Use of Virtual Reality for Overdose Management Educational Trainings
Phase: NA
Conditions: Drug Overdose, Virtual Reality
Sponsor: University of Pennsylvania

 
Study name: Use of Virtual Reality for Overdose Management Educational Trainings 
Short title: VR OD Education 
Registration: NCT04091659 
Attached protocol approved by University of Pennsylvania Institutional Review Board: 
08/22/2019 10:07:46 AM 
 

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Confirmation number:
 
cjgbgeif
IRB status:
 
Exempted
Created by:
 
GIORDANO, NICHOLAS A
Principal investigator:
 
GIORDANO, NICHOLAS A
Protocol title:
 
VR OD Education
Protocol description:
 
This cluster-randomized trial will compare changes in attitudes and knowledge on administering
naloxone based on exposure to either a virtual reality educational training or the current standard
educational trainings (e.g. on-line videos, printed information handouts) offered at local libraries.
Individuals attending local library's naloxone training days will voluntarily complete an anonymous
validated survey pre and post attending either the virtual reality or standard educational training.
Resubmission:
 
No
Application type:
 
EXEMPT Category 1
 
 
 
View Protocol Application Form
List of Attached Documents
There are no documents. 
 
Revision History:
 
Assigned to IRB #8, created on 08/08/2019 (cjgbgeif) 
 
Department Review History
Date
Reviewer
Dept Approval
Comments
08/11/2019 06:13:27 PM
GIORDANO, NICHOLAS A
Approved
Principal Investigator submitted the protocol.
08/12/2019 05:37:40 AM
COMPHER, CHARLENE W
Approved
 
 
IRB Review History
Decision date
Reviewer/approver
Decision
 
08/22/2019 10:07:46 AM
IRB chair/designee
Approved
 
 
IRB Correspondence
Date
Attached by
Attachment
 
08/23/2019
BURGESS, BARBARA K
EXEMPTED (2019-8-
22exemptgiordano833978kb.pdf)
 
Ancillary Committee Correspondence
None
 
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Page 1 of 11
Protocol Details
Basic Info
Conﬁrmation Number:
cjgbgeif
Protocol Number:
833978
Created By:
GIORDANO, NICHOLAS A
Principal Investigator:
GIORDANO, NICHOLAS A
Protocol Title:
Examining the Use of Virtual Reality for Overdose Management Educational Trainings
Short Title:
VR OD Education
Protocol Description:
This cluster-randomized trial will compare changes in attitudes and knowledge on administering 
naloxone based on exposure to either a virtual reality educational training or the current 
standard educational trainings (e.g. on-line videos, printed information handouts) offered at local 
libraries. Individuals attending local library's naloxone training days will voluntarily complete an 
anonymous validated survey pre and post attending either the virtual reality or standard 
educational training.
Application Type:
EXEMPT Category 1
Resubmission*
No
Study Personnel
Principal Investigator
Name:
Dept / School / Div:
Campus Address
Mail Code
Address:
City State Zip:
Phone:
Fax:
Pager:
Email:
HS Training Completed:
Training Expiration Date:
Name of course completed :
GIORDANO, NICHOLAS A
602 - Biobehavioral and Health Sciences
418 Curie Blvd, Philadelphia PA 
-
Yes
03/04/2022
CITI Protection of Human Subjects Research Training - ORA

Page 4 of 11
products, tissues or body ﬂuids)?
No
Medical Information Disclosure*
Does the research proposal involve the use and disclosure of research subject's medical information for 
research purposes?
No
If the answer is YES, indicate which items is is provided with this submission:
CTRC Resources*
Does the research involve CTRC resources?
No
Pathology and Laboratory Medicine Resources*
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System?
No
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components?
No
Research involving blood transfusion or drug infusions*
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes?
No
Trial in Radiation Oncology
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee?
N/A
Study in Radiation Oncology
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group?
N/A
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures*, whether considered routine care or strictly for research purposes?
No
Primary Focus*
Survey research (the main focus of the research is administration of a survey to research subjects)

Page 5 of 11
Protocol Interventions
Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
x Survey instrument
None of the above
The following documents are currently attached to this item:
There are no documents attached for this item.
Sponsors
Business Administrator
Name:
Dept / School / Div:
Phone:
Fax:
Pager:
Email:
GIORDANO, NICHOLAS A
602 - Biobehavioral and Health Sciences 
-
-
Department budget code
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Funding Sponsors
Funding sponsors billing address
If you have selected a commercial or industry sponsor, please provide the appropriate address and 
contact information for the Sponsor for the purposes of billing for IRB review fees (initial review, 
continuing review and convened modiﬁcation fees apply here). If the Sponsor is not industry/
commercial, this information is not necessary to provide with your application.
Funding sponsors gift
Is this research being funded by a philanthropic gift?
No
Project Funding*
Is this project funded by or associated with a grant or contract?
No
Sponsor Funding
Is this study funded by an industry sponsor?
Status of contract
The following documents are currently attached to this item:

Page 6 of 11
There are no documents attached for this item.
Protocol
Objectives
Overall objectives
The central hypothesis is that immersive virtual reality opioid related overdose educational trainings 
will result in increased knowledge retention and comfort level to administer naloxone among 
community members voluntarily participating in in-person trainings at libraries.
Background
Since 2000, the United States has experienced a 200% increase in the rates of deaths by overdose that 
involve opioids, including opioid pain relievers and heroin. Since 2010, deaths from heroin overdose 
have more than tripled. In response to this epidemic of deaths by opioid overdose, the state of 
Pennsylvania, along with more than 40 other states in the nation, have enacted standing orders of 
Naloxone (Narcan®), a fast acting opiate antagonist. This means that Naloxone, which has been shown 
to prevent death by reversing opioid overdoses, is available for anyone, without a visit with a healthcare 
provider, to request and ﬁll a prescription at local pharmacies. As the opioid overdose epidemic 
worsens, there is an urgent need to prepare individuals to be competent actors in cases of opioid 
overdoses. Providing access to optimal education on naloxone administration is an important 
intervention in the effort to reduce deaths by opioid overdose. Library patrons are uniquely positioned 
to reduce preventable overdose deaths in their communities if properly trained to know when and how 
to respond. Penn researchers recently developed a nurse led, evidence-based 9 minute virtual reality 
(VR) naloxone administration educational training. Preliminary results indicate that healthcare 
profession students participating in VR training at Penn preformed just as well as those who received in 
person high-tech, high-cost simulation training in regard to their knowledge and attitudes about 
administering naloxone. Compared to in-person trainings, VR offers an engaging informative naloxone 
training that requires less manpower and has fewer geographic or time constraints. Assuring optimal 
education to these key personnel is an important intervention in the ﬁght to reduce deaths by opioid 
overdose. In September 2019, the Philadelphia Department of Public Health will offer "Narcan Handout 
Days" at libraries across the city. Health Department staff are present at libraries, sitting at display 
booths providing training materials and free naloxone kits to library patrons interested in learning more 
about how to help address the public health crisis. We want to leverage this unique opportunity 
occurring in September to evaluate the use of virtual reality to provide comprehensive opioid overdose 
education.
Study Design
Design
This study will utilize a cluster-randomized trial design. Entire libraries will be randomized to either 
offer community members the virtual reality training or the standard educational offerings (e.g. 
handouts, online videos). Volunteers will be asked to complete the brief, anonymous, and validated 
Opioid Overdose Knowledge Scale & Opioid Overdose Attitudes Scale prior to receiving an education 
intervention (pretest) and then again immediately after (posttest). Neither participants nor investigators 
will be blinded. Library patrons who do not participate in the study will be offered current standard 
training materials. Regardless of the library's randomization, to either virtual reality or standard 
training, all patrons completing pre and post test surveys will have the opportunity to view the virtual 
reality training or other public health department materials.
Study duration
The new project dates of the proposed study are September 2019-August 2020. This will enable 
enrollment to occur throughout September at "Naloxone Handout Days" as well as at once monthly 
trainings offered by the department of public health at the South Philadelphia Library for local 
community members to walk in.

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Characteristics of the Study Population
Target population
Our target population includes library patrons voluntarily attending the department of public health's 
"naloxone handout days" and monthly educational trainings. This enrollment strategy across free 
libraries and zip codes will provide ample opportunities for local city residents living in diverse settings 
to attend and receive valuable opioid overdose education.
Subjects enrolled by Penn Researchers
125
Subjects enrolled by Collaborating Researchers
0
Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject recruitment
The investigators and personnel listed on this study protocol will be present at each library sitting next 
to the Department of Public Health staff at a table in each library's lobby. For recruitment of library 
patrons in September 2019, the investigator or study personnel at the library site on "Naloxone Handout 
Days" will read a pre-developed script describing the study, explaining potential risks and beneﬁts, and 
making clear that participation, choosing not to participate, or withdrawing from the study will not 
inﬂuence a patron's ability to use the library or department of public health's resources. This script will 
be used to guide a brief talk given by a study investigator. A large ﬂyer will be posted next to the table 
promoting the Virtual reality training for individuals who are interested in learning more and talking to 
an investigator or study personnel about anonymously participating.  Informed consent will be obtained 
via participants signing the ﬁrst page before beginning the pre-test survey. After obtaining informed 
consent, respondents will be asked to complete the pretest baseline assessments. Participants can 
contact the PI to discuss the study at any time.
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
No
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
Yes
The following documents are currently attached to this item:
There are no documents attached for this item.

Page 8 of 11
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
None
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)?
No
Procedures
During the study period we will be committed to testing the 9 minute virtual reality training to review 
Naloxone administration and overdose management. The efﬁcacy of this virtual reality education 
compared to standard educational materials (e.g. online videos, printed handouts) on knowledge 
retention and attitudes will be evaluated according to the study procedure schema (uploaded separately). 
As shown in the study procedure schema, all voluntary participants in both experimental and control 
libraries will complete informed consent documents, provide demographic data, and complete pretest 
Opioid Overdose Knowledge Scale & Opioid Overdose Attitudes Scale surveys via Qualtrics, a secure 
online survey system maintained by the University of Pennsylvania and stored behind ﬁrewall protected 
servers. No identiﬁers will be collected. The surveys are anonymous.  Virtual Reality Education 
(Intervention): The experimental group of libraries will receive the virtual reality simulation, which is 
guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is 
based on scenes and dialogue conducted during the hybrid high-ﬁdelity simulation, from a script 
developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality 
education is an educational intervention. Standard Educational (Control): The public health 
department's training includes printed handouts on how to administer naloxone and youtube videos on 
how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to 
provide one on one verbal educational trainings to local community members voluntarily seeking 
education.  All individuals approaching the table at the library will be introduced to the study and its 
purpose. If an individual attending the free training is interested in participating the study they will be 
consented by an investigator listed on this personnel. After consenting all individuals will be asked to 
complete a brief pre-survey. If the library is randomized to a virtual reality cluster, participants will be 
asked to view the educational training using provided virtual reality headsets. If the library is 
randomized to a control cluster the participants will be offered training materials provided by the health 
department (e.g. youtube videos, printed handouts, on narcan administration). All participants, 
regardless of cluster will be asked to complete the same survey immediately after either the virtual 
reality or public health department training. All individuals who participate in the study will have the 
opportunity to view the virtual reality training or public health department materials at any library 
regardless of cluster assignment following completion of post-test survey. Those who do not wish to 
participate in the study will have the opportunity to revieve the public health department's training 
materials.
The following documents are currently attached to this item:
There are no documents attached for this item.
Deception
Does your project use deception?
No
International Research
Are you conducting research outside of the United States?
No
Analysis Plan
Descriptive statistics will be calculated for the sample by cluster. Cohorts will be evaluated, pretest, for 

Page 9 of 11
differences in demographic characteristics using independent sample t-test, or chi-square test of 
proportions when appropriate. Similarly, independent t-test will assess differences in pre-test 
knowledge and attitudes prior to intervention between control and experimental groups, and again with 
a posttest analysis. Paired t-test will assess within cohort changes in knowledge and attitudes towards 
recognizing signs of overdose and intervening during an observed opioid related overdose in the 
community settings. Sample sizes of 30-50 participants, when sampling 6-10 libraries, or clusters, with 
an with an average of 5 subjects in each cluster, achieves 85% to 94% power to detect a difference in 
OOKS scores between the group means of at least 4 points using a two sided t-test at signiﬁcance level 
of 0.05. The standard deviation of subjects is 5. The intracluster correlation coefﬁcient is assumed to be 
0.010. Structural equation modeling will assess differences in control and treatment participants post 
socres while adjusting for relevant covariates including baseline knowledge and attitudes. 
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject Conﬁdentiality
Sources of research material will include data obtained from the Opioid Overdose Knowledge Scale 
and Opioid Overdose Attitude Scale surveys as well as demographic data. Data will be collected via an 
anonymous Qualtrics Surveys. Data will be managed by the Principal Investigator on the ﬁrewall 
protected Penn Nursing servers. The minimal risk associated with this study is the risk related to 
identity protection. Because this study requires measurement of pretest and posttest data, participants 
data must be matched. Therefore, participants will be given unique identiﬁcation numbers to use in 
place of their names to mark their pre- and posttest surveys. In the event of the Qualtrics Survey not 
being accessible (e.g. wiﬁ outage) hard copies of the survey will be made available. These hardcopies 
will be stored in a locked ﬁle to which only the PI and co-investigator will have access. All electronic 
and digital data will be stored on a secure survey at the University of Pennsylvania for two years, after 
which point the data will be destroyed. No identiﬁers are asked on the anynmous survey.
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be 
excluded from the electronic medical record?
No
Data Disclosure
Will the data be disclosed to anyone who is not listed under Personnel?
No

Page 10 of 11
Data Protection*
Name
Street address, city, county, precinct, zip code, and equivalent geocodes
All elements of dates (except year) for dates directly related to an individual and all ages over 89
Telephone and fax number
Electronic mail addresses
Social security numbers
Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
x Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No
Consent
1. Consent Process
Overview
For recruitment, a script will be developed describing the study, explaining potential risks and beneﬁts, 
and making clear that participation, choosing not to participate, or withdrawing from the study will not 
inﬂuence their ability to access library or public health department resources. The study investigators at 
the library will review the consent form and answer questions any possible volunteer may have. 
Hardcopies of the form with study contact info will be available for community members to take home. 
An electronic version will be used for participants to sign and later saved on University ﬁrewall 
protected servers.
Risk / Beneﬁt
Potential Study Risks
The risk associated with this study is the risk related to identity protection. Because this study requires 
measurement of pretest and posttest data, participants data must be matched pre to post. Therefore, 
participants will be given unique identiﬁcation numbers to use in place of their names to mark their pre- 

Page 11 of 11
and posttest surveys. All hard copies will be stored in a locked ﬁle to which only the PI and co-
investigator will have access. All electronic and digital data will be stored on a secure survey at the 
University of Pennsylvania.
Potential Study Beneﬁts
Subjects may personally beneﬁt from increased knowledge retention and attitudes towards intervening 
in Narcan administration and opioid overdose intervention. This study will produce important 
knowledge about the comparison of virtual reality simulation and standard education regarding 
knowledge retention and attitudes about Narcan administration and opioid overdose intervention. 
Participants also beneﬁt from the opportunity to interact with cutting edge virtual reality simulation 
technology.
Risk / Beneﬁt Assessment
With the knowledge gained from this study, we can determine the optimal means of immersive 
education, improve Narcan carry-rates, and turn the tide of the opioid overdose epidemic. Because there 
is minimal risk to the research participants, the opportunity to gain this important knowledge should be 
supported.
General Attachments
The following documents are currently attached to this item:
Questionnaires (ooksooas.docx)
Recruitment materials (virtualrealityandhybridsimulation_recruitment_library.docx)
Informed consent form (informedconsentdocument_library.doc)
Additional forms (hco.upenn-vr_los.pdf)
Additional forms (studyschema.docx)
Cover Letter (coverlettergiordano.pdf)