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An Enhanced Medical Home for High-Risk Chronically Ill Children

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ClinicalTrials.gov Identifier: NCT02128776
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : May 1, 2014
Sponsor:
Collaborators:
Centers for Medicare and Medicaid Services
Texas Department of State Health Services
Information provided by (Responsible Party):
Jon Edward Tyson, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to assess whether an enhanced medical home providing comprehensive care is cost-effective in preventing serious illness (death, pediatric intensive care admission, or hospital stay >7d) among high-risk chronically ill children.

Condition or disease Intervention/treatment Phase
Chronic Illnesses Other: Comprehensive care medical home Other: Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Comprehensive Care Provided in an Enhanced Medical Home to Improve Outcomes and Reduce Costs for High-Risk Chronically Ill Children
Study Start Date : March 2011
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Usual Care
Usual care provided in the offices of private pediatricians or our general pediatrics clinic staffed by faculty-supervised residents.
Other: Usual Care
Usual care provided in the offices of private pediatricians or our general pediatrics clinic staffed by faculty-supervised residents.

Active Comparator: Comprehensive care medical home
Comprehensive care provided in our High-Risk Children's Clinic as a medical home augmented by measures to prevent serious illness
Other: Comprehensive care medical home
Comprehensive care provided in our High-Risk Children's Clinic as a medical home augmented by measures to prevent serious illness




Primary Outcome Measures :
  1. Cost per prevented child with serious illness [ Time Frame: Up to 2 and 1/2 years ]
    Cost per prevented child with serious illness


Secondary Outcome Measures :
  1. Total costs of care [ Time Frame: Up to 2 and 1/2 years ]
    Total costs of clinic and hospital care (in 2014 US$)

  2. Episodes of serious illnesses [ Time Frame: Up to 2 and 1/2 years ]
    Number of episodes of serious illnesses

  3. Emergency department visits [ Time Frame: Up to 2 and 1/2 years ]
    Number of emergency department visits

  4. Hospitalizations [ Time Frame: Up to 2 and 1/2 years ]
    Number of hospitalizations

  5. Intensive care admissions [ Time Frame: Up to 2 and 1/2 years ]
    Number of intensive care admissions

  6. Parent ratings of care at the end of 1st year [ Time Frame: 12 months after enrollment ]
    Parent ratings of care (on a scale of 0-10) are obtained by research personnel uninvolved in patient care who administer the Consumer Assessment of Healthcare Providers and Systems Survey in Spanish or English to each mother 12 months after enrollment. The investigators preselected five questions as most important to optimizing our patient outcomes (questions 6, 15, 18, 20, and 23).



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years old or younger with a chronic illness, high healthcare utilization (>3 emergency department visits, >2 hospitalizations or >1 pediatric intensive care unit admission in the prior year), and a >50% likelihood of hospitalization in the coming year (as estimated from the patient's diagnosis and clinical course by our clinic's medical director), who lived within a one-hour commute of our center.

Exclusion Criteria:

  • Patients with complex problems given primary care by a specialist at all hours (e.g. infants in our neonatal follow-up program and children with serious unrepaired congenital heart disease, a mitochondrial disorder, organ transplant, treatment with dialysis or central lines; or a do-not-resuscitate order).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128776


Locations
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United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Centers for Medicare and Medicaid Services
Texas Department of State Health Services
Investigators
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Principal Investigator: Jon Tyson, MD, MPH The University of Texas Health Science Center, Houston
Study Director: Ricardo Mosquera, MD The University of Texas Health Science Center, Houston

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jon Edward Tyson, Michelle Bain Distinguished Professor, Vice Dean for Healthcare Quality and Clinical Research, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02128776     History of Changes
Other Study ID Numbers: HSC-MS-10-0658
1C1MS331044-01-00 ( Other Grant/Funding Number: Centers for Medicare & Medicaid Services Health Care Innovation Award )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Jon Edward Tyson, The University of Texas Health Science Center, Houston:
Children
Chronic illnesses

Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes