NCT06995365

Brief Summary

This study aims to improve how lab results are communicated to older adults by refining a predictive model that uses electronic health record (EHR) data. The model was originally developed to estimate the risk of chronic kidney disease (CKD) progression. Researchers will use existing health data to test and improve the accuracy of the model and explore how it might be adapted for use in other health conditions. The study does not involve direct interaction with patients and is conducted entirely using de-identified data in a secure environment.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 20, 2025

Last Update Submit

May 20, 2025

Conditions

Keywords

Lab Result CommunicationRisk Stratification

Outcome Measures

Primary Outcomes (1)

  • Performance of the Risk Prediction Model

    Evaluate the predictive performance of a machine learning-based risk model using retrospective Electronic Health Records (EHR) data. The model estimates the likelihood of disease progression in older adults. The model should be designed to be adaptable to various clinical conditions. Metrics include Area Under the Receiver Operating Characteristic Curve (AUC-ROC), sensitivity, and specificity.

    Up to 5 years of retrospective follow up

Interventions

This study analyzes retrospective electronic health record (EHR) data from older adults to refine and validate a predictive model for other conditions in future studies.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 65 and older who received care within the UCLA or UC Health system, have at least 5 years of clinical follow-up, and have had a serum creatinine test. Data are drawn from existing electronic health records.

You may qualify if:

  • being over the age of 65; having at least 5 years of clinical follow up; and having a serum creatinine lab test conducted

You may not qualify if:

  • Patients younger than 65 years old
  • Patients with less than 5 years of clinical follow-up
  • Patients from health systems outside of the UC Health network.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Health System

Los Angeles, California, 90024, United States

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 29, 2025

Study Start

August 1, 2025

Primary Completion

December 1, 2025

Study Completion

March 1, 2026

Last Updated

May 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations