Implicit BiasNCT07095335
Evaluating Simulation Experiences to Help Navigate Racism and Hidden Bias
A study testing education intervention A-CHARM in people with Implicit Bias, run by Queen's University at 1 site in Canada.
Trial summary
This study utilizes a quasi-experimental design to examine the acceptability, usability and impact of the A-CHARM resources including the pre-learning, the SEs and the debrief. Consenting participants will be asked to complete a demographic questionnaire and pre-simulation assessment of cultural humility using the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Implicit Bias
- What is being tested?
- education intervention A-CHARM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- undergraduate and graduate nursing students at a University in Southern Ontario
- clinical faculty at a University in Southern Ontario
- speak, read and understand English.
- able to navigate a virtual simulation experience using an electronic device.
Who cannot join
- students not enrolled in the nursing program
- faculty not teaching in the nursing program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Effectiveness of Simulation Experiences to Help Navigate Racism and Hidden Bias
This study utilizes a quasi-experimental design to examine the acceptability, usability and impact of the A-CHARM resources including the pre-learning, the SEs and the debrief. Consenting participants will be asked to complete a demographic questionnaire and pre-simulation assessment of cultural humility using the Cultural Humility Scale, and cultural awareness using the Cultural Diversity Awareness Questionnaire. Participants will complete an education intervention that provides definitions of race, racism, and discrimination and provides an overview of the Six-Step Approach, ERASE framework and Microaggression Triangle model. Following the education intervention, they will complete a SE and a post-simulation questionnaire that reassess cultural humility, cultural awareness and the usability and acceptability of the SE.
Read the detailed description
Background and Literature Review:
Anti-Black and anti-Asian racism has increased significantly since the COVID-19 pandemic, with the number of hate crimes committed due to race or ethnicity increasing by 80% in Canada in 2020. This includes police-reported hate crimes targeting the Black, East or Southeast Asian, Indigenous, and South Asian peoples. Healthcare providers, including nurses who are persons of color, are not exempt from experiencing racism and hidden biases. These experiences often occur in the clinical setting, are unreported or underreported, and have a negative impact on nurses. A study conducted with nurses (n= 788) in New Jersey, United States, examined the direct, indirect, and interactive effects of individual (race), interpersonal (workplace racial microaggressions), and institutional (racial climate) factors on hospital-based nurses' emotional well- being. Compared to White nurses, non-white nurses reported higher emotional distress, more negative racial climates, and more microaggressions due to race.
Nursing students who experience racism or inappropriate comments in the clinical setting often do not possess appropriate strategies regarding how to respond. In addition, faculty, colleagues or other bystanders may not know how to respond. Traditionally, the method of coping has been avoidance or silence.
However, by not addressing racism it can indicate that inappropriate behaviours are acceptable. Providing nursing students with opportunities to critically examine how they may navigate inappropriate comments or racism, if they experience or witness it, is one strategy that can be utilized. Simulation education provides an opportunity for nursing students to engage in scenarios that based on real life experiences in a safe environment. In this proposed study we utilize the term simulation experiences (SEs) to highlight the lived experiences that the simulations are based on.
Due to the lack of available resources an education session and five virtual simulation experiences (SEs) were developed through the A-CHARM (Addressing Culturally based Hidden bias and RacisM) nursing project.
A search of the literature for frameworks or steps that healthcare professionals, including nursing students, can use to address inappropriate comments or racism in the clinical setting was also conducted. Three models were found and include the: 1) Six-Step Approach, 2) ERASE framework 3) Microaggression Triangle model.
Nursing students and clinical faculty require the opportunity to practice using these frameworks in a safe environment prior to utilizing them in real world situations. Simulation experiences can be used to create a safe environment for nursing students to critically assess how they could us these frameworks to address hidden-bias and racism prior to experiencing or witnessing them. These SEs can be a great resource; however, they need to be evaluated.
Research question and objectives: The research question for this study is: In nursing students and clinical nursing faculty/instructors, what is the effectiveness of an education session and virtual simulation experiences (SE's) on cultural awareness and the ability to utilize strategies to navigate racism and inappropriate comments in the clinical setting.
The specific objectives are:
- To describe the acceptability, and usability of the virtual simulation experiences (SEs) that focus on how to professionally address racism and inappropriate comments.
- To examine the effect of the education intervention and the SEs on cultural humility and cultural awareness.
Method:
This cohort study utilizes a quasi-experimental design (quantitative and qualitative) to examine the acceptability, usability and impact of the A-CHARM resources including the pre-learning, the SEs and the debrief. Consenting participants will be asked to complete a demographic questionnaire and pre-simulation assessment of cultural humility using the Cultural Humility Scale, and cultural awareness using the Cultural Diversity Awareness Questionnaire.
Intervention: Participants will complete an education session that provides definitions of race, racism, and discrimination and provides an overview of the Six-Step Approach, ERASE framework and Microaggression Triangle model. Following the education session, they will complete a SE and a post-simulation questionnaire that reassess cultural humility, cultural awareness and the usability and acceptability of the SE.
Sample: The target population for this study includes undergraduate and graduate nursing students and clinical faculty at Queen's University. A convenience sample of a minimum of 100 nursing students and 20 clinical faculty/clinical instructors will be recruited to participate in this study. Clinical faculty/instructors will be introduced to the study and invited to participate in person during their yearly faculty orientation. Nursing students will be invited to participate via email and in person during their classes.
Setting: The setting will include a University, School of Nursing, in Southern, Ontario, Canada.
Quantitative data will be collected using a web-based survey through Qualtrics©. All participants will assign themselves an ID number (see Appendix for how the ID number will be created).
Participants will be asked to enter this ID number at the beginning of the pre-simulation and post- simulation questionnaires. After providing consent to participate in the study, participants will immediately complete the demographic information and the pre-simulation questionnaire. Once this information has been obtained, they will complete the education session and they will receive an electronic link to the simulation experience (SE) and the post-simulation questionnaire.
Outcome measures: To evaluate usability, engagement, and impact as perceived by participants the ClassRoom Instructional Support Perceptions (CRISP-VS) will be used. The CRISP-VS is 23 item, valid and reliable outcome measure previously used in studies with nursing students.
Reliability testing for the CRISP-VS reports a Cronbach's α of 0.79 for the usability subscale, 0.89 for the engagement subscale, and 0.82 for the impact subscale.
To evaluate cultural humility the Foronda's Cultural Humility Scale will be used. This outcome measure includes 19 questions and was validated and tested with 322 undergraduate nursing and health sciences students and yielded a Cronbach's α = 0.85.
The Foronda Cultural Humility Scale has three subscales including 1) context for difference in perspective; 2) self-attributes; and 3) outcomes of cultural humility. To evaluate cultural awareness the Cultural Diversity Awareness Questionnaire will be used. This questionnaire is designed to measure beliefs and behaviours regarding cultural diversity and inclusion. It is scored by summing the numbers chosen on the questionnaire (1 = never, 2 = almost, 3 = sometimes, 4 = almost always, 5 = always). A high score indicates the individual/participant has a good awareness of their biases and how their behaviours may impact others, the individual relates to others in ways that value diversity. The validity and reliability for the Cultural Diversity Awareness Questionnaire was tested with public school educators and it has a Cronbach's α = 0.9.
Data Analysis: Data will be analyzed using SPSS (IBM, V 29.0.1.1, 2021). Demographic data and the CRISP-VS will be analyzed using descriptive statistics including means, standard deviations and frequencies. To examine if there is a significant difference between pre-simulation and post-simulation cultural humility and cultural awareness scores, paired t-tests will be completed if the data is normally distributed. If the data is not normally distributed a Wilcoxon nonparametric test will be completed. A p- value of 0.05 or less will be considered significant. Reliability testing will also be conducted on the Cultural Diversity Awareness Questionnaire by calculating the Cronbach's α as this outcome measure has not been utilized with the Canadian nursing and nursing student population.
- Conditions
- Implicit Bias
- Being tested
- education intervention A-CHARM
- Keywords
- Implicit bias, racism, nurisng, clinical settings, nursing students, simulation experiences, education intervention
- Medical subject headings
- Bias, Implicit, Racism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education intervention A-CHARMOther
Didactic education plus virtual simulation regarding discrimination in the hospital setting
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A-CHARM education and virtual simulation Receives: Other: education intervention A-CHARM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cultural Humility
To evaluate cultural humility the Foronda's Cultural Humility Scale will be used. This outcome measure includes 19 questions and was validated and tested with 322 undergraduate nursing and health sciences students and yielded a Cronbach's α = 0.85 (Foronda, Porter \& Phitwong, 2021).
The Foronda Cultural Humility Scale has three subscales including 1) context for difference in perspective; 2) self-attributes; and 3) outcomes of cultural humility.
Measured: Day 1
Secondary outcomes (2)
Cultural Awareness
. To evaluate cultural awareness the Cultural Diversity Awareness Questionnaire will be used (Bennett, 1986, Van Hook, 2000). This questionnaire is designed to measure beliefs and behaviours regarding cultural diversity and inclusion. It is scored by summing the numbers chosen on the questionnaire (1 = never, 2 = almost, 3 = sometimes, 4 = almost always, 5 = always). A high score indicates the individual/participant has a good awareness of their biases and how their behaviours may impact others, the individual relates to others in ways that value diversity (Illinois Leadership Project, 2016). The validity and reliability for the Cultural Diversity Awareness Questionnaire was tested with public school educators and it has a Cronbach's α = 0.9 (Henry, 1995).
Measured: Day 1
usability, engagement, and impact
To evaluate usability, engagement, and impact as perceived by participants the ClassRoom Instructional Support Perceptions (CRISP-VS) will be used. (see Appendix) The CRISP-VS is 23 item, valid and reliable outcome measure previously used in studies with nursing students.
Reliability testing for the CRISP-VS reports a Cronbach's α of 0.79 for the usability subscale, 0.89 for the engagement subscale, and 0.82 for the impact subscale (Sheng, et al., 2019).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start22 Aug 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
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 Implicit BiasStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monakshi Sawhney, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07095335
- Sponsor's protocol ID
- 6041616
- Status last verified
- Mar 2026
- First submitted
- 18 May 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li JS, Patterson M, Gumapac NP, Sau C, Mohamed S, Yusef HA, Sawhney M. Simulation Experiences Focusing on Addressing Culturally Based Hidden Bias and RacisM (A-CHARM). J Nurs Educ. 2025 Jul;64(7):449-453. doi: 10.3928/01484834-20240612-04. Epub 2024 Sep 20.
PubMed 39292736
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Simulation Experiences to Help Navigate Racism and Hidden Bias
- ClinicalTrials.gov ID
- NCT07095335
- Acronym / sponsor ID
- 6041616
- Conditions
- Implicit Bias
- Keywords
- Implicit bias, racism, nurisng, clinical settings, nursing students, simulation experiences, education intervention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 Jul 2025 (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 study utilizes a quasi-experimental design to examine the acceptability, usability and impact of the A-CHARM resources including the pre-learning, the SEs and the debrief. Consenting participants will be asked to complete a demographic questionnaire and pre-simulation assessment of cultural humility using the Cultural Humility Scale, and cultural awareness using the Cultural Diversity Awareness Questionnaire. Participants will complete an education intervention that provides definitions of race, racism, and discrimination and provides an overview of the Six-Step Approach, ERASE framework and Microaggression Triangle model. Following the education intervention, they will complete a SE and a post-simulation questionnaire that reassess cultural humility, cultural awareness and the usability and acceptability of the SE.
Detailed description
Background and Literature Review:
Anti-Black and anti-Asian racism has increased significantly since the COVID-19 pandemic, with the number of hate crimes committed due to race or ethnicity increasing by 80% in Canada in 2020. This includes police-reported hate crimes targeting the Black, East or Southeast Asian, Indigenous, and South Asian peoples. Healthcare providers, including nurses who are persons of color, are not exempt from experiencing racism and hidden biases. These experiences often occur in the clinical setting, are unreported or underreported, and have a negative impact on nurses. A study conducted with nurses (n= 788) in New Jersey, United States, examined the direct, indirect, and interactive effects of individual (race), interpersonal (workplace racial microaggressions), and institutional (racial climate) factors on hospital-based nurses' emotional well- being. Compared to White nurses, non-white nurses reported higher emotional distress, more negative racial climates, and more microaggressions due to race.
Nursing students who experience racism or inappropriate comments in the clinical setting often do not possess appropriate strategies regarding how to respond. In addition, faculty, colleagues or other bystanders may not know how to respond. Traditionally, the method of coping has been avoidance or silence.
However, by not addressing racism it can indicate that inappropriate behaviours are acceptable. Providing nursing students with opportunities to critically examine how they may navigate inappropriate comments or racism, if they experience or witness it, is one strategy that can be utilized. Simulation education provides an opportunity for nursing students to engage in scenarios that based on real life experiences in a safe environment. In this proposed study we utilize the term simulation experiences (SEs) to highlight the lived experiences that the simulations are based on.
Due to the lack of available resources an education session and five virtual simulation experiences (SEs) were developed through the A-CHARM (Addressing Culturally based Hidden bias and RacisM) nursing project.
A search of the literature for frameworks or steps that healthcare professionals, including nursing students, can use to address inappropriate comments or racism in the clinical setting was also conducted. Three models were found and include the: 1) Six-Step Approach, 2) ERASE framework 3) Microaggression Triangle model.
Nursing students and clinical faculty require the opportunity to practice using these frameworks in a safe environment prior to utilizing them in real world situations. Simulation experiences can be used to create a safe environment for nursing students to critically assess how they could us these frameworks to address hidden-bias and racism prior to experiencing or witnessing them. These SEs can be a great resource; however, they need to be evaluated.
Research question and objectives: The research question for this study is: In nursing students and clinical nursing faculty/instructors, what is the effectiveness of an education session and virtual simulation experiences (SE's) on cultural awareness and the ability to utilize strategies to navigate racism and inappropriate comments in the clinical setting.
The specific objectives are:
- To describe the acceptability, and usability of the virtual simulation experiences (SEs) that focus on how to professionally address racism and inappropriate comments.
- To examine the effect of the education intervention and the SEs on cultural humility and cultural awareness.
Method:
This cohort study utilizes a quasi-experimental design (quantitative and qualitative) to examine the acceptability, usability and impact of the A-CHARM resources including the pre-learning, the SEs and the debrief. Consenting participants will be asked to complete a demographic questionnaire and pre-simulation assessment of cultural humility using the Cultural Humility Scale, and cultural awareness using the Cultural Diversity Awareness Questionnaire.
Intervention: Participants will complete an education session that provides definitions of race, racism, and discrimination and provides an overview of the Six-Step Approach, ERASE framework and Microaggression Triangle model. Following the education session, they will complete a SE and a post-simulation questionnaire that reassess cultural humility, cultural awareness and the usability and acceptability of the SE.
Sample: The target population for this study includes undergraduate and graduate nursing students and clinical faculty at Queen's University. A convenience sample of a minimum of 100 nursing students and 20 clinical faculty/clinical instructors will be recruited to participate in this study. Clinical faculty/instructors will be introduced to the study and invited to participate in person during their yearly faculty orientation. Nursing students will be invited to participate via email and in person during their classes.
Setting: The setting will include a University, School of Nursing, in Southern, Ontario, Canada.
Quantitative data will be collected using a web-based survey through Qualtrics©. All participants will assign themselves an ID number (see Appendix for how the ID number will be created).
Participants will be asked to enter this ID number at the beginning of the pre-simulation and post- simulation questionnaires. After providing consent to participate in the study, participants will immediately complete the demographic information and the pre-simulation questionnaire. Once this information has been obtained, they will complete the education session and they will receive an electronic link to the simulation experience (SE) and the post-simulation questionnaire.
Outcome measures: To evaluate usability, engagement, and impact as perceived by participants the ClassRoom Instructional Support Perceptions (CRISP-VS) will be used. The CRISP-VS is 23 item, valid and reliable outcome measure previously used in studies with nursing students.
Reliability testing for the CRISP-VS reports a Cronbach's α of 0.79 for the usability subscale, 0.89 for the engagement subscale, and 0.82 for the impact subscale.
To evaluate cultural humility the Foronda's Cultural Humility Scale will be used. This outcome measure includes 19 questions and was validated and tested with 322 undergraduate nursing and health sciences students and yielded a Cronbach's α = 0.85.
The Foronda Cultural Humility Scale has three subscales including 1) context for difference in perspective; 2) self-attributes; and 3) outcomes of cultural humility. To evaluate cultural awareness the Cultural Diversity Awareness Questionnaire will be used. This questionnaire is designed to measure beliefs and behaviours regarding cultural diversity and inclusion. It is scored by summing the numbers chosen on the questionnaire (1 = never, 2 = almost, 3 = sometimes, 4 = almost always, 5 = always). A high score indicates the individual/participant has a good awareness of their biases and how their behaviours may impact others, the individual relates to others in ways that value diversity. The validity and reliability for the Cultural Diversity Awareness Questionnaire was tested with public school educators and it has a Cronbach's α = 0.9.
Data Analysis: Data will be analyzed using SPSS (IBM, V 29.0.1.1, 2021). Demographic data and the CRISP-VS will be analyzed using descriptive statistics including means, standard deviations and frequencies. To examine if there is a significant difference between pre-simulation and post-simulation cultural humility and cultural awareness scores, paired t-tests will be completed if the data is normally distributed. If the data is not normally distributed a Wilcoxon nonparametric test will be completed. A p- value of 0.05 or less will be considered significant. Reliability testing will also be conducted on the Cultural Diversity Awareness Questionnaire by calculating the Cronbach's α as this outcome measure has not been utilized with the Canadian nursing and nursing student population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: education intervention A-CHARMA-CHARM education and virtual simulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- undergraduate and graduate nursing students at a University in Southern Ontario
- clinical faculty at a University in Southern Ontario
- speak, read and understand English.
- able to navigate a virtual simulation experience using an electronic device.
Key exclusion criteria (2 listed)
- students not enrolled in the nursing program
- faculty not teaching in the nursing program
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 |
|---|---|---|
| education intervention A-CHARMDidactic education plus virtual simulation regarding discrimination in the hospital setting | Other | Intervention |
Primary outcome
Cultural Humility
Time frame: Day 1
To evaluate cultural humility the Foronda's Cultural Humility Scale will be used. This outcome measure includes 19 questions and was validated and tested with 322 undergraduate nursing and health sciences students and yielded a Cronbach's α = 0.85 (Foronda, Porter \& Phitwong, 2021). The Foronda Cultural Humility Scale has three subscales including 1) context for difference in perspective; 2) self-attributes; and 3) outcomes of cultural humility.
2 secondary outcomes
Cultural Awareness
Time frame: Day 1
usability, engagement, and impact
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication: PubMed 39292736Li JS, Patterson M, Gumapac NP, Sau C, Mohamed S, Yusef HA, Sawhney M. Simulation Experiences Focusing on Addressing Culturally Based Hidden Bias and RacisM (A-CHARM). J Nurs Educ. 2025 Jul;64(7):449-453. doi: 10.3928/01484834-20240612-04. Epub 2024 Sep 20.
- 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.
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 education intervention A-CHARM in people with Implicit Bias, run by Queen's University 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 4 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 20 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Cultural Humility (time frame: Day 1). 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 NCT07095335, 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 20 Mar 2026.