Study EHR Risk Stratification Tools
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of California, Los Angeles
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 65 years or older
Hemoglobin A1c in the prediabetes range (5.7- but not including 6.0%)
Disqualifiers
Have lab results outside the defined inclusion range
No UCLA primary care provider
Age <65 years
Trial design
Design model
Parallel
Treatments tested in this trial
Hemoglobin A1c Lab Result Communication Tool
DeviceA 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.
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Personalized Lab Result MessagingExperimental treatment 1 intervention
Group B: Standard Lab Result MessagingNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Prediabetes- Related Healthcare Utilization
Total 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.
Time frame
365 days after resultSecondary outcomes
1
Number of Repeat Hemoglobin A1c Tests
Total 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.
Time frame
365 days after result2
Number of Prescriptions for Diabetes-Related Medications
Total 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.
Time frame
180 days after result3
Total Number of Outpatient Healthcare
Total count of outpatient visits across all specialties following the index A1c result
Time frame
180 days after result4
Numbers of Referrals to Endocrinology
Total 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.
Time frame
14 days after initial resultOther outcomes
1
Self-Reported Quality of Life
Patient-reported quality of life assessed using survey responses evaluating overall physical, mental, and health-related well-being following receipt of lab result communication.
Time frame
30 days after initial survey invitation2
Self-Reported Physical Function Following Lab Result
Self-reported physical function asking about ability to perform activities such as household chores, stair climbing, walking, and running errands following receipt of lab result communication. This measure uses structured survey items to evaluate whether receipt of A1c lab result communication is associated with changes in exercise.
Time frame
30 days after initial survey invitation3
Self-Reported Dietary Behaviors Following Lab Result
Patient-reported dietary behaviors following receipt of lab result, including eating patterns, appetite, satiety, and food-related changes or restrictions due to concerns about lab results. These behaviors are assessed to understand potential impacts on health and weight-related decision-making. This measure uses structured survey items to evaluates whether receipt of A1c lab result communication is associated with changes dietary behaviors.
Time frame
30 days after initial survey invitation4
Patient Understanding and Anxiety Related to Lab Result Communication
Patient-reported understanding of lab report and emotional response to result communication, including perceived clarity, reassurance, and level of concern, assessed using structured survey items designed to measure comprehension and anxiety following receipt of laboratory result messaging.
Time frame
7 days after resultsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Los Angeles
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov