NCT06549998

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2024

Completed
14 days until next milestone

Study Start

First participant enrolled

August 26, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

9 months

First QC Date

August 5, 2024

Last Update Submit

July 10, 2025

Conditions

Keywords

nursingphysical therapyeducationinterprofessionalsimulationclinical reasoning

Outcome Measures

Primary Outcomes (3)

  • 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.

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

  • 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.

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

  • 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).

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

Study Arms (2)

Control

NO INTERVENTION

This group will not receive any simulation intervention

Experimental Group

EXPERIMENTAL

This group will receive 2 simulations

Other: Interprofessional Simulation Experience

Interventions

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.

Experimental Group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Youngstown State University

Youngstown, Ohio, 44555, United States

Location

Related Publications (12)

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

    PMID: 25194061BACKGROUND
  • 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.

    PMID: 31487353BACKGROUND
  • 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.

    PMID: 31167008BACKGROUND
  • 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.

    PMID: 28721117BACKGROUND
  • 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.

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

    PMID: 36889260BACKGROUND
  • 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.

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

    PMID: 31270256BACKGROUND
  • 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.

    PMID: 20467529BACKGROUND
  • 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.

    PMID: 23471282BACKGROUND
  • 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.

    PMID: 28276844BACKGROUND
  • 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.

    PMID: 28787067BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2024

First Posted

August 12, 2024

Study Start

August 26, 2024

Primary Completion

May 17, 2025

Study Completion

May 17, 2025

Last Updated

July 16, 2025

Record last verified: 2025-07

Locations