Impact of Visual Arts Immersion on Cultural Competency and Self-reflection Among Nurses Working in an Academic Health System
Phase: NA
Conditions: Cultural Competency, Personal Reflection
Sponsor: NYU Langone Health

Official Title: 
Impact of Visual Arts Immersion on Cultural Competency and Self-
reflection Among Nurses Working in an Academic Health System  
NCT Number:
NCT05877976
Study Number:
23-00530 
Document Type:
Study Protocol and Statistical Analysis Plan
Date of the 
Document: 
 
January 16, 2024 

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IMPACT OF VISUAL ARTS IMMERSION ON CULTURAL COMPETENCY 
AND SELF-REFLECTION AMONG NURSES WORKING IN AN 
ACADEMIC HEALTH SYSTEM
Principal Investigator:
Lita Anglin, MSIS
Lead, Programming and Clinical Support, NYU Health 
Sciences Library, NYU Langone Health 
577 First Avenue, New York, NY 10016
Office: 212-263-2519
lita.anglin@nyulangone.org
NYULH Study Number:
s23-00530
Funding Sponsor: 
National Network of the Library of Medicine
National Library of Medicine, NIH
Initial version:
5/10/2023 v3
Amended:
[date]
Amended:
[date]

Study number: s23-00530
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Statement of Compliance
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), any other applicable US government research regulations, and 
institutional research policies and procedures. The Principal Investigator will assure that no deviation from, 
or changes to the protocol will take place without prior agreement from the sponsor and documented 
approval from the Institutional Review Board (IRB), except where necessary to eliminate an immediate 
hazard(s) to the study participants. All personnel involved in the conduct of this study have completed 
Human Subjects Protection Training. 
 
 

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Table of Contents
PROTOCOL SUMMARY .............................................................................................................................. 1
SCHEMATIC OF STUDY DESIGN.................................................. ERROR! BOOKMARK NOT DEFINED.
1 
KEY ROLES ......................................................................................................................................... 2
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....................... 2
2.1
BACKGROUND INFORMATION AND RELEVANT LITERATURE................................................................2
2.2 
RATIONALE.................................................................................................................................... 2
2.2.1 
Known Potential Risks ............................................................................................................. 3
2.2.2
Known Potential Benefits ........................................................................................................ 3
3 
OBJECTIVES AND PURPOSE ........................................................................................................... 3
3.1 
PRIMARY OBJECTIVE ...................................................................................................................... 3
3.2
SECONDARY OBJECTIVES...............................................................................................................3
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................... 3
4.1 
DESCRIPTION OF STUDY DESIGN .................................................................................................... 3
5 
STUDY ENROLLMENT AND WITHDRAWAL .................................................................................... 4
5.1 
INCLUSION CRITERIA ...................................................................................................................... 4
5.2 
EXCLUSION CRITERIA ..................................................................................................................... 4
5.3 
VULNERABLE SUBJECTS................................................................................................................. 4
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION ............................................................................ 4
5.5 
DURATION OF STUDY PARTICIPATION.............................................................................................. 5
5.6 
TOTAL NUMBER OF PARTICIPANTS AND SITES .................................................................................. 5
5.7 
PARTICIPANT WITHDRAWAL OR TERMINATION.................................................................................. 5
5.7.1 
Reasons for Withdrawal or Termination .................................................................................. 5
5.7.2 
Handling of Participant Withdrawals or Termination ............................................................... 5
5.7.3 
Premature Termination or Suspension of Study ..................................................................... 5
6 
STUDY SCHEDULE............................................................................................................................. 5
6.1 
SCREENING ................................................................................................................................... 6
6.2 
ENROLLMENT/BASELINE ................................................................................................................. 6
6.3 
INTERMEDIATE VISITS ..................................................................................................................... 6
6.4 
FINAL STUDY VISIT ......................................................................................................................... 6
6.5
WITHDRAWAL VISIT........................................................................................................................ 6
6.6 
UNSCHEDULED VISIT ...................................................................................................................... 6
7
STUDY PROCEDURES/EVALUATIONS............................................................................................ 7
7.1 
PROCEDURES/EVALUATIONS .......................................................................................................... 7
8 
ADVERSE EVENTS ............................................................................................................................. 7
8.1 
DEFINITIONS .................................................................................................................................. 7
8.2 
RECORDING OF ADVERSE EVENTS.................................................................................................. 8
8.3 
REPORTING OF SERIOUS ADVERSE EVENTS AND UNANTICIPATED PROBLEMS ................................... 8
8.3.1 
Investigator reporting: notifying the IRB .................................................................................. 8
9 
STUDY OVERSIGHT ........................................................................................................................... 9
10
STATISTICAL CONSIDERATIONS .................................................................................................. 10
10.1
STUDY HYPOTHESES .................................................................................................................... 10
10.2
SAMPLE SIZE DETERMINATION ...................................................................................................... 10
10.3
STATISTICAL METHODS ................................................................................................................ 10

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11
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS.................................10
12
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 10
12.1
ETHICAL STANDARD.....................................................................................................................10
12.2
INSTITUTIONAL REVIEW BOARD.....................................................................................................11
12.3
INFORMED CONSENT PROCESS .................................................................................................... 11
12.3.1
Consent and Other Informational Documents Provided to Participants ...........................11
12.3.2
Consent Procedures and Documentation.........................................................................11
12.4
PARTICIPANT AND DATA CONFIDENTIALITY .................................................................................... 11
12.5
FUTURE USE OF STORED DATA .................................................................................................... 12
13
DATA HANDLING AND RECORD KEEPING...................................................................................12
13.1
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 12
13.2
STUDY RECORDS RETENTION ....................................................................................................... 12
13.3
PROTOCOL DEVIATIONS ...............................................................................................................12
13.4
PUBLICATION AND DATA SHARING POLICY..................................................................................... 12
14
STUDY FINANCES ............................................................................................................................ 12
14.1
FUNDING SOURCE........................................................................................................................12
14.2
COSTS TO THE PARTICIPANT ......................................................................................................... 13
14.3
PARTICIPANT REIMBURSEMENTS OR PAYMENTS ............................................................................ 13
15
STUDY ADMINISTRATION .................................................... ERROR! BOOKMARK NOT DEFINED.
15.1
STUDY LEADERSHIP ..................................................................... ERROR! BOOKMARK NOT DEFINED.
16
CONFLICT OF INTEREST POLICY .................................................................................................. 13
17
REFERENCES ................................................................................................................................... 14
 

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List of Abbreviations
AE
Adverse Event/Adverse Experience 
AT
Aromatherapy 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form
CSOC 
Clinical Study Oversight Committee 
DCC
Data Coordinating Center
DHHS
Department of Health and Human Services
FFR 
Federal Financial Report
FWA 
Federalwide Assurance
HIPAA
Health Insurance Portability and Accountability Act 
ICF
Informed Consent Form 
IRB
Institutional Review Board
MOP 
Manual of Procedures
N 
Number (typically refers to participants)
NIH
National Institutes of Health
NJSS 
Nurse Job Satisfaction Survey 
NYULH 
NYU Langone Health
OHQ 
Oxford Happiness Questionnaire
OHRP 
Office for Human Research Protections
OHSR 
Office of Human Subjects Research
PI 
Principal Investigator 
QA
Quality Assurance 
QC
Quality Control 
SAE
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
US 
United States 

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Drug/Device Template Version: 8 February 2019 
Protocol Summary
Title 
Impact of visual arts immersion on cultural competency and self-reflection 
among nurses working in an academic health system 
Short Title 
Impact of visual arts immersion
Brief Summary
The purpose of this study is to enhance engagement, coping and self-reflection 
by attuning nurses to creative and observational skills drawn from a visual arts 
pedagogical framework. To fulfill this goal, we will cultivate an existing 
relationship between NYULH Nursing, the NYU Health Sciences Library, and 
museum educators at The Met to design and deliver an intervention of museum 
educator-led workshops that introduce nurses to arts appreciation skills to 
improve their practice and overall wellbeing. Participants will be asked to 
complete two surveys, pre- and post-intervention, Cultural Awareness Scale 
(CAS), which measures cultural awareness, sensitivity, knowledge and skills, 
and the Interpersonal Reactivity Index (IRI), which measures four separate 
aspects of empathy and its relationships with measures of social functioning, 
self-esteem, emotionality, and sensitivity to others. We will also solicit 
qualitative feedback via REDCap survey at the end of the intervention to gain 
insight into nurse’s experiences of the art immersion program. 
Objectives 
The main objective is to determine if a visual arts educational intervention 
impacts nurse cultural competency and personal reflection skills.  
 
Secondary objective is to assess the feasibility of art immersion techniques 
for nurses as a broader pedagogical frameworks. We will solicit nurses’ 
qualitative feedback about this aspect of the program.  
Methodology 
Mixed methods, quantitative pre-post survey and qualitative survey 
Endpoint 
The endpoint is 7 months from recruitment to final intervention session. The 
secondary endpoint is a further 3 months for completion of analysis and 
identification of findings.
Study Duration 
The study will take 7 months to complete 
Participant Duration 
Subject participation will last 7 months from enrollment, to receive two arts 
education sessions.
Population 
Participants will be drawn from the population of NYULH nurses on all 
campuses.
Study Site
NYULH
Number of participants
Up to 60 participants to be enrolled across NYULH campuses.
Statistical Analysis 
Descriptive and inferential statistics will be used to analyze the data. 
Descriptive statistics will be used to describe the sample demographics. 
Dependent samples t-tests will be used to assess correlations and 
differences across time for the CAS and IRI surveys. Convergent analytic 
techniques will be used to link qualitative feedback to the quantitative survey 
results. 
 

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Key Roles 
Lita Anglin, MSIS 
Lead, Programming and Clinical Support, NYU Health Sciences Library, NYU Langone Health  
577 First Avenue, New York, NY 10016 
Office: 212-263-2519 
lita.anglin@nyulangone.org
Kathleen Evanovich Zavotsky PhD, RN, CCRN, CEN, ACNS-BC, FAEN, FCNS 
System Senior Director of Nursing Research and Program Evaluation, NYU Langone Health  
545 First Ave, GH-SC-1-164, New York, NY 10016 
Office: 212-263-2055 
Cell: 332-999-4742 
Kathleen.Zavotsky@nyulangone.org 
Benjamin Bass, MPH 
Research Coordinator, Center for Innovations in the Advancement of Care (CIAC), NYU Langone Health  
545 First Ave, GBH-SC-1-152C, New York, NY 10016 
Office: 212-263-4889 
Benjamin.Bass@nyulangone.org
1 
Introduction, Background Information and Scientific Rationale 
1.1
Background Information and Relevant Literature 
Nurses comprise the largest segment of the healthcare workforce both nationally and within our urban multi-
site academic health system (AHS). Over 4 million registered nurses live and work in the United States and 
over 9,000 nurses work in this multi-site AHS.  Nurses work in modern environments of escalating 
complexity, facing significant time pressures, staffing challenges and increased patient acuity. They face a 
myriad of emotional and occupational challenges that affect the nursing workforce, contributing to a 
cascading crisis in the healthcare workplace through staffing turnover. High stress and nurse burnout result 
in lower quality and safety of patient care (Keykaleh 2018). It is incumbent upon healthcare organizations 
to mitigate burnout by supporting overall employee wellbeing. While there are many approaches to 
activating employee engagement, this program specifically utilizes techniques of engaged observation 
through visual arts instructional techniques to help nurses hone their skills of perception and to reconnect 
to their practice. The World Health Organization defines stress to be the “body's response to anything that 
requires attention or action” (WHO 2022) and clinical workplaces are stressful environments of interruption, 
urgency and shifting attention.  More than ever, nurses need proficiency using in techniques, skills and 
interventions supporting personal health behaviors and wellness.   
1.2
Rationale
The overall goal of this project is to enhance engagement, resilience and cultural competence by 
introducing nurses to skills drawn from a visual arts pedagogical framework. Through reflective, experiential 
approaches nurses will be introduced to museum works by an expert educator and guided through 
interactive exercises and discussions. Though many academic papers describe visual arts frameworks 
used among nursing students, few describe using this format among nurses in practice with a validated 
cultural competence instrument. 

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1.3
Potential Risks & Benefits
1.3.1 Known Potential Risks 
The risk of being identified as participating in the study will be minimized by not collecting participant 
names. All collected information will be placed in REDCap. Once the study is complete emails and cell 
phone numbers will be destroyed. All de-identified data will be analyzed and reported in aggregate to 
decrease the chance of being identified. Participants can choose to withdraw from the study at any point.  
 
1.3.2 Known Potential Benefits 
Participants may or may not develop increased self-reflective skills that benefit performance and 
awareness of connections in nursing practice.  The results of this study will help to guide future 
interventions to assist nurses in developing self-reflective and cultural competency skills that translate to 
the workplace setting.  
 
2 
Objectives and Purpose 
2.1 Primary Objective
The main objective is to determine if a visual arts educational intervention impacts nurse cultural 
competency and personal reflection skills.  
 
2.2 Secondary Objectives  
The secondary objective is to understand if nurses believe training in the visual arts impacts their clinical 
practice and whether it can be widely applied to pedagogical nursing practice. 
3 
Study Design and Endpoints 
3.1
Description of Study Design
 
This is a single-site mixed methods longitudinal cohort with a pre-post measurement design. All NYULH 
registered nurses will be invited to participate. The purpose of this study is to enhance engagement, 
coping and self-reflection by attuning nurses to creative and observational skills drawn from a visual arts 
pedagogical framework. To fulfill this goal, we will cultivate an existing relationship between NYULH 
Nursing, the NYU Health Sciences Library, and museum educators at The Met to design and deliver an 
intervention of museum educator-led workshops that introduce nurses to arts appreciation skills to 
improve their practice and overall wellbeing.  
 
Participants will be asked to complete two surveys, pre- and post-intervention, the Cultural Awareness 
Scale, which measures cultural awareness, sensitivity, knowledge and skills, and the Interpersonal 
Reactivity Index, which measures four separate aspects of empathy and its relationships with measures 
of social functioning, self-esteem, emotionality, and sensitivity to others. We will also solicit qualitative 
feedback via REDCap survey at the end of the intervention to gain insight into nurse’s experiences of the 
art immersion program. All data will be analyzed in aggregate by the research coordinator and therefore 
no identifiable information will be available. 
 
Descriptive and inferential statistics will be used to analyze the data. Descriptive statistics will be used to 
describe the sample demographics. Dependent samples t-tests will be used to assess correlations and 

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differences pre- and post-intervention for the CAS and IRI surveys. Convergent analytic techniques will 
be used to link qualitative feedback to the quantitative survey results. 
 
4 
Study Enrollment and Withdrawal
4.1
Inclusion Criteria 
To be eligible to participate in this study, an individual must meet all the following criteria: 
1. A Registered Nurse at NYULH 
2. Willing to provide an email address or cell phone number of choice 
3. Willing to attend one workshop in person at The MET and one virtually via WebEx 
4. Willing and able to provide consent  
5. Age 18 years of age or older 
4.2
Exclusion Criteria
An individual who meets any of the following criteria will be excluded from participation in this study: 
1. Not a Registered Nurse at NYULH 
2. Not willing to provide an email address or cell phone number of choice 
3. Not willing to attend one workshop in person at The MET and one virtually via WebEx 
4.3
Vulnerable Subjects
The subjects in this study will be employees at NYULH. The study will only include the subject's email or 
phone number (for SMS texting only) of choice and no other identifiable information will be collected. All 
results will be analyzed and reported in aggregate and once the data is collected emails will be destroyed 
by the PI. Study team members are not direct supervisors of any potential participants. One of the art 
immersion program workshops will be held at the MET, the other session will be held virtually over 
WebEx. Research will be conducted outside of work hours where possible and appropriate to minimize 
the risk of breach of confidentiality. No data will be collected at The MET or any virtual session.  All 
research data will be collected via REDCap survey that will be sent as a link in an email or text message 
depending on the participants preference. The goal of this nursing study is to study the impact of an art 
immersion program on nurses and therefore the subjects must be nurses.   
 
Participation is voluntary. Decision whether or not to take part in this study will have no impact on the 
participants’ employment status, salary, or perfornance evaluation at NYU Langone Health.  
4.4
Strategies for Recruitment and Retention 
Passive recruitment strategies will be used to minimize any coercion/undue influence. Recruitment will be 
conducted so to ensure employees initiate contact with the study’s investigators and to self-identify as an 
interested participant in a way that maintains their confidentiality, rather than methods by which an 
investigator approaches or solicits specific employees. 
All subjects will be recruited through a recruitment email to specific nursing lists that Kathleen Zavotsky is 
the administrator over (# PhD-EdD Nursing Council <#PhD-EdDNursingCouncil@nyulangone.org>, 
#EdD/PhD council # DNP Council <#DNPCouncil@nyulangone.org> and campus specific Research 
Councils# Research Council <#ResearchCommittee@nyulangone.org> ) and study flyers will be available 
in person at staff meetings and other professional nursing forums that include Annual Nursing Science 
Day, Nurse Week Events Competency Training sessions). Recruitment email will be sent up to 3 times 
over a month to maximize participation. No direct supervisors of any potential subject will be involved in 
recruitment to minimize coercion. The PI Lita Anglin will be responsible for sending recruitment emails.  
An additional recruitment email will be sent via #_All_Nurses_to all NYU Langone Health nurses in month 
7 of the study, due to low enrollment in previous recruitment attempts. The email will be sent on behalf of 
the PI, Lita Anglin, who has no supervisory role over any nurses at NYU Langone Health.  

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To increase enrollment, Lita Anglin will add the sessions and a link to the REDCap as posted classes in 
the Health Sciences Library calendar of classes and events. The sessions will also be posted on nursing 
websites and in the CIAC newsletter. 
Approval from Department of Human Resources will be obtained recruitment of employees. 
4.5
Duration of Study Participation
The duration of the study for participants will not exceed 6 months.  
4.6 Total Number of Participants and Sites  
Up to 60 participants will be enrolled from different campuses of NYU Langone Health.  
4.7
Participant Withdrawal or Termination
4.7.1 Reasons for Withdrawal or Termination
Participants are free to withdraw from participation in the study at any time.  
4.7.2 Handling of Participant Withdrawals or Termination 
Participants who wish to withdraw may do so at any time with no consequence to their employment. 
There is no need to notify the PI, they may cease participation in the program or decline to complete 
surveys at their own discretion.  
4.7.3 Premature Termination or Suspension of Study 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to the IRB. If the study is prematurely terminated or suspended, 
the PI will promptly inform the IRB and will provide the reason(s) for the termination or suspension. 
Circumstances that may warrant termination or suspension include, but are not limited to: 
 
Determination of unexpected, significant, or unacceptable risk to participants 
 
Insufficient compliance to protocol requirements 
 
Data that are not sufficiently complete and/or evaluable 
 
Study may resume once concerns about protocol compliance and data quality are addressed and satisfy 
the IRB. 
 
5 
Study Schedule 
Activity 
Enrollment 
and Baseline 
Month 0 
Month 1.5 
Month 3 
Month 6 
Informed Consent 
X 
 
Demographic Survey 
X 
 
Cultural Assessment Survey
X 
 
X 
Interpersonal Reactivity Index
X
 
X
Art Workshop 1
X 
 

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Optional Self-directed Activity
X 
Art Workshop 2 
 
X 
Post-Intervention Qualitative Survey
 
X 
Additional Art workshops, due to low 
enrollment (1 in person, 1 online)
 
x 
5.1
Screening 
There is no official screening by study staff. 
5.2
Enrollment/Baseline 
Enrollment/Baseline Collection (Day 0) 
 
Obtain signed electronic consent from participant via REDCap. 
 
Participant will complete demographic information, baseline CAS and IRI surveys 
5.3
Intermediate Visits
Art Immersion Class 1 (1-2 months from baseline) 
 
In-person workshop at the MET  
 
Optional Self-Directed Activity (1.5 months from baseline) 
 
Independent self-directed reflective exercise with art materials and prompts provided by 
the MET. 
 
Art Immersion Class 2 (3-4 months from baseline) 
 
Virtual workshop with MET staff via WebEx 
 
Art Immersion Class 3  
 
Additional in-person workshop at the MET, added due to low enrollment in previous sessions 
 
Art immersion Class 4 
 
Additional virtual workshop with MET staff via WebEx, for same reason as above 
5.4
Final Study Visit
Final Data Collection (6 months from baseline) 
 
6-month CAS and IRI surveys 
 
Post-program qualitative evaluation survey 
5.5
Withdrawal Visit
No visit is required for withdrawal, participant may cease participation at any time 
5.6
Unscheduled Visit 
N/A 

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6 
Study Procedures/Evaluations
6.1
Procedures/Evaluations 
After consent has been obtained, the following will take place: 
 
Participants will be asked to provide their email or cell phone of choice so we may communicate 
study information, reminders, and surveys via email or text message.  
 
 
Participants will then be asked to complete a demographic survey, the Interpersonal Reactivity 
Index (IRI) and the Cultural Assessment Survey (CAS).  
o 
The demographic survey contains questions about age, race/ethnicity, gender, years of 
nursing experience, NYULH campus, specialty, shift time, and role (clinical or nurse 
leader).  
o 
CAS measures cultural awareness, sensitivity, knowledge and skills.  
o 
IRI measures four separate aspects of empathy and its relationships with measures of 
social functioning, self-esteem, emotionality, and sensitivity to others.  
 
 
Following completion of the surveys, participants will be asked to sign up for 2 art immersion 
classes. Participants will be offered 4 dates to sign up for the art immersion classes. An additional 
set of one in-person class and one virtual class will be added due to low enrollment. The first 
class will be an in-person class at the Metropolitan Museum of Art (MET) located on 5th Ave and 
86th New York, NY. The second class will be virtual via WebEx. Each class will last 60 minutes.  
 
 
There will also be an optional independent self-directed reflective exercise with art materials and 
prompts provided by the MET.  
 
 
At 7 months (after second class), participants will be asked to complete the IRI and the CAS 
surveys again. Participants will also be asked to complete a short qualitative survey about the 
overall impact of the art immersion program on your work and life.  
 
Museum educators from The MET will be providing the curriculum that will include an art immersion 
program that will select specific works/art in the museum as well as virtually that will help to stimulate self-
reflection and prompt connection to their nursing practice. MET staff will be conducting workshops as part 
of their paid job and will not be engaged in human subjects research as researchers.  
 
7 
Adverse Events 
7.1
Definitions 
Unanticipated Problems Involving Risk to Subjects or Others 
Any incident, experience, or outcome that meets all of the following criteria:  
 Unexpected in nature, severity, or frequency  (i.e. not described in study-related documents such 
as the IRB-approved protocol or consent form, the investigators brochure, etc) 
 Related or possibly related to participation in the research (i.e. possibly related means there is a 
reasonable possibility that the incident experience, or outcome may have been caused by the 
procedures involved in the research) 

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Suggests that the research places subjects or others at greater risk of harm (including physical, 
psychological, economic, or social harm). 
Adverse Event 
An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity 
during the course of the study.   
Serious Adverse Event 
Adverse events are classified as serious or non-serious.  A serious adverse event is any AE that is:  
 fatal 
 life-threatening 
 requires or prolongs hospital stay 
 results in persistent or significant disability or incapacity 
 
All adverse events that do not meet any of the criteria for serious should be regarded as non-serious 
adverse events.  
 
Post-study Adverse Event 
All unresolved adverse events should be followed by the investigator until the events are resolved, the 
subject is lost to follow-up, or the adverse event is otherwise explained.   
7.2
Recording of Adverse Events
At each contact with the subject, the investigator must seek information on adverse events by specific 
questioning and, as appropriate, by examination.  Information on all adverse events should be recorded 
immediately in the source document, and also in the appropriate adverse event module of the case report 
form (CRF).  All clearly related signs, symptoms, and abnormal diagnostic procedures results should 
recorded in the source document, though should be grouped under one diagnosis. 
All adverse events occurring during the study period must be recorded. The clinical course of each event 
should be followed until resolution, stabilization, or until it has been determined that the study treatment or 
participation is not the cause.  Serious adverse events that are still ongoing at the end of the study period 
must be followed up to determine the final outcome.  Any serious adverse event that occurs after the 
study period and is considered to be possibly related to study participation should be recorded and 
reported immediately. 
7.3
Reporting of Serious Adverse Events and Unanticipated Problems
For Narrative Reports of Safety Events 
If the report is supplied as a narrative, the minimum necessary information to be provided at the time of 
the initial report includes: 
 
Study identifier 
 
Study Center 
 
Subject number 
 
A description of the event 
 
Date of onset 
 
Current status 
 
Whether study treatment was discontinued 
 
The reason why the event is classified as 
serious 
 
Investigator assessment of the association 
between the event and study treatment
7.3.1 Investigator reporting: notifying the IRB 
Federal regulations require timely reporting by investigators to their local IRB of unanticipated problems 
posing risks to subjects or others.  The following describes the NYULMC IRB reporting requirements, 
though Investigators at participating sites are responsible for meeting the specific requirements of their 
IRB of record.  
 

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Report Promptly, but no later than 5 working days: 
Researchers are required to submit reports of the following problems promptly but no later than 5 working 
days from the time the investigator becomes aware of the event: 
 
Unanticipated problems including adverse events that are unexpected and related 
– Unexpected: An event is “unexpected” when its specificity and severity are not accurately 
reflected in the protocol-related documents, such as the IRB-approved research protocol, any 
applicable investigator brochure, and the current IRB-approved informed consent document 
and other relevant sources of information, such as product labeling and package inserts.  
– Related to the research procedures: An event is related to the research procedures if in the 
opinion of the principal investigator or sponsor, the event was more likely than not to be 
caused by the research procedures.  
– Harmful: either caused harm to subjects or others, or placed them at increased risk 
Other Reportable events:
The following events also require prompt reporting to the IRB, though no later than 5 working days: 
 Complaint of a research subject when the complaint indicates unexpected risks or the complaint 
cannot be resolved by the research team.
 Protocol deviations or violations (includes intentional and accidental/unintentional deviations 
from the IRB approved protocol) for any of the following situations:  
– one or more participants were placed at increased risk of harm  
– the event has the potential to occur again 
– the deviation was necessary to protect a subject from immediate harm 
 Breach of confidentiality 
 Incarceration of a participant when the research was not previously approved under Subpart C 
and the investigator believes it is in the best interest of the subject to remain on the study. 
 New Information indicating a change to the risks or potential benefits of the research, in 
terms of severity or frequency. (e.g. analysis indicates lower-than-expected response rate or a 
more severe or frequent side effect; Other research finds arm of study has no therapeutic value; 
FDA labeling change or withdrawal from market) 
Reporting Process 
The reportable events noted above will be reported to the IRB using a Reportable New Information 
submission and will include a description of the event with information regarding its fulfillment of the 
above criteria, follow-up/resolution, and need for revision to consent form and/or other study 
documentation. Copies of each report and documentation of IRB notification and receipt will be kept in the 
Clinical Investigator’s study file. 
8 
Study Oversight 
It is the responsibility of the Principal Investigator to oversee the safety of the study at her site.  This 
monitoring will include careful assessment and appropriate reporting of adverse events as noted above, 
as well as the construction and implementation of a data monitoring plan. The PI has experience in 
leading art immersion programs in collaboration with The MET and will have the support needed by 
Kathleen Zavotsky, PhD, RN, who is the System Senior Director of Nursing Research to ensure that the 
integrity of the research protocol is maintained across the campuses.  

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9
Statistical Considerations
9.1
Study Hypotheses
Primary: Visual arts training by museum educators is associated with increased skills in cultural 
competency and personal reflection among nurses in clinical practice in an academic health system. 
Secondary: Nurses believe training in the visual arts impacts their clinical practice and whether it can be 
widely applied to pedagogical nursing practice in an academic health system. 
9.2
Sample Size Determination
The target sample size is 60 NYULH nurses. Sample size calculations were performed in G*Power with 
the following parameters 
 
Test statistic: Dependent samples t-test 
 
Effect size estimation=0.4 
 
Type I error probability=0.90 
 
Type II error probability=0.05 
9.3
Statistical Methods 
Demographics will be reported with descriptive statistics including means and frequency counts. 
The main objective, to determine whether visual arts training by museum educators increases nurses’ skill 
in cultural competency and personal reflection, will be assessed with a dependent samples t-test. We will 
compare CAS and IRI at baseline and post-program to find if there is a significant difference in mean 
scores. 
 
The secondary objective, to understand nurse beliefs about the pedagogical value of visual arts education 
to nursing practice, will be explored via qualitative survey (attached as separate document) and 
thematically analyzed.  
 
10 
Source Documents and Access to Source Data/Documents 
REDcap will be the primary data collection instrument for the study.  
Access to study records will be limited to IRB-approved members of the study team. The PI will permit 
study-related monitoring, audits, and inspections by the IRB, the sponsor, government regulatory bodies, 
and University compliance and quality assurance groups of all study related documents (e.g. source 
documents, regulatory documents, data collection instruments, study data etc.). The PI will ensure the 
capability for inspections of applicable study-related facilities.  
 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 
 
11 
Ethics/Protection of Human Subjects 
11.1 Ethical Standard 

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The PI will ensure that this study is conducted in full conformity with Regulations for the Protection of 
Human Subjects of Research codified in 45 CFR Part 46. 
11.2 Institutional Review Board
The protocol, key information sheet, informed consent form, recruitment materials, and all participant 
materials will be submitted to the IRB for review and approval. Approval from NYU Langone Health IRB 
must be obtained before any participant is enrolled. Any amendment to the protocol will require review 
and approval by the IRB before the changes are implemented to the study. All changes to the consent 
form will be IRB approved; a determination will be made regarding whether previously consented 
participants need to be re-consented. 
MET staff will be conducting workshops as part of their paid job and will not be engaged in human 
subjects’ research as researchers. 
11.3 Informed Consent Process
11.3.1 Consent and Other Informational Documents Provided to Participants
Participants will be given information describing in detail the study intervention, study procedures, and 
risks prior to starting the intervention. The following consent materials are submitted with this protocol: 
Key Information Sheet and Informed Consent Form. 
11.3.2 Consent Procedures and Documentation 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. The informed consent process will begin with 
a concise and focused presentation of the key information using an IRB-approved Key Information Sheet. 
Extensive description of risks and possible benefits of participation will be provided to potential participants. 
If the potential participant is still interested in participating after reading the key information form, they will 
continue to the consent form and select “yes” or “no” to participating in the study. Should potential 
participants have any questions or concerns about the study before consenting, they may contact the PI, 
Lita Anglin, or Sub-I, Kathleen Zavotsky by phone. Phone numbers and emails for the PI and Sub-I will be 
provided on the REDCap e-consent form. Their participation is voluntary and confidential and neither the 
PI nor the Sub-I are in supervisory roles for any potential participants and are not responsible for terms of 
employment. The rights and welfare of the participants will be protected by emphasizing to them that their 
employment status, salary, or performance evaluation will not be adversely affected if they decline to 
participate in this study. 
 
Following a selection of “yes” on the consent, participants will continue to the surveys. A waiver of 
documentation of consent will be applied for as this study is minimal risk and research procedures do not 
involve procedures for which written consent is normally required outside of research.  In addition, this 
waiver would further minimize the risk of a breach of confidentiality for employees. The updated electronic 
consent form in REDCap will be submitted to the IRB for review in Research Navigator via Modification 
before use in the study. Language consistency with the IRB-approved consent materials will be reviewed 
and approved by the IRB before use. 
 
 
11.4 Participant and Data Confidentiality 
Participant emails will be the only identifiers attached to the data. Data will be stored in REDCap, only 
accessible to IRB-approved research staff members. Participant emails will be deleted upon completion 
of the study. Participant data will be kept confidential and not be accessible to anyone outside of the 
study team. No one on the study team is a supervisor of any participants. 

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Data will be analyzed and reported in aggregate. At the end of the study, all records will continue to be 
kept in a secure location for as long a period as dictated by local IRB and Institutional regulations. 
 
The study monitor, or representatives of the IRB may inspect all documents and records required to be 
maintained by the investigator. 
11.5 Future Use of Stored Data
Data collected as part of this study will not be stored for future research. 
12 Data Handling and Record Keeping 
12.1 Data Collection and Management Responsibilities
Data collection is the responsibility of the study staff at the site under the supervision of the PI. The 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported. All data will be collected and stored in REDCap, accessed exclusively by research staff. 
 
12.2 Study Records Retention 
Study documents and data will be retained for the longer of 3 years after close out or 5 years after final 
reporting/publication. These documents should be retained for a longer period, however, if required by 
local regulations. No records will be destroyed without the written consent of the sponsor, if applicable. It 
is the responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. 
 
12.3 Protocol Deviations
A protocol deviation is any noncompliance with the study protocol or MOP requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly. 
It is the responsibility of the site to use continuous vigilance to identify and report deviations within 5 
working days of identification of the protocol deviation, or within 5 working days of the scheduled protocol-
required activity. All deviations must be addressed in study source documents, reported to the IRB. 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is 
responsible for knowing and adhering to their IRB requirements. Further details about the handling of 
protocol deviations will be included in the MOP. 
12.4 Publication and Data Sharing Policy 
N/A 
13 Study Finances 
13.1 Funding Source 

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Observational Study Template Version: 18 July 2022
National Network of the Library of Medicine 
National Library of Medicine, NIH 
13.2 Costs to the Participant
There will be no costs to participants.  
13.3 Participant Reimbursements or Payments
Each participant will receive a travel stipend of $50, complimentary entry to the museum to 
participate in the class, plus an additional complimentary ticket to be used at any other time that 
you wish. Participants will also be provided with a bag of art supplies for them to keep. Screen 
shots of selected art supplies will be attached in research navigator.  
14
Conflict of Interest Policy
The independence of this study from any actual or perceived influence, such as by the pharmaceutical 
industry, is critical. Therefore any actual conflict of interest of persons who have a role in the design, 
conduct, analysis, publication, or any aspect of this study will be disclosed and managed. Furthermore, 
persons who have a perceived conflict of interest will be required to have such conflicts managed in a 
way that is appropriate to their participation in the study. The study leadership has established policies 
and procedures for all study group members to disclose all conflicts of interest and will establish a 
mechanism for the management of all reported dualities of interest.  
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Committee with a Committee-sanctioned conflict management plan that has 
been reviewed and approved by the study sponsor prior to participation in this study.  All NYULH 
investigators will follow the applicable conflict of interest policies. 
 
 
 

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15
References
Anglin C, Halpin-Healy C, Rosenfeld P. Reflecting Art in Nursing Practice: Developing Visual Arts 
Programs to Transform and Strengthen Practice. J Nurs Adm. 2020 May 1;50(5):274-280. doi: 
10.1097/NNA.0000000000000883. PMID: 34292918. 
  
Aoki, Y., & Katayama, H. (2021). Development of the Clinical Interpersonal Reactivity Index to evaluate 
nurses' empathy. Nursing & health sciences, 23(4), 862–870. https://doi.org/10.1111/nhs.12875
Botha E, Gwin T, Purpora C. The effectiveness of mindfulness based programs in reducing stress 
experienced by nurses in adult hospital settings: a systematic review of quantitative evidence protocol. 
JBI Database System Rev Implement Rep. 2015 Oct;13(10):21-9. doi: 10.11124/jbisrir-2015-2380. PMID: 
26571279. 
  
Keykaleh MS, Safarpour H, Yousefian S, Faghisolouk F, Mohammadi E, Ghomian Z. The Relationship 
between Nurse's Job Stress and Patient Safety. Open Access Maced J Med Sci. 2018 Nov 
23;6(11):2228-2232. doi: 10.3889/oamjms.2018.351. PMID: 30559893; PMCID: PMC6290432. 
  
Lyall, Sarah. Off the Beat and into a Museum: Art Helps Police Officers Learn to Look. The New York 
Times. 2016 April 26. https://www.nytimes.com/2016/04/27/arts/design/art-helps-police-officers-learn-to-
look.html 
The Met. Press release: The Metropolitan Museum of Art to Renew “Your Met Art Box” in Collaboration 
with Citymeals on Wheels. 2022 November  https://www.metmuseum.org/press/news/2021/your-met-art-
box 
Rew, L., Becker, H., Cookston, J., Khosropour, S., & Martinez, S. (2003). Measuring cultural awareness 
in nursing students. The Journal of nursing education, 42(6), 249–257. https://doi.org/10.3928/0148-4834-
20030601-07 
 
Slota, M., McLaughlin, M., Vittone, S., & Crowell, N. (2022). Visual intelligence education using an art-
based intervention: Outcomes evaluation with nursing graduate students. Journal of professional nursing : 
official journal of the American Association of Colleges of Nursing, 41, 1–7. 
https://doi.org/10.1016/j.profnurs.2022.03.012

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Drug/Device Template Version: 8 February 2019