NCT03914040

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

May 10, 2019

Status Verified

April 1, 2019

Enrollment Period

1 month

First QC Date

April 1, 2019

Last Update Submit

May 8, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Communication skills.

    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).

    From baseline to one month.

Secondary Outcomes (1)

  • Students' perception of the professional role of physician and nurse.

    From baseline to one month

Other Outcomes (3)

  • Students' self-confidence about learning in simulation.

    up to 1 week after intervention

  • Students' perception about learning in simulation

    up to 1 week after intervention

  • Students' perception of the presence of educational best practices in simulation

    up to 1 week after intervention

Study Arms (2)

IPSE program

EXPERIMENTAL

IPSE is conceptually divided in two phases: 1) pre-immersion preparation, 2) immersion.

Other: IPSE program

Traditional course

NO INTERVENTION

Participants in the control group will receive the current face-to-face course.

Interventions

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.

IPSE program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • students who had already failed the course in a previous year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università del Piemonte Orientale

Novara, 28100, Italy

Location

Study Officials

  • Massimiliano Panella

    Dipartimento di medicina traslazionale-Università degli studi del piemonte orientale

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of traslational medicine

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 12, 2019

Study Start

October 1, 2019

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

May 10, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Study protocol and final report will be submitted to peer-reviewed journal for possible publication.

Locations