Hospital Discharge Summary UnderstandingNCT06711458
Using Generative Artificial Intelligence (AI) to Create Patient-Friendly Discharge Summaries
A study testing AI-Generated Discharge Instructions in people with Hospital Discharge Summary Understanding, run by NYU Langone Health at 1 site in United States.
Trial summary
This will be an open-label, parallel-group, randomized trial. Patients will be randomized to review the patient-friendly discharge instructions at the time of discharge (intervention group) vs the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospital Discharge Summary Understanding
- What is being tested?
- AI-Generated Discharge Instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2025to 22 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Inpatient Medicine unit at NYULH
- Able to read and understand English
- Willing and able to consent to this research
Who cannot join
- Inpatient Hospice
- Discharged on home hospice
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Generative Artificial Intelligence to Transform Discharge Summaries Into Patient-Friendly Language and Format
This will be an open-label, parallel-group, randomized trial. Patients will be randomized to review the patient-friendly discharge instructions at the time of discharge (intervention group) vs the standard of care. The intervention differs from the standard of care in that patients will be given additional medical documentation in the intervention group.
- Conditions
- Hospital Discharge Summary Understanding
- Being tested
- AI-Generated Discharge Instructions, Standard of Care Discharge Instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Generated Discharge InstructionsBehavioural
Patient-friendly hospital discharge instructions generated by GPT-4, an advanced natural language processing model.
Standard of Care Discharge InstructionsBehavioural
Standard hospital discharge instructions.
| Study group | Role | What they receive |
|---|---|---|
| Generative AI Discharge Instructions | Experimental | At the time of discharge, patients will receive patient-friendly discharge instructions generated by GPT-4, an advanced natural language processing model, with the aim of enhancing patient readability and understandability in the discharge information. Receives: Behavioral: AI-Generated Discharge Instructions |
| Standard of Care Discharge Instructions | Active comparator | At the time of discharge, patients will receive standard discharge instructions (i.e., not generated by GPT-4). Receives: Behavioral: Standard of Care Discharge Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Summaries with Positive Outcome on Composite Measure of Readability and Understandability
This is a composite outcome measure. Readability of discharge summaries will be measured using the Flesch-Kincaid Grade Level assessment, which measures how challenging a text may be for readers. Scores on the Flesch-Kincaid assessment are rated as follows:
0-3: Basic reading level, (kindergarten or elementary school) 3-6: Basic reading level, (elementary school ) 6-9: Average reading level, (middle school) 9-12: Average reading level, (high school) 11-18: Skilled readers.
Understandability will be evaluated by the presence of simplified description of primary diagnosis and hospital intervention.
Summaries with both 1) presence of simplified description of primary diagnosis and hospital intervention, and 2) a Flesch-Kincaid grade level greater than or equal to 6 and less than 8, will be considered to have a "positive outcome."
Measured: Day 1 (At Discharge)
Secondary outcomes (4)
Changes made to AI-Generated Content
Changes made to content will be assessed using edit distance.
Measured: Day 1 (At Discharge)
AI-Generated Content Perception Survey: Safety
Patients will be given a survey in which they are asked whether they feel safe with the discharge instructions they were provided. The total score is the number of participants who respond "Yes, definitely" or "Yes, somewhat" to the question.
Measured: Day 1 (At Discharge)
AI-Generated Content Perception Survey: Understandability
Patients will be given a survey in which they are asked whether the instructions were easy to understand. The total score is the number of participants who respond "Yes, definitely" or "Yes, somewhat" to the question.
Measured: Day 1 (At Discharge)
AI-Generated Content Perception Survey: Empathy
Patients will be given a survey in which they are asked whether the instructions were written in an empathetic manner. The total score is the number of participants who respond "Yes, definitely" or "Yes, somewhat" to the question.
Measured: Day 1 (At Discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start29 Jan 2025
- Primary completion22 May 2025
- Study completion22 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hospital Discharge Summary UnderstandingStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonah Zaretsky, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711458
- Sponsor's protocol ID
- 23-01544
- Status last verified
- Jun 2025
- First submitted
- 27 Nov 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected from usual clinical care; these data cannot be easily deidentified or shared.
Publications
Zaretsky J, Kim C, Major V, Verplanke B, Sonne C, Small WR, Solanki P, Fenelon L, Tursunova N, Gutjahr A, Zhao Y, Blecker S, Austrian J, Testa P, Feldman J. Randomized Controlled Trial Comparing AI-Generated, Clinician-Edited to Human-Generated After-Visit Summaries. Mayo Clin Proc Digit Health. 2026 Aug 14;4(4):100395. doi: 10.1016/j.mcpdig.2026.100395. eCollection 2026 Dec.
PubMed 42733550
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Generative Artificial Intelligence to Transform Discharge Summaries Into Patient-Friendly Language and Format
- ClinicalTrials.gov ID
- NCT06711458
- Acronym / sponsor ID
- 23-01544
- Conditions
- Hospital Discharge Summary Understanding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 22 May 2025 (actual)
- Study completion
- 22 May 2025 (actual)
- First posted
- 2 Dec 2024 (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.
This will be an open-label, parallel-group, randomized trial. Patients will be randomized to review the patient-friendly discharge instructions at the time of discharge (intervention group) vs the standard of care. The intervention differs from the standard of care in that patients will be given additional medical documentation in the intervention group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Generative AI Discharge Instructions | Experimental | Behavioral: AI-Generated Discharge InstructionsAt the time of discharge, patients will receive patient-friendly discharge instructions generated by GPT-4, an advanced natural language processing model, with the aim of enhancing patient readability and understandability in the discharge information. |
| Standard of Care Discharge Instructions | Active comparator | Behavioral: Standard of Care Discharge InstructionsAt the time of discharge, patients will receive standard discharge instructions (i.e., not generated by GPT-4). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to Inpatient Medicine unit at NYULH
- Able to read and understand English
- Willing and able to consent to this research
Key exclusion criteria (2 listed)
- Inpatient Hospice
- Discharged on home hospice
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 |
|---|---|---|
| AI-Generated Discharge InstructionsPatient-friendly hospital discharge instructions generated by GPT-4, an advanced natural language processing model. | Behavioural | Generative AI Discharge Instructions |
| Standard of Care Discharge InstructionsStandard hospital discharge instructions. | Behavioural | Standard of Care Discharge Instructions |
Primary outcome
Number of Summaries with Positive Outcome on Composite Measure of Readability and Understandability
Time frame: Day 1 (At Discharge)
This is a composite outcome measure. Readability of discharge summaries will be measured using the Flesch-Kincaid Grade Level assessment, which measures how challenging a text may be for readers. Scores on the Flesch-Kincaid assessment are rated as follows: 0-3: Basic reading level, (kindergarten or elementary school) 3-6: Basic reading level, (elementary school ) 6-9: Average reading level, (middle school) 9-12: Average reading level, (high school) 11-18: Skilled readers. Understandability will be evaluated by the presence of simplified description of primary diagnosis and hospital intervention. Summaries with both 1) presence of simplified description of primary diagnosis and hospital intervention, and 2) a Flesch-Kincaid grade level greater than or equal to 6 and less than 8, will be considered to have a "positive outcome."
4 secondary outcomes
Changes made to AI-Generated Content
Time frame: Day 1 (At Discharge)
AI-Generated Content Perception Survey: Safety
Time frame: Day 1 (At Discharge)
AI-Generated Content Perception Survey: Understandability
Time frame: Day 1 (At Discharge)
AI-Generated Content Perception Survey: Empathy
Time frame: Day 1 (At Discharge)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Derived from this study: PubMed 42733550Zaretsky J, Kim C, Major V, Verplanke B, Sonne C, Small WR, Solanki P, Fenelon L, Tursunova N, Gutjahr A, Zhao Y, Blecker S, Austrian J, Testa P, Feldman J. Randomized Controlled Trial Comparing AI-Generated, Clinician-Edited to Human-Generated After-Visit Summaries. Mayo Clin Proc Digit Health. 2026 Aug 14;4(4):100395. doi: 10.1016/j.mcpdig.2026.100395. eCollection 2026 Dec.
- Individual participant dataSharing planned: No. Data collected from usual clinical care; these data cannot be easily deidentified or shared.
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. This study is not recruiting at the moment.
Jonah Zaretsky principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Generated Discharge Instructions in people with Hospital Discharge Summary Understanding, run by NYU Langone Health at 1 site in United States.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Summaries with Positive Outcome on Composite Measure of Readability and Understandability (time frame: Day 1 (At Discharge)). 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 NCT06711458, which also lists 1 linked publication.
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 6 Jun 2025.