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CommunicationNCT06969196

Artificial Intelligence-Generated Written Communication for Families of Intensive Care Unit Patients

A study testing Written Communicatoin in people with Communication and ICU, run by Rush University Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Our research group has developed an approach for providing families of ICU patients with daily written summaries of care as a supplement to traditional verbal communication. Written summaries describe the patient's main ICU problems and management plan and are delivered to families each day. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Communication, ICU
What is being tested?
Written Communicatoin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
7 Jul 2025to 20 Oct 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

Surrogate Inclusion

  • One self-identified adult decision maker for an adult medical ICU patient cared for on the 10W ICU
  • Member of the primary ICU team believes the respective patient will require at least three additional days of ICU care
  • Member of the primary ICU team has identified at least one communication challenge with the patient's surrogate(s) including but not limited to:
  1. Complex medical issues requiring frequent updates to families
  2. Complex family dynamics (i.e., multiple involved family members)
  3. Increased anxiety/stress of surrogate(s)
  4. Difficult to provide updates to family members because they do not visit ICU regularly or are hard to reach by phone

Surrogate Exclusion

  • Surrogate cannot read or understand English
  • Surrogate is unwilling or unable to participate in study procedures
  • Patient is decisional and refuses to allow surrogate participation

Clinician Inclusion • Advanced practice provider (APP) on the medical ICU team on the 10W ICU

Clinician Exclusion

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Rush University Medical Center

    Chicago, Illinois, 60612

Other trials in United States

About this study

Official title: Artificial Intelligence-Generated Written Communication for Families of Intensive Care Unit Patients - A Pilot Study

Our research group has developed an approach for providing families of ICU patients with daily written summaries of care as a supplement to traditional verbal communication. Written summaries describe the patient's main ICU problems and management plan and are delivered to families each day. Despite the benefits of written communication to both the family and clinician experience, the main barrier to implementing this communication approach is the time required for clinicians to create a written summary. For the proposed pilot study, the investgators will ask ICU clinicians to identify patients and respective families for whom there has been a challenge with communication. The investigators will ask ICU clinicians to edit AI-generated written summaries for content and clarity before they are delivered to families. The investigators hypothesize that this process will acceptable and feasible for ICU clinicians and families.

Conditions
Communication, ICU
Being tested
Written Communicatoin
Medical subject headings
Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Written CommunicatoinOther

    ICU clinicians will be asked to edit AI-generated written summaries for content and clarity before they are delivered to families

Study groups in NCT06969196
Study groupRoleWhat they receive
Written CommunicationExperimentalAI-edited, ICU clinician edited written communication
Receives: Other: Written Communicatoin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Communication Quality (Clinicians)

    Clinician participants will ratings of quality of AI-generated written summaries and whether written summaries address family-specific communication challenges (5-point Likert scale, 1-5 points with higher scores indicating better quality)

    Measured: Through study completion, an average of one week

  2. Communication Quality (Families/Surrogates)

    The Family Inpatient Communication Survey (FICS) is a 30-item survey measuring of the quality of communication with the treatment team from the perspective of families of hospitalized patients. Items on this survey measure the informational and emotional aspects of communication, and each item of this survey is rated on a 5-point Likert scale from strongly agree to strongly disagree (30-150 points with higher scores indicating better quality communication)

    Measured: Average one week after enrollment

  3. Acceptability of intervention

    Acceptability of the intervention will reflected in adequate enrollment and an average score of at least 3.5 on surveys with 5-point Likert scale measures including the Acceptability of Intervention (AIM), Appropriateness of Intervention (IAM), and Feasibility of Intervention Survey (FIM) (1-5 point with higher scores being better)

    Measured: Average one week after enrollment

  4. Feasibility of intervention

    Feasibility will be determined by written communication being created for at least 80% of all ICU days and less than 5 minutes on average being spent editing each AI-generated summary.

    Measured: Through study completion, an average of one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2025
  2. Study start7 Jul 2025
  3. Primary completion20 Sep 2025
  4. Study completion20 Oct 2025

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06969196
Sponsor's protocol ID
25040406
Status last verified
Dec 2025
First submitted
18 Apr 2025
Last updated
10 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lee JJ, Mathur S, Gerhart J, Glover CM, Ritz E, Basapur S, Greenberg JA. Written communication and the ICU team experience (WRITE): A pre-post intervention study. Intensive Crit Care Nurs. 2024 Oct;84:103753. doi: 10.1016/j.iccn.2024.103753. Epub 2024 Jun 25.

    PubMed 38924848

  • Greenberg JA, Basapur S, Quinn TV, Bulger JL, Schwartz NH, Oh SK, Ritz EM, Glover CM, Shah RC. Daily Written Care Summaries for Families of Critically Ill Patients: A Randomized Controlled Trial. Crit Care Med. 2022 Sep 1;50(9):1296-1305. doi: 10.1097/CCM.0000000000005583. Epub 2022 May 23.

    PubMed 35607975

  • Bulger JL, Quinn TV, Glover CM, Basapur S, Shah RC, Greenberg JA. Written Care Summaries Facilitate Communication Between Families and Providers of ICU Patients: A Pilot Study. Crit Care Explor. 2021 Jul 13;3(7):e0473. doi: 10.1097/CCE.0000000000000473. eCollection 2021 Jul.

    PubMed 34278309

Questions about this trial

What is this clinical trial studying?

A study testing Written Communicatoin in people with Communication and ICU, run by Rush University Medical Center 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?

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 10 Dec 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?

Communication Quality (Clinicians) (time frame: Through study completion, an average of one week). The study lists 4 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 NCT06969196, which also lists 3 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 10 Dec 2025.

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