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Evaluating the Use of Artificial Intelligence to Improve Family Conversations for Intensive Care Patients and Their Families

Utilizing Large Language Models to Augment Family Conversations in the Intensive Care Unit

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06756542
Enrollment
40
Registered
2025-01-03
Start date
2025-01-14
Completion date
2025-12-31
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Care, Intensive Care Medicine

Keywords

intensive care, artificial intelligence, large language models, administration reduction, patient satisfaction

Brief summary

This study looks at how artificial intelligence (AI), like generative pre-trained transformer (GPT-4), can help doctors in the intensive care unit (ICU) save time and improve communication with families. Right now, doctors spend a lot of time writing notes after family conversations, which takes time away from patient care. The investigators are testing whether AI can create accurate and easy-to-understand summaries of these conversations, making it quicker for doctors to document and clearer for families to understand. ICU doctors and adult family members of patients will take part in this study, with their full consent. The goal is to see if this new technology can make life easier for doctors while helping families better understand medical information.

Interventions

None listed

Sponsors

Davy van de Sande
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Informed-consent is signed by all participating family members during the conversation. * Informed-consent is signed by the ICU healthcare professionals. * The patient of the family must be admitted to the adult ICU. * All participating family members must be 18 years or older. * The family conversation must be in Dutch.

Exclusion criteria

* Trained to interpret medical jargon and/or intensive care terminology specifically * Difficulty reading and/or writing in the Dutch language

Design outcomes

Primary

MeasureTime frameDescription
Documentation quality of family conversationsWithin 30 days after the family conversation.The primary outcome measure is the documentation quality of family conversations, evaluated using a modified Physician Documentation Quality Instrument-9. Originally validated for progress notes and discharge summaries, Physician Documentation Quality Instrument-9 scores notes on nine attributes (accurate, thorough, useful, organized, comprehensible, succinct, synthesized, consistent, up-to-date) using a 1-5 scale (1 = not at all, 5 = extremely), for a total ranging from 9 to 45. To adapt it for AI-generated text, the investigators removed the up-to-date domain (focused on whether the note includes the latest test results/recommendations) and added two new attributes: freedom from hallucinations (unfounded information) and freedom from bias (discriminatory data, algorithms, or heuristics). These additions address potential pitfalls in large language model outputs, such as introducing incorrect content or skewed results.

Secondary

MeasureTime frameDescription
Time spent on documentation by ICU cliniciansWithin one day after the family conversation.The time clinicians spend on post-conversation documentation will be measured for both traditional and ambient listening methods. This outcome aims to quantify the efficiency of the ambient listening technology in reducing administrative burden.
Family satisfactionWithin 30 days after the family conversation.Family members' feedback on their satisfaction with the intensive care unit (ICU) communication process. Satisfaction will be measured using a structured questionnaire administered after reviewing a simplified ambient-generated note. The survey includes 16 questions: 5 about demographics (age, education, occupation, and reading skills); 3 adapted from the validated Family Satisfaction with the ICU-24 survey (score range: 1-5, higher scores indicate greater satisfaction) to assess clarity, completeness, and overall satisfaction; and 10 evaluating the summary's readability and utility at a B1 language proficiency level.

Countries

Netherlands

Contacts

Primary ContactDavy van de Sande, PhD
d.sande@erasmusmc.nl010 7035142
Backup ContactMichel E. van Genderen, MD PhD
m.vangenderen@erasmusmc.nl010 7035142

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026