Eine Studie über Sprachdolmetscherlösungen für Menschen mit Brustkrebs
RSMI HEALS (Health Equity Advances Through Language Solutions) (KI)
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.
Studienübersicht
Status
Bedingungen
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Francesca Gany, MD, MS
- Telefonnummer: 646-888-8054
- E-Mail: ganyf@mskcc.org
Studieren Sie die Kontaktsicherung
- Name: Lisa Diamond, MD
- Telefonnummer: 646-888-8061
- E-Mail: diamondl@mskcc.org
Studienorte
-
-
New Jersey
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Basking Ridge, New Jersey, Vereinigte Staaten, 07920
- Rekrutierung
- Memorial Sloan Kettering Basking Ridge (Consent Only)
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Kontakt:
- Francesca Gany, MD, MS
- Telefonnummer: 646-888-8054
-
Middletown, New Jersey, Vereinigte Staaten, 07748
- Rekrutierung
- Memorial Sloan Kettering Monmouth (Consent Only)
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Kontakt:
- Fransecsa Gany, MD, MS
- Telefonnummer: 646-888-8054
-
Montvale, New Jersey, Vereinigte Staaten, 07645
- Rekrutierung
- Memorial Sloan Kettering Bergen (Consent Only)
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Kontakt:
- Francesca Gany, MD, MS
- Telefonnummer: 646-888-8054
-
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New York
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Commack, New York, Vereinigte Staaten, 11725
- Rekrutierung
- Memorial Sloan Kettering Suffolk- Commack (Consent Only)
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Kontakt:
- Francesca Gany, MD, MS
- Telefonnummer: 646-888-8054
-
Harrison, New York, Vereinigte Staaten, 10604
- Rekrutierung
- Memorial Sloan Kettering Westchester (Consent Only)
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Kontakt:
- Francesca Gany, MD, MS
- Telefonnummer: 646-888-8054
-
New York, New York, Vereinigte Staaten, 10065
- Rekrutierung
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Kontakt:
- Francesca Gany, MD, MS
- Telefonnummer: 646-888-8054
-
New York, New York, Vereinigte Staaten, 10035
- Rekrutierung
- Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)
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Kontakt:
- Francesca Gany, MD
- Telefonnummer: 646-888-8054
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Rockville Centre, New York, Vereinigte Staaten, 11553
- Rekrutierung
- Memorial Sloan Kettering Nassau (All Protocol Activities)
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Kontakt:
- Franscesca Gany, MD, MS
- Telefonnummer: 646-888-8054
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Experimental: 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 |
|
Experimental: 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 |
|
Experimental: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Number of interpretation errors
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Francesca Gany, MD, MS, Memorial Sloan Kettering Cancer Center
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 24-350
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
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.
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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