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Pasientsentrert presisjonsmedisin Laboratorieringskommunikasjon for eldre voksne

7. juli 2026 oppdatert av: Catherine A. Sarkisian, University of California, Los Angeles

Pasientsentrert laboratorieresultatkommunikasjonsverktøy for eldre voksne med forhøyet hemoglobin A1C (A1C) eller kronisk nyresykdom (CKD)

For voksne> 65 år og deres leverandører vil vi teste brukervennligheten og utformingen av et verktøy for å erstatte standard ensartet rapportering av laboratorieresultater til pasienter og deres leverandører med et nytt personlig EHR-laboratorieresultatkommunikasjonsverktøy som: 1) trekker ut pasientnivå fra EHR; 2) beregner individuell risiko; og 3) for pasienter med veldig lav risiko, formidler den individualiserte risikoinformasjonen. Vi vil bruke en rekke brukeropplevelsesmetoder for å forstå hvordan pasient- og leverandørbrukere samhandler med det nye laboratorieresultatkommunikasjonsverktøyet og for å vurdere deres forståelse av laboratorieresultatene.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Antatt)

1200

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • Los Angeles, California, Forente stater, 90049
        • Rekruttering
        • UCLA Health System
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Catherine Sarkisian, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inkluderingskriterier:

Kriterier for inkludering av pasienter: eldre voksne (i alderen> 65 år) med en UCLA primærpleier som er:

  • Registrert i pasientportalen;
  • Engelsktalende (som verktøyets språk er foreløpig bare på engelsk, og det vil være upraktisk å ha validerte oversettelser laget for alle potensielle variasjoner og derivater av verktøyet mock-ups); og
  • Uten demens eller annen nevrokognitiv sykdom.

Kriterier for leverandør inkludering:

-ECLA helsetilbydere som pleier et stort antall eldre voksne i polikliniske omgivelser.

Eksklusjonskriterier:

Kriterier for eksklusjon av pasienter:

  • Har laboratorieresultater utenfor de definerte inkluderingsområdene;
  • Har ikke en UCLA PCP;
  • Er under 65 år;
  • Er ikke engelsktalende (ettersom verktøyprototypene bare er på engelsk før endelige verbiage er bestemt);
  • Er ikke registrert i UCLA Mychart pasientportal; eller
  • Får diagnosen demens

Kriterier for eksklusjon av leverandører:

-E ikke bry deg om et stort antall eldre voksne i polikliniske innstillinger

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Hemoglobin A1c Lab Result Communication Tool
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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prediabetes- Related Healthcare Utilization
Tidsramme: 365 days after result
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.
365 days after result

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Repeat Hemoglobin A1c Tests
Tidsramme: 365 days after result
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.
365 days after result
Number of Prescriptions for Diabetes-Related Medications
Tidsramme: 180 days after result
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.
180 days after result
Total Number of Outpatient Healthcare
Tidsramme: 180 days after result
Total count of outpatient visits across all specialties following the index A1c result
180 days after result
Numbers of Referrals to Endocrinology
Tidsramme: 14 days after initial result
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.
14 days after initial result
Number of Referrals to Nutrition Services
Tidsramme: 14 days after initial result
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.
14 days after initial result
Number of Referrals to Diabetes Education
Tidsramme: 14 days after initial result
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.
14 days after initial result
Number of Completed Endocrinology Visit
Tidsramme: 180 days after result
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.
180 days after result
Completed Nutrition Services Visit
Tidsramme: 180 days after result
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.
180 days after result
Completed Appointments to Diabetes Education
Tidsramme: 180 days after result
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.
180 days after result
Number of Patient MyChart Messages
Tidsramme: 7 days after viewing lab result
Count of MyChart Test Result Messages
7 days after viewing lab result
Numbers of Phone Calls Received after A1c Results
Tidsramme: 7 days after viewing lab result
Count of telephone encounters to ordering provider
7 days after viewing lab result

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-Reported Quality of Life
Tidsramme: 30 days after initial survey invitation
Patient-reported quality of life assessed using survey responses evaluating overall physical, mental, and health-related well-being following receipt of lab result communication.
30 days after initial survey invitation
Self-Reported Physical Function Following Lab Result
Tidsramme: 30 days after initial survey invitation
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.
30 days after initial survey invitation
Self-Reported Dietary Behaviors Following Lab Result
Tidsramme: 30 days after initial survey invitation
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.
30 days after initial survey invitation
Patient Understanding and Anxiety Related to Lab Result Communication
Tidsramme: 7 days after results
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.
7 days after results
Number of Incidence of Diabetes
Tidsramme: 3 years
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.
3 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, Los Angeles

Samarbeidspartnere

National Institute on Aging (NIA)

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

27. mai 2026

Primær fullføring (Antatt)

1. november 2026

Studiet fullført (Antatt)

1. september 2029

Datoer for studieregistrering

Først innsendt

20. mai 2025

Først innsendt som oppfylte QC-kriteriene

20. mai 2025

Først lagt ut (Faktiske)

29. mai 2025

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. juli 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-24-6052
  • P30AG073104 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

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