Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning Conversations by Hospitalists With Older Adults
Phase: NA
Conditions: Advance Care Planning
Sponsor: Dartmouth-Hitchcock Medical Center

D 
Study Protocol 
Hopewell Hospitalist: A Video Game Intervention to Increase Advance Care Planning by 
Hospitalists [Efficacy Trial] 
 
NCT 04557930 
17 March 2020 
 

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1. Introduction and Background 
 
Advance Care Planning (ACP) is an integral part of the National Academy of Medicine’s objective 
of ensuring that patients receive person-centered, family-oriented, and evidence-based care, 
particularly at the end-of-life. However, less than half of all people in the U.S. have documented 
advance care plans, such as an Advance Directive. Existing guidelines therefore advocate that 
physicians use the opportunity of hospitalization to initiate ACP conversations.  
 
ACP involves discussion of goals, values, and preferences for health care with the patient, family 
members, or surrogates. Discussions may include hospice care, end-of-life care options, power of 
attorney for health care decisions, living wills, and physician orders for life-sustaining treatment 
(POLST).  
 
Numerous barriers impede the initiation of ACP in the hospital. High-quality conversations 
require physicians to have both the willingness and the time necessary to engage in these emotionally 
complex interactions. As a result, physicians typically defer ACP for all except the most critically ill. In 
contrast, experts advocate that these conversations occur prior to discharge for every patient over 
the age of 65. How best to shift physicians’ decisional thresholds – convincing them to engage in ACP 
conversations with all eligible patients – remains unclear.  
 
In prior work, the PIs developed a customized video game to recalibrate physician heuristics 
(intuitive judgments) in trauma triage, drawing on research from other domains suggesting the 
potential effectiveness of using narrative engagement to change behavior. Narrative engagement 
interventions use messages designed to resonate with recipients in personally relevant and 
meaningful ways. The PIs found that physicians using the game made fewer diagnostic errors on a 
validated trauma triage simulation than those randomized to use a text-based educational program, a 
difference that persisted to six-month follow up. Given this success, this study hypothesizes that 
narrative engagement might also change physicians’ decisional thresholds and adapted the video 
game to address the problem of ACP in the hospital.  
 
This study is part of a larger project, “Physician Cognition, Inpatient Advance Care Planning, and 
Outcomes for Seriously Ill Older Adults,” and uses a pragmatic, minimal risk behavioral intervention to 
test the effect of the intervention, compared to usual care quality improvement alone, on the 
likelihood of ACP discussions by hospitalists with hospitalized patients aged 65 and older. Hospitalists 
employed by Sound Physicians – a large national physician practice that employs more than 2000 
acute care providers in hospital medicine at more than 200 hospitals in 38 states – are our study 
population. The primary outcome is billed ACP discussions.  
 
The usual care quality improvement includes: 1) mandatory and voluntary CME-accredited e-
learning, including modules on compliance with CMS billing codes 99497 (ACP first 30 mins) and 
99498 (ACP additional 30 mins), templated ACP documentation, and training in serious illness 
communication; 2) compensation incentives rewarding quality and productivity performance, 
including $20/ACP conversation; and 3) handheld and desktop IT tools (“SoundConnect”) that enable 
coding and billing and facilitate coordination and compliance with clinical pathways. The effect of 
these efforts will be treated as the baseline to which the effect of the game will be compared.  
 

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2. Objectives and Hypotheses 
 
 
This study will test the efficacy of using a customized theory-based video game to increase 
rates of ACP for hospitalized older adults.  
 
The primary outcome is physician billing for ACP (data available directly from Sound 
Physician-submitted claims with a 1 quarter lag). The primary hypothesis (H1) is that hospital ACP 
billing practices after distribution of the video game will increase (more than would be expected 
by secular trends alone). A priori post-hoc hypotheses include: (H2) The larger the proportion of 
hospital physicians who play the game, the greater the increase in ACP rates, and (H3) Differences 
in hospital billing practices before-and-after distribution of the video game will be positively 
associated with the proportion of physicians who have completed their organization’s ACP e-
curriculum. 
 
The secondary outcomes are episode-based patient healthcare use and mortality (data 
available from CMS with a 2-year lag). 
 
 
3. Study Design 
 
Note: All aspects of this study design will need to be re-appraised in light of the evolving Covid-
19 pandemic and the associated secular disruptions in hospital medicine staffing, medical 
decision-making processes, and mortality among older adults. 
 
30 hospitals (conditional on the response rate) will be randomized into an order for a 
stepped wedge cluster randomized trial.  The stepped wedge trial randomizes hospitalist 
participants at the group level (i.e., hospital) rather than the individual level (i.e. hospitalist).  We 
will use a stepped-wedge trial design for two reasons: 1) individual-level randomization risks 
misclassifying patients, contaminating unexposed physicians, and failing to address group-level 
attitudes to and practices of ACP; 2) a parallel cluster randomized design risks imbalance among 
groups because of the high intra-class correlation coefficient that exists for billing practices at the 
hospital-level. Each group ‘crosses over’ from control to intervention at a randomized timepoint 
and multiple ‘time steps’ of data collection occur. All the Sound-affiliated hospitalists at each 
hospital will be invited to use the video game intervention. If a participant accepts, the participant 
will receive an iPad with the video game pre-loaded.  The iPad will be mailed to either a 
participant’s home address or the hospital site where it will be distributed by the clinical 
performance nurse or nurse liaison. We will contact and consent a small sample of 20-30 
physicians who completed the efficacy portion of the trial for a semi-structured interview via 
Zoom to discuss their experiences playing the game. These semi-structured interviews will be 
recorded and transcribed, and participants will be compensated with a $50 Amazon gift card for 
          The planned study will test both the effect of the video game intervention on ACP billing 
practices as well as the impact of the distribution strategy in a hybrid efficacy-effectiveness clinical 
trial. We will use linked Sound-submitted claims data to quantify the influence of the intervention on 
ACP billing (available with a 3-month lag) and linked CMS-assembled claims data to quantify the 
influence of the intervention and any shifts in ACP behavior on secondary episode-based patient 
healthcare use and outcomes (available with a 2-year lag). 

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participating in the interview. All data will be collected through the game itself with Google 
Analytics and Qualtrics.  This data will be linked with Sound data and with Medicare claims that is 
regularly and continually collected by those external parties. Finally, we will ask Sound to abstract 
the charts of a random sample of 200-300 patients treated by trial physicians, so that we can test 
the validity of our outcome measures.  
 
 
4. Analysis 
 
Please see the Statistical Analysis Plan 
 
 
 
5. Study Progress Monitoring 
 
This study will be overseen by a Data Safety and Monitoring Board.  The DSMB has 
been empaneled.  It will be approved and the first meeting will be held before the start of 
the trial. In the process of establishing the DSMB charter, DSMB members will provide 
guidance on safety surveillance and reporting requirements.  
 
 
As determined by NIH, the DSMB will “1) periodically review and evaluate the 
accumulated study data for participant safety, study conduct and progress, and, when 
appropriate, efficacy, and 2) make recommendations to NIDCR concerning the continuation, 
modification, or termination of the trial. The DSMB considers study-specific data as well as 
relevant background knowledge about the disease, test agent, or patient population under 
study.” 
 
 
As described by NIH, “The DSMB is responsible for defining its deliberative processes, 
including: event triggers that would call for an unscheduled review, stopping procedures that 
are consistent with the protocol, unmasking (unblinding), and voting procedures. The DSMB 
is also responsible for maintaining the confidentiality of its internal discussions and activities 
as well as the contents of reports provided to it. 
 
 
The DSMB should review each protocol for any major concern prior to 
implementation. During the trial, the DSMB should review cumulative study data to evaluate 
safety, study conduct, and scientific validity and integrity of the trial. As part of this 
responsibility, DSMB members must be satisfied that the timeliness, completeness, and 
accuracy of the data submitted to them for review are sufficient for evaluation of the safety 
and welfare of study participants. The DSMB should also assess the performance of overall 
study operations and any other relevant issues, as necessary.”  
 
 
All eligible participants will be contacted at the start of the trial and receive the 
interventions as described under Section 3.  The trial will run for a total of 6 months. 
 
 
 
 
 
6. Risks & Benefits 
 

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Note: Risks may be physical, psychological, social, legal, economic, to reputation, or others.  
 
 
a. Describe any potential risks, their likelihood and seriousness: 
There are two categories of participants in this pragmatic trial: 1) Consented research 
participants (hospitalists); and 2) Unconsented research participants (patients of participating 
hospitalists). 
 
The consented research participants are the hospitalists employed by Sound Physicians. A 
key consideration in this study that the participants’ employer is a partner in conducting the trial. 
The primary outcome is the hospitalists’ behavior; specifically, the frequency with which 
hospitalists bill for ACP conversations with patients 65 and older.  
 
The unconsented research participants are the patients of participating hospitalists. Since 
the trial seeks to influence hospitalist ACP behavior during patient encounters, hospitalists’ 
patients will be indirectly affected.  A key consideration is that this study randomizes 
participation at the level of the hospital, and consent at the physician level, with the intent to 
improve the quality and patient-centeredness of patient care.  However, neither the hospitals nor 
the physicians will obtain consent from their patients  
 
Consented research participants (hospitalists): 
Potential Risks: There are no health risks to consented research participants (hospitalists). The 
three major potential risks are lack of voluntariness (coercion), impact on employability, and loss 
of confidentiality.  
 
Lack of voluntariness (i.e., undue influence). A central tenet of clinical research is that 
participation is voluntary. This study will make it very explicit that research participation is not a 
condition of employment by Sound. However, there may yet be a perception of lack of 
voluntariness. This study cannot completely separate research participation from employer 
purview. Study implementation requires the disclosure of study participation to members of the 
Sound study team who are responsible for programming the information technology (IT) 
platforms that will be used to deliver the intervention(s).  
 
Confidentiality. Participant data will be collected and stored with physician identifiers 
(e.g., names and UPIN numbers linked to unique study IDs). Strict confidentiality and privacy 
procedures have been put in place to protect against any potential public disclosure of individual 
provider performance data. All physician-level data will be de-identified for analysis and 
reporting. A compromise of security of survey, interview, intervention adherence, and ACP 
performance data outside of the study would result in a breach of confidentiality and violation of 
privacy.  
 
Sound and TDI each have detailed policies and procedures in place for the physical and 
electronic security of the SoundConnect and Medicare claims data.  
 
Employability. Study participation is not a condition of employment. Sound collects and 
reports multiple measures of hospitalist performance. These are conditions of employment. 
Hospitalists already receive data on their own ACP performance monthly, which is reported to 
their direct hospital supervisors in comparison with all of the hospital’s other hospitalists’ 
performance. There is no central Sound policy regarding how hospital supervisors use any 

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performance data, including ACP performance. This study will not change these reporting 
procedures. Therefore, responses should not influence employability. Indeed, if the 
intervention(s) are effective, participants randomized to active treatment will improve their 
performance. A theoretical concern is if increased attention to ACP crowded out hospitalists’ 
focus on other quality targets. While this was not originally a secondary outcome proposed in 
the original protocol, the administrative and statistical feasibility of adding this safety measure 
will be assessed (see below). 
 
Unconsented research participants (patients of hospitalists): 
The three main risks to unconsented research participants (patients of participating 
hospitalists) are violation of rights due to non-consent and lack of voluntariness, breach of 
confidentiality, and shortened survival time associated with preference-concordant treatment 
associated with modifying code status to “do not resuscitate” or completing ACP documents 
such as physician orders for life-sustaining treatment (POLST) as well as potential medical 
undertreatment associated these orders.  
 
ACP meets the minimal risk standard as defined at 45 C.F.R. § 46.102(i), “Minimal risk 
means that the probability and magnitude of harm or discomfort anticipated in the research are 
not greater in and of themselves than those ordinarily encountered in daily life or during the 
performance of routine physical or psychological examinations or tests.” ACP involves discussion 
about goals, values, and treatment preferences with the patient, family members, or surrogates. 
Discussions may include hospice care, end-of-life care options, power of attorney for health care 
decisions, living wills, and physician orders for life-sustaining treatment (POLST). Engagement in 
comprehensive ACP conversations are not strictly required and practices vary widely. 
Specifically, while the Joint Commission requires that patients be asked whether they have a 
pre-existing advance directive at the time of acute care admission and that code status be 
documented. Comprehensive ACP conversations are not currently a Joint Commission 
requirement. Medicare encourages comprehensive ACP conversations by paying for these 
services, but their policy states that the services are “voluntary,” meaning that if a provider 
broaches an ACP conversation with a patient, they must provide an opportunity to decline the 
services and documented in the record. Therefore, having or not having a comprehensive ACP 
conversation during an acute care admission are both currently medically recognized standards 
of care.  
 
Lack of voluntariness (i.e., non-consent). As outlined above, patients of consented and 
randomized hospitalist will not be provided with a choice regarding whether they are treated by 
an intervention or control hospitalist. This situation is common to cluster randomized studies 
designed to improve adherence with clinical practice guidelines.  
 
Confidentiality. The source of patient-level data for clinical trial outcomes is 
administrative billing data. This includes data collected by Sound Physicians for the purposes of 
billing the Centers for Medicare and Medicaid Services (CMS) and other payers for physician 
services during the index hospitalization (primary outcome: ACP billing) and additional claims 
data from CMS for data on predictors/risk-adjusters and secondary outcomes.  
 
The main procedures to protect against risks (lack of voluntariness, confidentiality, 
employability) to participation by the consented research participants (hospitalist physicians) 
involve separating research- and operations-related elements of the study. Specifically, 

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Dartmouth team members, not Sound Physician team members, will complete key research-
related activities such as recruitment, informed consent, primary data collection, data analysis 
and storage.  
 
To protect against lack of voluntariness, confidentiality, and threats to employability, no 
Sound Physician employee will participate in the recruitment and informed consent process 
beyond introducing the study and Dartmouth investigators to potential research participants. 
Any reports regarding undue influence will be treated as a SAE. No member of the study team 
will disclose study participation to Sound leadership (including co-investigator Birkmeyer) or to 
the hospitalists’ direct supervisors.  
 
Data elements will be entered directly by the research coordinator; these files are 
backed-up daily and archived weekly. All study subjects will be assigned unique study identifiers 
that will appear on all data collection instruments, documents, and files used in the statistical 
analysis and manuscript preparation. Limited team members will have access to identifiers 
needed for tracking and informed consent. We will follow TDI data security procedures to 
protect the confidentiality of physician research participant data along with Medicare 
beneficiary billing claims data (see below). 
 
The principal means of protecting against violation of patient rights and harming welfare 
of unconsented research participants (patients of participating hospitalists) for pragmatic trials 
like ours is thoughtful review by multiple experts in human subjects research ethics and 
regulation, including NIH staff, an independent DSMB, and the Dartmouth Institutional Review 
Board. The physician-directed behavioral interventions proposed in the current study augment a 
suite of non-randomized quality improvement interventions already deployed by Sound 
Physicians to increase ACP by hospitalists which are not subject to such review or to rigorous 
safety or efficacy evaluation.   
 
The PIs will audit a purposive sample of ACP conversations during the trial to assess 
quality. They will follow TDI data security procedures to protect the confidentiality of Medicare 
beneficiary billing claims data (see below).  
 
Data Security Procedures:  
 
 
TDI has a long and flawless history in maintaining and using extremely large confidential 
databases. The mission of the Data Analytic Core (DAC) at The Dartmouth Institute for Health 
Policy and Clinical Practice (TDI) is to provide support to research that contributes to the 
effectiveness, quality, equity, and efficiency of health care within the United States, which is 
complemented by its promise to respect personal privacy, safeguard the confidentiality of data 
and to provide a secure environment for the databases under its management. The DAC 
functions as the Data Coordinating Center for TDI. As detailed in the DAC Policies and Standards 
Manual (PSP), the DAC meets this commitment by ensuring data anonymity; maintaining 
principles and policies for the protection 55of health care data including strict policies which 
limit access to data and heightened security measures (organizational, technological, and 
physical) according to both FISMA (Federal Information Security Management Act) and HIPAA 
(Health Information Portability and Accountability Act) requirements; reviewing and approving 
research proposals requesting use of the data sets controlled by the DAC; assuring that 
appropriate and current data use agreements, institutional reviews and other approvals are in 

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place for research projects; an active IT Security Committee, at the working and governance 
levels;  annual staff training to keep health information protection matters a constant priority; 
requiring that ALL TDI and the Data and Analytic Core (DAC) users sign a TDI DAC Policies, 
Standards, and Procedures Information Security Acknowledgement and Agreement; regularly 
reviewing the DAC policies to ensure they are in line with current health information legislation 
and protection practices.  
 
 
Additionally, the DAC must adhere to both FISMA and HIPAA requirements as well as 
CMS requirements to ensure the security of protected health information (PHI). PHI is the 
terminology used in HIPAA legislation and by the Centers for Medicare and Medicaid Services 
(CMS). Under HIPAA, PHI consists of any “individually identifiable data such as SSN, birth date, 
admission date, discharge date or zip code”. The claims data used for research within the DAC at 
TDI contain files with PHI. The safeguards vary depending on the amount, distribution, format of 
the information, and the method of storage.  
 
Description of Security Measures 
 
The methods of protection in place for both the claims data and the physician level data 
as outlined above include:   
1. Physical measures; e.g., locked facility with tracked key access, locked filing cabinets, 
and restricted access to offices; 
2. Organizational measures; e.g., strict employee confidentiality agreements (with 
restrictive actions as a sanction) and limiting access on a “need-to-use” basis;  
3. Technological measures; e.g., the use of firewalls, “moating” of administrative data 
making it inaccessible externally, passwords, and encryption of data; use of VPN 
terminals and networks; and,  
4. Anonymity of data by stripping off conventional identifiers for data provided to users 
(when conventional identifiers are not necessary for research).  
 
 
As a condition of employment, all staff (full-and part-time) must sign the DAC Policies, 
Standards, and Procedures Information Security Acknowledgement and Agreement prior to 
working with the data. Staff includes TDI faculty, adjunct faculty, fellows, research analysts, 
programmers, students, and other approved researcher staff seeking access to or utilizing the 
DAC.  
 
 
All DAC servers, data storage, switches, and other peripherals are stored in isolated rack 
cages with DAC-dedicated key locks limiting access to only the DAC Network Systems 
Administrator. All DAC servers, are maintained by Dartmouth computing. All data traffic for the 
project is contained within a private, dedicated DAC VLAN network. All network traffic to the 
servers must pass through the Dartmouth hardware firewall. The only access to the servers is via 
SSH and requires 2-factor authentication (NetId/password and DUO). All networks located on 
switches are segmented and behind Dartmouth firewalls where the DAC data resides.  
 
 
Derivative data variable definitions and labeling will be confidential and described as per 
data type and use. Labeling will not include any PHI. 
 
 
 

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b. Describe why all the risks to subjects are reasonable in relation to both 
anticipated benefits and the knowledge expected to be gained from the study: 
  
 
There are no direct benefits to the study participants. Knowledge gained from the study 
will contribute to the academic literature on physician quality improvement and the efficacy of 
video games as behavioral interventions. This knowledge will inform how advances in technology 
may transform the means by which behavioral and social science interventions are delivered. 
These technologies ensure treatment fidelity and can extend treatment duration, thereby 
improving behavioral maintenance.  
 
 
Further, this study will inform how these technologies may be used in the context of 
ACP, as well as broadly because ACP is an extension of the game’s original use-case of trauma 
triage. This study will provide information about how hospital-based physicians initiate ACP 
conversations for patients admitted acutely and if the decision to initiate a conversation can be 
improved with a customized theory-based video game. 
 
 
 
7. Unexpected Events or Incidental Findings 
 
Note: It may be important to consider the potential for certain unanticipated events to occur, 
for example: 
● finding an anomaly in a MRI 
● discovering child abuse 
● causing distress in interviews of a sensitive nature 
 
Describe potential events and provide a plan of action: 
 
 
Unexpected events may include: unexpectedly high rates of advance care planning billing 
that raise concerns regarding Medicare billing fraud, or systematic biases or disparities in advance 
care planning conversations. No action will be taken regarding unexpectedly high advance care 
planning billing rates. Systemic biases will be reported back to the hospital without any identifying 
information.  
 
8. Deception 
 
Does any part of this study involve deception or withholding of information from 
participants? 
 
☐  Yes 
 
☒  No 
 
If Yes, provide an explanation which addresses the following: 
● A description of the deception being used 
● Why the deception is necessary 
● A plan for debriefing, or providing subjects with the pertinent information after 
participation 
 
 
9. Equitable Participant Selection 
 

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a. Estimated number of participants at Dartmouth CPHS reviewed sites:  
 
Sound Physicians is a national physician practice that employs acute care providers in hospital 
medicine, emergency medicine and critical care. We selected this physician practice as a partner in 
our efforts to test the effect of the video game for three reasons: 1) it staffs over 200 hospitals with a 
wide variety of geographic and organizational characteristics, increasing the generalizability of our 
observations; 2) it has already implemented best-practice quality improvement efforts to improve 
ACP practices at its hospitals, including providing employees with web-based didactic education on 
the importance of ACP in the hospital and a small financial incentive ($20) for each documented ACP 
conversation that meets Medicare’s criteria for reimbursement; 3) billing practices remain lower than 
desired.   
 
 
We will selectively sample 30-40 hospitals that contract with Sound Physicians, and will 
randomize them to the step in which they receive the intervention. We will stratify randomization 
based on hospitals' baseline characteristics (e.g., number of providers, region, baseline ACP billing 
rate). We will generate randomization schemas using Stata 13.0 (Statacorp, College Station, TX, USA) 
statistical software, using random block sizes of 4. Although we cannot blind study personnel and 
participants, we will mask the arm and group assignment during the analysis phase. 
 
 
b. Provide a justification of the proposed sample size 
 
For the Efficacy condition, we plan to recruit 120 physicians at 30 hospitals (conditional 
on willingness to participate) and will expose them sequentially to the video game intervention. 
If fewer physicians per hospital agree to participate, we will plan to increase the number of 
hospitals allocated to the efficacy trial. 
 
Assuming a baseline ACP rate of 14% (rising by 1.25%/quarter), a hospital intra-class 
correlation coefficient of 0.008-0.115, and 160 patients/physician/quarter, with 120 physicians, 
we can detect a 3% difference between ACP practices before and after the distribution of the 
intervention with an alpha of 0.05 and 80% power. 
 
For the Effectiveness condition, we will recruit 170 hospitals. This represents the 
remainder of the Sound hospitals. As part of our agreement with the funding agency, we are to 
deliver the intervention to all Sound hospitalists. The effectiveness study, therefore, is not 
specifically powered. 
 
c. Define the target population: 
 
The target population is physicians whose job responsibilities include ACP.  In this study, all 
inpatient hospitalist physicians who have worked for Sound Physicians at a study hospital for at 
least one quarter are eligible to participate. There are approximately 200 hospitals across the US 
providing a total of approximately 2000 eligible hospitalists.  The study aims to balance the 
sample in the following characteristics:  
● A hospital’s ACP billing rate. 
● Number of hospitalists at a hospital. 
● If the hospital is an academic medical center. 
● Availability of Clinical Performance Nurse to pull charts. 

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Additionally, the inclusion criteria are: a hospitalist must have worked for Sound for at least 6 
months, report use of ACP billing codes, provide contact information that matches a contact in 
our list of eligible physicians (i.e. full name match or partial name match and employer-based 
email match), and receive a working iPad. If participants do not meet any of these criteria, they 
will be informed that they are ineligible, but that they may play the video game intervention 
voluntarily and without compensation for their time. They will receive instructions on how to 
download and play the game, as well as complete the post-game questionnaire. Communications 
with eligible and ineligible participants may be modified if a participant contacts the study team 
directly with specific questions or concerns. The response will be modified to address the 
participant’s needs. 
 
 
 
 
d. Vulnerable populations 
 
Note: Certain populations are considered vulnerable to coercion and undue influence and 
are provided with additional protections when participating in a research study.   
 
Identify any of the below populations which you plan to recruit for this study.  In 
addition, complete the form(s) linked with each population as necessary and 
upload on the ‘Supporting Documents’ page in Rapport.  
☐ Pregnant Women, Fetuses and Neonates 
☐ Children 
☐ People with impaired decision-making capacity 
 
The following populations may also be considered vulnerable to coercion or 
other undue influence: 
● Prisoners 
● People who are economically disadvantaged  
● The elderly  
● People who are illiterate or do not speak English 
● Students and employees 
 
Describe any other potentially vulnerable population(s) and the additional 
protections provided to them: 
 
Employees. See section 6. 
 
 
10. Recruitment 
 
Describe method(s) of recruitment.  Associated advertisements and other materials 
to be used for recruitment should be uploaded to the ‘Consent Forms and 
Recruitment Materials’ page in Rapport. 
 
All participants will be offered the opportunity to “opt in” to participate.  

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Those who engage with the study procedures are provided with consent information at 
each step of engagement; including an agreement to proceed with pre- and post-game 
survey questionnaire completion on the face page of the Qualtrics surveys (efficacy); and 
information about the data captured by game use at the time of downloading the game App 
(effectiveness condition). 
 
Recruitment and “Opt-In” Consent Process: Game Use. All Sound hospitalist participants 
in the efficacy condition will provide “opt-in” consent for active participation (e.g., use of the 
game and provision of personal information). Sound Physician leadership will introduce the 
research study to regional and hospital team leaders at the annual leadership conference 
and to all eligible hospitals via e-mail, with a web-based link to a Qualtrics survey to opt-in to 
study participation. We seek a waiver of documentation from the Dartmouth IRB to use 
electronic consent documentation. 
 
Claims analysis. Sound hospitalist participants and their patients will not provide consent 
for use of their billing data. We have relevant data use agreements with Sound Physicians 
and CMS. We seek a waiver of informed consent from the Dartmouth IRB. 
 
11. Informed Consent, Assent, and Authorization 
 
All forms discussed in this section should be uploaded to the ‘Consent Forms and 
Recruitment Materials’ page in Rapport 
 
a. Please describe the consent and/or assent process, addressing the following: 
● Who will obtain consent/assent from participants 
● Where the consent/assent process will take place 
● The timeframe for providing information potential participants about a study, 
having the consent form signed, and beginning study activities 
● Any precautions taken to minimize the possibility of coercion or undue influence 
● The forms which will be used as well as any aids used to simplify scientific or 
technical information 
● How comprehension will be ensured 
 
 
Those who engage with the study procedures are provided with consent information at each 
step of engagement; including an agreement to proceed with pre- and post-game survey 
completion on the face page of the Qualtrics surveys (electronic research consent, efficacy 
consent); and information about the data captured by game use at the time of downloading 
the game App (electronic “terms of use” agreement, effectiveness condition).       
 
b. Waiver(s) or alteration(s) may be requested for research that involves no more 
than minimal risk.   
Indicate requested waiver(s) or alteration(s) below.  In addition, complete the 
corresponding section of the Waivers and Alterations Request Form and upload 
it to the ‘Consent Forms and Recruitment Materials’ page in Rapport.      
☐  For the informed consent process 
☒ For the documentation of informed consent 

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☐  For the HIPAA Authorization to use and/or disclose PHI 
☐ For a waiver of the requirement for medical record documentation 
 
 
12. Compensation or Gifts 
 
Please describe any payments, gifts or reimbursements participants will receive for taking part 
in the study: 
 
 
All participants in the Efficacy condition will be compensated for their time.  These participants 
will keep the iPads provided during the study. Participants from the efficacy condition who complete 
a semi-structured interview will be compensated with a $50 Amazon gift card for participating in the 
interview.  
All participants in the Effectiveness condition who are sent the game URL only will receive up to 
2 AMA PRA Category 1 Credit(s) TM if they complete the continuing medical education (CME) 
evaluation form. 
 
 
13. Privacy of Participants  
 
Note: Methods used to obtain information about participants may have an effect on privacy.  
For example: 
● Consent discussions or interviews held in public which concern sensitive subjects or 
behaviors 
● Observations of behavior, especially illicit behavior, in quasi-public settings 
 
Describe any activities or interactions which could lead to a breach of privacy and 
provide a plan to protect participant privacy: 
 
See section 6. 
 
 
 
14. Confidentiality of Data 
 
Note: Any person engaged in research collecting information that could cause financial, 
social or legal harm to participants may apply for a Certificate of Confidentiality.  
Certificates of Confidentiality are issued by the National Institutes of Health (NIH) to 
protect identifiable research information from forced disclosure. They are intended to 
allow the investigator and others who have access to research records to refuse to 
disclose identifying information on research participants in any civil, criminal, 
administrative, legislative, or other proceeding, whether at the federal, state, or local 
level.  
 
a. If disclosed, could any of the data collected be considered sensitive, with the 
potential to damage financial standing, employability, insurability, or 
reputation? 
 
☐  No 
 
☒  Yes 
 

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If Yes, describe the data or information, the rationale for their collection, and 
whether a Certificate of Confidentiality will be obtained: 
 
See Section 6. 
 
 
b. Describe the safeguards employed to secure, share, and maintain data during the 
study, addressing any of the following which may apply:  
● Administrative, ie. coding of participant data  
● Physical, ie. use of locked file cabinets 
● Technical, ie. encrypted data systems 
 
See Section 6. 
 
c. Describe the plan for storage or destruction of data upon study completion: 
 
See Section 6.