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

September 7, 2026 updated by: 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

Study Overview

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients illiterate in their preferred language who received audio instructions
audio discharge patient education provided in preferred language
audio instructions in preferred language

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Acceptability of Audio Discharge Instructions
Time Frame: 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
Time Frame: 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rose Ann Huynh, MD, MS, Women and Infants Hospital Rhode Island

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

July 28, 2026

First Submitted That Met QC Criteria

September 7, 2026

First Posted (Actual)

September 10, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • WIH-2323225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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