Overview

This trial is active, not recruiting.

Condition chronic illness
Treatments plans of action and care transitions, routine care
Phase phase 2
Sponsor University of California, Los Angeles
Start date November 2014
End date November 2016
Trial size 200 participants
Trial identifier NCT02277327, UCLAMedHomeRCT

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (subject, investigator)
Primary purpose health services research
Arm
(Experimental)
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)
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)
Subjects randomized to the "routine care" group will continue to receive their usual care from the Pediatric Medical Home Program at UCLA
routine care
Subjects randomized to the "control" group will continue to receive routine care within the medical home program

Primary Outcomes

Measure
(1) number of all-cause admissions, defined as any admission occurring during the study period
time frame: 18 to 24 months
(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

Eligibility Criteria

Male or female participants from 1 month up to 17 years old.

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

Additional Information

Official title Randomized Controlled Trial to Decrease Admission Rates in Medically Complex Children in a Medical Home Program
Principal investigator Thomas Klitzner, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.