Simulation-based Mastery Learning to Improve Communication in Times of Diagnostic Uncertainty: Randomized Control Trial
Phase: NA
Conditions: Uncertainty, Communication Research, Emergency Medicine
Sponsor: Thomas Jefferson University

PI: Rising, Kristin L 
IRB Control #: 19G.356  
 
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JEFFERSON—Office of Human Research 
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SUMMARY OF NON-INTERVENTIONAL HUMAN SUBJECTS RESEARCH 
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Version Date – FOR OHR USE: 1/21/19 
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5 
Use this form for social and behavioral research, research on education, questionnaire studies, 
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and other prospective studies not involving drugs, devices or medical/surgical procedures. Please 
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address all applicable points to create a complete and succinct synopsis of the protocol. If a point 
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does not apply to your study, please state “NA.” Use language, insofar as is possible, that can be 
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understood by a layperson, and provide meanings for all acronyms used. Attach surveys, 
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discussion/interview guides.  Form must be typewritten.  
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PART A- SUMMARY OF STUDY 
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1. Provide a brief (2-3 sentences) lay language synopsis of the study.  
15 
The goal of this study is to teach emergency medicine resident physicians a patient-centered 
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approach for communicating with patients at the time of emergency department discharge in the 
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setting of diagnostic uncertainty (i.e. no definitive cause identified for the patient’s symptoms). 
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The residents will complete an online educational curriculum that has been developed by the 
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study team, and will participate in video-based simulation deliberate practice (DP) and feedback 
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sessions using a simulation-based mastery learning (SBML) approach. They will be assessed 
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with the Uncertainty Communication Checklist (UCC), a tool already developed by the study 
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team, that has a minimum passing standard (MPS) that was established through engagement of 
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both patients and physicians. The investigators will perform a 2-arm wait-list randomized control 
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trial with resident physicians to test the efficacy of the SBML curriculum in training residents to 
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have a discharge discussion with patients discharged from the emergency department with 
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diagnostic uncertainty.  
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28 
2.  Objectives and Significance 
29 
 
a. State the primary objective(s) of the study. 
30 
Investigators will measure the percentage of residents who meet or exceed the MPS on 
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the UCC in the intervention group versus the control group.  
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b. State the secondary objectives(s) of the study. 
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Secondary analysis will look for the decay of learned skills and if residents’ performance 
35 
is maintained after completing a single intervention. Investigators will also evaluate: 1) 
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the association between number of DP sessions completed and achieving the MPS and 2) 
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the association of number of DP sessions completed with baseline characteristics, for 
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those who pass. 
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c. What benefit or knowledge will be gained? 
41 
This work develops an important framework to teach and assess clinical performance 
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competency in patient-centered communication in the setting of diagnostic uncertainty, 
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which occurs frequently (at least 1/3 of discharges) in the emergency department. In 
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addition, the project delivers and evaluates a technology-based educational curriculum. 
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This project has potential to significantly impact the training and competency of providers 
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in navigating safe and effective discharge communication for over one third of patients 
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discharged from the emergency department.  
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d. State research question or hypothesis you are testing. 
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We hypothesize that resident physicians who receive the SBML curriculum will be 
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significantly more likely to achieve mastery in this communication skill compared to 
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residents who do not receive the SBML curriculum, and that all residents exposed to the 
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curriculum will ultimately achieve mastery in this communication skill. 
54 
 
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3. Briefly describe the background and rationale for the research/evaluative study (whichever is 
56 
appropriate) in lay language. Please limit response to one paragraph. State the perceived 
57 
problem and why it is being investigated.  (Do not include references and please do not cut 
58 
and paste grant application or review articles.)  
59 
At least one third of patients treated in the emergency department (ED) are discharged without a 
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definitive diagnosis, thus leaving the encounter with diagnostic uncertainty. A recent national 
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survey of medical trainees found that 99% of trainees had experienced challenges discharging 
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patients with diagnostic uncertainty, and 51% wanted formal communication training regarding 
63 
uncertainty. Transitions of care are high-risk periods for patient safety, and effective 
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communication between providers and patients is essential to promote patient safety during care 
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transitions. Approaches for educating trainees and establishing competency around effective 
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communication during diagnostic uncertainty are needed to 
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improve the quality of communication at ED discharge, the most 
68 
common transition of care.  
69 
 
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4. Briefly describe the research/evaluative study design. (Use 
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charts and flow diagrams if applicable. “See protocol” is not 
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an acceptable response.) 
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a. Subjects:  State inclusion and exclusion criteria. 
75 
Eligible participants include all emergency medicine residents at 
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TJU and NU. 
77 
 
78 
b. Procedures: Explain study procedures/methods.  
79 
Members of the study team will approach all TJU and NU 
80 
Emergency medicine residents for possible study enrollment prior 
81 
to the Baseline Test (T1) to determine their interest in 
82 
participation. Residents will have the opportunity to further 
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discuss the study with an investigator prior to as well as on the 
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same day as T1, prior to initiation of testing. All residents 
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interested in participating will provide written informed consent 
86 
using procedures approved by the Institutional Review Boards of 
87 
TJU and NU.  
88 
Participants will be evenly assigned to Group A (intervention group) or Group B (control arm). 
89 
Three study test visits (T1-T3) will be planned for all participants, with additional test visits 
90 
being scheduled as needed for those who require additional practice and testing to achieve 
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mastery. T1 will consist of the baseline test, during which participants will complete a simulated 
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encounter with an SP to establish a baseline score on the UCC. Participants will be contacted 
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after their T1 visit by email to be informed of the group to which they have been randomized. 
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Participants in Group A will be given access to the intervention, an online interactive module, in 
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this initial randomization email and will be scheduled to participate in video-based DP sessions 
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with the SPs. The second visit will be scheduled 4-8 weeks after T1 and will consist of another 
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simulated test (T2) encounter with the SP for both Group A and B; following this session, 
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participants in Group B will be introduced to the intervention. Both groups will return for a third 
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study test visit (T3). All study test visits will involve participants completing a video-recorded 
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simulated encounter with SPs, though the clinical scenarios will vary to maximize participants’ 
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exposure to different scenarios. Participants will all be assigned a score for their performance in 
102 
each visit, with the primary endpoint being achievement of the MPS (yes/no). Participants will 
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complete surveys at each of the study test visits (T1-T3) to collect demographic information 
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and/or feedback on their experience with the educational curriculum. 
105 
 
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The content of the intervention involves educational modules, DP sessions, and an interactive 
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online game to practice skills taught within the modules. While participants will receive the 
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intervention at different times in the study depending on their group assignment (between T1 and 
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T2 for Group A, between T2 and T3 for Group B), once they are in the intervention period will 
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be able to complete the online educational module at a time of their own choosing within the 
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given study time window and to return to the module as frequently as they wish. After 
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completing the educational module, they will be able to schedule video-based DP sessions 
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conducted from a location of their convenience. After each practice session, participants will 
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receive immediate and detailed feedback from the SP regarding their performance, and notice of 
115 
if they achieved mastery as measured by a score that meets or exceeds the MPS. Each participant 
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will be required to complete one DP session, with the option to complete addition DP sessions 
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before their subsequent test visit (either T2 or T3) during which they will be officially scored. 
118 
After each DP session, participants will be asked whether they would like to complete any further 
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DP sessions. We will track the number of DP sessions that learners complete in order to 
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accurately estimate the average time-commitment required to achieve mastery for future 
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dissemination work. After completion of follow-up testing at T3, all participants who have not 
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yet achieved the MPS will complete additional DP and testing until mastery is achieved. 
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c. Data analysis: Provide the methods by which the study objectives/aims will be assessed 
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or measured, i.e., statistical analysis plan, qualitative research methods such as 
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procedures for conducting theme analysis and enhancing validity, program evaluation 
127 
methods and analysis plan, or mixed methods analysis plan.  
128 
The primary outcome of interest for Aim 3 is the percentage of residents in each arm who meet 
129 
or exceed the MPS of the UCC at the T2 assessment. We will use logistic regression to compare 
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groups with respect to the outcome at T2 adjusting for the test performance at T1 (stratification 
131 
variable). Secondary analysis will consider change within groups from T2 to T3 separately using 
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McNemar’s test. In Group A, this will be a test of whether mastery is retained versus not 
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retained. In Group B, this will be a supplemental test of the intervention’s efficacy. Association 
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between number of DP sessions completed and passing will be evaluated using logistic 
135 
regression. Among those who pass, association of number of DP sessions completed with 
136 
baseline characteristics will be evaluated using Poisson regression. 
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138 
For a quantitative study, include what statistical tools will be applied and how the study 
139 
is powered, if appropriate. 
140 
We estimate a baseline performance of 60% of residents meeting the MPS on the pre-test. We 
141 
expect waitlist subjects to have only a slight improvement in meeting MPS at T2 resulting in a 
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65% pass rate. Randomizing 92 participants and conservatively estimating ~90% retention at the 
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PI: Rising, Kristin L 
IRB Control #: 19G.356  
 
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T2 assessment (n=82, 41 per group), we will have 81% power to detect a difference of 25% 
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between study groups at T2 (pass rate of 90%) assuming a two-sided Type I error of 5%. 
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5. Delineate procedures that are standard of care from those that are being performed specifically 
147 
for the research. 
148 
The educational leadership of the programs at TJU and NU have committed to integrating this 
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uncertainty communication curriculum into the simulation curriculum at both institutions as part 
150 
of standard educational curriculum for this year. Therefore, all residents will be required to 
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complete the testing visits and the educational curriculum as part of their training. We have 
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scheduled five available dates for simulation at each testing time point to accommodate for the 
153 
different scheduling needs of residents, with the goal that all resident physicians enrolled in the 
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Emergency Medicine training programs at TJU and NU will be able to complete the educational 
155 
curriculum. Though residents are required to participate in the curriculum, they will still have the 
156 
choice of whether to participate in this research study. Therefore, the research components are 
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the collection of data on resident performance to be used in analyses and randomization of 
158 
residents who agree to participation into two different cohorts for timing of their educational 
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modules. 
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6. How will accuracy of data be assessed? 
162 
In order to assess accuracy of passing data and demonstrate reliability of SP scoring, a research 
163 
team member blinded to the participant’s study arm will complete ratings for at least a 40% 
164 
random sample of the videotaped encounters. 
165 
 
166 
7. Identify the sources of data obtained about human subjects in the form of specimens, records, 
167 
survey instruments, interviews, focus groups, observation, or other sources. 
168 
Surveys: Each participant will complete a total of 3 surveys. All participants will complete the 
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first survey prior to T1, with items collecting basic demographic characteristics (age, gender, 
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race/ethnicity, post-graduate-year). Additionally, participants will be asked open-ended questions 
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including how often they encounter clinical scenarios with diagnostic uncertainty in their clinical 
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practice, how comfortable they are in having these conversations, what strategies they have used 
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and found successful, and if they have had prior training on this topic. All participants will 
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additionally be asked to complete a survey following completion of study involvement. This 
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second survey will be used to gather feedback on each participant’s simulation experience with 
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the simulation scenarios and the SBML curriculum using both open- and closed-ended questions. 
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All participants in both groups will be contacted 3 months after completion of the RCT to ask 
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follow-up questions regarding their use of the new communication skills in clinical practice. 
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Questions will include topics such as: frequency of encounters with diagnostic uncertainty, 
180 
comfort level in discussing this topic with patients, patients’ reactions to the conversation and 
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request for anecdotes on patient encounters that could inform future training. 
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Performance Scores: Residents’ performance on the simulation will be rated at all study visits 
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using the MPS. The primary outcome of interest for this trial is the participant score (pass/fail) on 
184 
the UCC at T2 (post-intervention for Group A). Trained SPs will complete these ratings 
185 
immediately following the simulation sessions. Additionally, a research team member, blinded to 
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the participant’s study arm, will complete ratings for at least a 20% random sample of the 
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videotaped encounters to demonstrate reliability of scoring. 
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Curriculum Metrics: In order to assess the differences in participants’ effort required to achieve 
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mastery and thereby better characterize the ability to disseminate our intervention, we will track 
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the number of DP sessions completed and relationship between the number of sessions and 
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passing rates. We will also track the number of game sessions initiated (games are part of the 
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educational curriculum), amount of time spent playing the online game, the number of attempts 
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required to “pass” the game, and the number of times the participant “passed the game.” 
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8. The following steps must be taken to ensure that identifiable data remains confidential and 
196 
secure. Please check each box to confirm your understanding. There are fields below to 
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provide explanations and to describe deviations as well as additional measures. 
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a. 
 A separate research chart must be maintained apart from the medical record/chart of 
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the subject. 
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b. 
 There are 18 identifiers described in 45 CFR 164.514 that make data identifiable.  To 
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be considered de-identified, data must not contain any of the identifiers (also see OHR-5 
203 
for list of identifiers). 
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c. 
 When not in use, identifiable data should be stored in a locked cabinet or desk in a 
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locked room. 
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d. 
 Access to the data should be limited. Only the individuals who need the data should 
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have access. 
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e. 
 If hardcopies of identifiable data must be taken to another building, a locked container 
209 
such as a banker bag should be used. The container should be marked with instructions 
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for returning the container if misplaced. 
211 
f. 
 If hardcopies of identifiable data must be mailed, there must be a contract in place 
212 
which specifies the method of doing this. The data should be placed in one envelope 
213 
inside of another envelope. Both envelopes should have tamper-evident seals and should 
214 
be addressed to the specific recipient. Signatures should be required for receipt, or 
215 
lockable mailboxes should be used. 
216 
g. 
 If research data is stored on your work computer, encryption software must be 
217 
installed on the computer.  Contact IS&T if you are not sure if the encryption software is 
218 
installed. 
219 
h. 
 PHI may be emailed between Jefferson email addresses.  Jefferson email must not be 
220 
sent from or forwarded to a non-Jefferson email address such as your personal email. 
221 
i. 
 Research data and PHI should not be stored on portable devices including laptops.  If 
222 
research data must be stored on a portable device, contact IS&T.  
223 
j. 
 External monitors will only be given access to subjects’ medical records as specified 
224 
in the signed consent form. 
225 
k. 
 Research data and PHI must be maintained per Jefferson policies.   
226 
 
227 
If you have any explanations for, or deviations to the items listed above, please describe 
228 
them: N/A  
229 
 
230 
If applicable, please describe any additional measures that will be taken: 
231 
All electronic data are password-protected on network-level-access-secured computers. 
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All paper documents are secured in locked cabinets in a locked office accessible only to 
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research personnel. PHI is only collected to the extent required by our study protocol, and 
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records are de-identified as soon as possible. 
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PART B- SUBJECTS AND FACILITIES 
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1. What is the expected number of subjects to be enrolled?  
240 
 
241 
No. subjects 
per year  
Total No.  
subjects  
No. Subjects Nationally or 
Internationally (if applicable) 
No. subjects at collaborating 
Institutions (if applicable) 
Up to: 40 
Up to: 62 
N/A 
102 
 
242 
2. Identify where the research will be conducted and describe the adequacy of facilities.   
243 
The study will occur at two sites. The first site is Thomas Jefferson University (TJU). TJU 
244 
Hospital, the main clinical site at TJU, is an urban academic hospital located in Philadelphia, 
245 
Pennsylvania that serves approximately 39,000 inpatients each year, and has approximately 
246 
100,000 emergency department visits and 500,000 outpatient visits each year. The Department of 
247 
Emergency Medicine is ACGME accredited for a three year residency with a total of 39 residents 
248 
(13/year). Northwestern University (NU) will serve as the second site. Northwestern Memorial 
249 
Hospital, the main clinical site at Northwestern University, is an urban academic hospital, located 
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in Chicago, Illinois with over 88,000 adult ED patient visits per year. The Department of 
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Emergency Medicine has an ACGME accredited four-year residency training program with a 
252 
total complement of 60 residents annually (15/year). Both the TJU and NU emergency medicine 
253 
residency programs work closely with their institutional simulation centers and residents 
254 
participate in simulation training on a regular basis as part of their educational curriculum. See 
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more detail on the simulation centers in the resources pages. 
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3. Please identify any facilities to be used for research other than those assigned to Department or 
258 
division. 
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The study will use the simulation facilities at both TJU and NU. This includes TJU’s Rector 
260 
Clinical Skills and Simulation Center as well as NU’s Center for Simulation Technology and 
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Immersive Learning. 
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263 
4. Describe provisions to protect the privacy of subjects during the course of the study. (Privacy 
264 
can be defined as the subject’s desire to control the ways in which s/he is approached and/or 
265 
the ways in which his/her private information is shared with others.) 
266 
The entire study constitutes minimal risk to the enrolled patients. There is no expectation of any 
267 
physical risk. There is the possible risk of loss of confidentiality. All electronic data are 
268 
password-protected on network-level-access-secured computers. All paper documents are 
269 
secured in locked cabinets in a locked office accessible only to research personnel. PHI is only 
270 
collected to the extent required by our study protocol, and records are de-identified as soon as 
271 
possible. 
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5. How has the research staff been trained regarding study procedures/methods and their duties 
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(in-service, investigator meeting, etc.)? 
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All members of the research team are HIPAA-trained and PORCITI credentialed (CITI modules). 
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Team members who will be involved in participant enrollment have been trained to consent and 
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enroll patients into research studies at Jefferson. The team will have regular progress meetings to 
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ensure compliance with good clinical practices and study procedures, and will be overseen by the 
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study PI and Research Coordinator. The Principal Investigator and Co-Investigators will ensure 
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that all studies are run effectively and that data management, human resources and administrative 
281 
tasks meet performance metrics.  
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Standardized Patients (SPs) will be trained on the conduct of the simulated scenarios, rating of 
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participants (according to a rubric), and delivery of feedback. To ensure standardization between 
284 
the TJU and NU sites, training sessions will be recorded and assessed by the study investigators 
285 
for reliability. The SPs will be trained on scoring with the use of video-recorded pilot scenarios. 
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These pilot encounters will demonstrate participants with variable communication skill levels 
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and proficiency in demonstrating essential items on the UCC (resulting in some videos that 
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demonstrate mastery and others that fail to meet the MPS). SP raters will be trained to 
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demonstrate high inter-rater reliability with the research team Once they have completed training 
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on the conduct and scoring of the scenarios, SPs will be trained on giving real-time feedback to 
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the resident physicians. A key component of SBML is not simply practice, but DP with real-time 
292 
feedback on performance. Their feedback practice sessions will be video-recorded and critiqued 
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to ensure both high-quality feedback and uniformity of feedback between SPs. 
294 
 
295 
6. Which of the following groups are eligible to be subjects? 
296 
 
Yes 
No 
*Women of reproductive potential 
X 
 
Pregnant women/fetuses/neonates (if yes, and study targets pregnant women 
or is interventional, include OHR-27 as an addendum to the OHR-2) 
X 
 
 
Men of reproductive potential 
X 
 
Vulnerable Populations (Please see list below) 
 
 
Individuals with impaired decision-making capacity (check yes only if 
research targets and could benefit this population) Note:  If yes, please also 
review and complete the information in this form for decisionally –impaired 
subjects. 
 
X 
*Minorities 
X 
 
Prisoners (if yes, notify the IRB in advance of the meeting) 
 
X 
*Economically or educationally disadvantaged persons  
X 
 
Students/employees 
X 
 
 
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7. If applicable, what additional protective mechanisms are in place to protect the rights and 
298 
welfare of vulnerable populations? 
299 
Resident employees will be reminded that their participation in the research study is voluntary 
300 
throughout their participation and that their participation will not impact their access to the 
301 
education materials.  They will also be informed that their decision to participate in the research 
302 
study will not affect how they are graded on their performance.  
303 
 
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8.  If one of the populations with an (*) in the table above are excluded, provide the reason. 
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N/A 
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Note: NIH policy requires that minorities and women be adequately represented as research 
308 
subjects. If this is an NIH-funded study and you will be excluding either of these populations, you 
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must provide a scientific reason for such exclusion. 
310 
 
311 
PART C - RISKS, BENEFITS, AND ALTERNATIVES  
312 
 
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1. What are the risks of the research?  Address this at the individual and/or community level as 
314 
appropriate. 
315 
The entire study constitutes minimal risk to the enrolled participants. There is no expectation of 
316 
any physical risk. There is the possible risk of loss of confidentiality. All electronic data are 
317 
password-protected on network-level-access-secured computers. All paper documents are 
318 
secured in locked cabinets in a locked office accessible only to research personnel. PHI is only 
319 
collected to the extent required by our study protocol, and records are de-identified as soon as 
320 
possible. 
321 
 
322 
2. Discuss measures taken to minimize risks and maximize benefits associated with this research. 
323 
All electronic data are password-protected on network-level-access-secured computers. All paper 
324 
documents are secured in locked cabinets in a locked office accessible only to research personnel. 
325 
PHI is only collected to the extent required by our study protocol, and records are de-identified as 
326 
soon as possible. 
327 
 
328 
3. What are the potential benefits of participation? 
329 
Investigators hope that what we learn may be helpful to doctors and future patients. Possible 
330 
benefits from being in the study may include 1) learning a new approach to conducting a more 
331 
patient-centered emergency department discharge conversations for patients with diagnostic 
332 
uncertainty. Patients leaving the ED with diagnostic uncertainty have been found in prior studies 
333 
to have increased struggles in the transition back home, and improving the discharge 
334 
conversation may reduce post-discharge struggles for this population. Participants may be better 
335 
doctors as a result of this study and 2) contributing valuable information to inform the training of 
336 
future physicians to communicate more effectively. There is also a chance the subjects will 
337 
receive no direct benefit from participating in this study.    
338 
 
339 
4. Explain how the risks of the research are justified by potential benefit to the subject or society. 
340 
Given the significant opportunity for large-scale public benefit to patients, the minimal risk of 
341 
loss of confidentiality is reasonable, provided that all subjects participate in an informed consent 
342 
process ensuring that they fully understand and independently consent to withstand these risks 
343 
 
344 
PART D - CHILDREN 
345 
 
346 
1. Will this study involve children (age 17 or under)? 
347 
 
348 
___ YES - Submit form OHR-26, “Research Involving Children.” 
349 
_X_  NO - Delete the REST of this Children section and skip to Part E. 
350 
 
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PART E – RECRUITMENT, EQUITABLE SELECTION, AND CONSENT PROCESS 
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1.  Discuss the recruitment plan and describe recruitment methods and materials (e.g., physician 
354 
referral, newspaper ad, radio, TV spot, e-mail, membership lists, flyers, social networks, etc.) 
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Please attach all relevant materials for IRB review and approval. 
356 
Eligible participants include all emergency medicine residents at TJU and NU. Though residents 
357 
are required to participate in the curriculum, they will still have the choice of whether to 
358 
participate in this research study. An email will be sent to all residents at TJU and NU, to explain 
359 
the research study prior to baseline testing. The recruitment email has been attached to this IRB 
360 
submission.  
361 
Use of the University logo is dictated by University Policy. Guidelines regarding the logo’s use 
362 
are described on the Creative Services website. Any variation from the standards requires 
363 
approval according to the policy. Misuse of the University Logo may result in disciplinary action. 
364 
 
365 
2. Will all qualified subjects populations have adequate access to recruitment materials? Please 
366 
explain. 
367 
Yes, eligible participants include all emergency medicine residents at TJU and NU. Every 
368 
resident will have equal access to the recruitment materials.  
369 
 
370 
3. Is the location and cultural setting of the research equally accessible to all qualified subject 
371 
populations? If not, what can be done to make the location and setting more accessible? 
372 
Yes, the research will occur through the same mediums and at the same facilities as residents’ 
373 
other curricula.  The research will be equally accessible to all residents.  
374 
 
375 
4. Are non-English speaking participants anticipated?   
376 
Non-English speaking participants will not be included in this study. Resident physicians are 
377 
necessarily English-speaking, since the residency program as well as this particular curriculum 
378 
are delivered in English.  
379 
 
380 
5. If you are requesting a waiver of written consent, describe the information that will be 
381 
provided to subjects.  
382 
N/A 
383 
 
384 
6. Who will conduct the consent interview?  
385 
A study investigator will obtain consent on the day of study enrollment, prior to initiation of any 
386 
study procedures.  
387 
 
388 
7. Who will provide consent or permission (e.g., subject, legally authorized representative, 
389 
parent, caregiver, etc.)? 
390 
The subject will provide consent.  Persons who are unable to provide consent are excluded from 
391 
the study.   
392 
 
393 
8.  Where will the consent interview take place? 
394 
The consent interview will take place on-campus at either TJU or NU in a simulation space or 
395 
another place as determined most appropriate by the research team and educational faculty on the 
396 
day of enrollment. 
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9.  Provide a step-by-step description of the consent process. 
399 
A study investigator will obtain consent on the same day as their baseline testing, prior to 
400 
initiation of baseline testing. During the consent interview, a study investigator will explain that 
401 
enrollment in the study will involve consenting to the research team accessing the video 
402 
recordings of their simulation encounters and their individual scores, and completion of surveys 
403 
to provide demographic information, feedback on their experience with the educational 
404 
curriculum, and information regarding their use of the new communication skills in clinical 
405 
practice. Residents will have the opportunity to further discuss the study with an investigator on 
406 
the same day as their baseline testing, prior to initiation of testing. All residents interested in 
407 
participating will provide written informed consent using procedures approved by the 
408 
Institutional Review Boards of TJU and NU. 
409 
 
410 
10.  Describe your plan to assess a person’s capacity to consent. 
411 
N/A – this study will only recruit emergency medicine residents; participation in an emergency 
412 
residency program is in itself ensures decisional capacity to consent to a research study. 
413 
 
414 
11. Will you seek assent from decisionally-impaired individuals? If so, describe your plan for 
415 
obtaining assent. Note:  If decisionally-impaired subjects will be included and are not capable 
416 
of consenting themselves, the OHR-8 consent template must be submitted along with a 
417 
simplified consent form (e.g., OHR-8C) and/or the surrogate consent form (OHR-8B). 
418 
No, persons who are unable to provide consent are excluded from the study.   
419 
 
420 
12. Will the potential subject be informed of the research or be provided a copy of the consent to 
421 
review prior to the actual time of consent? If so, how much time in advance? How much time 
422 
will be available for the consent process? 
423 
An email explaining the research study will be sent to the residents at least one week prior to 
424 
baseline testing, which will also include a copy of the consent form. Residents will have the 
425 
opportunity to further discuss the study with an investigator either prior to or on the same day as 
426 
their baseline testing, prior to initiation of testing. A study investigator will conduct the consent 
427 
interview, and will explain that their enrollment will involve consenting to the research team 
428 
accessing the video recordings of their simulation encounters and their individual scores, and 
429 
completion of surveys. Residents will be given as much time as they need to go over the research 
430 
study details and ask questions. All residents interested in participating will provide written 
431 
informed consent using procedures approved by the Institutional Review Boards of TJU and NU. 
432 
Participants will be given a copy of the written informed consent to take with them.  
433 
 
434 
13. What provisions will be made if the potential subject does not wish to proceed with the 
435 
consent interview?  
436 
Residents who are not interested in participating will still be required to participate in all of the 
437 
educational activities, but they will not complete the additional research activities.  
438 
 
439 
14. Is surrogate consent involved?  YES ______ NO X 
440 
 
441 
15. Will subjects be paid or receive any other inducements for participating? If yes, please 
442 
explain. Please note that payment of subjects must be on a pro-rated basis unless there are 
443 

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compelling reasons not to prorate. There cannot be a requirement to finish all study 
444 
components in order for subjects to be paid, as this is considered coercive. 
445 
Participating residents will be compensated up to a total $75 for the sharing of their data and 
446 
their time in completing surveys. The total amount will be pro-rated as follows: $25 for baseline 
447 
survey and assessment and an additional $50 upon completion of the randomized clinical trial.  
448 
 
449 
16. Describe any steps taken to minimize the possibility of coercion or undue influence. 
450 
Undue influence is minimized in this study through the exclusion of vulnerable populations, such 
451 
as children and prisoners.  The informed consent process explains that residents may refuse to 
452 
participate in this investigation or withdraw consent and quit this study without penalty and 
453 
without affecting the ability to access the curriculum.  The possibility for coercion is further 
454 
mitigated through the use of reasonable financial incentives. 
455 
17. Does the study include any of the following MCARE procedures (check all that apply)? 
456 
 
457 
a. 
 The study’s initial or last continuing review was approved after March 2018 and 
458 
already contains the new Investigator signature template text. 
459 
b. 
  No MCARE procedures 
460 
c. 
 Administration of anesthesia 
461 
d. 
 Performance of surgical procedures 
462 
e. 
 Administration of chemotherapy and radiation 
463 
f. 
 Administration of blood and/or human source products 
464 
g. 
 Insertion of a surgical device or appliance 
465 
h. 
 Performance of any HIV-related testing 
466 
i. 
 Administration of experimental medication, use of an experimental device, use of an 
467 
approved medication or device in an experimental manner, or removal of bone, fluids or 
468 
tissue for use in research or in the manufacture of a product.  (This would not include 
469 
leftover tissues from clinical procedures.) 
470 
j. 
 Invasive procedures, such as halo placement, central venous catheterization, 
471 
pulmonary artery catheterization. (Routine needle sticks, such as peripheral intravenous 
472 
catheter placement, vaccination, and venipuncture are not considered invasive in the 
473 
context of this policy.) 
474 
 
475 
18. Select the most appropriate text to appear with the investigator signature line in the consent 
476 
form (check one): 
477 
 
478 
 Include the text below for studies involving any MCARE procedures (See OHR 
479 
policy IC 701): 
480 
The physician investigator’s signature certifies that s/he personally provided the study 
481 
participant with a description of the study, study procedures, risks, benefits and alternatives to 
482 
participation. 
483 
 
484 
 Include the text below for studies that receive FULL IRB review but do not include 
485 
any MCARE procedures (See OHR policy IC 701): 
486 
The investigator’s signature certifies that s/he personally provided the study participant with a 
487 
description of the study, study procedures, risks, benefits and alternatives to participation. 
488 
 
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 Include the text below for all other studies: 
490 
The investigator’s signature certifies that the study participant has been provided with a 
491 
description of the study, study procedures, risks, benefits and alternatives to participation.  
492 
 
493 
19. If the study does not meet one of the three criteria above (e.g., the study incudes MCARE 
494 
procedures, but a physician investigator will not be obtaining consent), please provide 
495 
rationale. 
496 
N/A 
497 
 
498 
PART F - LOCATION/COLLABORATION 
499 
 
500 
1.  This study involves research to be performed at/in/with (check ALL appropriate entries): 
501 
 Abington-Jefferson Health 
502 
 East Falls (Philadelphia University) 
503 
 Jefferson-Northeast 
504 
 Jefferson Health-New Jersey 
505 
 Jefferson-Center City 
506 
 Jefferson as part of a multi-center, commercially sponsored study 
507 
 Jefferson as part of an NCTN study 
508 
 JKCCN sites (specify sites): 
509 
 Rothman Institute (specify sites): 
510 
 Methodist 
511 
 Jefferson and Other Institution(s) Please name institutions only for investigator-initiated and 
512 
federally funded studies where data will be shared between institutions. Please provide copy of 
513 
collaborating institution IRB approval letter if applicable. The OHR will effect IRB 
514 
Authorization Agreements with collaborating institutions as required. Please name institutions: 
515 
Northwestern University 
516 
 Collaboration with City Services (City of Philadelphia IRB must approve study. For more 
517 
information, go to http://www.phila.gov/health/irb/.) Please list collaborating city services: 
518 
 Unaffiliated Investigators.  Each will need to complete an unaffiliated investigator agreement 
519 
available on the OHR website.  Please specify by name and role in study: 
520 
 
521 
2.   This question is not applicable if research is a commercially sponsored multi-center trial. 
522 
 
523 
 
Will research be conducted in states other than Pennsylvania? 
 YES     
 NO 
524 
 
525 
 
If YES, does research involve subjects age 17 or younger?   
 YES    
 NO 
526 
 
527 
 
If YES to either or both, in what state(s) will research be conducted? Illinois 
528 
 
529 
Below please (a) verify the age at which subjects in such state(s) have the ability to 
530 
consent to participation in research, including any medical treatments or procedures, if 
531 
applicable and/or (b) verify the requirements for determining who may serve as a Legally 
532 
Authorized Representative, including a guardian for a child to participate in research.  
533 
You must also provide information on any state specific regulations on privacy 
534 
requirements and genetic research if applicable.  Please contact the Office of Legal 
535 
Affairs for information, as needed.  
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537 
Age at which subjects have the ability to consent to participate in research:   __18__ 
538 
 
539 
State specific requirements: ___none________________________________________  
540 
 
541 
3.  If the investigator is the lead investigator or Jefferson is the lead site in a multi-site study, 
542 
please address the following: 
543 
 
544 
a. Where is the repository for adverse events and unanticipated problems and how will  
545 
information be disseminated to other sites? 
546 
The PI, Dr. Kristin Rising, will be responsible for disseminating adverse events and 
547 
unanticipated problems to the other study site.  The study team will communicate about 
548 
study related events via phone meetings.  
549 
 
550 
b. Who will tabulate and disseminate interim results? 
551 
The PI, Dr. Kristin Rising, will be responsible for tabulating and disseminating interim 
552 
results to the Co-Investigators and study sponsor.  The study team will communicate 
553 
about study related events via phone meetings. 
554 
 
555 
c. Who will provide information to other sites concerning methods/procedures 
556 
modifications?  
557 
The PI, Dr. Kristin Rising, will be responsible for providing information to other sites 
558 
concerning methods/procedures modifications.  The study team will communicate about 
559 
study related events via phone meetings. 
560 
 
561 
d. Describe how information that is relevant to subject safety will be managed (i.e., 
562 
notifying site investigators of SAEs and Unanticipated Problems Involving Risks to 
563 
Subjects or Others, communicating DSMB or Interim Reports, etc.)  
564 
The PI, Dr. Kristin Rising, will be responsible for providing subject safety information to 
565 
other sites.  The study team will communicate about study related events on a regular 
566 
basis via phone meetings. 
567 
 
568 
Collaborative Studies: For investigator-initiated studies that are collaborative or multi-center, or for 
569 
federally funded studies where Jefferson is the lead site, please provide IRB approvals for each 
570 
collaborating institution. If the institution does not have its own IRB, then the institution must first obtain 
571 
a Federal-Wide Assurance (FWA) from the Office of Human Research Protection (OHRP). This registers 
572 
the institution with the federal government for conducting human subjects research. The institution 
573 
should then fill out an IRB Authorization Agreement (IAA) that ties the institution to the TJU IRB for 
574 
this study. For more information, go to http://www.jefferson.edu/osa/irb/forms/. 
575 
 
576 
Unaffiliated investigators involved with this study should fill out an Unaffiliated Investigator Agreement, 
577 
also available at the above Website address. 
578 
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580 
PART G - CERTIFICATION 
581 
 
582 
Federal Regulations require the following responsibilities of the Principal Investigator. Please 
583 
check those items to which you have conformed, and sign. 
584 
 
585 
As Principal Investigator, I certify that:  (check appropriate boxes) 
586 
 
587 
 I have read the IRB Policy and Procedures Manual. 
588 
 I understand the federally-mandated responsibilities of a research investigator in conducting 
589 
research or evaluation involving human subjects. 
590 
 I will conduct this research in accordance with these responsibilities. 
591 
 I will consent all subjects with an IRB-approved consent form, if applicable to the project, 
592 
and store the consent forms in a safe repository. 
593 
 I will provide all subjects with a copy of their signed and dated consent form. 
594 
 All personnel have been appropriately trained for their assigned roles in this research. 
595 
 
596 
 
597 
 
598 
 
599 
 
 
 
 
 
    04/25/2019 
600 
_________________________________ 
    ___________ 
601 
Signature of Principal Investigator    Date 
602 
 
603