Focus on Illiteracy in Patients and Optimal Patient EducationNCT07813325
Closing the Gap in Language With Audio Instructions: An Exploratory Pilot Study
A study testing Audio Discharge patient education in people with Focus on Illiteracy in Patients and Optimal Patient Education, run by Women and Infants Hospital of Rhode Island.
Trial 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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Focus on Illiteracy in Patients and Optimal Patient Education
- What is being tested?
- Audio Discharge patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Declines intervention
- Does not have one of the above chief complaints/diagnoses
- Preferred language is Spanish and are literate in Spanish
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this 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.
Read more
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
- Being tested
- Audio Discharge patient education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio Discharge patient educationOther
audio instructions in preferred language
| Study group | Role | What they receive |
|---|---|---|
| Patients illiterate in their preferred language who received audio instructions | Experimental | audio discharge patient education provided in preferred language Receives: Other: Audio Discharge patient education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 72 hours after discharge/provision of patient audio education
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
Measured: From enrollment to conclusion of data collection.
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.
Measured: From enrollment to 72 hours after discharge/provision of patient audio education
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Focus on Illiteracy in Patients and Optimal Patient EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rose Ann Huynh, MD, MS, Principal investigator, Women and Infants Hospital Rhode Island
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813325
- Sponsor's protocol ID
- WIH-2323225
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 39980004Davis 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 31562199Sarkar 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 21057882Cowden 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 26314809Austad 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 39810841Wray 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 34125040Schott 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 31363416Lion 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closing the Gap in Language With Audio Instructions: An Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT07813325
- Acronym / sponsor ID
- WIH-2323225
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients illiterate in their preferred language who received audio instructions | Experimental | Other: Audio Discharge patient educationaudio discharge patient education provided in preferred language |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Declines intervention
- Does not have one of the above chief complaints/diagnoses
- Preferred language is Spanish and are literate in Spanish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio Discharge patient educationaudio instructions in preferred language | Other | Patients illiterate in their preferred language who received audio instructions |
Primary outcome
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.
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 39980004Austad 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.
- Background: PubMed 31562199Davis 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.
- Background: PubMed 21057882Sarkar 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.
- Background: PubMed 26314809Cowden 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.
- Background: PubMed 39810841Austad 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.
- Background: PubMed 34125040Wray 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.
- Background: PubMed 31363416Schott 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.
- Background: PubMed 30126714Lion 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rose Ann Huynh, MD, MS principal investigator
Women and Infants Hospital Rhode Island
Questions about this trial
What is this clinical trial studying?
A study testing Audio Discharge patient education in people with Focus on Illiteracy in Patients and Optimal Patient Education, run by Women and Infants Hospital of Rhode Island.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rose Ann Huynh, MD, MS (15042510803, rhuynh@carene.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Acceptability of Audio Discharge Instructions (time frame: From enrollment to 72 hours after discharge/provision of patient audio education). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07813325, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.