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Completed

NCT Number: NCT06969196

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

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.

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Key information

Conditions

Communication Behavior ICU

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Complex medical issues requiring frequent updates to families
  • Complex family dynamics (i.e., multiple involved family members)
  • Increased anxiety/stress of surrogate(s)
  • 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

Treatment and study plan

Written Communicatoin

Other

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

Primary outcomes

  1. Communication Quality (Clinicians)

    Time frame: Through study completion, an average of one week

    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)

  2. Communication Quality (Families/Surrogates)

    Time frame: Average one week after enrollment

    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)

  3. Acceptability of intervention

    Time frame: Average one week after enrollment

    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)

  4. Feasibility of intervention

    Time frame: Through study completion, an average of one week

    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.

Other outcomes

  1. Analysis of Individual Interviews

    Time frame: Average one week after enrollment

    Individual interviews will be conducted by a study investigator using an interview guide Interviews will last approximately 15 minutes. Interviews will be transcribed and coded. Themes identified in qualitative analysis will be used to inform and provide explanations for quantitative results.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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