Quality of Life Clinical Trial
Official title:
Comprehensive Care of Children With Medical Complexity: Piloting an Innovative Model
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.
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.
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