Nurse's RoleNCT03219151
Evaluation of a Gamified Electronic Medication Administration Record (eMAR) System
A study testing eMAR game and Normal pre-work in people with Nurse's Role and Medication Administered in Error, run by Western University, Canada at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nurse's Role, Medication Administered in Error, Simulation of Physical Illness
- What is being tested?
- eMAR game and Normal pre-work
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteCanada
- Study dates
- 29 Sep 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (1) second year nursing students; and, (2) partaking in clinical simulated education in either in Fall 2017 or Winter 2018 semesters.
Who cannot join
- (1) A student who is not enrolled the BScN program at the respective site of data collection, in Fall 2017 or Winter 2018.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- eMAR game, Normal pre-work
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eMAR gameDevice
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
Normal pre-workOther
Participants complete normal education pre-work related to eMAR administration, in advance of simulated return-demonstration
| Study group | Role | What they receive |
|---|---|---|
| eMAR game | Experimental | Participants provided access to eMAR simulator game in advance of simulated return-demonstration; also receive normal education pre-work related to eMAR administration Receives: Device: eMAR game; Other: Normal pre-work |
| Normal pre-work | Active comparator | Participants receive normal education pre-work related to eMAR administration, in advance of simulated return-demonstration Receives: Other: Normal pre-work |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of medication errors
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.
Measured: weeks 6-9
Secondary outcomes (3)
Self-efficacy of eMAR medication administration instrument
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
Measured: weeks 4-9
Game motivational and cognitive attributes of participants instrument
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.
Measured: week 9
Knowledge of eMAR medication administration instrument
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
Measured: weeks 4-9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start29 Sep 2017
- Primary completion31 Mar 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nurse's RoleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- eCampusOntario, Centre for Addiction and Mental Health, Texas Tech University Health Sciences Center, London Health Sciences Centre, St. Joseph's Health Care London, Wilfrid Laurier University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03219151
- Sponsor's protocol ID
- RI-WEST03
- Status last verified
- May 2017
- First submitted
- 6 Jun 2017
- Last updated
- 25 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Booth R, Sinclair B, McMurray J, Strudwick G, Watson G, Ladak H, Zwarenstein M, McBride S, Chan R, Brennan L. Evaluating a Serious Gaming Electronic Medication Administration Record System Among Nursing Students: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2018 May 28;7(5):e138. doi: 10.2196/resprot.9601.
PubMed 29807885
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mixed-methods Evaluation of a Gamified Electronic Medication Administration Record (eMAR) System for Use in the Simulated Nursing Education
- ClinicalTrials.gov ID
- NCT03219151
- Acronym / sponsor ID
- RI-WEST03
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Western University, CanadaUniversity, hospital or other
- Collaborators
- eCampusOntario, Centre for Addiction and Mental Health, Texas Tech University Health Sciences Center, London Health Sciences Centre, St. Joseph's Health Care London, Wilfrid Laurier University
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 17 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eMAR game | Experimental | Device: eMAR game, Other: Normal pre-workParticipants provided access to eMAR simulator game in advance of simulated return-demonstration; also receive normal education pre-work related to eMAR administration |
| Normal pre-work | Active comparator | Other: Normal pre-workParticipants receive normal education pre-work related to eMAR administration, in advance of simulated return-demonstration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) second year nursing students; and, (2) partaking in clinical simulated education in either in Fall 2017 or Winter 2018 semesters.
Key exclusion criteria (1 listed)
- (1) A student who is not enrolled the BScN program at the respective site of data collection, in Fall 2017 or Winter 2018.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eMAR gameThe 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 | Device | eMAR game |
| Normal pre-workParticipants complete normal education pre-work related to eMAR administration, in advance of simulated return-demonstration | Other | Normal pre-work, eMAR game |
Primary outcome
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.
3 secondary outcomes
Self-efficacy of eMAR medication administration instrument
Time frame: weeks 4-9
Game motivational and cognitive attributes of participants instrument
Time frame: week 9
Knowledge of eMAR medication administration instrument
Time frame: weeks 4-9
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
- Derived from this study: PubMed 29807885Booth R, Sinclair B, McMurray J, Strudwick G, Watson G, Ladak H, Zwarenstein M, McBride S, Chan R, Brennan L. Evaluating a Serious Gaming Electronic Medication Administration Record System Among Nursing Students: Protocol for a Pragmatic Randomized Controlled Trial. JMIR Res Protoc. 2018 May 28;7(5):e138. doi: 10.2196/resprot.9601.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eMAR game and Normal pre-work in people with Nurse's Role and Medication Administered in Error, run by Western University, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of medication errors (time frame: weeks 6-9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03219151, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2018.