Komunikacja wyników w laboratorium medycyny precyzyjnej medycyny precyzyjnej dla osób starszych
Narzędzie komunikacyjne wyników w laboratorium skoncentrowanym na pacjencie dla starszych dorosłych z podwyższoną hemoglobiną A1C (A1C) lub przewlekłą chorobą nerek (CKD)
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Katelyn Nguyen Assistant Clinical Research Coordinator
- Numer telefonu: 310-267-5250
- E-mail: katenguyen@mednet.ucla.edu
Lokalizacje studiów
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California
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Los Angeles, California, Stany Zjednoczone, 90049
- Rekrutacyjny
- UCLA Health System
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Kontakt:
- Katelyn Assistant Clinical Research Coordinator
- Numer telefonu: 310-267-5250
- E-mail: csarkisian@mednet.ucla.edu
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Kontakt:
- Catherine Sarkisian, MD
- Numer telefonu: 3102068272
- E-mail: csarkisian@mednet.ucla.edu
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Główny śledczy:
- Catherine Sarkisian, MD
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Kryteria włączenia:
Kryteria włączenia pacjenta: starsi dorośli (w wieku> 65 lat) z udziałem podstawowej opieki zdrowotnej UCLA:
- Zapisany do portalu pacjenta;
- Angielskojęzyczne (ponieważ język narzędzia jest obecnie tylko w języku angielskim i byłoby niepraktyczne, aby mieć potwierdzone tłumaczenia dla wszystkich potencjalnych odmian i pochodnych makiew narzędzi); I
- Bez demencji lub innej choroby neurokognitywnej.
Kryteria włączenia dostawcy:
-Ucla dostawcy opieki zdrowotnej, którzy opiekują się dużą liczbą starszych osób dorosłych w warunkach ambulatoryjnych.
Kryteria wykluczenia:
Kryteria wykluczenia pacjenta:
- Mieć wyniki laboratoryjne poza określonymi zakresami włączenia;
- Nie mieć UCLA PCP;
- Mają mniej niż 65 lat;
- Nie są anglojęzyczne (ponieważ prototypy narzędzi są tylko w języku angielskim do czasu ustalenia ostatecznego werbiage);
- Nie są zapisane do portalu pacjentów UCLA MyChart; Lub
- Zdiagnozowano demencję
Kryteria wykluczenia dostawcy:
-Nie dbaj o dużą liczbę osób starszych w warunkach ambulatoryjnych
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Prediabetes- Related Healthcare Utilization
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of Repeat Hemoglobin A1c Tests
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Self-Reported Quality of Life
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB-24-6052
- P30AG073104 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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