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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Care; Intensive Care Medicine

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Davy van de Sande, PhD; Phone Number: +31 010 7035142; Email: d.sande@erasmusmc.nl
• Study Contact Backup: Name: Michel E. van Genderen, MD PhD; Phone Number: +31 010 7035142; Email: m.vangenderen@erasmusmc.nl

Study Locations

• Netherlands
  • Rotterdam, Netherlands, 3015GD
    • Recruiting
    • Erasmus University Medical Center
    • Contact: Michel E. van Genderen, MD PhD; Phone Number: +31 0107039883; Email: m.vangenderen@erasmusmc.nl
  • Zuid-Holland
    • Rotterdam, Zuid-Holland, Netherlands, 3015GD
      • Not yet recruiting
      • Erasmus University Medical Center
      • Contact: Davy van de Sande, PhD; Phone Number: 31 010 7035142; Email: d.sande@erasmusmc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Intensive care professionals performing formal family conversations and family members of patients admitted to the adult intensive care.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documentation quality of family conversations	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.	Within 30 days after the family conversation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time spent on documentation by ICU clinicians	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.	Within one day after the family conversation.
Family satisfaction	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.	Within 30 days after the family conversation.

Collaborators and Investigators

• Sponsor: Davy van de Sande
• Investigators: Study Director: Diederik Gommers, MD PhD, Intensive Care Adults, Erasmus University Medical Center, Rotterdam, the Netherlands; Principal Investigator: Michel E. van Genderen, MD PhD, Intensive Care Adults, Erasmus University Medical Center, Rotterdam, the Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 24, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: artificial intelligence; intensive care; patient satisfaction; large language models; administration reduction
• Other Study ID Numbers: MEC-2024-0733

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No