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Improving Care for Children With Complex Needs (I3CN)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01587105
First Posted: April 27, 2012
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rita Mangione-Smith, Seattle Children's Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Care for Children With Complex Needs (I3CN) Study

Further study details as provided by Rita Mangione-Smith, Seattle Children's Hospital:

Primary Outcome Measures:
  • Cost of Care [ Time Frame: Baseline, 12 month, 18 month ]
    The investigators will examine whether the children in the CCM group experience decreased annual costs of care.

  • Health Care Quality Ranking [ Time Frame: Baseline, 12-months, 18-months ]
    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.

  • ED Visits Per Child [ Time Frame: Baseline, 12-month, 18-month ]
  • Inpatient Admissions Per Child [ Time Frame: Baseline, 12 month, 18 month ]
  • Hospital Days Per Child [ Time Frame: Baseline, 12-Month, 18-Month ]
    Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data


Secondary Outcome Measures:
  • Physician Satisfaction [ Time Frame: Baseline, 12 Months, 18 months ]
    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.


Enrollment: 331
Study Start Date: October 2010
Estimated Study Completion Date: August 31, 2017
Primary Completion Date: September 2014 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
  More Information

Responsible Party: Rita Mangione-Smith, Principal Investigator, Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01587105     History of Changes
Other Study ID Numbers: CCMS
First Submitted: April 25, 2012
First Posted: April 27, 2012
Results First Submitted: April 22, 2016
Results First Posted: February 20, 2017
Last Update Posted: June 8, 2017
Last Verified: May 2017