脳の健康に関する研究: 実用的で患者中心の臨床試験 (eRADAR)
電子医療記録データを使用した低コストの認知症検出: 実用的な患者中心の試験における電子医療記録のアルツハイマー病リスクおよび認知症評価ルール (eRADAR) アルゴリズムの検証とテスト。
The eRADAR Brain Health Study is an embedded, pragmatic clinical trial to determine whether targeted screening for dementia using the eRADAR algorithm increases dementia detection within primary care compared to usual care.
調査の概要
詳細な説明
eRADAR stands for "electronic health record (EHR) Risk of Alzheimer's and Dementia Assessment Rule." It is a low-cost tool or algorithm that uses readily available EHR data elements to identify patients at risk of undiagnosed dementia. The investigators will conduct a pragmatic randomized controlled trial to assess the impact of implementing eRADAR as part of a supported outreach process on dementia detection rates. The investigators will also explore the impact of eRADAR implementation on healthcare utilization and patient experience.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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California
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San Francisco、California、アメリカ、94107
- UCSF Primary Care at China Basin
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San Francisco、California、アメリカ、94115
- Division of General Internal Medicine
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San Francisco、California、アメリカ、94143
- Women's Health Primary Care
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- No prior diagnosis of dementia (defined from EHR diagnosis codes) and not receiving medications for dementia
- Active patient at participating clinic
- Adequate data to calculate eRADAR score
Exclusion Criteria:
- Currently receiving hospice care
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：ふるい分け
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Brain Health Intervention
Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician (PCP), who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable. |
Research interventionists, who will be trained and licensed health practitioners (e.g., social workers), will ask participants about changes in memory or thinking and daily function, screen for depression, and administer a standard cognitive screening test. Research interventionalists will use a standardized note template to document results in the participant's EHR. Research interventionists will notify participants and PCPs if follow-up is recommended. |
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介入なし：Usual Care
Individuals in this arm did not receive any intervention but rather usual care. University of California, San Francisco (UCSF) does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force). |
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 |
|---|---|---|
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New Diagnoses of Dementia (12 Months)
時間枠：12 months after index date
|
Number of patients who received new dementia diagnoses within 12 months, identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes |
12 months after index date
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
New Diagnoses of Dementia or Mild Cognitive Impairment (12 Months)
時間枠：12 months after index date
|
Number of patients who received a new diagnosis of dementia or mild cognitive impairment within 12 months, defined from EHR data |
12 months after index date
|
|
New Diagnoses of Dementia (18 Months)
時間枠：18 months after index date
|
Number of patients who received a new diagnosis of dementia within 18 months of index date, defined from EHR data |
18 months after index date
|
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New Diagnoses of Dementia (6 Months)
時間枠：6 months after index date
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Number of patients receiving new dementia diagnoses within 6 months of index date, defined using EHR data |
6 months after index date
|
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New Dementia Medications (12 Months)
時間枠：12 months after index date
|
Number of patients who received a new medication for dementia in 12 months, defined from medication orders or dispensings in the electronic health record |
12 months after index date
|
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Urgent Care or Emergency Department Visits (12 Months)
時間枠：12 months after index date
|
Number of patients who had at least 1 urgent care or emergency department visit in the 12 months following their index date |
12 months after index date
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Hospitalizations and Inpatient Admissions (12 Months)
時間枠：12 months after index date
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Average number of hospitalizations and inpatient stays per participant within 12 months of index date |
12 months after index date
|
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Scheduled Visits Missed (12 Months)
時間枠：12 months after index date
|
Average number of scheduled clinic visits missed ("no shows") per participant |
12 months after index date
|
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Primary Care Visits (6 Months)
時間枠：6 months after index date
|
Average number of visits per participant in primary care within 6 months after the index date |
6 months after index date
|
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Primary Care Visits (12 Months)
時間枠：12 months after index date
|
Average number of primary care visits per participant in the 12 months after their index date |
12 months after index date
|
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B-12 Lab Tests (12 Months)
時間枠：12 months after index date
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Number of patients with at least one B12 lab test in the 12 months after their index date |
12 months after index date
|
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Neuroimaging Tests (12 Months)
時間枠：12 months after index date
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Number of patients with at least one neuroimaging study (CT head, MRI brain) in the 12 months after their index date |
12 months after index date
|
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Neurology Referrals (12 Months)
時間枠：12 months after index date
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Number of patients with at least one referral to Neurology or the Memory and Aging Center in the 12 months after their index date |
12 months after index date
|
協力者と研究者
捜査官
- 主任研究者：Sascha Dublin, MD, PhD、KP Washington Health Research Institute
- 主任研究者：Deborah Barnes, PhD、University of California, San Francisco
出版物と役立つリンク
一般刊行物
- Barnes DE, Zhou J, Walker RL, Larson EB, Lee SJ, Boscardin WJ, Marcum ZA, Dublin S. Development and Validation of eRADAR: A Tool Using EHR Data to Detect Unrecognized Dementia. J Am Geriatr Soc. 2020 Jan;68(1):103-111. doi: 10.1111/jgs.16182. Epub 2019 Oct 14.
- Lee SJ, Larson EB, Dublin S, Walker R, Marcum Z, Barnes D. A Cohort Study of Healthcare Utilization in Older Adults with Undiagnosed Dementia. J Gen Intern Med. 2018 Jan;33(1):13-15. doi: 10.1007/s11606-017-4162-3. No abstract available.
- Coley RY, Smith JJ, Karliner L, Idu AE, Lee SJ, Fuller S, Lam R, Barnes DE, Dublin S. External Validation of the eRADAR Risk Score for Detecting Undiagnosed Dementia in Two Real-World Healthcare Systems. J Gen Intern Med. 2023 Feb;38(2):351-360. doi: 10.1007/s11606-022-07736-6. Epub 2022 Jul 29.
- Dublin S, Greenwood-Hickman MA, Karliner L, Hsu C, Coley RY, Colemon L, Carrasco A, King D, Grace A, Lee SJ, Walsh JME, Barrett T, Broussard J, Singh U, Idu A, Yaffe K, Boustani M, Barnes DE. The electronic health record Risk of Alzheimer's and Dementia Assessment Rule (eRADAR) Brain Health Trial: Protocol for an embedded, pragmatic clinical trial of a low-cost dementia detection algorithm. Contemp Clin Trials. 2023 Dec;135:107356. doi: 10.1016/j.cct.2023.107356. Epub 2023 Oct 17.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
本研究に関する用語
その他の研究ID番号
- 1R01AG069734 (米国 NIH グラント/契約)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
This Individual Participant Data (IPD) plan applies to all quantitative study data, such as data collected specifically for the study and those derived from electronic health records (EHR), as well as the data collected via planned study surveys, which include only short qualitative free-text fields. The investigators do not plan to share transcripts from in-depth qualitative interviews or recorded study assessment visits.
Data will be maintained on secure servers behind the firewalls at the University of California, San Francisco (UCSF). De-identified or limited datasets containing individual-level data on which publications are based will be made available to qualified researchers for specified analyses. The investigators will make the data available to users only under a data-use agreement (DUA).
IPD 共有時間枠
Data can be requested after the primary study paper is accepted for publication, up until 5 years after study completion.
IPD 共有アクセス基準
Individuals interested in using data will be required to complete a standard form, sign a Data Use Agreement (DUA) and provide documentation of IRB approval. User registration will be required in order to access or download data files. As part of the registration process, users must agree to the conditions of use governing access to the data, including restrictions against attempting to identify study participants, destruction of the data after analyses are completed, reporting responsibilities, restrictions on redistribution of the data to third parties, and proper acknowledgment of the data resource. The UCSF Industry Contracts Division (ICD), which oversees incoming and outgoing transfer of all UCSF data, will review registration materials for compliance with UCSF policies.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。