Trial to Reduce Hospitalizations in Children With Medical Complexity

• ClinicalTrials.gov Identifier: NCT02277327
• Recruitment Status: Completed
• First Posted: October 29, 2014
• Last Update Posted: October 26, 2017
• Sponsor: University of California, Los Angeles
• Information provided by (Responsible Party): Thomas Klitzner, MD, PhD, University of California, Los Angeles

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.

Condition or disease	Intervention/treatment	Phase
Chronic Illness	Behavioral: Plans of Action and Care Transitions; Behavioral: Routine Care	Phase 2

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 (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• Official Title: Randomized Controlled Trial to Decrease Admission Rates in Medically Complex Children in a Medical Home Program
• Study Start Date: November 2014
• Actual Primary Completion Date: November 2016
• Actual Study Completion Date: November 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; 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)	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)
Placebo Comparator: Routine Care; Subjects randomized to the "routine care" group will continue to receive their usual care from the Pediatric Medical Home Program at UCLA	Behavioral: Routine Care; Subjects randomized to the "control" group will continue to receive routine care within the medical home program

Outcome Measures

Primary Outcome Measures :

1. (1) number of all-cause admissions, defined as any admission occurring during the study period [ Time Frame: 18 to 24 months ]
2. (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

• Ages Eligible for Study: 1 Month to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

UCLA

Los Angeles, California, United States, 90095

Sponsors and Collaborators

University of California, Los Angeles

Investigators

• Principal Investigator: Thomas Klitzner, MD, PhD; University of California, Los Angeles

More Information

• Responsible Party: Thomas Klitzner, MD, PhD, Executive Directior, Pediatric Medical Home Program at UCLA, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT02277327
• Other Study ID Numbers: UCLAMedHomeRCT
• First Posted: October 29, 2014
• Last Update Posted: October 26, 2017
• Last Verified: October 2017

Keywords provided by Thomas Klitzner, MD, PhD, University of California, Los Angeles:

Hospitalization; Readmissions; Medical complexity

Additional relevant MeSH terms:

Chronic Disease; Disease Attributes; Pathologic Processes