Improving Care for Children With Complex Needs

NCT01587105 | Completed Results DMC

• 1 other identifier: CCMS
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• ED Visits Per Child

  Baseline, 12-month, 18-month

• Inpatient Admissions Per Child

  Baseline, 12 month, 18 month

• 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 Outcomes (1)

• Physician Satisfaction

  Baseline, 12 Months, 18 months

Study Arms (2)

Control

NO INTERVENTION

Usual Care Group

Comprehensive Care Management Service

EXPERIMENTAL

Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital

Behavioral: Comprehensive Case Management Service

Interventions

Comprehensive Case Management Service BEHAVIORAL

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.

Comprehensive Care Management Service

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Results Point of Contact

• Title: Rita Mangione-Smith, MD, MPH
• Organization: Seattle Children's Hospital

Rita.Mangione-Smith@seattlechildrens.org

2068848242

Study Officials

• Rita Mangione-Smith, MD, MPH

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 25, 2012
• First Posted: April 27, 2012
• Study Start: October 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 29, 2017
• Last Updated: November 13, 2017
• Results First Posted: February 20, 2017

Record last verified: 2017-10

Locations

US (1)