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Not yet recruitingNCT07813325Updated Nov 5, 2026

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

An interventional study of Audio Discharge patient education in Focus on Illiteracy in Patients and Optimal Patient Education, sponsored by Women and Infants Hospital of Rhode Island. Not yet recruiting. Open to female participants. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Women and Infants Hospital of Rhode Island · Not applicable, Interventional, and Supportive care

Updated Nov 5, 2026Start date movedPrimary completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Sex
Female
01

Study summary

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
02

Conditions studied

  • Focus on Illiteracy in Patients and Optimal Patient Education
03

In context

Lead sponsor

Women and Infants Hospital of Rhode Island is the lead sponsor of 93 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Declines intervention
  • Does not have one of the above chief complaints/diagnoses
  • Preferred language is Spanish and are literate in Spanish
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Patients illiterate in their preferred language who received audio instructions

    audio discharge patient education provided in preferred language

    Other: Audio Discharge patient education

Interventions

  • OtherAudio Discharge patient education

    audio instructions in preferred language

06

What researchers measure

Primary outcomes

  1. Patient Acceptability of Audio Discharge Instructions

    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.

    Time frame: From enrollment to 72 hours after discharge/provision of patient audio education

  2. Feasibility of Intervention

    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

    Time frame: From enrollment to conclusion of data collection.

  3. Usefulness of Audio Discharge Instructions to Patients

    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.

    Time frame: From enrollment to 72 hours after discharge/provision of patient audio education

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Austad K, Lee JH, Lanney H, Rapoport VO, Wornhoff R, McDaniel K, Li-Garrison L, Jack BW. Evaluating the quality and equity of patient hospital discharge instructions. BMC Health Serv Res. 2025 Feb 21;25(1):291. doi: 10.1186/s12913-025-12410-8. PubMed 39980004 ↗
  • Davis SH, Rosenberg J, Nguyen J, Jimenez M, Lion KC, Jenicek G, Dallmann H, Yun K. Translating Discharge Instructions for Limited English-Proficient Families: Strategies and Barriers. Hosp Pediatr. 2019 Oct;9(10):779-787. doi: 10.1542/hpeds.2019-0055. PubMed 31562199 ↗
  • Sarkar U, Schillinger D, Lopez A, Sudore R. Validation of self-reported health literacy questions among diverse English and Spanish-speaking populations. J Gen Intern Med. 2011 Mar;26(3):265-71. doi: 10.1007/s11606-010-1552-1. Epub 2010 Nov 6. PubMed 21057882 ↗
  • Cowden JD, Wilkerson-Amendell S, Weathers L, Gonzalez ED, Dinakar C, Westbrook DH, Williams AR. The talking card: Randomized controlled trial of a novel audio-recording tool for asthma control. Allergy Asthma Proc. 2015 Sep-Oct;36(5):e86-91. doi: 10.2500/aap.2015.36.3881. PubMed 26314809 ↗
  • Austad K, Thai C, Zavatti A, Nguyen N, Bautista-Hurtado D, Kenney P, Lugo N, Lee JH, Lanney H, Xuan Z, Cordova-Ramos EG, Drainoni ML, Jack B. Tools to improve discharge equity: Protocol for the pilot TIDE trial. Contemp Clin Trials Commun. 2024 Dec 21;43:101419. doi: 10.1016/j.conctc.2024.101419. eCollection 2025 Feb. PubMed 39810841 ↗
  • Wray A, Goubert R, Gadepally R, Boysen-Osborn M, Wiechmann W, Toohey S. Utilization of Educational Videos to Improve Communication and Discharge Instructions. West J Emerg Med. 2021 Apr 27;22(3):644-647. doi: 10.5811/westjem.2021.1.48968. PubMed 34125040 ↗
  • Schott SL, Dannenberg MD, Dodge SE, Schoonmaker JA, Caisse MM, Barr PJ, O'Malley AJ, Bruce ML. Heart sounds: a pilot randomised trial to determine the feasibility and acceptability of audio recordings to improve discharge communication for cardiology inpatients protocol. Open Heart. 2019 Jul 11;6(2):e001062. doi: 10.1136/openhrt-2019-001062. eCollection 2019. PubMed 31363416 ↗
  • Lion KC, Kieran K, Desai A, Hencz P, Ebel BE, Adem A, Forbes S, Kraus J, Gutman C, Horn I. Audio-Recorded Discharge Instructions for Limited English Proficient Parents: A Pilot Study. Jt Comm J Qual Patient Saf. 2019 Feb;45(2):98-107. doi: 10.1016/j.jcjq.2018.06.001. Epub 2018 Aug 17. PubMed 30126714 ↗

Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Start date
Sep 15, 2026→Dec 15, 2026
Nov 5, 2026
Primary completion
Dec 31, 2026→Jun 30, 2027
Nov 5, 2026
Show all 2 updates
  1. Nov 5, 2026
    Start date Sep 15, 2026→Dec 15, 2026
    Primary completion Dec 31, 2026→Jun 30, 2027
  2. Sep 30, 2026
    Minor edits only
    + 1 other change: references

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07813325
Lead sponsor
Women and Infants Hospital of Rhode Island
Responsible party
Sponsor
First posted
Sep 10, 2026
Start date
Dec 15, 2026 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 5, 2026

Study contacts

Rose Ann Huynh, MD, MS
Contact
rhuynh@carene.org
15042510803
Joni Harris, MS, CCRP
Contact
jonharris@wihri.org
401-274-1122 ext. 48553
Rose Ann Huynh, MD, MS
principal investigator · Women and Infants Hospital Rhode Island

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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