Condition category
Not Applicable
Date applied
03/07/2020
Date assigned
03/07/2020
Last edited
06/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Nurses must meet professional standards by attending continuing education activities. Despite the potential of virtual patient simulation in nursing education, it has rarely been used in nurses’ continuing education to address relational skills. We developed an automated virtual patient simulation informed by motivational interviewing to enhance nurses’ relational skills. The simulation features an HIV-positive man struggling to adhere to his medication. Quizzes and feedback loops embedded in the simulation allow learners to observe the consequences of their choices. This study aimed to assess nurses’ perception of simulation’s acceptability. Specific objectives were: to measure the simulation design elements, its role in supporting practice, its quality and technology acceptance, and the achievement of learning objectives; to explore nurses’ learning experience.

Who can participate?
French-speaking registered nurses working in Quebec, Canada, who self-reported as having basic computer skills.

What does the study involve?
Nurses have to fill out a first online questionnaire to get an overall picture of their sociodemographic characteristics (e.g. age, experience as nurses, etc). Then, they are invited to consult the virtual patient simulation, which is a form of digital training lasting 45 minutes, to help them in consolidating their communications skills with the virtual patient. When they complete their participation in the virtual patient simulation, they are invited to complete an online questionnaire (around 20 minutes). The last step, involving the nurses who want to share their experience of having participated in the virtual patient simulation, is the online focus group (qualitative data collection).

What are the possible benefits and risks of participating?
The possible benefits are: the improvement of nurses' communication skills, the awareness of their own communication style, the identification of nurses' strengths and weaknesses.
The risk of participating is the stress caused by the use of a computer.

Where is the study run from?
This is an online study. All the nurses from Quebec have access to it. However, the study is run from Montreal (Canada)

When is the study starting and how long is it expected to run for?
August 2018 to September 2019.

Who is funding the study?
The development of this simulation was funded by a student project grant from Quebec Network on Nursing Intervention Research, by a planning and dissemination grant from the Canadian Institutes of Health Research (CIHR) [144030], and by a doctoral scholarship allocated to GR from the CIHR [337439]. GR received doctoral scholarships from the Quebec Network on Nursing Intervention Research, the Fonds de recherche du Québec santé, the CIHR, and Quebec’s Ministère de l’Éducation et de l’Enseignement supérieur.

Who is the main contact?
Geneviève Rouleau, RN, PhD candidate
genevieve.rouleau.chum@ssss.gouv.qc.ca

Trial website

Contact information

Type

Scientific

Primary contact

Ms Geneviève Rouleau

ORCID ID

http://orcid.org/0000-0003-1093-6577

Contact details

850 rue St-Denis
Pavillon S
Door S01-110.4
Montreal
H2X0A9
Canada
+1 5148908000 ext 12744
genevieve.rouleau.chum@ssss.gouv.qc.ca

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Virtual patient simulation to improve nurses’ relational skills in a continuing education context: A convergent mixed-methods study

Acronym

Study hypothesis

This study aimed to quantitatively and qualitatively assess the acceptability of a virtual patient (VP) simulation to improve nurses’ relational skills in a continuing education (CE) context.
Our specific research objectives were: a) to measure the extent of the VP simulation nurses’ perceived acceptability in regards of the simulation design elements, of the global system quality and the technology acceptance, of the role simulation plays in supporting nurses’ professional practice, and of the achievement of learning objectives; b) to explore nurses’ learning experience; c) to deepen understanding of how the VP simulation can contribute to nurses’ uptake of relational skills, to overall learning and its transfer into practice.

Ethics approval

Approved 20/11/2018, Research Ethics Committee of the University of Montreal Hospital Centre (Tour R, 900 St-Denis Street, 3rd floor, Montreal, Qc/Canada, H2X 0A9; 1-514-890-8000, extension14485; ethique.recherche.chum@ssss.gouv.qc.ca), ref 18.243

Study design

Multicenter interventional study

Primary study design

Interventional

Secondary study design

Mixed methods study (pre-experimental design and qualitative exploratory design)

Trial setting

Internet

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

The simulation is about nurses' communication skills in a situation of medication non-adherence

Intervention

A convergent mixed methods study. First, a pre-experimental study is performed with a one-group post-test design to measure nurses’ perceptions of the VP simulation. Second, a qualitative exploratory design is used to describe nurses’ learning experience and to further nuance and deepen understanding of the acceptability of the intervention by using complementary topics that are not covered by the quantitative component.

A Web- and screen-based program, available on computer or tablet, that allows learners to interact with a two-dimensional animated human character called the “virtual patient.” Learners emulate the role of the healthcare providers, within a first-person perspective.
There is one 45-minutes consultation session.
Regarding the pre-experimental nature of the trial, there is no control group.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. VP simulation design elements; global system quality and technology acceptance; role of simulation in supporting nurses’ professional practice and achievement of learning objectives are measured with a 4-points Likert scale (1 = Strongly disagree; 2 = Disagree; 3 = Agree; 4 = Strongly agree) post-intervention (no timeline).
2. In the qualitative data collection at a single timepoint post-intervention, these topics are of interest: motivations, perceived difficulties for study participation, and concrete implications for nursing practice following participation in the virtual patient simulation.

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/08/2018

Overall trial end date

24/09/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Registered nurses working in Quebec (Canada)
2. Self-reported having basic computer literacy skills
3. Understand and speak French.

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

30

Total final enrolment

54

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

24/03/2019

Recruitment end date

24/08/2019

Locations

Countries of recruitment

Canada

Trial participating centre

University of Montreal Hospital Centre
1000, Rue Saint-Denis
Montreal
H2X 0C1
Canada

Sponsor information

Organisation

Université Laval

Sponsor details

Pavillon Ferdinand-Vandry
1050
avenue de la Médecine
local 3645
Quebec
G1V 0A6
Canada
+1 418 656 3356
fsi@fsi.ulaval.ca

Sponsor type

Other

Website

https://www.fsi.ulaval.ca/

Funders

Funder type

Government

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de recherche en santé du Canada, CIHR

Funding Body Type

unknown

Funding Body Subtype

Location

Funder name

Réseau de recherche portant sur les interventions en sciences infirmières du Québec

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Quebec Healthcare Research Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Quebec Ministry of Higher Education

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in BMC Nursing

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Geneviève Rouleau, Genevieve.rouleau.chum@ssss.gouv.qc.ca
Type of data: descriptive statistical analyses
Data anonymisation and individual information will be changed to protect the privacy and confidentiality of participants’ identity.
No date is fixed because the datasets will become available only if the principal investigator has reasonable request. Because the study’s findings are part of Geneviève Rouleau’s PhD thesis, the datasets won’t be available until the final deposit of the thesis will be approved by Université Laval.

Intention to publish date

06/07/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/07/2020: Internal review. 03/07/2020: Trial’s existence confirmed by Research Ethics Committee of the University of Montreal Hospital Centre.