Back to resultsTrial to Reduce Hospitalizations in Children With Medical Complexity
Primary Purpose
Chronic Illness
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Plans of Action and Care Transitions
Routine Care
Sponsored by
About this trial
This is an interventional health services research trial for Chronic Illness focused on measuring Hospitalization, Readmissions, Medical complexity
Eligibility 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
Sites / Locations
- UCLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention
Routine Care
Arm Description
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)
Subjects randomized to the "routine care" group will continue to receive their usual care from the Pediatric Medical Home Program at UCLA
Outcomes
Primary Outcome Measures
(1) number of all-cause admissions, defined as any admission occurring during the study period
(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
Secondary Outcome Measures
Full Information
NCT ID
NCT02277327
First Posted
October 24, 2014
Last Updated
October 24, 2017
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02277327
Brief Title
Trial to Reduce Hospitalizations in Children With Medical Complexity
Official Title
Randomized Controlled Trial to Decrease Admission Rates in Medically Complex Children in a Medical Home Program
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Illness
Keywords
Hospitalization, Readmissions, Medical complexity
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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)
Arm Title
Routine Care
Arm Type
Placebo Comparator
Arm Description
Subjects randomized to the "routine care" group will continue to receive their usual care from the Pediatric Medical Home Program at UCLA
Intervention Type
Behavioral
Intervention Name(s)
Plans of Action and Care Transitions
Intervention Description
Subjects randomized to the "intervention" will participate in action planning and care transitions (if hospitalized during the study period)
Intervention Type
Behavioral
Intervention Name(s)
Routine Care
Intervention Description
Subjects randomized to the "control" group will continue to receive routine care within the medical home program
Primary Outcome Measure Information:
Title
(1) number of all-cause admissions, defined as any admission occurring during the study period
Time Frame
18 to 24 months
Title
(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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Klitzner, MD, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
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Trial to Reduce Hospitalizations in Children With Medical Complexity
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