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

Recruiting

• Conditions: Intensive Care Medicine; Critical Care

• Registration Number: NCT06756542
• Lead Sponsor: Davy van de Sande

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-01-03
• Study Start: 2025-01-14
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Documentation quality of family conversations	Within 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 Outcome Measures

Name	Time	Method
Time spent on documentation by ICU clinicians	Within 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 satisfaction	Within 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.

Trial Locations

Locations (1)

Erasmus University Medical Center; 🇳🇱 Rotterdam, Netherlands