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Closing the Gap in Language With Audio Instructions: An Exploratory Pilot Study

7 de septiembre de 2026 actualizado por: Women and Infants Hospital of Rhode Island

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:

  1. Establish Degree of the Problem
  2. 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
  3. 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.
  4. 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

  1. Patient identification question:

    • Name
    • DOB
    • MRN
  2. What is your preferred language?
  3. Are you able to understand written text? Y N
  4. Have you ever been asked if you understand written text in the healthcare setting?
  5. If you have received written instructions from any hospital prior, what was your satisfaction with them?
  6. On a scale of 0-10, how helpful were the audio discharge instructions?
  7. Did you feel confident in the instructions you received? Y N
  8. How many times did you or your family members listen to the audio recording?
  9. Would you use the audio discharge tool in the future?
  10. Would you recommend the audio discharge tool to others?
  11. In your own words, can you describe how the audio discharge tool helped you understand your medical care?
  12. Can you tell us one thing you learned from the instructions?
  13. Is there another form of instructions you prefer: Written, Audio only, Video with Audio

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

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

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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:

  • Participant's ease of accessing the audio discharge instructions will be assessed using 5-point Likert-type response options. Responses range from 1 (Very Difficult) to 5 (Very Easy), with higher scores indicating greater acceptability and a better outcome.
  • The number of times the participant or loved ones listened to audio instructions with a score >0 indicating feasibility of receiving instructions
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:

  • A 5-point Likert-type scale ranging from 1 (Very Unhelpful) to 5 (Very Helpful). Higher scores indicate greater perceived usefulness and a better outcome.
  • Participant's understanding of discharge instructions will be rated by the Understanding of Discharge Instructions (UDI) Scale. Responses will be categorized from 1 (Poor Understanding) to 4 (Excellent Understanding) based on the number of return precautions they can discuss without omissions or inaccuracies.
From enrollment to 72 hours after discharge/provision of patient audio education

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Rose Ann Huynh, MD, MS, Women and Infants Hospital Rhode Island

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

15 de septiembre de 2026

Finalización primaria (Estimado)

31 de diciembre de 2026

Finalización del estudio (Estimado)

31 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

7 de septiembre de 2026

Publicado por primera vez (Actual)

10 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

7 de septiembre de 2026

Última verificación

1 de julio de 2026

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)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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