Comunicação do Laboratório de Medicina de Precisão Centrada no Paciente para Adultos idosos
Ferramenta de comunicação de resultado do laboratório centrada no paciente para adultos mais velhos com hemoglobina A1C (A1C) ou doença renal crônica (DRC) (DRC)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Katelyn Nguyen Assistant Clinical Research Coordinator
- Número de telefone: 310-267-5250
- E-mail: katenguyen@mednet.ucla.edu
Locais de estudo
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California
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Los Angeles, California, Estados Unidos, 90049
- Recrutamento
- UCLA Health System
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Contato:
- Katelyn Assistant Clinical Research Coordinator
- Número de telefone: 310-267-5250
- E-mail: csarkisian@mednet.ucla.edu
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Contato:
- Catherine Sarkisian, MD
- Número de telefone: 3102068272
- E-mail: csarkisian@mednet.ucla.edu
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Investigador principal:
- Catherine Sarkisian, MD
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Critérios de inclusão:
Critérios de inclusão do paciente: adultos mais velhos (com idade> 65 anos) com um prestador de cuidados primários da UCLA:
- Inscrito no portal do paciente;
- Atualmente, a língua inglesa (como o idioma da ferramenta é apenas em inglês, e seria impraticável ter validado traduções criadas para todas as variações e derivados em potencial das modelos de ferramentas); e
- Sem demência ou outra doença neurocognitiva.
Critérios de inclusão de provedores:
-Ucla Provedores de saúde que cuidam de um grande número de adultos mais velhos em ambientes ambulatoriais.
Critérios de exclusão:
Critérios de exclusão do paciente:
- Ter resultados de laboratório fora dos intervalos de inclusão definidos;
- Não possui um pcp da UCLA;
- Têm menos de 65 anos;
- Não são falantes em inglês (pois os protótipos da ferramenta são apenas em inglês até que a verborragem final seja determinada);
- Não estão inscritos no portal de pacientes da UCLA MyChart; ou
- São diagnosticados com demência
Critérios de exclusão de provedores:
-Não não se importe com um grande número de adultos mais velhos em ambientes ambulatoriais
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
|
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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Prediabetes- Related Healthcare Utilization
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Repeat Hemoglobin A1c Tests
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 7 days after viewing lab result
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Count of telephone encounters to ordering provider
|
7 days after viewing lab result
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Self-Reported Quality of Life
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-24-6052
- P30AG073104 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
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