Improving Care for Children With Complex Needs (I3CN)
Medically Complex Children
Patient Care Team or Organization
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
Health Related Quality of Life
Satisfaction With Care
Family Experience of Care
Quality Health Care
Behavioral: Comprehensive Case Management Service
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Improving Care for Children With Complex Needs (I3CN) Study|
- Healthcare Utilization/Cost of Care [ Time Frame: Assessed every six months for 2.5 years ] [ Designated as safety issue: No ]The investigators will examine whether the children in the CCM group experience decreased annual costs of care, emergency department visits, hospital admissions, and hospital lengths of stay.
- Parent Satisfaction [ Time Frame: Assessed every six months for 2.5 years ] [ Designated as safety issue: No ]Parent perception of quality of care, shared decision making and patient satisfaction.
- Physician Satisfaction [ Time Frame: Assessed every six months for 2.5 years ] [ Designated as safety issue: No ]PCP report of their level of satisfaction in caring for patients with complex chronic conditions and their parents.
|Study Start Date:||October 2010|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
No Intervention: Control
Usual Care Group
Experimental: Comprehensive Care Management Service
Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital
Behavioral: Comprehensive Case Management Service
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587105
|United States, Washington|
|Seattle Children's Hospital|
|Seattle, Washington, United States, 98105|
|Principal Investigator:||Rita Mangione-Smith, MD, MPH||Seattle Children's Hospital|