Improving Care for Children With Complex Needs (I3CN)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rita Mangione-Smith, Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01587105
First received: April 25, 2012
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

Seattle Children's Hospital (SCH), in collaboration with several health plans and Washington State Department of Social and Health Services developed the Comprehensive Case Management (CCM) program with the goal to reduce costs of care for medically complex children cared for at SCH as well as improve their health status and the quality of care they receive. The CCM program aims to develop and facilitate a reliable and standardized process that empowers the child's primary care provider and provides him/her with the resources s/he needs to avoid unnecessary emergency department visits and admissions. Our study will include children who had a hospitalization or emergency department visit at Seattle Children's between 2009-2012 and, at that time, had multiple active chronic medical issues but had no specialty service at Seattle Children's to help their primary care providers manage them.


Condition Intervention
Medically Complex Children
Care Coordination
Case Manager
Care Manager
Collaborative Care
Disease Management
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
Health Related Quality of Life
Satisfaction With Care
Care Coordinator
Family Experience of Care
Quality Health Care
Behavioral: Comprehensive Case Management Service

Study Type: Interventional
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

Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 277
Study Start Date: October 2010
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587105

Locations
United States, Washington
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Rita Mangione-Smith, MD, MPH Seattle Children's Hospital