Choosing an Effective Healthcare Spokesperson: An Interactive Intervention
Phase: NA
Conditions: Surrogate Decision-making, Healthcare Spokesperson, Advance Care Planning
Sponsor: Milton S. Hershey Medical Center

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HRP-591 - Protocol for 
Human Subject Research
Protocol Title:
Provide the full title of the study as listed in item 1 on the “Basic Information” page in CATS IRB (http://irb.psu.edu). 
Choosing an Effective Healthcare Spokesperson: An Interactive Intervention
Principal Investigator:
Name: Benjamin Levi, MD, PhD 
Department: Humanities
Telephone: 717.531.7887
E-mail Address: blevi@pennstatehealth.psu.edu
Version Date:
Provide the date of this submission. This date must be updated each time the submission is provided to the IRB office 
with revisions.  DO NOT revise the version date in the footer of this document. 
13JUN2022
Clinicaltrials.gov Registration #:
Provide the registration number for this study, if applicable. See “HRP-103- Investigator Manual, When do I have to 
register my project at ClinicalTrials.gov?” for more information. 
NCT04599166
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Table of Contents
1.0
Objectives
2.0
Background
3.0
Inclusion and Exclusion Criteria
4.0
Recruitment Methods
5.0
Consent Process and Documentation
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
7.0
Study Design and Procedures
8.0
Subject Numbers and Statistical Plan
9.0
Data and Safety Monitoring Plan
10.0
Risks
11.0
Potential Benefits to Subjects and Others
12.0
Sharing Results with Subjects
13.0
Subject Payment and/or Travel Reimbursements
14.0
Economic Burden to Subjects
15.0
Resources Available
16.0
Other Approvals
17.0
Multi-Site Study
18.0
Adverse Event Reporting
19.0
Study Monitoring, Auditing and Inspecting
20.0
Future Undetermined Research: Data and Specimen Banking
21.0
References
22.0
Confidentiality, Privacy and Data Management
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1.0
Objectives
1.1
Study Objectives
Advance care planning (ACP) is the process of thinking through and articulating in advance one’s 
preferences for future medical care. It has long been promoted as a way for people to receive medical 
treatment consistent with their values, goals, and preferences. While ACP typically involves decision-
making about specific life sustaining treatments, choosing who will make medical decisions when the 
patient cannot is considered by many to be the single most important ACP action a person can take. 
When patients fail to designate a healthcare spokesperson (henceforth spokesperson), it leads to 
uncertainty about who will make medical decisions, what treatments are to be accepted or declined, 
and on what basis4–which can lead to familial conflict, unwanted and costly medical care, and 
avoidable patient suffering. So, too, when patients choose the “wrong” person to represent them, their 
wishes are less likely to be known or respected. Our own research suggests that when patients prefer 
fewer aggressive medical treatments, there is significantly lower concordance between spokespersons’ 
decisions and patients’ wishes.
Patients, families, and ACP experts have identified several qualities as being especially important for 
spokespersons to have. Ideally, they should know the patient’s values, be available when needed, be 
trustworthy and caring, have good judgment, and be able to stand up under pressure. That said, many 
individuals (and state laws) assign spokespersons on the basis of relationship (spouse, parent, etc.) 
rather than personal qualities. Surprisingly, no interventions (to our knowledge) are explicitly designed 
to help people consider the actual qualities of the person they choose, much less engage this individual 
to confirm they can fully represent the patient’s wishes should the need arise. 
To address these gaps, we have developed a novel intervention that includes a “serious game” to help 
people consider the qualities they want in their spokesperson, then engage the person they choose for 
this role. Combining a serious topic with an enjoyable activity (“gamification”11) has been effective at 
changing health related behaviors in multiple settings with our target population (“sandwich 
generation” and older adults). The game element of our intervention, “Who Would You Choose: Serious 
Fun” (WWYC), prompts players (using scenarios and metaphors) to choose a spokesperson whose 
qualities are best suited to the role. At the end of the game, players identify a real-life spokesperson 
based on the qualities considered during gameplay. Then, using an online interface, WWYC will spark 
communication between the player and their chosen spokesperson. The long-term goal of this project 
is to help people make more thoughtful and informed choices when selecting a spokesperson, and to 
help these spokespersons be better prepared for their role as surrogate decision-makers. The current 
mixed methods study proposed here is designed to learn whether and how WWYC helps individuals 
select an appropriate spokesperson for healthcare decisions, as assessed via three Specific Aims: 
Aim 1 (QUALITATIVE): To explore how playing a novel game affects people’s choice of a spokesperson. 
Qualitative focus groups will be used to examine the group experience playing WWYC. One-on-one 
interviews will be used to explore how the game affected individual players’ thought process for 
choosing a spokesperson, and whether that choice changed as a result of game-play. 
Aim 2 (QUANTITATIVE): To establish that WWYC is a feasible way to help individuals choose and 
engage a spokesperson. We will judge WWYC as feasible if: 
•
We can efficiently recruit 100 individuals to play the game; 
•
>75% of game players report that playing the game is helpful for choosing a spokesperson; 
•
>75% of game players endorse the game, as measured by the Net Promoter Score;
•
>75% of spokespersons engage with WWYC (using its online interface) following player request  
Aim 3 (CONVERGENT MIXED METHODS): To integrate qualitative and quantitative data via a joint 
display to explain how the experience of playing WWYC relates to their spokesperson’s willingness to 
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engage. We hypothesize that positive player experience with WWYC will be associated with successful 
engagement with their spokesperson. 
If successful, this study will establish the feasibility of a serious game for helping people choose a 
spokesperson for medical decision-making, and result in the creation a fully functional prototype 
(including its online interface). We will then be positioned to conduct a randomized controlled trial 
evaluating the efficacy of WWYC (compared to standard methods) for improving concordance between 
patients’ wishes and spokespersons’ decisions on their behalf. 
1.2
Primary Study Endpoints
Successful completion of data collection of 800 participants (400 players and 400 spokespersons) who 
play the “Who Would You Choose” game.
1.3
Secondary Study Endpoints
Establish feasibility of game intervention
2.0
Background 
2.1
Scientific Background and Gaps
The value of advance care planning (ACP, which includes the key task of choosing a spokesperson) has a strong 
scientific premise grounded in decades of randomized controlled trials and public health research.  Engaging in 
ACP: 1) reduces unwanted end-of-life medical interventions:  2) decreases stress; and 3) reduces end-of-life costs 
by up to 36%. Despite the importance of choosing a healthcare spokesperson, there are surprisingly little data on 
how to optimize that choice. To our knowledge, no studies examine how best to get people to designate a 
spokesperson, or how to choose a spokesperson who can/will accurately represents one’s wishes. Our own 
research demonstrates that (for a given clinical scenario) spokespersons do a poorer job representing patients’ 
wishes when patients desire less aggressive care (see Preliminary Studies). Moreover, in many states, unless next 
of kin are formally designated as spokesperson, they (by law) cannot decline life-sustaining treatment unless the 
patient is permanently unconscious or has an “end-stage condition.”31 Accordingly, to help respect patient 
autonomy and prevent unwanted end-of-life treatment, interventions are needed that prompt people to 
designate a spokesperson who can/will accurately represent their wishes when decisions need to be made.
Though there is strong professional consensus about the qualities that make for a good spokesperson (is available, 
has good judgment, knows patient’s values, etc.), little is known about which qualities the public considers most 
important, their rationales for choosing a spokesperson, or the best way to increase concordance between 
patients’ wishes and spokespersons’ decisions. A recent systematic review showed that the widely used 
intervention, Respecting Choices,32,33 does increase advance directive completion rates and improve patient–
spokesperson concordance, but the model is labor intensive, expensive to implement, and population specific.  
Less intensive ACP initiatives demonstrate much smaller effect sizes (10% increase in advance directive 
completion); difficulty getting people to make time for ACP); over-emphasis on static advance directive 
documents; and problems with implementation. Surprisingly, there is little research on how to help patients 
choose good spokespersons or prepare them for making treatment decisions. This is important because 
spokespersons often are unprepared to represent patients’ wishes.44 
What is needed are low-cost, high yield interventions that help people not only designate a spokesperson, but 
choose the right spokesperson. To succeed, such interventions must be appealing and readily scalable. This project 
will use the novel serious game, Who Would You Choose: Serious Fun (WWYC), to deepen our understanding of 
how people choose a spokesperson, and move us closer towards a scalable intervention for helping people 
optimize that choice. 
2.2
Previous Data
Describe any relevant preliminary data.
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We conducted feasibility and pilot testing of a revised WWYC game at 9 different venues with 93 participants (77% 
female, 25% minorities, see Table 3). Using a 10-point scale, we found that the majority of participants enjoyed 
playing the game (7.6 +/- 1.6), found it engaging (8.3 +/- 1.6), and would recommend it to others (7.3 +/- 2.3). 
More importantly, 84% (78/93) of participants reported that playing the game helped them “to think more deeply 
about the characteristics a healthcare spokesperson should have,” and 75% (70/93) said it prompted them “to 
think more deeply about who should be their own healthcare spokesperson.”
We refined the game by holding multiple informal game 
sessions to elicit feedback on game mechanics. 
Following modifications, we held formal game events 
using beta-versions of WWYC at 4 different venues 
(n=39 participants) with games facilitated by research 
staff 
to ensure rigor and fidelity. In post-game focus groups, 
players reported that playing WWYC was thought-
provoking and enjoyable, and that it changed their views 
about choosing a spokesperson. 
2.3
Study Rationale
The serious game WWYC departs from standard ACP practice by transforming the task of “choosing a 
spokesperson” into a fun, engaging social activity that: 1) is self-contained; 2) does not require extensive training, 
resource investment, or infrastructure; 3) is readily scalable; and 4) leverages mobile technology (ie, smart-
phones) to operationalize one’s choice of a spokesperson and (eventually) assess whether that spokesperson 
knows one’s wishes for healthcare. WWYC is innovative in that its purpose is not just to get people to choose a 
spokesperson, but to improve that choice –which no other initiative has explicitly attempted.
WWYC is different from typical efforts to designate spokespersons in that it is experiential, not didactic. It employs 
imaginative and metaphorical questions to help players consider key qualities of ideal spokespersons, to help them 
realize who in their own life embodies these qualities. This use of playful and thought-provoking questions 
represents a paradigm-shift for helping people engage in ACP. While other ACP-related games exist, WWYC is 
unique in its focus on the behavior of choosing a spokesperson, as opposed to prompting general conversations 
about values, goals, and beliefs.  
While most ACP interventions emphasize the somewhat daunting assignment of creating detailed instructions for 
future medical care, WWYC focuses on a single task: identifying a spokesperson. WWYC will also provide 
opportunities and structure for meaningful engagement between individuals and their spokespersons. After 
completing game-play, the WWYC App will prompt players to 1) state which medical treatments they would want 
in various clinical scenarios, and then 2) send their spokesperson a request (and web link) to predict which medical 
treatments they (the spokesperson) think the player would want in those scenarios. As described in Future 
Directions, the WWYC App will eventually provide notifications to the player/spokesperson dyad about how their 
answers match up, and send tailored text messages that prompt discussions to help spokespersons be better 
prepared for their role. 
3.0
Inclusion and Exclusion Criteria
3.1
Inclusion Criteria
Participants must be:
o
 >18 years old
o
able to read, write, and speak English
o
have a working smart phone
o
able and willing to forward post-activity survey to potential spokesperson
Table 3
GAME 
(Stage 1A)
GAME   
(Stage 1B)
Participants (n)
39
93
Female
9 (24%)
72 (77%)
Caucasian
18 (46%)
93 (75%)
Events (n)
4
9
Games (n)
8
18
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Spokesperson must be:
o
 >18 years old
o
able to read, write, and speak English
o
have a working smart phone
3.2
Exclusion Criteria
Participants will be excluded, if they are:
o
<18 years old
o
unable to read, write, and speak English
o
not have a working smart phone
o
unable or unwilling to forward post-activity survey to potential spokesperson
Spokesperson will be excluded, if they are:
o
<18 years old
o
unable to read, write, and speak English
o
not have a working smart phone
3.3
Early Withdrawal of Subjects
3.3.1 Criteria for removal from study
n/a
3.3.2 Follow-up for withdrawn subjects
n/a
4.0
Recruitment Methods
4.1
Identification of subjects
To recruit participants, we will advertise via Study Finder, newspaper, radio, fliers posted in local community 
centers, places of worship, Penn State patient care areas, patient support groups, and word-of mouth of personal 
contacts, which may also include social media.
4.2
Recruitment process
4.2.1 How potential subjects will be recruited.
To recruit participants, we will advertise via Study Finder, newspaper, radio, fliers posted in local 
community centers, places of worship, Penn State patient care areas, patient support groups, and word-of 
mouth of personal contacts, which may also include social media.
4.2.2 Where potential subjects will be recruited.
Participants will be recruited throughout Pennsylvania and New Jersey regions.
4.2.3 When potential subjects will be recruited.
August 2021 to June 2023
4.2.4 Describe the eligibility screening process and indicate whether the screening process will 
occur before or after obtaining informed consent. Screening begins when the investigator 
obtains information about or from a prospective participant in order to determine their 
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eligibility.  In some studies, these procedures may not take place unless HIPAA Authorization 
is obtained OR a waiver of HIPAA Authorization when applicable for the screening procedures 
is approved by the IRB.
Interested participants will be informed about the study and screened for eligibility during that initial 
conversation (in person, via telephone, email or Zoom).  Names, phone numbers, or emails will only 
be used for screening or scheduling purposes and will not be linked to Participant ID or data.  
5.0
Consent Process and Documentation 
5.1
Consent Process:
Check all applicable boxes below:
 Informed consent will be sought and documented with a written consent form [Complete Sections 
5.2 and 5.6] 
 Implied or verbal consent will be obtained – subjects will not sign a consent form (waiver of 
written documentation of consent) [Complete Sections 5.2, 5.3 and 5.6] 
  Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception). [Complete section 5.2, 5.4 and 5.6] 
 Informed consent will not be obtained – request to completely waive the informed consent 
requirement. [Complete Section 5.5]
The following checkbox is for all locations EXCEPT Penn State Health and College of Medicine: 
 
 Exempt Research at all Locations Except Penn State Health and the College of Medicine: If you 
believe that the research activities outlined meet one or more of the criteria outlined in “HRP-312- 
Worksheet- Exemption Determination.” Please verify by checking this box that if conducting an 
exempt research study, the consent process will disclose the following (all of which are included in 
“HRP-590- Consent Guidance for Exempt Research”):
Penn State affiliation; name and contact information for the researcher and advisor (if the 
researcher is a student); the activities involve research; the procedures to be performed; 
participation is voluntary; that there are adequate provisions to maintain the privacy interests of 
subjects and the confidentiality of the data; and subjects may choose not to answer specific 
questions.  
If the research includes the use of student educational records include the following language in 
this section (otherwise delete): The parent or eligible student will provide a signed and dated 
written consent that discloses: the records that may be disclosed; the purpose of the disclosure; the 
party or class of parties to whom the disclosure may be made; if a parent or adult student requests, 
the school will provide him or her with a copy of the records disclosed; if the parent of a student 
who is not an adult so requests, the school will provide the student with a copy of the records 
disclosed.
Note: If this box has been checked, skip the remainder of section 5 and proceed to section 6 of this 
protocol. If the investigator’s assessment is inaccurate, an IRB Analyst will request revision to the 
protocol and that an informed consent form be submitted for review and approval. Except for 
exemptions where Limited IRB Review (see “HRP-312- Worksheet- Exemption Determination”) is 
required or where otherwise requested by the IRB, informed consent forms for research activities 
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determined to be exempt without Limited IRB Review are generally not required to be submitted 
for review and approval by the University Park IRB. 
5.2
Obtaining Informed Consent 
5.2.1 Timing and Location of Consent 
Players:  
Consent will be obtained at the time of the single study visit which will take place at Penn State 
Hershey Medical Center and public locations within the community.
Spokespersons:  
Consent will be obtained within REDCap ahead of survey questions.
5.2.2 Coercion or Undue Influence during Consent 
-
Subjects will be notified in writing (see Summary Explanation of Research) that participation in this 
research is strictly voluntary.
-
If the subject does not agree to participate, they will not be included in the study activities.
-
Participants will be given as much time as needed to ask and have questions answered about the 
study and their decision whether to participate.
5.3
Waiver of Written Documentation of Consent 
5.3.1 Indicate which of the following conditions applies to this research:
  The research presents no more that minimal risk of harm to subjects and involves no 
procedures for which written consent is normally required outside of the research context.
OR
   The only record linking the subject and the research would be the consent document and the 
principal risk would be potential harm resulting from a breach of confidentiality. Each subject 
will be asked whether the subject wants documentation linking the subject with the research, 
and the subject’s wishes will govern. (Note: This condition is not applicable for FDA-regulated 
research. If this category is chosen, include copies of a consent form and /or parental 
permission form for participants who want written documentation linking them to the 
research.)
OR
  If the subjects or legally authorized representatives are members of a distinct cultural group 
or community in which signing forms is not the norm, that the research presents no more 
than minimal risk of harm to subjects and provided there is an appropriate alternative 
mechanism for documenting that informed consent was obtained.  (Note: This condition is not 
applicable for FDA-regulated research.) 
Describe the alternative mechanism for documenting that informed consent was obtained:
5.3.2 Indicate what materials, if any, will be used to inform potential subjects about the research 
(e.g., a letter accompanying a questionnaire, verbal script, implied consent form, or summary 
explanation of the research)
Players: 
A Summary Explanation of Research will be provided prior to the start of study activities.
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Spokespersons: 
A Summary Explanation of Research will be provided within REDCap prior to the start of survey 
questions.
5.4
Informed consent will be sought but some of the elements of informed consent will be omitted or 
altered (e.g., deception).
5.4.1 Indicate the elements of informed consent to be omitted or altered
Not applicable.
5.4.2 Indicate why the research could not practicably be carried out without the omission or 
alteration of consent elements
Not applicable.
5.4.3 Describe why the research involves no more than minimal risk to subjects.
Not applicable.
5.4.4 Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects.
Not applicable.
5.4.5 If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format.
Not applicable.
5.4.6 Debriefing 
Not applicable.
5.5
Informed consent will not be obtained – request to completely waive the informed consent 
requirement
5.5.1 Indicate why the research could not practicably be carried out without the waiver of consent
Not applicable.
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5.5.2 Describe why the research involves no more than minimal risk to subjects.
Not applicable.
5.5.3 Describe why the alteration/omission will not adversely affect the rights and welfare of 
subjects.
Not applicable.
5.5.4 If the research involves using identifiable private information or identifiable biospecimens, 
describe why the research could not be practicably be carried out without using such 
information or biospecimens in an identifiable format.
Not applicable.
5.5.5 Additional pertinent information after participation
Not applicable.
5.6
Consent – Other Considerations 
5.6.1 Non-English-Speaking Subjects
Not applicable.
5.6.2 Cognitively Impaired Adults
5.6.2.1 Capability of Providing Consent
Not applicable.
5.6.2.2
Adults Unable to Consent
Not applicable.
5.6.2.3 Assent of Adults Unable to Consent
Not applicable.
5.6.3 Subjects who are not yet adults (infants, children, teenagers) 
5.6.3.1 Parental Permission
Not applicable.
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5.6.3.2 Assent of subjects who are not yet adults
Not applicable.
6.0
HIPAA Research Authorization and/or Waiver or Alteration of Authorization
6.1
Authorization and/or Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
Check all that apply:
 
Not applicable, no identifiable protected health information (PHI) is accessed, used or 
disclosed in this study. [Mark all parts of sections 6.2 and 6.3 as not applicable]
Authorization will be obtained and documented as part of the consent process. [If this is the 
only box checked, mark sections 6.2 and 6.3 as not applicable]
Partial waiver is requested for recruitment purposes only (Check this box if patients’ medical 
records will be accessed to determine eligibility before consent/authorization has been 
obtained). [Complete all parts of sections 6.2 and 6.3]
Full waiver is requested for entire research study (e.g., medical record review studies). 
[Complete all parts of sections 6.2 and 6.3]
Alteration is requested to waive requirement for written documentation of authorization 
(verbal authorization will be obtained). [Complete all parts of sections 6.2 and 6.3]
6.2
Waiver or Alteration of Authorization for the Uses and Disclosures of PHI
6.2.1 Access, use or disclosure of PHI representing no more than a minimal risk to the privacy of the 
individual
Not applicable.
6.2.2 Explanation for why the research could not practicably be conducted without access to and 
use of PHI
Not applicable.
6.2.3 Explanation for why the research could not practicably be conducted without the waiver or 
alteration of authorization
Not applicable.
6.3
Waiver or alteration of authorization statements of agreement
Not applicable.
7.0
Study Design and Procedures
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7.1
Study Design
This study will use a convergent mixed methods design to: 1) explore how playing the serious game, 
“Who Would You Choose” (WWYC), affects individuals’ choice of a spokesperson; 2) establish the 
feasibility of using WWYC for helping people designate an appropriate spokesperson for healthcare 
decisions and 3) receive a positive response from the spokesperson which will be confirmed with a 
completed REDCap survey. In each game event (lasting ~2 hours), research staff will help facilitate 
game-play for groups of 4 players, who will also 1) complete baseline questionnaires, 2) complete post-
game questionnaires, and 3) participate in post-game focus group discussions. Then, players will use text 
messages initiated by the associated WWYC smartphone App to engage their chosen spokespersons by 
sending a text message inviting them to complete a brief REDCap survey asking what medical 
preferences they think the player would want in various clinical scenarios. If this spokesperson does not 
respond or complete the survey within one week, the player may forward the same test message with 
REDCap survey link to an alternate spokesperson.  If the alternate spokesperson does not respond ro 
complete the survey, no additional spokespersons will be contacted. Approximately 2 weeks after the 
game event, players will be contacted by phone for a one-on-one interview.
Game piece examples:
7.2
Study Procedures
Prior to Game Play:
-
After eliciting informed consent, participants will be asked to complete the following :
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o
Demographics (i.e. age, race/ethnicity, religiosity, education, gender, experience with 
surrogate medical decision-making, experience playing games, attitudes about ACP)
o
Stage of Readiness to engage in ACP
o
Choosing a Spokesperson (pre-activity)
o
Install WYYC game app onto their personal smart phone
Game Play:
WWYC is played with 4 - 6 individuals via a smart phone app with card game components.  Players 1) 
enter answers to game questions, 2) guess which player entered each answer (with points awarded for 
correct guesses), and 3) explain why they answered the way they did. The other players then decide 
whether a given player’s explanation is good (merits an extra point), OK (no extra point), or poor (merits 
taking away a point). In addition to the “game choice,” players also enter a “real-life choice” for each 
question –which is not shared, but will help them with the game’s final question. 
Across the 7 rounds, the game questions are intentionally unrelated to medical care so as to create a 
playful environment that still encourages players to reflect on spokesperson qualities. Game-play 
concludes after 7 rounds are completed (<1 hour), and a “winner” is identified by having the highest 
number of points earned. Then, one player reads instructions allowed to direct each player to choose a 
spokesperson (see Box 2).
There are 7 rounds to the 
game, corresponding to 7 
qualities that a good 
spokesperson (or surrogate 
medical decision maker) 
should possess. These 
qualities were identified 
from a review of the 
literature and our pilot 
work (see Preliminary 
Data). For each 
round/quality, there are 11 
question cards, and a roll of 
the dice determines which 
question is to be answered 
for that round. The player 
who rolled the dice also 
flicks a spinner to narrow 
game-choices to 1 of 4 general categories (Public figure, Fictional character, Entertainer, or Historical 
figure). After the question is read aloud each player enters a game-choice (which gets shared), as well 
as a “real-life choice” (which does not get shared). If players need help coming up with a game-choice, 
they may choose from the “Need-a-Name” options. In this version of WWYC, both answers and guesses 
will be recorded using a smart-phone App, but in our test version (see Preliminary Data) players wrote 
responses manually.
The WWYC smart-phone App will supplement the cards, dice, and spinner to provide a secure dynamic 
database for up to 6 players at a time. Once the game question for a given round has been selected, 
and each player has typed a response using their smart-phone, the App will display all responses, and 
allow players to guess which player gave which response. The App will keep track of players’ scores 
(reflecting the number of correct guesses), as well as point totals.  Because the App is also intended to 
promote engagement with spokespersons, the App will allow players to invite their spokesperson to 
participate. Through the App, participants will share a link with their spokesperson via text message. 
Box 2. Now that you have played “Who Would You Choose,” there is one 
final question to answer. This question is just for you, and you don’t need to 
share your answer with the other players.
Please reflect on the choices you made, and what this says about your 
priorities and values when it comes to making medical decisions. Now, 
imagine being in a situation where you were unable to make medical 
decisions for yourself, and someone else needed to make them for you. What 
kind of person would you want to take on that role as your surrogate 
decision-maker (also known as a spokesperson)? To start, it should be 
someone who knows you well.  But experts agree that this person should 
have other characteristics as well –specifically, those described on the 
question cards. So, ideally, this person would be available when needed, and 
would be someone you trust, is caring, would honor your wishes, can stand 
up under pressure, has good judgment, and shares your values. Please review 
the list of characteristics and your responses. When you are ready, write 
down the name of the person in your life who best embodies these qualities 
and who you would want to make medical decisions for you should the need 
arise. This individual is called your “surrogate decision-maker” and acts as 
your spokesperson.
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Research staff coordinating the game event will visually confirm participants have forwarded this survey 
to their potential spokesperson.  By clicking the link, the spokesperson will view the Summary 
Explanation of Research, confirm willingness to participate, and provide basic demographic information 
through REDCap.  Should this spokesperson not respond after seven days, the player may forward the 
survey invitation link to an alternative spokesperson.  Should the alternate not respond, no additional 
invitations will be sent.  Upon leaving the event, participants will be given a formal healthcare power of 
attorney form to complete.  Additionally, ~2 weeks after the event, the research team will contact 
participants by phone to conduct follow-up interviews.
Post-Game Outcomes Measured:

Experience/process of game-play (i.e., one-on-one interviews, focus groups)

Net Promoter Score

Stage of Readiness to Choose a Spokesperson

Choosing a Spokesperson

Spokespersons’ Engagement with Online Interface

Player Evaluation
7.2 Duration of Participation
Players:

Up to 2 hours. Anticipated time allotment is as follows:

5-10 minutes Informed Consent

5-10 minutes Explanation of game

45-60 minutes Game

30-40 minutes Feedback from participants

20-30 minute follow-up phone interview
Spokespersons (Surrogates):

15-20 minutes to read and complete online survey
8
Subject Numbers and Statistical Plan
8.2 Number of Subjects
Up to 800 participants (400 players and 400 spokespersons, with each game consisting of 4 players 
each)
8.3 Sample size determination
Using purposive sampling, aim to recruit 50% female and >25% ethnic/racial minority participants. As a 
feasibility study, the main objective is to establish viability of the intervention rather than efficacy. Thus 
a power analysis is not necessary. The sample size reflects the number of participants we expect to be 
able to recruit in this time period to obtain the information necessary to answer study questions.  
8.4 Statistical methods
Quantitative data will be analyzed by first summarizing all variables with frequencies and percentages, 
or means, standard deviations, medians, and quartiles. The primary outcome variables will then be 
defined based on criteria stated above and summarized with frequencies and percentages to determine 
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if they reach the needed feasibility levels. As a feasibility study, we are not performing statistical testing 
or seeking significance as a primary goal. All analyses will be performed using SAS version 9.4 
Qualitative data will undergo conventional content analysis to identify emergent themes–with focus 
groups and 1:1 interviews analyzed separately. All inter-disciplinary team members will review 20% of 
transcripts independently to create broad categories. Categories and subcategories will then be 
organized into a preliminary codebook, and exemplars selected to further define the codes –which will 
then be used to code an additional 20% of transcripts using the constant comparison method.
Biological variables including age and gender will be assigned as attributes to examine effects on 
participant experiences. Inter-rater reliability will be judged using a kappa >0.7; discrepancies will be 
managed by group discussion to arrive at consensus codebook for coding the entire dataset (2 coders 
per transcript). Experienced qualitative researchers (Van Scoy, Badzek) will oversee analyses; coders will 
be trained by experienced members of the Penn State Qualitative Mixed Methods Core. Published 
criteria for methodological rigor of qualitative research will be used to attend to the truth-value, 
applicability, consistency, and neutrality of findings. To evaluate credibility (i.e., truth-value) of findings, 
a sub-set of participants will be asked to review a summary of data to ensure accuracy (member 
checking).  To bolster applicability of findings to other contexts, rich/thick descriptions from interviews 
will be obtained to assess and compare experiences. Consistency and dependability of data will be 
maintained by inter-rater reliability analyses using intra-class correlation coefficients. Researchers will 
bracket biases and create an audit trail of coding decisions to maximize data neutrality.
9
Data and Safety Monitoring Plan
9.2 Periodic evaluation of data
All game events will be monitored for the possibility of adverse reactions to the game experience (the 
only study intervention).
9.3 Data that are reviewed
Adverse reactions (e.g. emotional distress) experienced by player participants.
9.4 Method of collection of safety information
Direct observation
9.5 Frequency of data collection
Every game event
9.6 Individuals reviewing the data
PIs and data safety monitor (Dr. Volpe)
9.7 Frequency of review of cumulative data
Quarterly
9.8 Statistical tests
Not applicable.
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9.9 Suspension of research
In the unlikely event that the game intervention routinely provokes emotional distress, the game will be 
stopped pending reassessment by the study PIs and data safety monitor (Dr. Volpe).
10 Risks
This is a minimal risk study. It is possible that some individuals may experience emotional distress, however 
we suspect that individuals with a negative predisposition toward difficult conversations about surrogate 
decision-making will self-select to not participate in this research.
11 Potential Benefits to Subjects and Others 
11.2
Potential Benefits to Subjects
Participation in this study has the potential to give people new insights into the process of surrogate 
decision making.
11.3
Potential Benefits to Others
Data from this research will help our research team improve the game, “Who Would You Choose: 
Serious Fun (WWYC),” and thereby provide a stronger foundation for subsequent research on the 
game’s efficacy for helping people choose better surrogate decisions-makers (spokespersons) for 
medical care.
12 Sharing Results with Subjects
Not applicable.
13 Subject Payment and/or Travel Reimbursements
Player participants will be offered a $50 gift card in appreciation of their participation. Spokesperson 
participants will not be offered any reimbursement due to the very limited nature of their participation.  The 
Controller’s office has provided this study an exemption from using the Greenphire system.  (Exemption letter 
can be found in Local Site Documents.)
14 Economic Burden to Subjects
14.2
Costs
Not applicable.
14.3
Compensation for research-related injury
Not applicable.
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15 Resources Available 
15.2
Facilities and locations
Study activities will take place at Penn State Milton S. Hershey Medical Center and at public locations in 
the community.
15.3
Feasibility of recruiting the required number of subjects
To maximize recruitment, study inclusion criteria are broad, and study activities will require minimal 
burden. We anticipate being able to recruit enough participants to meet project needs.
15.4
PI Time devoted to conducting the research
The PI (BH Levi) and Co-PI (MJ Green) will oversee all aspects of the study –including design, 
implementation, and analysis.
15.5
Availability of medical or psychological resources
In the event that a participant experiences psychological distress from study activities, study team 
personnel will work with the participant to address the distress. If further assistance is needed, we will 
contact David Simmons, director of pastoral services to assist.
15.6
Process for informing Study Team
The research team will meet weekly throughout the study period to ensure protocols are followed.
16 Other Approvals
16.2
Other Approvals from External Entities
Not applicable.
16.3
Internal PSU Committee Approvals
Check all that apply:
  Anatomic Pathology – Penn State Health only – Research involves the collection of tissues or use of 
pathologic specimens. Upload a copy of “HRP-902 - Human Tissue For Research Form” in CATS IRB. 
  Animal Care and Use – All campuses – Human research involves animals and humans or the use of 
human tissues in animals
  Biosafety – All campuses – Research involves biohazardous materials (human biological specimens 
in a PSU research lab, biological toxins, carcinogens, infectious agents, recombinant viruses or DNA 
or gene therapy).
  Clinical Laboratories – Penn State Health only – Collection, processing and/or storage of extra tubes 
of body fluid specimens for research purposes by the Clinical Laboratories; and/or use of body fluids 
that had been collected for clinical purposes but are no longer needed for clinical use. Upload a copy 
of “HRP-901 - Human Body Fluids for Research Form” in CATS IRB. 
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  Clinical Research Center (CRC) Advisory Committee – All campuses – Research involves the use of 
CRC services in any way.
  Conflict of Interest Review – All campuses – Research has one or more of study team members 
indicated as having a financial interest.
  Radiation Safety – Penn State Health only – Research involves research-related radiation 
procedures. All research involving radiation procedures (standard of care and/or research-related) 
must upload a copy of “HRP-903 - Radiation Review Form” in CATS IRB. 
  IND/IDE Audit – All campuses – Research in which the PSU researcher holds the IND or IDE or 
intends to hold the IND or IDE.
  Scientific Review – Penn State Health only – All investigator-written research studies requiring 
review by the convened IRB must provide documentation of scientific review with the IRB 
submission. The scientific review requirement may be fulfilled by one of the following: (1) external 
peer-review process; (2) department/institute scientific review committee; or (3) scientific review by 
the Clinical Research Center Advisory committee.  NOTE: Review by the Penn State Health Cancer 
Institute (PSCI) Protocol Review Committee or the PSCI Disease Team is required if the study 
involves cancer prevention studies or cancer patients, records and/or tissues. For more information 
about this requirement see the IRB website.
17 Multi-Site Study
If this is a multi-site study (i.e., a study in which two or more institutions coordinate, with each institution 
completing all research activities outlined in a specific protocol) and the Penn State PI is the lead investigator, 
describe the processes to ensure communication among sites in the sections below.
[Do not type here]
17.2
Other sites 
Not applicable.
17.3
Communication Plans
Not applicable.
17.4
Data Submission and Security Plan
Not applicable.
17.5
Subject Enrollment
Not applicable.
17.6
Reporting of Adverse Events and New Information
Not applicable.
17.7
Audit and Monitoring Plans
Not applicable.
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18 Adverse Event Reporting
18.2
Reporting Adverse Reactions and Unanticipated Problems to the Responsible IRB
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: 
In accordance with applicable policies of The Pennsylvania State University Institutional Review Board 
(IRB), the investigator will report, to the IRB, any observed or reported harm (adverse event) experienced 
by a subject or other individual, which in the opinion of the investigator is determined to be (1) 
unexpected; and (2) probably related to the research procedures. Harms (adverse events) will be 
submitted to the IRB in accordance with the IRB policies and procedures.
19 Study Monitoring, Auditing and Inspecting
19.2
Auditing and Inspecting
By submitting this study for review, you agree to the following statement – DO NOT ALTER OR DELETE: 
The investigator will permit study-related monitoring, audits, and inspections by the Penn State quality 
assurance program office(s), IRB, the sponsor, and government regulatory bodies, of all study related 
documents (e.g., source documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-related facilities (e.g., 
pharmacy, diagnostic laboratory, etc.).
20 Future Undetermined Research: Data and Specimen Banking
20.2
Data and/or specimens being stored
Not applicable.
20.3
Location of storage
Not applicable. 
20.4
Duration of storage
Not applicable. 
20.5
Access to data and/or specimens
Not applicable. 
20.6
Procedures to release data or specimens
Not applicable. 
20.7
Process for returning results
Not applicable.
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21 References
Not applicable.
22 Confidentiality, Privacy and Data Management 
IMPORTANT: The following section is required for all locations EXCEPT Penn State Health and the College of 
Medicine.  Penn State Health and College of Medicine should skip this section and complete “HRP-598 
Research Data Plan Review Form.” In order to avoid redundancy, for this section state “See the Research Data 
Plan Review Form” if you are conducting Penn State Health research. Delete all other sub-sections of section 
22.
See HRP-598 Research Data Plan Review Form.
       
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