Functional Incremental Stepping in Place Test (F-IST) Validation
NCT06853236
Acute Care Medical, Intensive Care Medicine
Boca Raton, Florida, United States
View Trial DetailsNCT Number: NCT06756542
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Erasmus University Medical Center, Rotterdam, South Holland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Davy van de Sande, PhD
CONTACT
010 7035142 ext. +31
Michel E. van Genderen, MD PhD
CONTACT
010 7035142 ext. +31
Davy van de Sande
Other
Utilizing Large Language Models to Augment Family Conversations in the Intensive Care Unit
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.
Published trials that share one or more normalized conditions with this study.
NCT06853236
Acute Care Medical, Intensive Care Medicine
Boca Raton, Florida, United States
View Trial DetailsNCT06595602
Intensive Care Medicine, Mechanical Ventilation
Dresden, Germany
View Trial DetailsNCT07249749
Critical Illness, Critically Ill
Villavicencio, Meta Department, Colombia
View Trial DetailsNCT06526533
ARDS (Acute Respiratory Distress Syndrome), Acute Lung Injury
Camperdown, New South Wales, Australia
View Trial Details