Nursing Students' Recognition of and Response to Deteriorating Patients

August 20, 2019 updated by: Eli Andås, University of Agder
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.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Simulation-based nursing education is an increasingly used pedagogical approach.

The overall aim of this intervention study is to examine the effects of an high-fidelity simulation intervention developed to identify how recognizing and responding to patient deterioration improves the knowledge and self-confidence of undergraduate nursing students.

Specific aims:

  1. To describe and estimate the change in undergraduate nursing students' knowledge and perceived self-confidence after an high-fidelity simulation intervention.
  2. To identify the barriers and enablers that may impact on a successful implementation of the high-fidelity simulation intervention.

Half of the participants will receive an intervention with high-fidelity simulation, while the other half will not receive any instructional intervention. All participants will answer a questionnaire developed to measure perceived knowledge and levels of self-confidence pre- and post-intervention or before and after a meeting (control group). Five students and six faculty members will also be interviewed as a part of a process evaluation.

The study is part of a PhD project.

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

- None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-fidelity simulation
The participants in the intervention group will receive an high-fidelity simulation intervention
The set up in the high-fidelity simulation intervention is a deteriorating patient scenario.
No Intervention: Control
The participants in the control group will not receive any instructional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Levels of self-confidence
Time Frame: Baseline (immediately before intervention) and immediately after intervention (the intervention will last for 3 hours)
Change in total responses using 20 questions with five response alternatives (from not at all confident to very confident) 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Mariann Fossum, Professor, University of Agder

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2016

Primary Completion (Actual)

December 16, 2018

Study Completion (Actual)

December 16, 2018

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

August 17, 2019

First Posted (Actual)

August 21, 2019

Study Record Updates

Last Update Posted (Actual)

August 22, 2019

Last Update Submitted That Met QC Criteria

August 20, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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