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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02277327
Other study ID # UCLAMedHomeRCT
Secondary ID
Status Completed
Phase Phase 2
First received October 24, 2014
Last updated October 24, 2017
Start date November 2014
Est. completion date November 2016

Study information

Verified date October 2017
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date November 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 1 Month to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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)
Routine Care
Subjects randomized to the "control" group will continue to receive routine care within the medical home program

Locations

Country Name City State
United States UCLA Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary (1) number of all-cause admissions, defined as any admission occurring during the study period 18 to 24 months
Primary (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 18 to 24 months
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