乳がん患者のための言語通訳ソリューションに関する研究
RSMI HEALS (言語ソリューションによる健康の公平性の向上) (AI)
The study will be conducted in 2 overlapping phases. In Phase 1, there will be a 3-arm randomized controlled trial of Remote Simultaneous Medical Interpreting/RSMI (Arm 1), versus Remote Consecutive Medical Interpreting/RCMI (Arm 2) and versus Remote Consecutive Video Medical Interpreting/RCVI (Arm 3) in breast cancer outpatient clinical encounters with Spanish- and Mandarin-speaking patients with Limited English Proficiency/LEP (Stages II and III disease) and English- speaking providers (who do not speak Spanish/Mandarin). In Phase 2, there will be a sequential mixed-methods explanatory, multi-stakeholder process evaluation to gather implementation potential data.
調査の概要
状態
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：Francesca Gany, MD, MS
- 電話番号：646-888-8054
- メール：ganyf@mskcc.org
研究連絡先のバックアップ
- 名前：Lisa Diamond, MD
- 電話番号：646-888-8061
- メール：diamondl@mskcc.org
研究場所
-
-
New Jersey
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Basking Ridge、New Jersey、アメリカ、07920
- 募集
- Memorial Sloan Kettering Basking Ridge (Consent Only)
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コンタクト：
- Francesca Gany, MD, MS
- 電話番号：646-888-8054
-
Middletown、New Jersey、アメリカ、07748
- 募集
- Memorial Sloan Kettering Monmouth (Consent Only)
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コンタクト：
- Fransecsa Gany, MD, MS
- 電話番号：646-888-8054
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Montvale、New Jersey、アメリカ、07645
- 募集
- Memorial Sloan Kettering Bergen (Consent Only)
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コンタクト：
- Francesca Gany, MD, MS
- 電話番号：646-888-8054
-
-
New York
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Commack、New York、アメリカ、11725
- 募集
- Memorial Sloan Kettering Suffolk- Commack (Consent Only)
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コンタクト：
- Francesca Gany, MD, MS
- 電話番号：646-888-8054
-
Harrison、New York、アメリカ、10604
- 募集
- Memorial Sloan Kettering Westchester (Consent Only)
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コンタクト：
- Francesca Gany, MD, MS
- 電話番号：646-888-8054
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New York、New York、アメリカ、10065
- 募集
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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コンタクト：
- Francesca Gany, MD, MS
- 電話番号：646-888-8054
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New York、New York、アメリカ、10035
- 募集
- Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)
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コンタクト：
- Francesca Gany, MD
- 電話番号：646-888-8054
-
Rockville Centre、New York、アメリカ、11553
- 募集
- Memorial Sloan Kettering Nassau (All Protocol Activities)
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コンタクト：
- Franscesca Gany, MD, MS
- 電話番号：646-888-8054
-
-
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:
Phase I Patients
- Age >=18 years (per EMR)
- Preferred language for healthcare is Spanish or Mandarin (per self-report)
- Limited English Proficient; cannot speak English "very well" (per self-report)
- Diagnosis of breast cancer or gastrointestinal (per EMR)
- Will be visiting MSK oncology teams for the first or second appointment (per EMR)
- Agrees to be audio-recorded (per self-report)
Phase 1 Providers
- Breast or gastrointestinal cancer provider who sees patients (e.g., breast or gastrointestinal oncologists, advanced practice providers, and/or nurses)
- Does not speak Spanish and/or Mandarin; providers who speak one language and not the other may participate (e.g., speaks Spanish but not Mandarin) (per self-report)
- Agrees to be audio-record (per self-report) Phase 2 (clinic staff only; patient participants will be drawn from Phase 1)
- Is a staff member who works/worked in one of the study clinic sites during the period of Phase 1 RCT study activities
- Agrees to be audio-recorded (per self-report)
Exclusion Criteria:
Phase 1 Patients
- Has significant psychiatric disturbance (i.e., acute psychiatric symptoms) sufficient to preclude completion of the assessments, interviews, or informed consent (per EMR, patient's care team, or study team)
- Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection (per EMR, patients, care team, or study team)
Phase I Providers
- None
Phase 2 (clinic staff only; Phase 1 patient participants follow above criteria)
- None
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：Phase I: Remote Simultaneous Medical Interpreting/RSMI (Arm 1)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers |
Remote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter, which holds tremendous promise for closely approximating a same language encounter, decreasing interpreting errors, and improving outcomes. |
|
実験的：Phase I: Remote Consecutive Medical Interpreting/RCMI (Arm 2)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers |
Remote Consecutive Medical Interpreting (RCMI; "audio consecutive"), is the most commonly utilized remote interpreting |
|
実験的：Phase I: Remote Consecutive Video Medical Interpreting/RCVI (Arm 3)
This phase will enroll Spanish- and Mandarin-speaking patients with LEP (Stages II and III disease) and English- speaking providers |
Remote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter |
|
実験的：Phase II: CFIR mixed-methods explanatory, multi- stakeholder process evaluation
Will examine RSMI utilization (Arm 1 participants only and clinic staff), intervention barriers and facilitators, and implementation potential |
Remote Simultaneous Medical Interpreting (RSMI), "UN-style" simultaneous interpreting applied to the medical encounter, which holds tremendous promise for closely approximating a same language encounter, decreasing interpreting errors, and improving outcomes. |
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 |
|---|---|---|
|
Number of interpretation errors
時間枠：up to 30 days
|
Via translation and transcription of audio recordings, errors will be determined in the interpretation of medical facts made in each of the RCT arms during Study Visit 1 (post- diagnosis) |
up to 30 days
|
協力者と研究者
捜査官
- 主任研究者：Francesca Gany, MD, MS、Memorial Sloan Kettering Cancer Center
出版物と役立つリンク
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
本研究に関する用語
その他の研究ID番号
- 24-350
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
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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。