Quality of Life Clinical Trial
Official title:
Comprehensive Care of Children With Medical Complexity: Piloting an Innovative Model
Verified date | October 2019 |
Source | Seton Healthcare Family |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | September 30, 2016 |
Est. primary completion date | September 30, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 17 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's Comprehensive Care at 'Specially for Children | Austin | Texas |
Lead Sponsor | Collaborator |
---|---|
Seton Healthcare Family | University of Texas at Austin |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Change in Quality and Satisfaction, using the CAHPS Clinician & Group Survey, Version: 12-Month Survey with Patient-Centered Medical Home (PCMH) Items | Standard instruments will be used to assess Quality and Satisfaction with the patient's current medical home, primary care practice | at entry into study, after 1 year, and then annually thereafter, for a total of three years | |
Secondary | Change in Family Impact, using the PedsQL Family Impact Module | Standard instruments will be used to assess the impact of illness to study families | at entry into study, after 1 year, and then annually thereafter, for a total of three years | |
Secondary | Change in family experience, using Qualitative Interviews | 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. | 6 months and 1 year post-enrollment to the study |
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