高齢者向けの患者中心の精密医療ラボの結果コミュニケーション
ヘモグロビンA1C（A1C）または慢性腎疾患（CKD）の上昇を伴う高齢者向けの患者中心のラボ結果コミュニケーションツール
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Katelyn Nguyen Assistant Clinical Research Coordinator
- 電話番号：310-267-5250
- メール：katenguyen@mednet.ucla.edu
研究場所
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California
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Los Angeles、California、アメリカ、90049
- 募集
- UCLA Health System
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コンタクト：
- Katelyn Assistant Clinical Research Coordinator
- 電話番号：310-267-5250
- メール：csarkisian@mednet.ucla.edu
-
コンタクト：
- Catherine Sarkisian, MD
- 電話番号：3102068272
- メール：csarkisian@mednet.ucla.edu
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主任研究者：
- Catherine Sarkisian, MD
-
-
参加基準
適格基準
就学可能な年齢
- 高齢者
健康ボランティアの受け入れ
説明
包含基準：
患者の包含基準：UCLAプライマリケアプロバイダーとの高齢者（65歳以上）：
- 患者ポータルに登録。
- 英語を話す（ツールの言語は現在英語のみであり、ツールモックアップのすべての潜在的なバリエーションと派生物のために作成された翻訳を検証したことは実用的ではないでしょう）。そして
- 認知症や他の神経認知疾患なし。
プロバイダーインクルージョン基準：
- 外来患者の環境で多数の高齢者を気にするUCLAの医療提供者。
除外基準：
患者の除外基準：
- 定義された包含範囲の外側にラボの結果があります。
- UCLA PCPを持っていません。
- 65歳未満です。
- 英語を話すものではありません（ツールのプロトタイプは最終的な言葉遣いが決定されるまで英語のみです）。
- UCLA MyChart患者ポータルに登録されていません。または
- 認知症と診断されます
プロバイダー除外基準：
- 外来患者の環境で多数の高齢者を気にしない
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prediabetes- Related Healthcare Utilization
時間枠：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.
|
365 days after result
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of Repeat Hemoglobin A1c Tests
時間枠：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.
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365 days after result
|
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Number of Prescriptions for Diabetes-Related Medications
時間枠：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.
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180 days after result
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Total Number of Outpatient Healthcare
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
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180 days after result
|
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Completed Appointments to Diabetes Education
時間枠：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.
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180 days after result
|
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Number of Patient MyChart Messages
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Self-Reported Quality of Life
時間枠：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.
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30 days after initial survey invitation
|
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Self-Reported Physical Function Following Lab Result
時間枠：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
時間枠：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
時間枠：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.
|
7 days after results
|
|
Number of Incidence of Diabetes
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。