Comprehensive Care of Children With Medical Complexity

NCT01834456 | Completed DMC

• 1 other identifier: CR-11-125
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Under the auspice of 'Specially for Children and with funding from the Seton Healthcare Family, Children's Comprehensive Care (CCC) in Austin, Texas, has developed a coordinated and integrated model of care for children with medical complexity. This model serves as the patient's Medical Home (primary care provider, (PCP)), and uses extensivists (physicians who work as hospitalists and within the PCP) and nurse practitioners to provide continuous care between hospital and primary care. This model seeks to provide a system of care that more fully meets the complex needs of the child and family, while implementing innovations in care delivery, fully implementing family-centered practice, and "embedding" behavioral, psychiatric, psychosocial, and palliative care. This study is a randomized intervention trial that evaluates the effectiveness of the newly-created Children's Comprehensive Care on two outcomes: utilization and cost of care; and, evaluation of the experience of parents and their families.

Conditions

Quality of Life; Chronic Disease; Chronic Illness

Keywords

Medically Complex Children; Family Experience in Healthcare; Patient Centered Care; Family Centered Care; Case Management; Care Management; Care Coordination; Care Plan; Extensivist; Medical Home; Children with Special Health Care Needs; Coordinated Care; Quality in Healthcare; Satisfaction in Healthcare; Cost; Utilization; Impact on Family; Quality of Life; Palliative Care; Complex Chronic Conditions; Life-limiting illness; Integrative Care; Primary Care; Comprehensive Care; Behavioral Care

Outcome Measures

Primary Outcomes (1)

• Change in Healthcare Utilization and Cost of Care

  The investigators will compare cost and utilization between children enrolled int the intervention group and the usual care group, including ED visits, hospitalizations, and specialist visits.

  Assessed every 2 months for three years

Secondary Outcomes (3)

• Change in Quality and Satisfaction, using the CAHPS Clinician & Group Survey, Version: 12-Month Survey with Patient-Centered Medical Home (PCMH) Items

  at entry into study, after 1 year, and then annually thereafter, for a total of three years

• Change in Family Impact, using the PedsQL Family Impact Module

  at entry into study, after 1 year, and then annually thereafter, for a total of three years

• Change in family experience, using Qualitative Interviews

  6 months and 1 year post-enrollment to the study

Study Arms (2)

Med Complex Children Intervention

EXPERIMENTAL

Children with Medical Complexity, previously defined in research as, "children with complex chronic conditions," "children with life-limiting conditions," "fragile children," "complex chronic illness," or a subset of "children with special healthcare needs." Meeting criteria for complexity is a combination of high utilization, multiple chronic diagnoses, use of medical technology (g-tube, tracheostomy, shunt, etc.), functional impairment, and contextual needs. Medically Complex Children in the Intervention group will be treated at an innovative primary care facility designed for their care. This includes actively addressing QOL, care coordination, and behavioral needs of the child, and addressing contextual and support needs for the child's family.

Other: Med Complex Children Intervention

Med Complex Children Control

NO INTERVENTION

Children with Medical Complexity, previously defined in research as, "children with complex chronic conditions," "children with life-limiting conditions," "fragile children," "complex chronic illness," or a subset of "children with special healthcare needs." Meeting criteria for complexity is a combination of high utilization, multiple chronic diagnoses, use of medical technology (g-tube, tracheostomy, shunt, etc.), functional impairment, and contextual needs. The control group will continue to receive usual care as they did before they enrolled in this study

Interventions

Med Complex Children Intervention OTHER

Comprehensive Care, including creating a care plan, offering and integrating developmental and behavioral care, with added care coordination in a Medical Home/Primary Care Practice

Med Complex Children Intervention

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• between the ages of birth to 17 years
• has profound autism and one other significant medical condition
• are determined by the study team to be complex when considering multiple diagnoses, functional impairment, use of medical technology, or contextual needs, or by a combination of these things

You may not qualify if:

• primary diagnosis is related to an oncologic diagnosis
• primary diagnosis is Cystic Fibrosis
• has Down Syndrome and does not have significant comorbid diagnoses

Sponsors & Collaborators

• Seton Healthcare Family: lead
• University of Texas at Austin: collaborator

Study Sites (1)

Children's Comprehensive Care at 'Specially for Children

Austin, Texas, 78723, United States

Location

Related Publications (1)

• Lalji R, Koh L, Francis A, Khalid R, Guha C, Johnson DW, Wong G. Patient navigator programmes for children and adolescents with chronic diseases. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD014688. doi: 10.1002/14651858.CD014688.pub2.

  PMID: 39382077 DERIVED

MeSH Terms

Conditions

Chronic Disease; Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Mark Shen, M.D.

  Seton Healthcare Family, Children's Comprehensive Care

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: April 17, 2013
• Study Start: November 1, 2011
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

US (1)