Chronic DiseaseNCT06916247
Evaluation of AI Cost Prediction Model to Enroll Patients in Complex Care Management Program
A study testing Complex care management program in people with Chronic Disease, run by University of California, Los Angeles at 1 site in United States.
Trial summary
Currently, UCLA Health (specifically the Office of Population Health and Accountable Care, or OPHAC) runs a complex care management program called Proactive Care (goal is to reduce care utilization by providing personalized care navigation/case management). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Complex care management program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,962 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 28 Apr 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Enrolled in a UCLA Managed Care Plan
- Cost prediction model identifies patient as having high predicted costs over the next 12 months
Who cannot join
- Currently enrolled in any UCLA care management program
- Enrolled in any UCLA care management program in the last 12 months
- Already has an active referral to a care management program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of MA Proactive Care Program Using Cost Prediction Model With Randomized Waitlist
Currently, UCLA Health (specifically the Office of Population Health and Accountable Care, or OPHAC) runs a complex care management program called Proactive Care (goal is to reduce care utilization by providing personalized care navigation/case management). Every month, an AI Population Risk tool runs to identify around 250 of the 480,000 or so UCLA primary care patients, and RNs contact these 250 patients to enroll in Proactive Care. Starting in December 2024, OPHAC launched a new method of enrolling UCLA's Medicare Advantage (MA) patients into Proactive Care: an AI Cost Prediction model. The idea is the same-- the top 250 highest predicted cost patients will be enrolled in Proactive Care. The investigators will evaluate this model and subsequent enrollment into the program by randomizing the waitlist of MA patients waiting to enroll in Proactive Care, thereby creating a control group. The top 500 highest predicted cost patients will be identified each month, and following a 1:1 randomization, 250 will be contacted for enrollment and the rest will be put on a wait-list control group for 10 months unless otherwise requested by their provider to be enrolled in the Proactive Care program earlier.
- Conditions
- Chronic Disease
- Being tested
- Complex care management program
- Keywords
- High utilization, Complex care management, Cost prediction model
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex care management programBehavioural
Intensive outpatient care management program that includes contact from nurses and case managers to help coordinate care, detect clinical red flags, and reduce overall unplanned acute care utilization.
| Study group | Role | What they receive |
|---|---|---|
| Complex Care Management | Active comparator | Patients randomized to be contacted for enrollment into the complex care management program called ProActive Care. Receives: Behavioral: Complex care management program |
| Care as usual | No intervention | Patient randomized to be put on a waitlist for being contacted for enrollment into ProActive Care (ie, not enrolled in ProActive Care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive and out of hospital (DAOH) at 120 days from randomization
The sum of the number of days that a patient is not hospitalized under inpatient or observation status, and alive, out of a maximum of 120 days post-randomization.
Measured: 120 days after randomization
Secondary outcomes (8)
Days alive and out of hospital (DAOH) at 30 days from randomization
The sum of the number of days that a patient is not hospitalized under inpatient or observation status, and alive, out of a maximum of 30 days post-randomization.
Measured: 30 days after randomization
Days alive and out of hospital (DAOH) at 90 days from randomization
The sum of the number of days that a patient is not hospitalized under inpatient or observation status, and alive, out of a maximum of 90 days post-randomization.
Measured: 90 days after randomization
Days alive and out of hospital (DAOH) at 10 months from randomization
The sum of the number of days that a patient is not hospitalized under inpatient or observation status, and alive, out of a maximum of 300 days post-randomization.
Measured: 10 months post-randomization
Total healthcare expenditures at 10 months from randomization
The sum of all healthcare expenditures (inpatient, outpatient, prescription, etc.) as determined by claims data.
Measured: 10 months post-randomization
All-cause hospitalizations at 10 months from randomization
The total number of hospitalizations under inpatient or observation status for any cause
Measured: 10 months post-randomization
All-cause emergency department visits at 10 months from randomization
The total number of emergency department visits that did not result in hospitalization, for any cause.
Measured: 10 months post-randomization
All-cause mortality at 10 months from randomization
The total number of deaths from any cause
Measured: 10 months post-randomization
Ambulator contact days
The number of days a patient spends outside the home receiving health care, defined as the total number of days with a primary care or specialty care office visit, test, imaging, procedure, or treatment
Measured: 10 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start31 Jul 2024
- Primary completion26 Aug 2025
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic DiseaseStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 4,962 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard K. Leuchter, MD, University of California, Los Angeles
- Investigators
- Richard K Leuchter, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916247
- Sponsor's protocol ID
- IRB-24-0849
- Status last verified
- Jul 2026
- First submitted
- 21 Mar 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MA Proactive Care Program Using Cost Prediction Model With Randomized Waitlist
- ClinicalTrials.gov ID
- NCT06916247
- Acronym / sponsor ID
- IRB-24-0849
- Conditions
- Chronic Disease
- Keywords
- High utilization, Complex care management, Cost prediction model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,962 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 26 Aug 2025 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 8 Apr 2025 (actual)
- 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.
Currently, UCLA Health (specifically the Office of Population Health and Accountable Care, or OPHAC) runs a complex care management program called Proactive Care (goal is to reduce care utilization by providing personalized care navigation/case management). Every month, an AI Population Risk tool runs to identify around 250 of the 480,000 or so UCLA primary care patients, and RNs contact these 250 patients to enroll in Proactive Care. Starting in December 2024, OPHAC launched a new method of enrolling UCLA's Medicare Advantage (MA) patients into Proactive Care: an AI Cost Prediction model. The idea is the same-- the top 250 highest predicted cost patients will be enrolled in Proactive Care. The investigators will evaluate this model and subsequent enrollment into the program by randomizing the waitlist of MA patients waiting to enroll in Proactive Care, thereby creating a control group. The top 500 highest predicted cost patients will be identified each month, and following a 1:1 randomization, 250 will be contacted for enrollment and the rest will be put on a wait-list control group for 10 months unless otherwise requested by their provider to be enrolled in the Proactive Care program earlier.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Complex Care Management | Active comparator | Behavioral: Complex care management programPatients randomized to be contacted for enrollment into the complex care management program called ProActive Care. |
| Care as usual | No intervention | –Patient randomized to be put on a waitlist for being contacted for enrollment into ProActive Care (ie, not enrolled in ProActive Care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years of age
- Enrolled in a UCLA Managed Care Plan
- Cost prediction model identifies patient as having high predicted costs over the next 12 months
Key exclusion criteria (3 listed)
- Currently enrolled in any UCLA care management program
- Enrolled in any UCLA care management program in the last 12 months
- Already has an active referral to a care management program
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 |
|---|---|---|
| Complex care management programIntensive outpatient care management program that includes contact from nurses and case managers to help coordinate care, detect clinical red flags, and reduce overall unplanned acute care utilization. | Behavioural | Complex Care Management |
Primary outcome
Days alive and out of hospital (DAOH) at 120 days from randomization
Time frame: 120 days after randomization
The sum of the number of days that a patient is not hospitalized under inpatient or observation status, and alive, out of a maximum of 120 days post-randomization.
8 secondary outcomes
Days alive and out of hospital (DAOH) at 30 days from randomization
Time frame: 30 days after randomization
Days alive and out of hospital (DAOH) at 90 days from randomization
Time frame: 90 days after randomization
Days alive and out of hospital (DAOH) at 10 months from randomization
Time frame: 10 months post-randomization
Total healthcare expenditures at 10 months from randomization
Time frame: 10 months post-randomization
All-cause hospitalizations at 10 months from randomization
Time frame: 10 months post-randomization
All-cause emergency department visits at 10 months from randomization
Time frame: 10 months post-randomization
All-cause mortality at 10 months from randomization
Time frame: 10 months post-randomization
Ambulator contact days
Time frame: 10 months post-randomization
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 16 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Disease
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Richard K Leuchter, MD 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 study testing Complex care management program in people with Chronic Disease, 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 3 inclusion and 3 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 16 Jul 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Days alive and out of hospital (DAOH) at 120 days from randomization (time frame: 120 days after randomization). 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 16 Jul 2026.