临床试验
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