Chronic IllnessPhase 2NCT02277327
Trial to Reduce Hospitalizations in Children With Medical Complexity
A Phase 2 study testing Plans of Action and Care Transitions and Routine Care in people with Chronic Illness, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Chronic Illness
- What is being tested?
- Plans of Action and Care Transitions and Routine Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children ages 0 to 17 years old who are enrolled in the Pediatric Medical Home Program at UCLA
- English and Spanish-speaking only
Who cannot join
- Children older than 17 years old who are enrolled in the Pediatric Medical Home Program
- Non-English and Non-Spanish speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Illness
- Being tested
- Plans of Action and Care Transitions, Routine Care
- Keywords
- Hospitalization, Readmissions, Medical complexity
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plans of Action and Care TransitionsBehavioural
Subjects randomized to the "intervention" will participate in action planning and care transitions (if hospitalized during the study period)
Routine CareBehavioural
Subjects randomized to the "control" group will continue to receive routine care within the medical home program
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Behavioral: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
(1) number of all-cause admissions, defined as any admission occurring during the study period
Measured: 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
Measured: 18 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic IllnessStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Klitzner, MD, PhD, University of California, Los Angeles
- Investigators
- Thomas Klitzner, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277327
- Sponsor's protocol ID
- UCLAMedHomeRCT
- Status last verified
- Oct 2017
- First submitted
- 24 Oct 2014
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Decrease Admission Rates in Medically Complex Children in a Medical Home Program
- ClinicalTrials.gov ID
- NCT02277327
- Acronym / sponsor ID
- UCLAMedHomeRCT
- Conditions
- Chronic Illness
- Keywords
- Hospitalization, Readmissions, Medical complexity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 29 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Plans of Action and Care TransitionsSubjects 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) |
| Routine Care | Placebo comparator | Behavioral: Routine CareSubjects randomized to the "routine care" group will continue to receive their usual care from the Pediatric Medical Home Program at UCLA |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children ages 0 to 17 years old who are enrolled in the Pediatric Medical Home Program at UCLA
- English and Spanish-speaking only
Key exclusion criteria (2 listed)
- Children older than 17 years old who are enrolled in the Pediatric Medical Home Program
- Non-English and Non-Spanish speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plans of Action and Care TransitionsSubjects randomized to the "intervention" will participate in action planning and care transitions (if hospitalized during the study period) | Behavioural | Intervention |
| Routine CareSubjects randomized to the "control" group will continue to receive routine care within the medical home program | Behavioural | Routine Care |
Primary outcome
(1) number of all-cause admissions, defined as any admission occurring during the study period
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Klitzner, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plans of Action and Care Transitions and Routine Care in people with Chronic Illness, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(1) number of all-cause admissions, defined as any admission occurring during the study period (time frame: 18 to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.