- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07813325
Closing the Gap in Language With Audio Instructions: An Exploratory Pilot Study
Significance: Not all patients can read discharge instructions even when the documentation is provided in their preferred language. Our emergency department strives to provide language-concordant discharge instructions to all patients; however, we do not have access to written instructions in Haitian creole, K'iche, or other less commonly spoken languages. Providers often give these patients discharge instructions in English, or the next closest language, such as French for our Haitian creole speaking patients, or Spanish for K'iche speaking patients. Discharge instructions are also provided verbally using a language-concordant phone interpreter. However, connectivity issues and interpreter access often pose challenges to effective communication and verbal instructions are often an overwhelming amount of information to process and remember. At Women and Infants Hospital, the most vulnerable populations are Haitian Creole and K'iche, but those of Spanish speaking descent are also at risk.
Hypothesis/Outcomes: For patients who cannot read in their preferred language, if they are provided audio instructions in their preferred language, these instructions will be acceptable, feasible, and useful to patients.
Procedures:
- Establish Degree of the Problem
Administer initial exploratory survey (part of the post-intervention survey) to:
- Determine literacy
- Preferred mode of instructions: written vs audio vs video
- Satisfaction of discharge instructions from previous experiences
Provide Intervention
- Work with interpreter services to interpret audio instructions in Spanish, Haitian Creole and K'iche for the following complaints: Labor/Preterm Labor, Vaginal Bleeding in Pregnancy (2TM/3TM and threatened miscarriage), Fetal Kick Counts
- Store Audio Instructions on an online database with associated QR code.
Post-Intervention Survey
- Medical student will verbally go through the post-intervention survey with patients
- To be provided within 48-72 hours post-discharge
- Medical student to confirm telephone number and good time to call.
- Will include an extra question concerning how many times they listened to the audio recording VS having the QR code record the number of listens.
Post-Intervention Survey Questions
Patient identification question:
- Name
- DOB
- MRN
- What is your preferred language?
- Are you able to understand written text? Y N
- Have you ever been asked if you understand written text in the healthcare setting?
- If you have received written instructions from any hospital prior, what was your satisfaction with them?
- On a scale of 0-10, how helpful were the audio discharge instructions?
- Did you feel confident in the instructions you received? Y N
- How many times did you or your family members listen to the audio recording?
- Would you use the audio discharge tool in the future?
- Would you recommend the audio discharge tool to others?
- In your own words, can you describe how the audio discharge tool helped you understand your medical care?
- Can you tell us one thing you learned from the instructions?
- Is there another form of instructions you prefer: Written, Audio only, Video with Audio
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rose Ann Huynh, MD, MS
- Número de teléfono: 15042510803
- Correo electrónico: rhuynh@carene.org
Copia de seguridad de contactos de estudio
- Nombre: Joni Harris, MS, CCRP
- Número de teléfono: 48553 401-274-1122
- Correo electrónico: jonharris@wihri.org
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pregnant patients with intrauterine pregnancies of all gestational ages
- Preferred language is Spanish, Haitian Creole or K'iche
- Discharge plan or order in place
- Chief Complaint/Diagnosis is:
- Labor/Preterm Labor
- Vaginal Bleeding in Pregnancy (2TM/3TM and threatened miscarriage)
- Decreased fetal movement
- Access to a smart phone
Exclusion Criteria:
- Declines intervention
- Does not have one of the above chief complaints/diagnoses
- Preferred language is Spanish and are literate in Spanish
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Patients illiterate in their preferred language who received audio instructions
audio discharge patient education provided in preferred language
|
audio instructions in preferred language
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient Acceptability of Audio Discharge Instructions
Periodo de tiempo: From enrollment to 72 hours after discharge/provision of patient audio education
|
Patient acceptability of the audio discharge instructions will be assessed using 5-point Likert-type response options for satisfaction with the instructions, ease of access, helpfulness, and confidence in the instructions received.
Responses range from 1 (Very Dissatisfied) to 5 (Very Satisfied), with higher scores indicating greater acceptability and a better outcome.
|
From enrollment to 72 hours after discharge/provision of patient audio education
|
|
Feasibility of Intervention
Periodo de tiempo: From enrollment to conclusion of data collection.
|
To be determined by 2 measures:
|
From enrollment to conclusion of data collection.
|
|
Usefulness of Audio Discharge Instructions to Patients
Periodo de tiempo: From enrollment to 72 hours after discharge/provision of patient audio education
|
Perceived usefulness of the audio discharge instructions will be assessed using 2 measures:
|
From enrollment to 72 hours after discharge/provision of patient audio education
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Rose Ann Huynh, MD, MS, Women and Infants Hospital Rhode Island
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- WIH-2323225
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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