- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07811245
Effect of GenAI Patient Simulation on Clinical Preparedness and Clinical Competence in Nursing Students
Effectiveness of Generative Artificial Intelligence (GenAI) Patient Simulation on Preparedness for Clinical Practicum and Clinical Competence Among Undergraduate Nursing Students: A Waitlist Randomized Controlled Trial and Mixed-methods Study
The transition from theoretical knowledge to clinical practice is a critical and challenging phase for nursing students. Limited opportunities for scenario-based learning before an clinical practicum impacts students' preparedness for practice and clinical competence. Consequently, this lack of preparation directly fuels stress, creating a a negative feedback loop where this stress inhibits cognitive processing and effective learning. Generative artificial intelligence (GenAI) has emerged as a novel educational technology capable of providing interactive, flexible, and learner-centred simulation experiences.
This waitlist randomised controlled trial aims to examine the effectiveness of incorporating the GenAI patient simulation in preparing the undergraduate nursing students for clinical practicum and enhancing the clinical competence compared to the current practice. Hypotheses of this study include:
- Participants using the GenAI patient simulation will report higher preparedness for the first acute clinical practicum (CP) and higher clinical competence scores compared to the usual practice group at all time points.
- The frequency of using the GenAI patient simulation will be positively correlated with preparedness for the CP and clinical competence.
- Participants using the GenAI patient simulation will report lower perceived stress before and during the CP compared to the usual practice group.
- The frequency of using of the GenAI patient simulation will negatively correlate with the levels of perceived stress before and during the CP.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Clinical practicum represents a critical transition point in undergraduate nursing education. Although pre-practicum workshops are commonly provided, students continue to experience difficulties in applying theoretical knowledge during the clinical practicum in acute care settings. A substantial gap often exists between the workshop and the start of clinical practicum, during which opportunities for ongoing learning, reinforcement of knowledge, and practice through virtual clinical scenarios are limited. GenAI patient simulation provide additional opportunities for experiential learning, deliberate practice, and self-directed preparation before clinical exposure.
The intervention of this study is a GenAI Patient Simulation Platform.
Participants in the intervention group will receive the pre-practicum workshop as usual followed by a two-phase GenAI patient simulation intervention:
Phase 1 - a 2-hour facilitated face-to-face simulation exercise session using the scenarios in the GenAI platform.
Phase 2 - a self-initiated, wall-free GenAI patient simulation scenario package. Participants is allowed to access the platform and do the exercises before and during clinical practicum.
Participants in the waitlist control group will receive the same intervention after completion of the study.
A total of forty-four undergraduate nursing students will be recruited and randomly assigned to intervention group and waitlist control group with 1:1 allocation ratio. Participants will be fully informed about the interventions, benefits and risks of the study. Participation is entirely voluntary, and individuals may withdraw at any time without penalty.
Baseline data will be collected before randomisation (T0). All participants will complete the questionnaires immediately after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3). Participants in the intervention group will be invited to join a semi-structured interview by the end of the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Choi Fung Mabel LAM
- Phone Number: 39176694
- Email: lamcfm@hku.hk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Year 3 nursing students of a 5-year full-time Bachelor in Nursing programme,
- of any nationality including non-local and non-Chinese students, and
- able to read and understand English, and
- completed the introduction of clinical nursing practicum in year 2, and
- scheduled to undertake their first acute clinical practicum within the same academic year.
Exclusion Criteria:
Year 3 nursing students of a 5-year full-time Bachelor in Nursing programme, who will not have their first acute clinical practicum within that academic year.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm 1
|
The intervention is a two-phase GenAI patient simulation platform. Phase 1 - a 2-hour facilitated face-to-face simulation exercise session using the scenarios in the GenAI platform. Phase 2 - a self-initiated, wall-free GenAI patient simulation scenario package. Participants is allowed to access the platform and do the exercises before and during clinical practicum.
Same intervention after completion of the study.
|
|
Other: Arm 2
Waitlist control
|
The intervention is a two-phase GenAI patient simulation platform. Phase 1 - a 2-hour facilitated face-to-face simulation exercise session using the scenarios in the GenAI platform. Phase 2 - a self-initiated, wall-free GenAI patient simulation scenario package. Participants is allowed to access the platform and do the exercises before and during clinical practicum.
Same intervention after completion of the study.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preparedness for Clinical Practicum
Time Frame: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
|
Preparedness for clinical practicum will be measured using the Casey-Fink Readiness for Practice Survey (CF-RPS), consists of 15 items in three domains: clinical problem solving (6 items), learning activities (5 items), and practice readiness (4 items).
|
Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
|
|
Clinical Competence
Time Frame: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
|
Measured by the Clinical Competency Questionnaire (CCQ), consists of 47 items divided into four domains: nursing professional behaviour, general performance, core nursing skills and advanced nursing skills.
|
Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perceived Stress
Time Frame: Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
|
Measured by the Perceived Stress Scale (PSS-10).
|
Baseline (T0), immediate after Phase 1 (T1), 2 weeks prior to the clinical practicum (T2), and within 1 week after completion of the clinical practicum (T3)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- EA260547
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.