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Clinical Trials/NCT02277327
NCT02277327CompletedPhase 2

Randomized Controlled Trial to Decrease Admission Rates in Medically Complex Children in a Medical Home Program

University of California, Los Angeles1 site in 1 country200 target enrollmentStarted: November 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
(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

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Health Services Research
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
1 Month to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Intervention

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)

Intervention: Plans of Action and Care Transitions (Behavioral)

Routine Care

Placebo Comparator

Subjects randomized to the "routine care" group will continue to receive their usual care from the Pediatric Medical Home Program at UCLA

Intervention: Routine Care (Behavioral)

Outcomes

Primary Outcomes

(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

(1) number of all-cause admissions, defined as any admission occurring during the study period

Time Frame: 18 to 24 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Thomas Klitzner, MD, PhD

Executive Directior, Pediatric Medical Home Program at UCLA

University of California, Los Angeles

Study Sites (1)

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