Comunicazione del risultato di medicina di precisione incentrata sul paziente per gli anziani
Strumento di comunicazione del risultato di laboratorio centrato sul paziente per adulti più anziani con emoglobina elevata A1C (A1C) o malattia renale cronica (CKD)
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Katelyn Nguyen Assistant Clinical Research Coordinator
- Numero di telefono: 310-267-5250
- Email: katenguyen@mednet.ucla.edu
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90049
- UCLA Health System
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Contatto:
- Katelyn Assistant Clinical Research Coordinator
- Numero di telefono: 310-267-5250
- Email: csarkisian@mednet.ucla.edu
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Contatto:
- Catherine Sarkisian, MD
- Numero di telefono: 3102068272
- Email: csarkisian@mednet.ucla.edu
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Investigatore principale:
- Catherine Sarkisian, MD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto più anziano
Accetta volontari sani
Descrizione
Criteri di inclusione:
Criteri di inclusione dei pazienti: adulti più anziani (di età> 65 anni) con un fornitore di cure primarie dell'UCLA che sono:
- Iscritto nel portale del paziente;
- Speaking inglese (poiché la lingua dello strumento è attualmente in inglese e non sarebbe pratico avere traduzioni convalidate create per tutte le potenziali variazioni e derivati dei modelli dello strumento); E
- Senza demenza o altre malattie neurocognitive.
Criteri di inclusione del fornitore:
-UCLA I fornitori di servizi sanitari che si prendono cura di un gran numero di adulti più anziani in contesti ambulatoriali.
Criteri di esclusione:
Criteri di esclusione del paziente:
- Avere risultati di laboratorio al di fuori degli intervalli di inclusione definiti;
- Non hanno un PCP UCLA;
- Hanno meno di 65 anni;
- Non stanno parlando in inglese (poiché i prototipi dello strumento sono solo in inglese fino a quando non viene determinato la verbosità finale);
- Non sono iscritti al portale del paziente UCLA MyChart; O
- Sono diagnosticati con demenza
Criteri di esclusione del fornitore:
-Non cura di un gran numero di adulti più anziani in ambienti ambulatoriali
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Prediabetes- Related Healthcare Utilization
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Number of Repeat Hemoglobin A1c Tests
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Self-Reported Quality of Life
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
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Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB-24-6052
- P30AG073104 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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