- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06995378
- Juicio original
Comunicación de resultados de laboratorio de medicina de precisión centrada en el paciente para adultos mayores
Herramienta de comunicación de resultados de laboratorio centrada en el paciente para adultos mayores con hemoglobina elevada A1C (A1C) o enfermedad renal crónica (ERC)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Katelyn Nguyen Assistant Clinical Research Coordinator
- Número de teléfono: 310-267-5250
- Correo electrónico: katenguyen@mednet.ucla.edu
Ubicaciones de estudio
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California
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Los Angeles, California, Estados Unidos, 90049
- Reclutamiento
- UCLA Health System
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Contacto:
- Katelyn Assistant Clinical Research Coordinator
- Número de teléfono: 310-267-5250
- Correo electrónico: csarkisian@mednet.ucla.edu
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Contacto:
- Catherine Sarkisian, MD
- Número de teléfono: 3102068272
- Correo electrónico: csarkisian@mednet.ucla.edu
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Investigador principal:
- Catherine Sarkisian, MD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
Criterios de inclusión del paciente: adultos mayores (edad> 65 años) con un proveedor de atención primaria de UCLA que son:
- Inscrito en el portal del paciente;
- Habla inglés (como el idioma de la herramienta está actualmente solo en inglés, y no sería práctico tener traducciones validadas creadas para todas las posibles variaciones y derivadas de las maquetas de herramientas); y
- Sin demencia u otra enfermedad neurocognitiva.
Criterios de inclusión del proveedor:
-Clave proveedores de salud que atienden a un gran número de adultos mayores en entornos ambulatorios.
Criterios de exclusión:
Criterios de exclusión del paciente:
- Tener resultados de laboratorio fuera de los rangos de inclusión definidos;
- No tienen un PCP UCLA;
- Tienen menos de 65 años;
- No se hablan inglés (ya que los prototipos de herramientas están solo en inglés hasta que se determina la verborje final);
- No están inscritos en el portal de pacientes de UCLA MyChart; o
- Son diagnosticados con demencia
Criterios de exclusión del proveedor:
-No cuida un gran número de adultos mayores en entornos ambulatorios
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Personalized Lab Result Messaging
Participants receive modified electronic health record (EHR) lab result communications in the patient portal (MyChart) and provider-facing EHR interface that include a qualitative "very low risk" label generated by a machine learning-based tool, along with brief explanatory text providing context about their current results and indicating a low level of concern at this time.
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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.
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Sin intervención: Standard Lab Result Messaging
Participants receive standard electronic health record (EHR) lab result communications without any machine learning-generated risk labeling or explanatory text providing additional context about level of concern.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Prediabetes- Related Healthcare Utilization
Periodo de tiempo: 365 days after result
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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.
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365 days after result
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Repeat Hemoglobin A1c Tests
Periodo de tiempo: 365 days after result
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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.
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365 days after result
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Number of Prescriptions for Diabetes-Related Medications
Periodo de tiempo: 180 days after result
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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.
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180 days after result
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Total Number of Outpatient Healthcare
Periodo de tiempo: 180 days after result
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Total count of outpatient visits across all specialties following the index A1c result
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180 days after result
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Numbers of Referrals to Endocrinology
Periodo de tiempo: 14 days after initial result
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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.
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14 days after initial result
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Number of Referrals to Nutrition Services
Periodo de tiempo: 14 days after initial result
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Number 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.
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14 days after initial result
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Number of Referrals to Diabetes Education
Periodo de tiempo: 14 days after initial result
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Number 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.
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14 days after initial result
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Number of Completed Endocrinology Visit
Periodo de tiempo: 180 days after result
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Number 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.
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180 days after result
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Completed Nutrition Services Visit
Periodo de tiempo: 180 days after result
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Number 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.
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180 days after result
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Completed Appointments to Diabetes Education
Periodo de tiempo: 180 days after result
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Number 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.
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180 days after result
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Number of Patient MyChart Messages
Periodo de tiempo: 7 days after viewing lab result
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Count of MyChart Test Result Messages
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7 days after viewing lab result
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Numbers of Phone Calls Received after A1c Results
Periodo de tiempo: 7 days after viewing lab result
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Count of telephone encounters to ordering provider
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7 days after viewing lab result
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Self-Reported Quality of Life
Periodo de tiempo: 30 days after initial survey invitation
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Patient-reported quality of life assessed using survey responses evaluating overall physical, mental, and health-related well-being following receipt of lab result communication.
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30 days after initial survey invitation
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Self-Reported Physical Function Following Lab Result
Periodo de tiempo: 30 days after initial survey invitation
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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.
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30 days after initial survey invitation
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Self-Reported Dietary Behaviors Following Lab Result
Periodo de tiempo: 30 days after initial survey invitation
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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.
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30 days after initial survey invitation
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Patient Understanding and Anxiety Related to Lab Result Communication
Periodo de tiempo: 7 days after results
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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.
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7 days after results
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Number of Incidence of Diabetes
Periodo de tiempo: 3 years
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Proportion of participants who progress from prediabetes to diabetes based on electronic health record data, defined by meeting diagnostic criteria for diabetes during follow-up.
This outcome is included to monitor long-term clinical safety and progression.
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3 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB-24-6052
- P30AG073104 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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