Effectiveness of Artificial Intelligence Integrated Mixed Reality-based High-Alert Medications Management Simulation Program
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Primary Endpoint
- High-Alert Medication clinical performance
Study Overview
Brief Summary
The goal of this clinical trial is to learn if a Artificial Intelligence integrated Mixed Reality-based High-Alert Medications Management Simulation Program (AIMR-HAM) helps hospital nurses manage high-alert medicines (HAMs) more safely. MR mixes real and virtual elements to let nurses practice in realistic scenarios.
The main questions are:
Does the AIMR-HAM improve nurses' medication safety skills? Does the AIMR-HAM lower medication errors and improve clinical performance?
Researchers will compare two groups to answer these questions:
Intervention group: AIMR-HAM Control group: standard education only
Who can take part:
Nurses who work at large hospitals and have 1 to 6 years of clinical experience.
About 60 nurses will join the study.
What participants will do:
Attend the assigned training (AIMR-HAM or standard education only). Complete short tests and surveys before and after training to measure skills, communication, and clinical reasoning.
Report any medication errors that occur during the study. Why this matters: The study will show whether AIMR-HAM training can improve how nurses handle HAMs and make patient care safer.
Detailed Description
This trial evaluates whether a Artificial Intelligence integrated Mixed Reality-based High-Alert Medications Management Simulation Program (AIMR-HAM) improves high-alert medications (HAMs) management skills, clinical performance (simulation-based observed assessments), communication, and medication error rates among hospital nurses with 1-6 years of clinical experience. The trial aims to assess the effectiveness of AIMR-HAM in enhancing practical competency and patient safety in real-world clinical practice.
Study design and randomization The study is a single-center, parallel-group, randomized controlled trial with approximately 60 participating nurses. Participants are randomly assigned 1:1 to the intervention or control group using a computer-generated randomization schedule (e.g., block randomization). Randomization is performed by an independent data manager to maintain allocation concealment. Outcome assessors are blinded to group assignment (assessor-blinded).
Intervention - AIMR-HAM (intervention group)
Overview: The intervention combines MR headset-based, scenario-driven hands-on practice.
Key components:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Nurses with at least one to six years of clinical experience.
- •Those who understand the purpose and procedures of this study and have given written consent to participate.
- •Those who have no physical or cognitive limitations in using mixed reality devices.
- •④ Those who are able to communicate in Korean and understand and respond to questions.
Exclusion Criteria
- •Those who do not wish to participate in the study. ② Those who have participated in education related to high-alert medications within the past six months.
- •Those who are unable or have difficulty participating in the mixed reality education program due to visual, hearing, or neurological impairments, or adverse effects such as dizziness or motion sickness.
- •Those who voluntarily withdraw from the study midway through.
Arms & Interventions
Arm 1
Participants receive a Artificial Intelligence integrated Mixed Reality-based High-Alert Medications Management Simulation Program
Intervention: Artificial Intelligence integrated Mixed Reality-based Simulation Program (Other)
Arm 2
Participants receive the hospital's standard medication-management education
Intervention: Standard medication-management education (Other)
Outcomes
Primary Outcomes
High-Alert Medication clinical performance
Time Frame: Baseline, immediately post-intervention
The high-alert medication clinical performance competency assessment will utilize a questionnaire developed by our research team. The tool consists of 23 questions, of which 4 will vary depending on the simulation progress, resulting in a final assessment measuring 19 questions. Each item will be graded by the instructor on a scale of 0 for failure or incorrect execution, 1 for insufficient or inadequate execution, and 2 for accurate execution. The developed items will undergo a validity assessment by six experts before being revised and supplemented for use. Higher scores indicate greater clinical performance in high-alert medication.
Secondary Outcomes
- Global Interpersonal Communication Competence(Baseline, immediately post-intervention)
- Clinical Reasoning Competency(Baseline, immediately post-intervention)
- Medication Safety Competence(Baseline, immediately post-intervention)
Investigators
Jinkyung Park
professor
Chonnam National University Hospital