Comprehensive Care of Children With Medical Complexity

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Seton Family of Hospitals
Sponsor:
Collaborator:
University of Texas at Austin
Information provided by (Responsible Party):
Seton Family of Hospitals
ClinicalTrials.gov Identifier:
NCT01834456
First received: December 21, 2012
Last updated: January 3, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Quality of Life
Chronic Disease
Chronic Illness
Other: Med Complex Children Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Comprehensive Care of Children With Medical Complexity: Piloting an Innovative Model

Resource links provided by NLM:


Further study details as provided by Seton Family of Hospitals:

Primary Outcome Measures:
  • Change in Healthcare Utilization and Cost of Care [ Time Frame: Assessed every 2 months for three years ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Quality and Satisfaction, using the CAHPS Clinician & Group Survey, Version: 12-Month Survey with Patient-Centered Medical Home (PCMH) Items [ Time Frame: at entry into study, after 1 year, and then annually thereafter, for a total of three years ] [ Designated as safety issue: No ]
    Standard instruments will be used to assess Quality and Satisfaction with the patient's current medical home, primary care practice

  • Change in Family Impact, using the PedsQL Family Impact Module [ Time Frame: at entry into study, after 1 year, and then annually thereafter, for a total of three years ] [ Designated as safety issue: No ]
    Standard instruments will be used to assess the impact of illness to study families

  • Change in family experience, using Qualitative Interviews [ Time Frame: 6 months and 1 year post-enrollment to the study ] [ Designated as safety issue: No ]
    40 Structured qualitative interviews will be conducted with the parents of children who are enrolled in the study. 20 interviews will be with Spanish-speaking-only parents. 20 interviews will be conducted with English-speaking parents. Parents will be randomized and drawn from both the control and treatment groups.


Estimated Enrollment: 450
Study Start Date: November 2011
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Med Complex Children 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.

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
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
No Intervention: Med Complex Children Control

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


Detailed Description:

Advances in medical technology and more effective treatment for life-limiting illness have allowed children with complex chronic conditions to survive not only the neonatal period but also their adolescent years, with an ever-increasing number living well into adulthood.

Often their families are not well prepared or supported. Currently, outpatient pediatric health care services are designed primarily for episodic diagnosis and treatment of acute diseases, and are not designed to provide holistic, comprehensive, family-center care that is directed at improving the quality of life of these children and their families. There is usually no mechanism for effective coordination between subspecialists. As a result, care is fragmented, redundant, inefficient, and very costly. Despite their small number, this population accounts for a disproportionate amount of the costs associated with pediatric medicine. Furthermore, current services are rarely comprehensive and some services such as pain-management, sleep-management, life-span palliative care, and psychosocial and behavioral interventions (including transition to adult medicine) are often inconsistently accessible or non-existent.

The investigators plan to enroll 450 patients into this study, randomizing about half to the new care at Children's Comprehensive Care (CCC) and half to a control group which continues in the care that they are currently receiving. If they are randomized to the intervention group, the child will receive primary care, including preventative care, acute care, well checks, and immunizations from CCC. If this child is hospitalized at Dell Children's Medical Center (not including day surgery procedures), a practitioner from CCC will visit the child shortly after admission and collaborate with the hospital team to coordinate care at discharge. In addition, CCC will coordinate and monitor all other aspects of the child's medical, dental, behavioral, and developmental care, including the development of individualized care plans that are reviewed annually or with change of medical status, and implemented and maintained by CCC. Other changes to care delivery include access to embedded palliative, developmental, and behavioral care; use of a consultant-model for specialist care; use of telemedicine, greater use of care coordination and case management; and, holistic care of child and family-including psycho-social screening and referral. CCC will use Social Workers, Registered Nurse (RN) Case-managers, and a Child Life Specialist to offer more holistic care coordination, family support, and case-management.

If they are randomized to the control group they will continue in whatever type care they are currently being treated and will be given no clinical intervention by Children's Comprehensive Care.

The investigators' goal is to evaluate whether children who are patients at Children's Comprehensive Care receive better care or not, as defined by cost and utilization, parent-report for quality and satisfaction, and impact-on-family.

Cost and Utilization matrices include-hospitalizations, Emergency Department (ED) visits, and specialist visits within the Seton system of care (locally, Dell Children's Hospital, a member of the Seton Healthcare Family is the only Children's hospital in the Austin area.) Investigators will also evaluate quality and satisfaction using the Consumer Assessment of Healthcare and System (CAHPS) 12-Month Survey with Patient-Centered Medical Home (PCMH), and impact-on-family using the PedsQL Family Impact Module (version 2.0). This study will seek to analyze three years worth of data.

  Eligibility

Ages Eligible for Study:   up to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • primary diagnosis is related to an oncologic diagnosis
  • primary diagnosis is Cystic Fibrosis
  • has Down Syndrome and does not have significant comorbid diagnoses
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834456

Contacts
Contact: Kendra D Koch 512-538-2264 kdkoch@seton.org
Contact: Mark Shen, M.D. (512) 628-1898 MShen@seton.org

Locations
United States, Texas
Children's Comprehensive Care at 'Specially for Children, Far West Recruiting
Austin, Texas, United States, 78731
Contact: Kendra Koch, MA    512-628-1942    kkoch@sfcaustin.com   
Contact: Rahel Berhane, M.D.    (512) 628-1898      
Principal Investigator: Mark Shen, MD         
Sub-Investigator: Rahel Berhane, MD         
Sub-Investigator: Christine Jesser, PhD         
Sub-Investigator: Barbara Jones, PhD         
Sub-Investigator: Kendra D Koch, MA         
Sponsors and Collaborators
Seton Family of Hospitals
University of Texas at Austin
Investigators
Principal Investigator: Mark Shen, M.D. Seton Healthcare Family, Children's Comprehensive Care
  More Information

No publications provided

Responsible Party: Seton Family of Hospitals
ClinicalTrials.gov Identifier: NCT01834456     History of Changes
Other Study ID Numbers: CR-11-125
Study First Received: December 21, 2012
Last Updated: January 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Seton Family of Hospitals:
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

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014