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Serious Game-Based Training for Withholding and Withdrawing Life-Sustaining Treatments in the ICU

Serious Game-Based Training for Withholding and Withdrawing Life-Sustaining Treatments in the ICU: the HUGS Randomized Controlled Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07812727
Acronym
HUGS
Enrollment
164
Registered
2026-09-10
Start date
2025-05-01
Completion date
2026-06-01
Last updated
2026-09-10

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

Conditions

Medical Students in Intensive Care Unit

Keywords

life sustaining treatment

Brief summary

Background: Withholding and withdrawing life-sustaining treatments (WWLST) are frequent in ICU and raise important ethical, legal, and communication issues. Despite their importance, specific training on WWLST remains limited. Study Objective: evaluating the impact of a serious game on medical students' knowledge and skills regarding WWLST in ICU Population: The study population consists of 164 medical students who are randomly assigned to two groups Study design: prospective, multicenter, randomized controlled, single-blind study. The study will compare two educational approaches: a 25-minute serious game (SG) and a 25-minute narrated PowerPoint lecture (PPL) Parameters: The primary objective is to assess the impact of the serious game on students' competencies, measured by an Objective Structured Clinical Examination (OSCE) on WWLST in ICU. Secondary outcomes include a multiple-choice 10 questions (MCQ), two Script Concordance Tests (SCTs) immediately after training and satisfaction scales Hypothesis: A serious game-based training program on a highly complex topic such as WWLST in ICU could enable medical students to develop better skills and experience greater satisfaction compared to a conventional teaching method.

Detailed description

The HUGS study ("Helpful Use of serious Game in life-Sustaining withdrawal") is a prospective, multicenter, randomized controlled, single-blind study evaluating the impact of a serious game on medical students' knowledge and skills regarding Withholding and withdrawing life-sustaining treatments (WWLST) in ICU WWLST are frequent in ICU and raise important ethical, legal, and communication issues. In France, these decisions are governed by the Claeys-Leonetti law, which emphasizes respect for patients' wishes, avoidance of unreasonable treatment, collegial decision-making, consultation with an external physician, and documentation. Despite their importance, specific training on WWLST remains limited. The study will compare two educational approaches: a 25-minute serious game (SG) and a 25-minute narrated PowerPoint lecture (PPL). The serious game was developed to strengthen knowledge of the decision-making process, ethical considerations, and communication with healthcare teams and patients' relatives. The primary objective is to assess the impact of the serious game on students' competencies, measured by an Objective Structured Clinical Examination (OSCE) on WWLST in ICU. Secondary outcomes include a multiple-choice 10 questions (MCQ) and two Script Concordance Tests (SCTs) immediately after training, satisfaction with the educational method, and self-assessment of competence following the OSCE. Participants will be medical students in years DFASM1-3 undertaking internships in anesthesia and intensive care departments of the PARABOL university medical group. Eligible participants must be aged 18 or older. Students who have previously completed the serious game or the control training will be excluded. A total of 164 students (82 per group) will be recruited across four centers: Bichat-Claude Bernard, Lariboisière, Saint-Louis, and Beaujon hospitals. The inclusion period will last 12 months. Using a previously published distribution of OSCE scores among medical students (standard deviation = 5 points), and assuming 90% power with a two-sided type I error of 5%, the required sample size was calculated to be 164 participants (82 per group).

Interventions

OTHERserious game (SG) on WWLST

serious game (SG) on WWLST

OTHERpowerpoint lecture (PPL) on WWLST

powerpoint lecture (PPL) on WWLST

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Eligibility

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

Inclusion criteria

students from "Université Paris Cité" (UPC, Paris, France), completing internships in 5 ICU

Exclusion criteria

* prior participation in the WWLST serious game or previous exposure to the control training.

Design outcomes

Primary

MeasureTime frameDescription
WWLST competencies in the ICUend of the 3-month ICU internshipObjective Structured Clinical Examination (OSCE) score (out of 17) assessing WWLST competencies in the ICU

Secondary

MeasureTime frameDescription
communication skills and attitudesend of the 3-month ICU internshipScore out of 5 on the OSCE "communication skills and attitudes" grid
clinical aptitudeend of the 3-month ICU internshipScore out of 12 on the OSCE "clinical aptitude" grid
knowledge assessmentend of the 3-month ICU internshipScore out of 10 on a multiple-choice question (MCQ) knowledge assessment
Script Concordance Testsend of the 3-month ICU internshipEvaluation via two Script Concordance Tests (SCTs) on WWLST in the ICU
satisfaction with the training modalityend of the 3-month ICU internshipAssessment of participants' satisfaction with the training modality
participants' perceived competenceend of the 3-month ICU internshipAssessment of participants' perceived competence following the skills test

Countries

France

Contacts

STUDY_DIRECTORsebastien tanaka

APHP

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026