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HealthyNCT06549998

High-Fidelity Patient Simulation on Clinical Reasoning Skills and Interprofessional Competencies

A study testing Interprofessional Simulation Experience in people with Healthy, run by Youngstown State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The proposed study is looking to examine the effects of High-Fidelity Patient Simulation (HFPS) on clinical reasoning skills and interprofessional competencies in Physical Therapy and Nursing students. The proposed study will have two objectives: 1. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Interprofessional Simulation Experience
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
26 Aug 2024to 17 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Youngstown State University

    Youngstown, Ohio, 44555

Other trials in United States

About this study

Official title: Effects of High-Fidelity Patient Simulation on Clinical Reasoning Skills and Interprofessional Competencies in Physical Therapy and Nursing Students

The proposed study is looking to examine the effects of High-Fidelity Patient Simulation (HFPS) on clinical reasoning skills and interprofessional competencies in Physical Therapy and Nursing students.

The proposed study will have two objectives:

Read more
  1. Assess the use of HFPS and whether it has an effect of improving physical therapy and nursing student performance related to clinical reasoning skills during simulated clinical situations.
  2. Assess the use of HFPS and whether it has an effect of improving physical therapy and nursing student self-reported changes in team work and communication based on the IPEC core competencies

Researchers will compare students who do not receive a simulation (Group C) to those who receive two simulations (Group E).

Participants will:

  1. Be assigned to one of 2 groups (Group C, Group E)
  2. Based on group assignment receive no simulation or 2 simulations
  3. Each group will be assessed at the end for their inter-professional attitudes and clinical reasoning skills
Read the detailed description

Background Information Patient-centered care is important in helping individuals who live with multiple health conditions, requiring collaboration among healthcare professionals of different disciplines. Interprofessional collaborative practice has been defined by the World Health Organization as "multiple health workers from different professional backgrounds working together with patients, families, caregivers, and communities to deliver the highest quality of care". It is difficult for any one healthcare professional to address the number and variety of healthcare problems, making collaboration an important part of healthcare. An ability to effectively collaborate among health care disciplines in the areas of communication, role identification, team working skills, and conflict resolution are critical components of practice for health care professionals. This has led to educational institutions placing a greater emphasis on the development and integration of interprofessional education (IPE) into health professions curricula. The emphasis of IPE is to prepare health professions students to work together with the aim of building a safe, patient-centered health care environment5.

Experiential learning provides learners an opportunity to practice skills and techniques learned in the classroom in a real-world or practical setting. The benefits of experiential learning have long been held in high regard and include enhancing understanding of content and improvement in interpersonal skills. Implementation of experiential learning varies significantly across PT curricula. Some experiential learning methods are time and labor intensive, while others are less so. Cost, feasibility, time constraints, and course outcomes play a role in determining which methods work best for a particular course or program. Simulation has been used for decades to assist with skill acquisition and assessment. High-fidelity human patient simulation (HFPS) with a focus on clinical situations/scenarios is highly conducive to IPE. The term "simulation" refers to an experiential educational technique which "creates a situation or environment to allow persons to experience a representation of a real event for the purpose of practice, learning, evaluation, testing, or to gain understanding of systems or human actions.". In health care simulation, high-fidelity refers to "simulation experiences that are extremely realistic and provide a high level of interactivity and realism for the learner".

The use of simulation as a teaching pedagogy can be especially valuable in replicating the acute care setting.

Statement of the Problem The Interprofessional Education Collaborative (IPEC) set forth a series of core competencies for interprofessional collaborative practice. The IPEC describes these core competencies as: " to the safe, high-quality, accessible, patient-centered care and enhanced population health outcomes desired by all". These core competencies were developed in order to prepare students to engage in lifelong learning and collaboration to improve community health outcomes. These competencies include: Values and Ethics (work with team members to maintain a climate of shared values, ethical conduct, and mutual respect), Roles and Responsibilities (Use the knowledge of one's own role and team members' expertise to address health outcomes), Communication (Communicate in a responsive, responsible, respectful, and compassionate manner with team members.), Teams and Teamwork (Apply values and principles of team science to adapt one\'s own role in a variety of team settings).

The use of HFPS has been utilized in education settings involving physical therapy students. A recent review that examined the effect of HFPS learning in Acute Cardiorespiratory Physical Therapy noted that there is currently a lack of quality studies that have examined this area of study. Part of the quality involved the choice of research design and the lack of validated outcome measures to assess variables of interest. The review was unable to determine whether HFPS can improve physical therapists\' clinical performance and/or preparedness. In addition, many studies examine pre-post simulation when capturing outcome data, demonstrating a further need for longer longitudinal studies to further assess student performance. There is also reported variability in how HFPS is used, the optimal delivery, timing, volume, and content.

The proposed study will have two objectives:

  1. Assess the use of HFPS and whether it has an effect of improving physical therapy and nursing student performance related to clinical reasoning skills during simulated clinical situations.
  2. Assess the use of HFPS and whether it has an effect of improving physical therapy and nursing student self-reported changes in team work and communication based on the IPEC core competencies.
Conditions
Healthy
Being tested
Interprofessional Simulation Experience
Keywords
nursing, physical therapy, education, interprofessional, simulation, clinical reasoning

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interprofessional Simulation ExperienceOther

    Phase 1 (Pre-Brief): Nursing and physical therapy students will have 10 minutes to gather as a group and prepare for the simulation experience.

    The students will work together to review the simulated patient's medical chart, which includes a hand off report, physician orders, patient demographic data, disci-pline-specific progress notes, a physical therapy evaluation, and information from lab results posted on a tri-fold board.

    Phase 2 (Simulation): After reviewing the chart and establishing a plan as a group for getting the simulated patient out of bed, the interprofessional team of nursing and physical therapy students will enter the simulated hospital room. The goal for the approximately 20-minute encounter is for the interprofessional group to help the simulated patient to get out of bed while closely monitoring the physiological responses to activity.

    Phase 3: The simulation will conclude with a 30-minute faculty guided and structured debriefing session.

Study groups in NCT06549998
Study groupRoleWhat they receive
ControlNo interventionThis group will not receive any simulation intervention
Experimental GroupExperimentalThis group will receive 2 simulations
Receives: Other: Interprofessional Simulation Experience

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Interprofessional Attitudes Scale (IPAS)

    The tool measures 5 subscales that include: Teamwork roles and responsibilities, Patient centeredness, Interprofessional biases, Diversity and ethics, Community centeredness. The IPAS is based off of the 4 competencies for interprofessional education.

    The tool is a 27 item 5-point agreement scale ranging from strongly disagree to strongly agree. Internal consistency reliability for the sub-scales were good (i.e., Cronbach alpha = 0.62 to 0.92). Exploratory factor analysis revealed that items loaded sufficiently (i.e., loading greater than 0.30) on only one of five factors (i.e., did not cross-load). Confirmatory factor analysis supported the sub-scale structure, Goodness of Fit Index (GFI) = 0.86 and Root Mean Squared Error of Approximation (RMSEA) = 0.90.

    Measured: baseline and through study completion (an average of 8 months)

  2. Lasater Clinical Judgment Rubric (LCJR)

    The rubric's 11 dimensions of student performance are grouped into 4 subscales (Noticing, Interpreting, Responding, and Reflecting), with clear performance descriptions for dimension scores between 1 (beginning) and 4 (exemplary), and LCJR totals between 11 and 44 points. The LCJR is considered a valid and reliable instrument with the Cronbach α for total scores between 0.80 and 0.97 and subscale results of 0.89 to 0.93. Although it has been mainly used in simulation, use of the LCJR in clinically focused studies has been successful with Manetti reporting reliability of 0.89.

    Measured: baseline and through study completion (an average of 8 months)

  3. Performance Assessment Communication and Teamwork Tool Set (PACT)

    The PACT tools are designed to provide assessment feedback for learners, and evaluation information for program faculty. For this study, only the expert observation rating tool will be used. The overall inter-rater reliability of the novice, expert, and video observational tools was good (Intraclass Correlation Coefficient (ICC) = 0.85, 0.76, and 0.90, respectively). The inter-rater reliability for four of the five domains in the expert observational tool were acceptable (ICC = 0.44-0.66); the exception was the team structure domain (ICC = 0.21). The inter-rater reliability for all five domains in the video observational tool were acceptable (ICC = 0.54-0.84).

    Measured: baseline and through study completion (an average of 8 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2024
  2. Study start26 Aug 2024
  3. Primary completion17 May 2025
  4. Study completion17 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06549998
Sponsor's protocol ID
2024-260
Status last verified
Jul 2025
First submitted
5 Aug 2024
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Nandan M, Scott PA. Interprofessional practice and education: holistic approaches to complex health care challenges. J Allied Health. 2014 Aug;43(3):150-6.

    PubMed 25194061
  • Nichols A, Wiley S, Morrell BL, Jochum JE, Moore ES, Carmack JN, Hetzler KE, Toon J, Hess JL, Meer M, Moore SM. Interprofessional Healthcare Students' Perceptions of a Simulation-Based Learning Experience. J Allied Health. 2019 Fall;48(3):159-166.

    PubMed 31487353
  • Bethea DP, Smith N, Allison LK, Bell CS, Collins ME, Migliarese SJ, Darby R. Live Standardized Patient Scenario Improves Attitudes Toward and Readiness for Interprofessional Education in Occupational Therapy and Physical Therapy Students. J Allied Health. 2019 Summer;48(2):81-87.

    PubMed 31167008
  • Smith SN, Crocker AF. Experiential learning in physical therapy education. Adv Med Educ Pract. 2017 Jun 28;8:427-433. doi: 10.2147/AMEP.S140373. eCollection 2017.

    PubMed 28721117
  • Rossler KL, Kimble LP. Capturing readiness to learn and collaboration as explored with an interprofessional simulation scenario: A mixed-methods research study. Nurse Educ Today. 2016 Jan;36:348-53. doi: 10.1016/j.nedt.2015.08.018. Epub 2015 Sep 1.

    PubMed 26363963
  • Blaseg NA. Simulation-Based Interprofessional ICU Bedside Rounding Course. S D Med. 2022 Oct;75(10):449-450.

    PubMed 36889260
  • Coppola AC, Coppard BM, Qi Y. Impact of Participation in an Interprofessional Acute Care High-Fidelity Simulation for Occupational and Physical Therapy Graduate Students. J Allied Health. 2019 Winter;48(4):248-256.

    PubMed 31800654
  • Karnish K, Shustack L, Brogan L, Capitano G, Cunfer A. Interprofessional Socialization Through Acute-Care Simulation. Radiol Technol. 2019 Jul;90(6):552-562.

    PubMed 31270256
  • Shoemaker MJ, Riemersma L, Perkins R. Use of high fidelity human simulation to teach physical therapist decision-making skills for the intensive care setting. Cardiopulm Phys Ther J. 2009 Mar;20(1):13-8.

    PubMed 20467529
  • Silberman NJ, Panzarella KJ, Melzer BA. Using human simulation to prepare physical therapy students for acute care clinical practice. J Allied Health. 2013 Spring;42(1):25-32.

    PubMed 23471282
  • Thomas EM, Rybski MF, Apke TL, Kegelmeyer DA, Kloos AD. An acute interprofessional simulation experience for occupational and physical therapy students: Key findings from a survey study. J Interprof Care. 2017 May;31(3):317-324. doi: 10.1080/13561820.2017.1280006. Epub 2017 Feb 28.

    PubMed 28276844
  • Wellmon R, Lefebvre KM, Ferry D. Effects of High-Fidelity Simulation on Physical Therapy and Nursing Students' Attitudes Toward Interprofessional Learning and Collaboration. J Nurs Educ. 2017 Aug 1;56(8):456-465. doi: 10.3928/01484834-20170712-03.

    PubMed 28787067

Questions about this trial

What is this clinical trial studying?

A study testing Interprofessional Simulation Experience in people with Healthy, run by Youngstown State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Interprofessional Attitudes Scale (IPAS) (time frame: baseline and through study completion (an average of 8 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06549998, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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Clinical Trial NCT06549998 | AzTrials