Trial to Reduce Hospitalizations in Children With Medical Complexity

NCT02277327 | Completed Phase 2

• 1 other identifier: UCLAMedHomeRCT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Illness

Keywords

Hospitalization; Readmissions; Medical complexity

Outcome Measures

Primary Outcomes (2)

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

  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

  18 to 24 months

Study Arms (2)

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)

Behavioral: Plans of Action and Care Transitions

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

Behavioral: Routine Care

Interventions

Plans of Action and Care Transitions BEHAVIORAL

Subjects randomized to the "intervention" will participate in action planning and care transitions (if hospitalized during the study period)

Intervention

Routine Care BEHAVIORAL

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

Routine Care

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children ages 0 to 17 years old who are enrolled in the Pediatric Medical Home Program at UCLA
• English and Spanish-speaking only

You may not qualify if:

• Children older than 17 years old who are enrolled in the Pediatric Medical Home Program
• Non-English and Non-Spanish speakers

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Chronic Disease

Interventions

Patient Transfer

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Hospitalization; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Thomas Klitzner, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Executive Directior, Pediatric Medical Home Program at UCLA

Study Record Dates

• First Submitted: October 24, 2014
• First Posted: October 29, 2014
• Study Start: November 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)