Trial to Reduce Hospitalizations in Children With Medical Complexity

Chronic Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277327
• Other study ID #: UCLAMedHomeRCT
• 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
• 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

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness

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