An Enhanced Medical Home for High-Risk Chronically Ill Children

NCT02128776 | Completed

• 2 other identifiers: HSC-MS-10-06581C1MS331044-01-00
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Illnesses

Keywords

Children; Chronic illnesses

Outcome Measures

Primary Outcomes (1)

• Cost per prevented child with serious illness

  Cost per prevented child with serious illness

  Up to 2 and 1/2 years

Secondary Outcomes (6)

• Total costs of care

  Up to 2 and 1/2 years

• Episodes of serious illnesses

  Up to 2 and 1/2 years

• Emergency department visits

  Up to 2 and 1/2 years

• Hospitalizations

  Up to 2 and 1/2 years

• Intensive care admissions

  Up to 2 and 1/2 years

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Usual care provided in the offices of private pediatricians or our general pediatrics clinic staffed by faculty-supervised residents.

Other: Usual Care

Comprehensive care medical home

ACTIVE COMPARATOR

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

Interventions

Comprehensive care medical home OTHER

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

Comprehensive care medical home

Usual Care OTHER

Usual care provided in the offices of private pediatricians or our general pediatrics clinic staffed by faculty-supervised residents.

Usual Care

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Centers for Medicare and Medicaid Services: collaborator
• Texas Department of State Health Services: collaborator

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (7)

• Burke R, Liptak GS; Council on Children with Disabilities. Providing a primary care medical home for children and youth with spina bifida. Pediatrics. 2011 Dec;128(6):e1645-57. doi: 10.1542/peds.2011-2219. Epub 2011 Nov 28.

  PMID: 22123894 BACKGROUND

• Cohen E, Jovcevska V, Kuo DZ, Mahant S. Hospital-based comprehensive care programs for children with special health care needs: a systematic review. Arch Pediatr Adolesc Med. 2011 Jun;165(6):554-61. doi: 10.1001/archpediatrics.2011.74.

  PMID: 21646589 BACKGROUND

• Homer CJ, Klatka K, Romm D, Kuhlthau K, Bloom S, Newacheck P, Van Cleave J, Perrin JM. A review of the evidence for the medical home for children with special health care needs. Pediatrics. 2008 Oct;122(4):e922-37. doi: 10.1542/peds.2007-3762.

  PMID: 18829788 BACKGROUND

• Jackson GL, Powers BJ, Chatterjee R, Bettger JP, Kemper AR, Hasselblad V, Dolor RJ, Irvine RJ, Heidenfelder BL, Kendrick AS, Gray R, Williams JW. The patient centered medical home. A systematic review. Ann Intern Med. 2013 Feb 5;158(3):169-78. doi: 10.7326/0003-4819-158-3-201302050-00579.

  PMID: 24779044 BACKGROUND

• Liptak GS, Murphy NA; Council on Children With Disabilities. Providing a primary care medical home for children and youth with cerebral palsy. Pediatrics. 2011 Nov;128(5):e1321-9. doi: 10.1542/peds.2011-1468. Epub 2011 Oct 31.

  PMID: 22042817 BACKGROUND

• Malouin RA, Turner J. A review of the evidence for the medical home for children with special health care needs. Pediatrics. 2009 Feb;123(2):e369. doi: 10.1542/peds.2008-3250. No abstract available.

  PMID: 19171603 BACKGROUND

• Mosquera RA, Avritscher EB, Samuels CL, Harris TS, Pedroza C, Evans P, Navarro F, Wootton SH, Pacheco S, Clifton G, Moody S, Franzini L, Zupancic J, Tyson JE. Effect of an enhanced medical home on serious illness and cost of care among high-risk children with chronic illness: a randomized clinical trial. JAMA. 2014 Dec 24-31;312(24):2640-8. doi: 10.1001/jama.2014.16419.

  PMID: 25536255 DERIVED

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jon Tyson, MD, MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Ricardo Mosquera, MD

  The University of Texas Health Science Center, Houston

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Michelle Bain Distinguished Professor, Vice Dean for Healthcare Quality and Clinical Research

Study Record Dates

• First Submitted: April 24, 2014
• First Posted: May 1, 2014
• Study Start: March 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: May 1, 2014

Record last verified: 2014-04

Locations

US (1)