- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06916247
Evaluation of AI Cost Prediction Model to Enroll Patients in Complex Care Management Program
January 27, 2026 updated by: Richard K. Leuchter, MD, University of California, Los Angeles
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
5000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Richard K Leuchter, MD
- Phone Number: 310-267-9111
- Email: rleuchter@mednet.ucla.edu
Study Contact Backup
- Name: William Turner, BA
- Phone Number: 310-267-9111
- Email: wturner@mednet.ucla.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- Recruiting
- UCLA Health
-
Contact:
- Richard Leuchter, MD
- Email: rleuchter@mednet.ucla.edu
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Complex Care Management
Patients randomized to be contacted for enrollment into the complex care management program called ProActive Care.
|
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.
|
|
No Intervention: Care as usual
Patient randomized to be put on a waitlist for being contacted for enrollment into ProActive Care (ie, not enrolled in ProActive Care).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
120 days after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days alive and out of hospital (DAOH) at 30 days from randomization
Time Frame: 30 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 30 days post-randomization.
|
30 days after randomization
|
|
Days alive and out of hospital (DAOH) at 90 days from randomization
Time Frame: 90 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 90 days post-randomization.
|
90 days after randomization
|
|
Days alive and out of hospital (DAOH) at 10 months from randomization
Time Frame: 10 months post-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.
|
10 months post-randomization
|
|
Total healthcare expenditures at 10 months from randomization
Time Frame: 10 months post-randomization
|
The sum of all healthcare expenditures (inpatient, outpatient, prescription, etc.) as determined by claims data.
|
10 months post-randomization
|
|
All-cause hospitalizations at 10 months from randomization
Time Frame: 10 months post-randomization
|
The total number of hospitalizations under inpatient or observation status for any cause
|
10 months post-randomization
|
|
All-cause emergency department visits at 10 months from randomization
Time Frame: 10 months post-randomization
|
The total number of emergency department visits that did not result in hospitalization, for any cause.
|
10 months post-randomization
|
|
All-cause mortality at 10 months from randomization
Time Frame: 10 months post-randomization
|
The total number of deaths from any cause
|
10 months post-randomization
|
|
Ambulator contact days
Time Frame: 10 months post-randomization
|
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
|
10 months post-randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cost prediction model performance over 22 months, as measured by area under the receiver operating characteristic curve
Time Frame: 12 months after the final cohort enrolls
|
Observed healthcare expenditures for each month's control cohort will be measured over the subsequent 12 months after randomization (ie, 10 months of enrollment + 12 months of follow-up= 22 months), and compared to model-predicted healthcare expenditures.
This analysis will only be conducted in the control group, as the intervention is designed to affect healthcare expenditures in the treatment group.
|
12 months after the final cohort enrolls
|
|
Protocol fidelity over the 10 months of enrollment
Time Frame: 14 months post-randomization
|
The sum of two metrics:
|
14 months post-randomization
|
|
Avoidable hospitalizations
Time Frame: 10 months post-randomization
|
The number of hospitalizations that could have been avoided through timely access to ambulatory care
|
10 months post-randomization
|
|
Avoidable emergency department visits
Time Frame: 10 months post-randomization
|
The number of emergency department visits that could have been avoided through timely access to ambulatory care
|
10 months post-randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Richard K Leuchter, MD, 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 (Actual)
August 16, 2024
Primary Completion (Actual)
September 9, 2025
Study Completion (Estimated)
May 12, 2026
Study Registration Dates
First Submitted
March 21, 2025
First Submitted That Met QC Criteria
March 31, 2025
First Posted (Actual)
April 8, 2025
Study Record Updates
Last Update Posted (Actual)
January 29, 2026
Last Update Submitted That Met QC Criteria
January 27, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-24-0849
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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