Evaluation of a Gamified Electronic Medication Administration Record (eMAR) System

June 20, 2018 updated by: Western University, Canada

A Mixed-methods Evaluation of a Gamified Electronic Medication Administration Record (eMAR) System for Use in the Simulated Nursing Education

This research project will evaluate a gamified electronic medication administration record (eMAR) system simulator as a mechanism to improve students' learning of medication administration in simulated clinical education. The gamified eMAR simulator will be evaluated using a pragmatic randomized controlled trial design in order to determine the effectiveness of the game as a technology-enabled, online learning intervention.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The main objective of this study is to examine whether the use of a gamified medication administration simulator improves nursing students' medication administration safety within simulated practice; increases student self-efficacy and knowledge of the medication administration process; and, improves motivational and cognitive processing attributes related to student learning in a technology-enabled environment. It is hoped that by completing this trial, the effectiveness of using an eMAR simulator as an educational tool to better prepare nursing students to administer medications using eMAR technology for practice will be ascertained.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
115

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A3K7
        • Western University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • (1) second year nursing students; and, (2) partaking in clinical simulated education in either in Fall 2017 or Winter 2018 semesters.

Exclusion Criteria:

  • (1) A student who is not enrolled the BScN program at the respective site of data collection, in Fall 2017 or Winter 2018.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: eMAR game
Participants provided access to eMAR simulator game in advance of simulated return-demonstration; also receive normal education pre-work related to eMAR administration
Device: eMAR game
The eMAR simulator videogame affords students a virtual and immersive opportunity to practice medication administration using an eMAR system, in a structured fashion that provides real-time feedback related to best-practices and safety compliance of the medication process
Other: Normal pre-work
Participants complete normal education pre-work related to eMAR administration, in advance of simulated return-demonstration
Active Comparator: Normal pre-work
Participants receive normal education pre-work related to eMAR administration, in advance of simulated return-demonstration
Other: Normal pre-work
Participants complete normal education pre-work related to eMAR administration, in advance of simulated return-demonstration

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of medication errors
Time Frame: weeks 6-9
Number medication errors generated by nursing students, as assessed by a previously modified researcher-developed rubric that assists observers to quantify the number of medication errors generated during a return-demonstration in clinical simulation (DOI:10.1097/NNE.0000000000000361 / 10.1016/j.ecns.2017.05.016). The quantity of medication errors are codified in six categories: infection control; assessment; verification; scan; administration; documentation.
weeks 6-9

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-efficacy of eMAR medication administration instrument
Time Frame: weeks 4-9
Self-efficacy of eMAR medication process will be assessed through a pre/post survey. The scale is 6 item scale (1=not confident; 7=absolutely confident). The higher the index, the higher an individual's perceived self-efficacy toward eMAR medication administration. Used as a pre/post test, this instrument will measure changes over time related to eMAR medication administration self-efficacy
weeks 4-9
Game motivational and cognitive attributes of participants instrument
Time Frame: week 9
Cross-sectional data will be collected using questions modified from the Huang et al. (2011) validated instrument that measures motivational (i.e., attention, relevance, confidence, satisfaction) and cognitive processing of learning in technology-enabled environments (20 questions, Cronbach's alpha = 0.91). This composite outcome is reported through tests of dimensionality, using a canonical correlational analysis, providing standardized coefficients between the instrument's sub-components.
week 9
Knowledge of eMAR medication administration instrument
Time Frame: weeks 4-9
Knowledge of eMAR medication process will be assessed through a pre/post survey. The scale is 8 item scale (1=not prepared; 7=absolutely prepared). The higher the index, the higher an individual's perceived knowledge toward eMAR medication administration. Used as a pre/post test, this instrument will measure changes over time related to eMAR medication administration knowledge
weeks 4-9

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Western University, Canada

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centre for Addiction and Mental Health
London Health Sciences Centre
Texas Tech University Health Sciences Center
St. Joseph's Health Care London
Wilfrid Laurier University
eCampusOntario

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 29, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RI-WEST03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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