Documentation of Serious Illness Communication for Critically Ill PatientsPALMSNCT07915908
Pilot Trial of Ambient Listening for Intensive Care Unit Family Meeting Summaries
A study testing Receipt of ambient listening-generated draft clinical note in people with Documentation of Serious Illness Communication for Critically Ill Patients, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether ambient listening can help healthcare providers create written summaries of conversations with the families of patients in the medical intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Documentation of Serious Illness Communication for Critically Ill Patients
- What is being tested?
- Receipt of ambient listening-generated draft clinical note
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Jun 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be the surrogate decision maker for a patient admitted to a participating medical intensive care unit; and
- Have a family meeting scheduled with the patient's medical team.
Who cannot join
- Be less than 18 years of age; or
- Be the surrogate of a patient who is less than 18 years of age; or
- Have a preferred language other than English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Catherine Auriemma, MD, MSHP, 267-595-8742, Catherine.Auriemma@pennmedicine.upenn.edu
About this study
Official title: Pilot Trial of Ambient Listening for Intensive Care Unit Family Meeting Summaries (PALMS)
The goal of this clinical trial is to learn whether ambient listening can help healthcare providers create written summaries of conversations with the families of patients in the medical intensive care unit (ICU). Ambient listening is an artificial intelligence-enabled tool that records a medical visit and creates a written summary. Healthcare providers already use this technology for many types of appointments. The main questions this trial aims to answer are: Do patients, families, and healthcare providers feel comfortable using ambient listening to record and summarize ICU family meetings? and How much do healthcare providers use content created by ambient listening when it is available to them? and Can ambient listening generate useful summaries of family meetings for patients and their families? Researchers will compare clinical summaries written using an AI-enabled tool to summaries written without the tool to see if using ambient listening makes summaries clearer and more useful to healthcare providers.
Participants will:
Allow researchers to record and transcribe a family meeting with the patient's ICU medical team.
- Being tested
- Receipt of ambient listening-generated draft clinical note
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receipt of ambient listening-generated draft clinical noteBehavioural
Intervention-arm clinicians will receive a draft structured clinical note generated by ambient listening technology immediately following the scheduled family meeting and may choose to use this draft content when creating their final signed note in the patient's medical record.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Clinicians receive draft clinical note generated by ambient listening. Receives: Behavioral: Receipt of ambient listening-generated draft clinical note |
| Control | No intervention | Clinicians do not receive draft clinical note generated by ambient listening. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of approached surrogates agreeing to enroll
Acceptability of enrollment: Proportion of approached surrogate decision makers who agree to enroll.
Measured: At enrollment
Secondary outcomes (3)
Proportion of clinicians utilizing summary content
Feasibility: Proportion of intervention-arm clinicians who access the ambient listening-generated summary and the proportion of overlap between the draft summary and the final signed note.
Measured: 1 day after intervention
Clinical documentation quality rating
Ratings by an independent panel of clinician reviewers, assessing quality of each extracted clinical note (composite of completeness, clarity, and clinical utility).
Measured: Up to 6 months after intervention
Proportion of clinicians finding patient- and family-facing summaries acceptable
Acceptability of patient- and family-facing summaries: Whether clinicians would be comfortable with an ambient listening-generated, patient- and family-facing summary of the meeting being provided to the patient and family, either as-generated or with clinician edits.
Measured: 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Documentation of Serious Illness Communication for Critically Ill PatientsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Auriemma, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915908
- Sponsor's protocol ID
- 26-8441
- Acronym
- PALMS
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified clinical notes; demographic and clinical data; associated scores and responses from clinicians for each note.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Ambient Listening for Intensive Care Unit Family Meeting Summaries (PALMS)
- ClinicalTrials.gov ID
- NCT07915908
- Acronym / sponsor ID
- PALMS / 26-8441
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Dec 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 4 Nov 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.
The goal of this clinical trial is to learn whether ambient listening can help healthcare providers create written summaries of conversations with the families of patients in the medical intensive care unit (ICU). Ambient listening is an artificial intelligence-enabled tool that records a medical visit and creates a written summary. Healthcare providers already use this technology for many types of appointments. The main questions this trial aims to answer are: Do patients, families, and healthcare providers feel comfortable using ambient listening to record and summarize ICU family meetings? and How much do healthcare providers use content created by ambient listening when it is available to them? and Can ambient listening generate useful summaries of family meetings for patients and their families? Researchers will compare clinical summaries written using an AI-enabled tool to summaries written without the tool to see if using ambient listening makes summaries clearer and more useful to healthcare providers.
Participants will:
Allow researchers to record and transcribe a family meeting with the patient's ICU medical team.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Receipt of ambient listening-generated draft clinical noteClinicians receive draft clinical note generated by ambient listening. |
| Control | No intervention | –Clinicians do not receive draft clinical note generated by ambient listening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be the surrogate decision maker for a patient admitted to a participating medical intensive care unit; and
- Have a family meeting scheduled with the patient's medical team.
Key exclusion criteria (3 listed)
- Be less than 18 years of age; or
- Be the surrogate of a patient who is less than 18 years of age; or
- Have a preferred language other than English.
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 |
|---|---|---|
| Receipt of ambient listening-generated draft clinical noteIntervention-arm clinicians will receive a draft structured clinical note generated by ambient listening technology immediately following the scheduled family meeting and may choose to use this draft content when creating their final signed note in the patient's medical record. | Behavioural | Intervention |
Primary outcome
Proportion of approached surrogates agreeing to enroll
Time frame: At enrollment
Acceptability of enrollment: Proportion of approached surrogate decision makers who agree to enroll.
3 secondary outcomes
Proportion of clinicians utilizing summary content
Time frame: 1 day after intervention
Clinical documentation quality rating
Time frame: Up to 6 months after intervention
Proportion of clinicians finding patient- and family-facing summaries acceptable
Time frame: 1 week after intervention
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 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Deidentified clinical notes; demographic and clinical data; associated scores and responses from clinicians for each note.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receipt of ambient listening-generated draft clinical note in people with Documentation of Serious Illness Communication for Critically Ill Patients, run by University of Pennsylvania 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 2 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 4 Nov 2026. 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?
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 Catherine Auriemma, MD, MSHP (267-595-8742, Catherine.Auriemma@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of approached surrogates agreeing to enroll (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Nov 2026.