Improving Care for Children With Complex Needs

Health Related Quality of Life Clinical Trial

— I3CN  

Official title:

Improving Care for Children With Complex Needs (I3CN) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01587105
• Other study ID #: CCMS
• Status: Completed
• Phase: N/A
• First received: April 25, 2012
• Last updated: October 10, 2017
• Start date: October 2010
• Est. completion date: September 29, 2017

Study information

• Verified date: October 2017
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: September 29, 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence to Care
• Care Coordination
• Care Coordinator
• Care Manager
• Case Manager
• Children With Chronic Conditions
• Children With Special Health Care Needs
• Collaborative Care
• Disease Management
• Family Experience of Care
• Functional Status and Productivity
• Health Care and Resource Utilization
• Health Related Quality of Life
• Managed Care
• Medically Complex Children
• Patient Care Plan
• Patient Care Team or Organization
• Quality Health Care
• Satisfaction With Care
• Shared Care Plan

Intervention

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.

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost of Care	The investigators will examine whether the children in the CCM group experience decreased annual costs of care.	Baseline, 12 month, 18 month
Primary	Health Care Quality Ranking	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.	Baseline, 12-months, 18-months
Primary	ED Visits Per Child		Baseline, 12-month, 18-month
Primary	Inpatient Admissions Per Child		Baseline, 12 month, 18 month
Primary	Hospital Days Per Child	Number of days each participant stayed in the hospital; assessed from hospital administrative discharge data	Baseline, 12-Month, 18-Month
Secondary	Physician Satisfaction	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.	Baseline, 12 Months, 18 months