- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277327
Trial to Reduce Hospitalizations in Children With Medical Complexity
October 24, 2017 updated by: Thomas Klitzner, MD, PhD, University of California, Los Angeles
Randomized Controlled Trial to Decrease Admission Rates in Medically Complex Children in a Medical Home Program
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- UCLA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 17 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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)
|
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
|
Subjects randomized to the "control" group will continue to receive routine care within the medical home program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
(1) number of all-cause admissions, defined as any admission occurring during the study period
Time Frame: 18 to 24 months
|
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
|
18 to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Thomas Klitzner, MD, PhD, University of California, Los Angeles
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
October 24, 2014
First Submitted That Met QC Criteria
October 28, 2014
First Posted (Estimate)
October 29, 2014
Study Record Updates
Last Update Posted (Actual)
October 26, 2017
Last Update Submitted That Met QC Criteria
October 24, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCLAMedHomeRCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Illness
-
National Institutes of Health Clinical Center (CC)CompletedSevere Chronic IllnessUnited States
-
University of OsloSykehuset Innlandet HF; Lovisenberg Diakonale HospitalEnrolling by invitationSiblings of Children With Chronic IllnessNorway
-
Palo Alto Veterans Institute for ResearchUnited States Department of DefenseCompletedChronic Pain | Gulf War Illness | Chronic IllnessUnited States
-
VA Office of Research and DevelopmentCompleted
-
MedImmune LLCCompletedHealthy or Stable Chronic IllnessUnited States
-
War Related Illness and Injury Study CenterGeorgetown University; Uniformed Services University of the Health SciencesUnknownChronic Multisymptom IllnessUnited States
-
Yuzuncu Yıl UniversityKahramanmaras Sutcu Imam University; Izmir Ataturk Training and Research HospitalCompleted
-
VA Palo Alto Health Care SystemUS Department of Veterans Affairs; Veterans Affairs Office of Connected CareCompletedChronic Disease, Mental IllnessUnited States
-
University of British ColumbiaCompletedChildren Receiving Ventilation at Home for Chronic Illness or DiseaseCanada
-
VA Office of Research and DevelopmentRecruitingPain Predominant Chronic Multisymptom IllnessUnited States
Clinical Trials on Plans of Action and Care Transitions
-
Auburn UniversityCompleted
-
University of ChicagoCOPD Foundation; Society of Hospital Medicine; Onda Collective; The Hospital Medicine...Recruiting
-
Georgetown UniversityCompleted
-
University of South FloridaPatient-Centered Outcomes Research Institute; AdventHealth; Tampa General Hospital and other collaboratorsNot yet recruitingHospital Readmissions
-
Université de SherbrookeCanadian Institutes of Health Research (CIHR); Laval University; Université de...RecruitingTelerehabilitation | Stroke Rehabilitation | Decision Making, SharedCanada
-
Jonsson Comprehensive Cancer CenterCompletedBreast CancerUnited States
-
Columbia UniversityPatient-Centered Outcomes Research InstituteRecruiting
-
University of PennsylvaniaUnitedHealth GroupCompletedCare TransitionsUnited States
-
Washington University School of MedicineBiovicaRecruiting
-
National Jewish HealthTeva Pharmaceuticals USAUnknown