Study EHR Risk Stratification Tools
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemoglobin A1c Lab Result Communication Tool.
- Who it may be relevant to
- Registry conditions: Prediabetes, Health Communication, Patient Comprehension. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Evaluation of Patient and Provider Facing EHR-embedded Risk Stratification Tools
Overview
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
- Device Hemoglobin 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.
Primary outcome measures
- Prediabetes- Related Healthcare Utilization [Time frame: 365 days after result]
Secondary outcome measures (11)
- Number of Repeat Hemoglobin A1c Tests [Time frame: 365 days after result]
- Number of Prescriptions for Diabetes-Related Medications [Time frame: 180 days after result]
- Total Number of Outpatient Healthcare [Time frame: 180 days after result]
- Numbers of Referrals to Endocrinology [Time frame: 14 days after initial result]
- Number of Referrals to Nutrition Services [Time frame: 14 days after initial result]
- Number of Referrals to Diabetes Education [Time frame: 14 days after initial result]
- Number of Completed Endocrinology Visit [Time frame: 180 days after result]
- Completed Nutrition Services Visit [Time frame: 180 days after result]
- Completed Appointments to Diabetes Education [Time frame: 180 days after result]
- Number of Patient MyChart Messages [Time frame: 7 days after viewing lab result]
- Numbers of Phone Calls Received after A1c Results [Time frame: 7 days after viewing lab result]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- UCLA Health System — Los Angeles
Identifiers
NCT: NCT06995378 · IRB-24-6052