Simulation Training for Clinical Skills in Healthy Subjects

Overseen By Edmund Ickert

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Youngstown State University

Disqualifiers: Not enrolled in program

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how high-tech patient simulations, known as High-Fidelity Patient Simulation, can enhance clinical reasoning skills and teamwork among physical therapy and nursing students. The study will compare students who practice with two simulations to those who do not. The goal is to determine if these simulations improve students' ability to think quickly and collaborate effectively. Students currently enrolled in a physical therapy or nursing program may be eligible to participate. As an unphased trial, this study provides a unique opportunity to enhance clinical skills and teamwork abilities through innovative simulations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that High-Fidelity Patient Simulation is safe for improving clinical skills?

High-Fidelity Patient Simulation (HFPS) serves as a proven, safe, and effective training tool. Research has shown that HFPS improves clinical skills and enhances patient safety by allowing students to practice in realistic medical scenarios.

Studies have reported positive results with HFPS, such as reducing medical errors and improving students' problem-solving abilities. These findings indicate that HFPS is well-received, with no reports of harm or negative effects, making it a safe option for training future healthcare professionals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of high-fidelity patient simulation to enhance clinical skills in healthcare professionals. Unlike traditional learning methods, which often rely on textbooks and lectures, this approach uses realistic, immersive simulations to provide hands-on experience in a controlled environment. This method has the potential to improve decision-making and reduce errors without risking patient safety, offering a dynamic and engaging way to practice critical skills.

What evidence suggests that High-Fidelity Patient Simulation is effective for improving clinical reasoning skills and interprofessional competencies?

This trial will compare the effects of High-Fidelity Patient Simulation (HFPS) on clinical skills. Studies have shown that HFPS improves clinical skills, enhancing clinical competence, patient safety, and decision-making among nursing students. One study found that nursing students using HFPS developed better communication skills. Simulation-based training significantly enhances learning for healthcare professionals. Overall, HFPS is a proven tool for improving essential skills in medical education. Participants in the experimental group of this trial will receive two simulations to assess these benefits. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Physical Therapy and Nursing students who are healthy. The study aims to see if practicing with high-tech patient simulators can improve their clinical reasoning and teamwork skills. Students will be randomly placed into groups, some of which will experience no simulations, while others will have one or two simulation sessions.

Inclusion Criteria

Must be a student currently enrolled in either the physical therapy or nursing program

Exclusion Criteria

Not currently enrolled as a student in the physical therapy or nursing program

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Simulation Intervention

Participants in the experimental group receive 2 high-fidelity patient simulations to assess clinical reasoning skills and interprofessional competencies.

8 months

Assessment

Participants are assessed for interprofessional attitudes and clinical reasoning skills using IPAS, LCJR, and PACT tools.

8 months

Follow-up

Participants are monitored for changes in interprofessional competencies and clinical reasoning skills post-intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-Fidelity Patient Simulation

Trial Overview

The trial is testing the impact of High-Fidelity Patient Simulation (HFPS) on developing clinical reasoning and interprofessional competencies in students. It compares the performance of those who undergo zero, one, or two simulation experiences against each other.

How Is the Trial Designed?

Group I: Experimental Group Experimental Treatment 1 Intervention

This group will receive 2 simulations

Group II: Control Active Control 1 Intervention

This group will not receive any simulation intervention

Who Is Running the Clinical Trial?

Youngstown State University

Lead Sponsor

Trials

27

Recruited

2,000+

Published Research Related to This Trial

High-fidelity simulation (HFS) education is crucial for new hospital nurses to improve their competencies and reduce medication errors, which are a significant threat to patient safety and hospital budgets.

Investing in HFS education is cost-effective, as most hospitals can recover their investment costs within 12 months, making it a practical solution for enhancing nursing training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Safety: Simulation Education for New RNs Promises an Excellent Return on Investment. Zimmerman, DM., House, P.[2016]

High fidelity simulation is an effective training tool for developing teamwork skills in high-risk industries like healthcare, aviation, and nuclear power, as it allows for controlled practice and feedback in a safe environment.

The authors emphasize that simulation fidelity should not be viewed as a one-size-fits-all solution; instead, the design and goals of the training are crucial for its effectiveness, and they provide guidelines to enhance the training process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of simulation for training teamwork skills in health care: how low can you go? Beaubien, JM., Baker, DP.[2022]

Standardized participants (SPs) significantly improve the realism and educational value of high-fidelity medical simulations compared to using simulators alone.

The article outlines SP methodology and provides practical suggestions for effectively incorporating SPs into medical simulation scenarios, addressing a gap in the existing literature.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of standardized patients into simulation. Cantrell, MJ., Deloney, LA.[2007]

Pediatric residents who participated in high-fidelity patient simulation (HFPS) during their cardiology rotation scored significantly higher on a case quiz compared to those who did not have HFPS exposure, indicating improved clinical reasoning (P = .024).

Residents' confidence in managing pediatric cardiology patients increased significantly after HFPS, with average scores rising from 5.1 to 7.5 on a scale of 0-10 (P < .001), suggesting that simulation training enhances both confidence and knowledge retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Embedding patient simulation in a pediatric cardiology rotation: a unique opportunity for improving resident education. Mohan, S., Follansbee, C., Nwankwo, U., et al.[2022]

High-fidelity patient simulation (HFPS) significantly improves nursing students' knowledge and performance compared to other teaching methods, with effect sizes of 0.49 and 0.50 respectively, based on a systematic review of 33 studies.

The review highlights the need for further research to assess HFPS's impact on nursing competence and patient outcomes, as significant variability among studies was noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of high-fidelity simulation based on life-threatening clinical condition scenarios on learning outcomes of undergraduate and postgraduate nursing students: a systematic review and meta-analysis. La Cerra, C., Dante, A., Caponnetto, V., et al.[2020]

The Portable Pediatric Simulation Training and Assessment Program was developed to provide effective team training and skill assessment in pediatric anesthesia, demonstrating its utility at national meetings.

Feedback from participants was overwhelmingly positive, with 100% agreeing that the course was useful, enjoyable, and realistic, highlighting its effectiveness as a training tool in emergency response skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Affordable simulation for small-scale training and assessment. Edler, AA., Chen, M., Honkanen, A., et al.[2011]

High-fidelity simulation (HFS) significantly improved undergraduate nursing students' knowledge, self-confidence, satisfaction, and self-efficacy in managing oncology emergencies, as shown by a pre-test post-test study design with significant statistical results (p < 0.001).

The experimental group that underwent HFS scored notably higher in all measured areas compared to the control group, indicating that HFS is an effective teaching method for enhancing skills in critical situations like septic shock and infusion reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing simulation in oncology emergencies education: A quasi- experimental design. Sharour, LA.[2019]

Spain currently has 80 clinical centers equipped with high fidelity simulators (HFS), primarily located in university and hospital settings, indicating a significant investment in advanced training tools for healthcare professionals.

The integration of HFS into training programs is growing, with 56% of university centers incorporating it into their curricula, highlighting its importance in enhancing medical education and patient care skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[High fidelity simulation in Spain: from dreams to reality]. Durá, MJ., Merino, F., Abajas, R., et al.[2016]

High-fidelity patient simulators (HFPSs) significantly improved toxicology knowledge among second-year medical students, with test scores increasing from 59% before training to 80% after simulation exercises.

The study suggests that incorporating HFPS into problem-based learning (PBL) curricula can enhance critical thinking and knowledge acquisition, making it a valuable tool for medical education, especially before clinical clerkships.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving toxicology knowledge in preclinical medical students using high-fidelity patient simulators. Halm, BM., Lee, MT., Franke, AA.[2021]

The systematic review identified 19 instruments for assessing non-technical skills (NTS) in healthcare providers during high-fidelity simulations, with the Team Emergency Assessment Measure (TEAM) being the only one recommended for use due to its established validity.

Out of 26 studies included, most NTS instruments showed varying degrees of content validity, but further research is needed to confirm the reliability and effectiveness of these tools in evaluating NTS during training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Instruments to evaluate non-technical skills during high fidelity simulation: A systematic review. Gawronski, O., Thekkan, KR., Genna, C., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11075587/

The Effectiveness of High-Fidelity Simulation on Clinical ...

The purpose of the study was to find the effectiveness of high fidelity simulation (HFS) on clinical competence among nursing students.

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1876139925000829

Acceptance and effectiveness of high-fidelity simulation in ...

High-fidelity simulation (HFS) is a cornerstone methodology in nursing education, enhancing clinical competence, patient safety, and decision-making skills.

3.

nursingsimulation.org

nursingsimulation.org/article/S1876-1399(25)00028-3/fulltext

The impact of high-fidelity simulation training on first-year ...

This study evaluated the effects of high-fidelity simulation training on first-year nursing students' attitudes toward learning communication skills.

4.

journals.lww.com

journals.lww.com/md-journal/fulltext/2024/07050/the_impact_of_simulation_based_training_in_medical.22.aspx

The impact of simulation-based training in medical education

Simulation-based training (SBT) has emerged as a transformative approach in medical education, significantly enhancing healthcare professionals' learning ...

5.

bmcnurs.biomedcentral.com

bmcnurs.biomedcentral.com/articles/10.1186/s12912-025-03300-9

Effectiveness of high-fidelity simulation on practice ...

The purpose of the study was to evaluate the efficacy of employing high-fidelity simulation (HFS) in enhancing mental health nursing students' practice, ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11224887/

The impact of simulation-based training in medical education

Research has consistently shown that SBT improves clinical skills, enhances patient safety, and improves clinical outcomes than traditional ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1471595319307954

High fidelity simulation evaluation studies in nursing ...

This synthesis included 20 research studies focusing on evaluating outcomes of high-fidelity simulation in undergraduate pre-licensure baccalaureate nursing ...

8.

journalofnursingregulation.com

journalofnursingregulation.com/article/S2155-8256(23)00028-5/fulltext

High-Fidelity Simulation's Impact on Clinical Reasoning ...

This scoping review aims to summarize the literature on the impact of high-fidelity simulation (HFS) on students' clinical reasoning and patients' safety.

9.

bmcnurs.biomedcentral.com

bmcnurs.biomedcentral.com/articles/10.1186/s12912-025-03561-4

Effects of high-fidelity simulation and e-learning methods on ...

... patient safety concepts, reporting positive outcomes in reducing medical errors. Simulations using high-fidelity simulators facilitate the ...