Potilaskeskeinen tarkkuuslääketieteen laboratoriotulosviestintä vanhemmille aikuisille
Potilaskeskeinen laboratoriotuloksen viestintätyökalu vanhemmille aikuisille, joilla on kohonnut hemoglobiini A1C (A1C) tai krooninen munuaissairaus (CKD)
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Katelyn Nguyen Assistant Clinical Research Coordinator
- Puhelinnumero: 310-267-5250
- Sähköposti: katenguyen@mednet.ucla.edu
Opiskelupaikat
-
-
California
-
Los Angeles, California, Yhdysvallat, 90049
- Rekrytointi
- UCLA Health System
-
Ottaa yhteyttä:
- Katelyn Assistant Clinical Research Coordinator
- Puhelinnumero: 310-267-5250
- Sähköposti: csarkisian@mednet.ucla.edu
-
Ottaa yhteyttä:
- Catherine Sarkisian, MD
- Puhelinnumero: 3102068272
- Sähköposti: csarkisian@mednet.ucla.edu
-
Päätutkija:
- Catherine Sarkisian, MD
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Sisällyttämiskriteerit:
Potilaan sisällyttämiskriteerit: vanhemmat aikuiset (> 65 -vuotiaat) UCLA: n perusterveydenhuollon tarjoajan kanssa, jotka ovat:
- Ilmoittautui potilasportaaliin;
- Englanninkieliset (koska työkalun kieli on tällä hetkellä vain englanniksi, ja olisi epäkäytännöllistä validoitujen käännöksiä, jotka on luotu kaikkiin työkalujen mallistojen mahdollisille variaatioille ja johdannaisille); ja
- Ilman dementiaa tai muuta neurokognitiivista sairautta.
Palveluntarjoajan osallisuuskriteerit:
-UCLA: n terveydenhuollon tarjoajat, jotka hoitavat suurta määrää vanhempia aikuisia avohoidossa.
Poissulkemiskriteerit:
Potilaiden poissulkemiskriteerit:
- On laboratoriotuloksia määritellyn sisällyttämisalueiden ulkopuolella;
- Ei ole UCLA PCP: tä;
- Ovat alle 65 -vuotiaita;
- Eivät ole englanninkielisiä (koska työkaluprototyypit ovat vain englanniksi, kunnes lopullinen sanamuoto määritetään);
- Eivät ole ilmoittautuneet UCLA Mychart -potilasportaaliin; tai
- Diagnosoidaan dementia
Palveluntarjoajan poissulkemiskriteerit:
-Älä välitä suuresta määrästä vanhempia aikuisia avohoidossa
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Ei väliintuloa: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Prediabetes- Related Healthcare Utilization
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of Repeat Hemoglobin A1c Tests
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 7 days after viewing lab result
|
Count of telephone encounters to ordering provider
|
7 days after viewing lab result
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Self-Reported Quality of Life
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- IRB-24-6052
- P30AG073104 (Yhdysvaltain NIH-apuraha/sopimus)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .