NCT04063319

Brief Summary

The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention in undergraduate nursing education developed to identify recognizing and responding to patient deterioration. Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2016

Typical duration for not_applicable

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

Study Start

First participant enrolled

August 15, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
Last Updated

August 22, 2019

Status Verified

August 1, 2019

Enrollment Period

2.3 years

First QC Date

June 21, 2019

Last Update Submit

August 20, 2019

Conditions

Keywords

High-fidelity simulationSelf-confidenceDeteriorating patientsOrdinal dataQuestionnaire

Outcome Measures

Primary Outcomes (1)

  • Knowledge

    Change in total score from 0-20 using 20 multiple choice questions about vital signs, clinical changes in vital signs after major acute blood loss, and nursing procedures. Higher scores at post-intervention represent a better outcome.

    Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)

Secondary Outcomes (1)

  • Levels of self-confidence

    Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)

Study Arms (2)

High-fidelity simulation

EXPERIMENTAL

The participants in the intervention group will receive an high-fidelity simulation intervention

Other: High-fidelity simulation

Control

NO INTERVENTION

The participants in the control group will not receive any instructional intervention

Interventions

The set up in the high-fidelity simulation intervention is a deteriorating patient scenario.

High-fidelity simulation

Eligibility Criteria

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

You may qualify if:

  • All undergraduate nursing students at two universities enrolling in a specific course that includes high-fidelity simulation

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Haddeland K, Slettebo A, Fossum M. Enablers of the successful implementation of simulation exercises: a qualitative study among nurse teachers in undergraduate nursing education. BMC Nurs. 2021 Nov 22;20(1):234. doi: 10.1186/s12912-021-00756-3.

MeSH Terms

Conditions

Behavior

Study Officials

  • Mariann Fossum, Professor

    University of Agder

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Adviser

Study Record Dates

First Submitted

June 21, 2019

First Posted

August 21, 2019

Study Start

August 15, 2016

Primary Completion

December 16, 2018

Study Completion

December 16, 2018

Last Updated

August 22, 2019

Record last verified: 2019-08