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Trial to Reduce Hospitalizations in Children With Medical Complexity

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ClinicalTrials.gov Identifier: NCT02277327
Recruitment Status : Completed
First Posted : October 29, 2014
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Klitzner, MD, PhD, University of California, Los Angeles

Brief Summary:
The investigators hypothesize that an intervention, within an established patient-centered medical home, aimed at reducing modifiable risks for hospitalization, can decrease hospital utilization among medically complex children.

Condition or disease Intervention/treatment Phase
Chronic Illness Behavioral: Plans of Action and Care Transitions Behavioral: Routine Care Phase 2

Detailed Description:
The investigators will pilot test an intervention that includes contingency planning and care transitions within an established medical home program caring for children with medical complexity. Children with medical complexity receiving care within the UCLA Medical Home Program will be randomized to the pilot intervention or usual medical home care. The primary goal will be to reduce admissions and readmissions in the intervention group.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: Randomized Controlled Trial to Decrease Admission Rates in Medically Complex Children in a Medical Home Program
Study Start Date : November 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: Intervention
Subjects randomized to the "intervention group" will participate in a bundled intervention that includes action planning and care transitions (for those hospitalized during the study period)
Behavioral: Plans of Action and Care Transitions
Subjects randomized to the "intervention" will participate in action planning and care transitions (if hospitalized during the study period)

Placebo Comparator: Routine Care
Subjects randomized to the "routine care" group will continue to receive their usual care from the Pediatric Medical Home Program at UCLA
Behavioral: Routine Care
Subjects randomized to the "control" group will continue to receive routine care within the medical home program




Primary Outcome Measures :
  1. (1) number of all-cause admissions, defined as any admission occurring during the study period [ Time Frame: 18 to 24 months ]
  2. (2) preventable admissions, defined by 2 independent physicians blinded to study assignment as an admission due primarily to one of the preventable factors identified from Phase 1 of the study [ Time Frame: 18 to 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children ages 0 to 17 years old who are enrolled in the Pediatric Medical Home Program at UCLA
  • English and Spanish-speaking only

Exclusion Criteria:

  • Children older than 17 years old who are enrolled in the Pediatric Medical Home Program
  • Non-English and Non-Spanish speakers

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): NCT02277327


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Thomas Klitzner, MD, PhD University of California, Los Angeles
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Responsible Party: Thomas Klitzner, MD, PhD, Executive Directior, Pediatric Medical Home Program at UCLA, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02277327    
Other Study ID Numbers: UCLAMedHomeRCT
First Posted: October 29, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Thomas Klitzner, MD, PhD, University of California, Los Angeles:
Hospitalization
Readmissions
Medical complexity
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes