Une étude des solutions d'interprétation linguistique pour les personnes atteintes d'un cancer du sein
RSMI HEALS (L’équité en santé progresse grâce aux solutions linguistiques) (IA)
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Francesca Gany, MD, MS
- Numéro de téléphone: 646-888-8054
- E-mail: ganyf@mskcc.org
Sauvegarde des contacts de l'étude
- Nom: Lisa Diamond, MD
- Numéro de téléphone: 646-888-8061
- E-mail: diamondl@mskcc.org
Lieux d'étude
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New Jersey
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Basking Ridge, New Jersey, États-Unis, 07920
- Recrutement
- Memorial Sloan Kettering Basking Ridge (Consent Only)
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Contact:
- Francesca Gany, MD, MS
- Numéro de téléphone: 646-888-8054
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Middletown, New Jersey, États-Unis, 07748
- Recrutement
- Memorial Sloan Kettering Monmouth (Consent Only)
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Contact:
- Fransecsa Gany, MD, MS
- Numéro de téléphone: 646-888-8054
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Montvale, New Jersey, États-Unis, 07645
- Recrutement
- Memorial Sloan Kettering Bergen (Consent Only)
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Contact:
- Francesca Gany, MD, MS
- Numéro de téléphone: 646-888-8054
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New York
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Commack, New York, États-Unis, 11725
- Recrutement
- Memorial Sloan Kettering Suffolk- Commack (Consent Only)
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Contact:
- Francesca Gany, MD, MS
- Numéro de téléphone: 646-888-8054
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Harrison, New York, États-Unis, 10604
- Recrutement
- Memorial Sloan Kettering Westchester (Consent Only)
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Contact:
- Francesca Gany, MD, MS
- Numéro de téléphone: 646-888-8054
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New York, New York, États-Unis, 10065
- Recrutement
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
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Contact:
- Francesca Gany, MD, MS
- Numéro de téléphone: 646-888-8054
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New York, New York, États-Unis, 10035
- Recrutement
- Memorial Sloan Kettering at Ralph Lauren Center (All Protocol Activities)
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Contact:
- Francesca Gany, MD
- Numéro de téléphone: 646-888-8054
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Rockville Centre, New York, États-Unis, 11553
- Recrutement
- Memorial Sloan Kettering Nassau (All Protocol Activities)
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Contact:
- Franscesca Gany, MD, MS
- Numéro de téléphone: 646-888-8054
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of interpretation errors
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Francesca Gany, MD, MS, Memorial Sloan Kettering Cancer Center
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 24-350
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Informations sur les médicaments et les dispositifs, documents d'étude
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