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Study EHR Risk Stratification Tools

Evaluation of Patient and Provider Facing EHR-embedded Risk Stratification Tools

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06995378
Enrollment
1200
Registered
2025-05-29
Start date
2026-05-27
Completion date
2029-09-01
Last updated
2026-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Communication, Patient Comprehension, Prediabetes

Keywords

Prediabetes, Machine Learning, Risk Stratification, Electronic Health Record, Lab Result Communication, Predictive Modeling, Patient Comprehension

Brief summary

This study evaluates whether adding machine learning-based risk information to electronic health record (EHR) lab result messages helps older adults better understand their risk of developing diabetes and influences their emotional responses, quality of life, and healthcare use. Eligible participants are adults aged 65 years and older with a UCLA primary care provider and a hemoglobin A1c level in the range (5.7-6.0%). Participants are identified automatically at the time their lab results are processed and are randomly assigned to receive either standard lab result messages or modified messages that include a "very low risk" label generated by a machine learning model. All participants who are randomized are invited to complete two surveys: one shortly after their lab result is posted in MyChart and a follow-up survey approximately 30 days later. The study also uses de-identified EHR data to examine patterns of healthcare utilization and progression to diabetes. Provider comments related to lab result messaging will be analyzed to explore differences in response patterns between the two groups.

Detailed description

Prediabetes thresholds based on hemoglobin A1c were originally developed using younger, healthier populations and may not reflect the slower and more variable glycemic changes observed in older adults. Evidence from large community-based cohorts suggests that adults aged 65 years and older with A1c values in the prediabetes range are often more likely to return to normal glycemia than to progress to diabetes, creating uncertainty for patients and providers when interpreting lab results. Machine learning models developed using de-identified UCLA Health EHR data from multiple annual cohorts between 2020 and 2024 demonstrated strong performance in predicting progression to diabetes. The final model uses a CatBoost architecture and incorporates approximately 94 routinely collected clinical variables to generate patient-specific risk scores. Model performance was evaluated across yearly cohorts, and the selected model is locked for the duration of the study without updating or adapting to new data. The study follows a real-world, randomized deployment design in which eligible individuals in the lowest 15% of model-predicted risk within the eligible study population are identified automatically at the time lab results are processed and assigned to either modified or standard lab result messaging. De-identified EHR data and free-text provider comments are used to examine healthcare utilization, disease progression, and provider response patterns over time. All participants who are randomized are invited to complete two surveys. The first survey is administered shortly after receipt of the laboratory result and is designed to assess immediate patient understanding of the result and emotional responses such as anxiety or reassurance. A second survey is administered approximately one month later and uses validated instruments to measure health-related quality of life, food-related quality of life and eating behavior, and perceived burden of healthcare. Both study arms receive the same surveys, allowing comparison of patient-reported outcomes between standard and modified laboratory result messaging. Surveys are distributed only to participants who have been randomized to either modified or standard laboratory result messaging. Therefore, no additional eligibility criteria apply for survey participation beyond randomization. By embedding model-generated risk information directly into routine EHR workflows, this study aims to generate evidence on whether precision-based communication can support more individualized, patient-centered care and inform future implementation across broader patient populations and clinical use cases.

Interventions

DEVICEHemoglobin A1c Lab Result Communication Tool

A behavioral intervention delivered through a personalized Electronic Health Record (EHR)-integrated lab result communication tool designed to improve emotional and cognitive responses to lab results among adults aged 65+. The tool applies behavioral science principles such as risk personalization, simplified messaging, and visual framing to reduce patient anxiety, enhance understanding, and support informed decision-making.

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age 65 years or older * Hemoglobin A1c in the prediabetes range (5.7- but not including 6.0%)

Exclusion criteria

* Have lab results outside the defined inclusion range * No UCLA primary care provider * Age \<65 years * Eligibility for Surveys: All randomized participants are eligible to receive study surveys. No additional eligibility criteria apply for survey participation. HgbA1c of 6.0 or above is not eligible.

Design outcomes

Primary

MeasureTime frameDescription
Prediabetes- Related Healthcare Utilization365 days after resultTotal count of prediabetes-related healthcare utilization defined as the sum of outpatient visits to endocrinology, repeat hemoglobin A1c tests, and new prescriptions for diabetes-related medications following the index A1c result.

Secondary

MeasureTime frameDescription
Number of Repeat Hemoglobin A1c Tests365 days after resultTotal number of repeat hemoglobin A1c laboratory tests performed after the index test. This measure reflects follow-up glycemic testing and serves as an indicator of diabetes-related monitoring and healthcare utilization.
Number of Prescriptions for Diabetes-Related Medications180 days after resultTotal number of prescriptions issued for medications commonly used for glycemic management (e.g., metformin) following the index hemoglobin A1c result. This outcome captures initiation of pharmacologic treatment related to diabetes risk.
Total Number of Outpatient Healthcare180 days after resultTotal count of outpatient visits across all specialties following the index A1c result
Numbers of Referrals to Endocrinology14 days after initial resultTotal number of outpatient referrals to an endocrinologist occurring after the index hemoglobin A1c laboratory result. This measure is used to quantify diabetes-related specialty care utilization potentially associated with interpretation of the laboratory result communication.
Number of Referrals to Nutrition Services14 days after initial resultNumber of participants with an electronic referral order placed to clinical nutrition services documented in the electronic health record after release of the hemoglobin A1c result.
Number of Referrals to Diabetes Education14 days after initial resultNumber of participants with an electronic referral order placed to diabetes education services documented in the electronic health record after release of the hemoglobin A1c result.
Number of Completed Endocrinology Visit180 days after resultNumber of participants who complete an outpatient endocrinology encounter documented in the electronic health record after laboratory result notification. Visit completion will be identified using encounter records associated with endocrinology clinic services.
Completed Nutrition Services Visit180 days after resultNumber of participants who complete an outpatient visit with clinical nutrition services documented in the electronic health record following laboratory result notification. Completion will be determined using encounter data associated with nutrition services.
Completed Appointments to Diabetes Education180 days after resultNumber of participants who complete an outpatient visit with diabetes education services documented in the electronic health record following laboratory result notification. Completion will be determined using encounter data associated with diabetes education.
Number of Patient MyChart Messages7 days after viewing lab resultCount of MyChart Test Result Messages
Numbers of Phone Calls Received after A1c Results7 days after viewing lab resultCount of telephone encounters to ordering provider

Countries

United States

Contacts

CONTACTKatelyn Nguyen Assistant Clinical Research Coordinator
katenguyen@mednet.ucla.edu310-267-5250

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 10, 2026