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Effectiveness of Interprofessional Learning and Simulation on Healthy Aging in Undergraduate Medical and Nursing Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914040
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Massimiliano Panella, Università degli Studi del Piemonte Orientale "Amedeo Avogadro"

Tracking Information
First Submitted Date  ICMJE April 1, 2019
First Posted Date  ICMJE April 12, 2019
Last Update Posted Date May 10, 2019
Estimated Study Start Date  ICMJE October 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Communication skills. [ Time Frame: From baseline to one month. ]
Communication Skill Attitude Scale (CSAS).CSAS is a 26-item questionnaire in two dimensions that has been developed to measure positive and negative attitudes towards learning communication skills. Each of the two subscales consists of 13 items, the Positive Attitude Scale (PAS) and the Negative Attitude Scale (NAS).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2019)
Students' perception of the professional role of physician and nurse. [ Time Frame: From baseline to one month ]
The measurement tool is the semantic differential test. It consists of a series of 16 bipolar adjective-pair scales for measuring psychological meanings related to three concepts: "me as a medical or nursing student", "physician using lifestyle medicine approach" and "nurse using lifestyle medicine approach".The meaning of the concept is measured by individual, selecting a point along a seven-point scale. The point selected indicates both the quality and intensity of the participant's subjective assessment of the association between the adjective pair and the related concept.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 10, 2019)
  • Students' self-confidence about learning in simulation. [ Time Frame: up to 1 week after intervention ]
    The Student Satisfaction and Self-Confidence in Learning Scale (SCLS). A total of 13 items assess the attitudes toward satisfaction with instruction and self-confidence in learning in simulation. For each item, participants indicated their personal feelings about a statement that described their own attitudes or beliefs. Response options are 1) strongly disagree, 2) disagree, 3) undecided, 4) agree, and 5) strongly agree using a Likert-style scale. Scores are calculated by summing responses; higher scores indicate more satisfaction and more self-confidence, respectively.
  • Students' perception about learning in simulation [ Time Frame: up to 1 week after intervention ]
    Simulation Design Scale (SDS). A total of 20 items assess perceptions of objectives, information, support, problem solving, feedback, and fidelity in simulation. For each item, participants indicate their perceptions about a statement that described the presence of simulation design features. Response options for statements related to presence of simulation design features are 1) strongly disagree, 2) disagree, 3) undecided, 4) agree, 5) strongly agree, and NA) not applicable using a Likert-style scale. Scores are calculated by summing responses; higher scores represent increased recognition of design features in simulation.
  • Students' perception of the presence of educational best practices in simulation [ Time Frame: up to 1 week after intervention ]
    Educational Practices Questionnaire (EPQ).The instrument consists in 16 items. For each item, participants indicated their perceptions about a statement that described presence of educational best practices. Items are rated on a Likert-type scale ranging from 1 (strongly disagree) to 5 (strongly agree). Scores are calculated by summing responses; higher scores represent increased recognition of educational best practices in simulation.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Interprofessional Learning and Simulation on Healthy Aging in Undergraduate Medical and Nursing Program
Official Title  ICMJE Interprofessional Learning and Simulation Versus Traditional Course on Healthy Aging: a Randomized Control Trial
Brief Summary

Aging population is an important public health issue and require coordinated and comprehensive response. Medical and nursing schools need to address challenges in health care delivery, and interprofessional simulation-based education (IPSE) provides realistic learning experiences in which interprofessional communication, roles and teamwork can be developed and assessed.

The study aims to examine the effectiveness of delivering an IPSE program versus traditional course to nursing and medical students. The primary outcome is improved communication skills, assessed by Communication Skill Attitude Scale (CSAS) divided in two subscales: Positive Attitude Scale (PAS) and Negative Attitude Scale (NAS).

Detailed Description

Design: this is a randomized, controlled study. Eligible participants will be randomly allocated to intervention group (IPSE) or control group (traditional course) in a 1:1 ratio. The investigator will use a block size of four with no stratification: for each block of 4 students, a different random ordering of 2 assignments to each treatment will be produced. A table of random numbers will be used to produce 2 randomization lists: one for nursing students and one for medical students.

Setting and participants: the study will be performed at the Università del Piemonte Orientale (Italy). In this study, second-year student volunteers from the Nursing School and fourth and fifth-year student volunteers from the School of Medicine will be recruited through an information session.

Intervention: IPSE program is divided in two phases: 1) a self-study course will be offered about lifestyle modification, 2) four different learning methods: didactic lecture, role playing, standardized patient and a new immersive advanced simulation learning environment will be provided.

Data collection: demographic data (gender, age, education) will be gathered to obtain a basic profile of participants prior to allocation. Before the randomization and after the completion of the program, each participant will complete the evaluation session.

Sample size calculation: a minimal total study sample size of 60 (24 nursing and 36 medical students) would be required to provide 80% power to reject the null hypothesis that no difference existed between the two research arms in NAS/PAS score, with a two-sided type 1 error of 5%. To balance the sample size of the two groups, the investigator decided to recruit the same number of nursing and medical students: 36 participants for each group. With a 10% allowance for students lost at follow up, a sample size of 80 students would be required and will be used.

Analyses: all analyses will be based on the Intention-To-Treat (ITT) approach. Students who do not start intervention or only complete the 25% of the course will not be included in the analysis. Descriptive statistical analyses will be conducted separately for each student group using the information collected at baseline. For categorical variables, number and percentage of participants in each category will be reported while, for normally distributed continuous variables, the mean and Standard Deviation values will be calculated. If the data are not normal, the investigator will use median and interquartile range. Subsequently, the analyses will be conducted categorizing the continuous variables and joining levels of ordinal variables to avoid the occurrence of scattered data phenomena.

In order to evaluate baseline differences between nursing and medical students, approximate (Chi square) or exact (Fisher) association tests will be performed for categorical variables while, for numeric ones, the investigator will use the independent T-test(parametric) or the Mann-Whitney U test (nonparametric). The obtained p value values will be reported.

The individual response profiles of primary outcomes will be implemented. Then, subjects will be categorized into two groups: successful if they increase positive scores/decrease negative scores and unsuccessful if they decrease positive scores/increase negative scores. The association with these binary outcomes and the recorded variables will be evaluated with appropriate tests (Chi-square, Fisher Exact, T, Mann-Withey). For each outcome the Relative Risks will be calculated with the respective 95% Confidence Interval using a Poisson regression with a robust error variance.

Study data will gather and manage with REDCap31 electronic data-capture tools, and the analyses will be performed by using SAS version 9.4.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Healthy Aging
  • Interprofessional Relations
  • Education, Professional
Intervention  ICMJE Other: IPSE program
  1. Pre-immersion preparation. A self-study course will be offered about lifestyle modification. Some readings will be suggested to introduce students to the concepts of health promotion and prevention of metabolic syndrome.
  2. Immersion. Four different learning methods will be provided: I) four hours of didactic lectures followed by group discussion, II) four hours per student of role playing, III) 30' per students of standardized patient experiences and IV) 30' per students of a new immersive advanced simulation learning environment (e-REAL). Four case-studies will be used to create scenarious, including woman with menopause weight gain, obese young adult, obese child and adult with unhealthy behaviours.
Study Arms  ICMJE
  • Experimental: IPSE program
    IPSE is conceptually divided in two phases: 1) pre-immersion preparation, 2) immersion.
    Intervention: Other: IPSE program
  • No Intervention: Traditional course
    Participants in the control group will receive the current face-to-face course.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • second-year nursing students,
  • fourth and fifth-year medical students.

Exclusion Criteria:

  • students who had already failed the course in a previous year.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Massimiliano Panella 0321 660 635 massimiliano.panella@med.uniupo.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03914040
Other Study ID Numbers  ICMJE IPSE_UPO students
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Study protocol and final report will be submitted to peer-reviewed journal for possible publication.
Responsible Party Massimiliano Panella, Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Study Sponsor  ICMJE Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Massimiliano Panella Dipartimento di medicina traslazionale-Università degli studi del piemonte orientale
PRS Account Università degli Studi del Piemonte Orientale "Amedeo Avogadro"
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP