Virtual Role-Plays to Reduce the Occurrence of Childhood Obesity
Phase: NA
Conditions: Childhood Obesity
Sponsor: HealthPartners Institute

SIM-PLICITY Science and Merit Protocol – 7/20/2017 
Staff Only 
Project # 
PI:   
Submission Date(s):  
If you need help with this document, contact the Research Subjects Protection Program office at 651-254-4757. Please 
save a copy of this document to your desktop AND upload it using the icon in the Research Application. 
The following 9 headings/sections highlighted in blue correspond with the criteria used to evaluate your proposal. All 
the questions/requests are highlighted in yellow; they all must be answered providing sufficient detail for a reviewer to 
determine whether the review criteria have been met.  
You must answer each question or list the page and paragraph numbers from an attached proposal, making sure that the 
reference fully answers the question; a combination of both is acceptable. It is helpful if you highlight the area of the 
proposal you are referencing that relates to the specific question on this form. 
 
 
****MAIN RESEARCH QUESTIONS, STUDY AIMS, SPECIFIC HYPOTHESES**** 
1.1 
Please clearly state your overall research questions and/or study aims.  
The prevalence of childhood obesity has tripled within the last twenty-five years (Skelton et al., 2009). Interventions 
targeting children are a high priority because children bear the greatest lifetime health risk from overweight and obesity 
(Ogden et al., 2007; Franks et al., 2010). Health professionals in primary care settings have the potential to reach large 
numbers of parents and children and address obesity because they have regular interactions with and are influential in the 
lives of families. Studies show that even brief advice delivered well can have a meaningful impact. To support providers in 
this important role, the Centers for Disease Control and Prevention collaborated with other health organizations to develop 
recommendations for assessment, prevention, and treatment of childhood and adolescent overweight and obesity. 
Despite the 2007 publication of these recommendations and increasing recognition of childhood obesity as a public health 
problem, rates of provision of obesity-related guidance and counseling remain low (Tanda & Salsberry, 2013), and 
research indicates that health care providers could use additional education, training, and support related to obesity 
prevention and treatment. Thus, effective strategies to support pediatric primary care providers in their efforts to intervene 
against address childhood obesity are needed. Building off the successes achieved in their Phase I study, SIMmersion 
LLC, in collaboration with Dr. Nancy Sherwood from HealthPartners Institute , Dr. Jayne Fulkerson from the University of 
Minnesota, and Dr. Michael Fleming from Northwestern University, will expand the Phase I simulation prototype, utilizing 
feedback provided by a team of independent experts. The innovative computer-based training system with interactive 
role-play simulations will provide health care providers with much needed experiential opportunities to develop skills in 
conducting discussions with parents and children about obesity. The product’s efficacy will be evaluated in a randomized 
controlled trial (RCT); 100 pediatric, family practice, and nursing clinicians and trainees at various levels of experience will 
be recruited to participate. Half of the participants will be randomly assigned to the intervention group during which they 
will use the newly developed simulation product to develop their skills and half of participants will be randomly assigned to 
the wait-list control group; the primary outcome is performance in a role play with trained actors at 3 month follow-up. 
 
Primary Aim: Participants randomized to the simulation intervention will have higher ratings on the trained actor role play 
at 3 month follow-up relative to participants randomized to the wait-list control group.  
 
****1.  BACKGROUND & SIGNIFICANCE**** 
1.2 
What is the specific knowledge gap that the project intends to fill? Include a brief review of past research 
in this area, numbering your citations to relevant literature as well as including them in the reference 
section #9.1. 
Obesity in the United States is at historically high levels and is an important public health problem (Flegal et al., 2010; 
Ogden et al., 2012a). Although increases in obesity prevalence over the last few decades have been dramatic in all age 
groups, trends among youth have been particularly alarming (Jolliffe, 2004; Ogden et al., 2006; Ogden et al., 2010; 
Skelton et al., 2009). Currently, 16.9% of 2- to 19-year-old children are obese, with an additional 15% of youth classified 

as overweight (Ogden et al., 2012b). Interventions targeting children are a high priority because children bear the greatest 
lifetime health risk from overweight and obesity. 
Unfortunately, a recent meta-analysis demonstrated that over half of parents underestimate their overweight/obese 
children’s weight status (Lundahl et al., 2014); meaning their motivation for change is likely low as well. There is a critical 
need to inform parents of overweight and obese youth of obesity’s sequelae, but the increase in prevalence of childhood 
obesity has made population reach an important issue. For most people information provided by their health care 
professionals has significant credibility, and even brief advice, if it is informed and delivered appropriately, can have a 
meaningful impact. In a study of overweight and obese adult patients, those who had weight-related communication with 
their healthcare providers were almost nine times more likely to believe that their weight status is damaging to their health 
(Durant et al., 2009). Obesity treatment interventions targeted toward children have been shown to be more effective than 
those for adults (Epstein et al., 1998), but these empirically supported family-based treatment programs typically require 
frequent intensive in-person visits, limiting their reach. In contrast, pediatric care providers have frequent, albeit brief, 
interactions with families, putting them in the perfect position to provide guidance and behavioral support for prevention in 
addition to treatment. Despite the increasing recognition, focus, and research, rates of provision of obesity-related 
guidance and counseling from primary care providers to parents remain low (Tanda & Salsberry, 2013). 
Research also indicates that health care providers could use additional education, training, and support related to 
effective communication and motivation of patients. The types of communication between providers and patients are 
important in these brief encounters. Research suggests that just talking with patients about obesity is not sufficient. 
Rather, how providers talk with patients about obesity during a health care visit is of critical importance. When providers 
were asked about the primary barriers to preventing childhood obesity, they indicated the lack of parent and child 
motivation, family sedentary behavior, and poor eating habits in the family (Spivack et al., 2010). Similarly, parents of 
overweight children frequently mention child and family food preferences, resistance to change, and economic barriers to 
change (Sonneville et al., 2009). Lack of motivation and unhealthful family habits are likely to be difficult to change and 
require specific targeted training in order to be effective. The use of motivational interviewing techniques that are patient-
centered and engaging has been associated with weight loss in adults (Pollak et al., 2010). The goal of such interactions 
would be to raise awareness of the issues and activate parental concern and behavior change in a supportive way without 
causing undue discomfort.  But skill acquisition in this area requires more than didactic materials. Brief training limited to 
“key talking points” may not be enough and could elicit defensiveness among parents. Thus, role-playing or interactive 
education training methods may be more effective in preparing health care providers for interactions with parents of 
overweight and obese youth. 
To meet this imminent need, we are proposing to evaluate a training system with role-play simulations to train primary 
care providers to effectively conduct discussions with parents to provide intervention for, and reduce the likelihood of 
progression to, childhood obesity. 
 
1.3 
What preliminary results do you have that support your proposal? 
We worked with SIMmersion LLC on a SBIR Phase 1 grant during which we developed an early version of the online 
simulation. During Phase 1, we obtained initial feedback about the simulation from experts in the field.  
 
1.4 
What is the importance of the research to the scientific community? 
The proposed training system is significant because it will ensure that the necessary skills are appropriately acquired and 
maintained by providing trainees with ample opportunities to apply knowledge and build skills while receiving ongoing 
feedback. Additionally, developing computer-based training package will provide a cost-effective solution that will allow for 
the broad dissemination across the diverse range of student affairs personnel. By providing an effective training package 
that has the potential to broaden the number of personnel who receive training, this proposal will ensure that primary care 
providers acquire evidence-based approaches to provide parents the education and support they need to make healthy 
lifestyle changes for their families. 
 
 
****2.  APPROACH**** 
Some questions in this section do not apply to all study designs; please mark Not Applicable as appropriate. 
2.1 
Describe the study design (e.g., “This is a randomized controlled trial to test the effect of a guided 
imagery intervention on sleep quality”). Please see this List of Study Designs. 
The efficacy of the simulation will be evaluated in a randomized controlled trial (RCT); 100 pediatric, family practice, and 
nursing clinicians and trainees at various levels of experience will be recruited to participate. Half of the participants will be 

randomly assigned to the intervention group during which they will use the newly developed simulation product to develop 
their skills and half of participants will be randomly assigned to the wait-list control group; the primary outcome is 
performance in a role play with trained actors at 3 month follow-up. 
2.2 
How are you identifying eligible subjects or records? (e.g., clinic visit, search of Epic, registry, etc.) 
 
Not Applicable 
We will identify providers through the HealthPartners Medical Group and Park Nicollet clinic system from our internal 
resources and we will identify nursing students, medical students, and residents through the School of Nursing and the 
Academic Health Center at the University of Minnesota. Respondents will be screened to identify initial eligibility.  
2.3  
What is the study population of interest and what are the study inclusion/exclusion criteria? 
The subjects for the study are primary care pediatricians, family practice physicians, and nurse practitioners, as well as 
medical and nursing students and residents. These health care providers will be recruited from clinics within the 
HealthPartners Medical Group system, the Park Nicollet clinic system, the University of Minnesota pediatrics and family 
medicine residency program, and the University Of Minnesota School Of Nursing. The study will include equal numbers of 
male and female subjects, all 21 years of age or older.  
Eligible if: 
21 years of age or older 
A health care provider within the HealthPartners Medical Group system or Park Nicollet clinic system OR a 
resident in the University of Minnesota pediatrics and family medicine residency program OR a student in the 
University of Minnesota nurse practitioner program 
Willing and able to participate in measurement visits and intervention activities 
See pediatric patients greater than or equal to 1/3 of their practice time 
Ineligible if: 
< 21 years of age 
Unable to ensure commitment to study measurement and intervention activities 
See pediatric patients less than 1/3 of their practice time 
 
2.4 
If you are not using the entire population of interest, what is the method for obtaining a subset or sample 
of this population? 
X 
Not Applicable 
 
 
2.5 
Will you need to perform “preparation for research” activities prior to consenting subjects for research? 
X 
No 
 
Yes 
 
Not 
Applicable 
 
If you answered yes above, appropriate preparation for research activities prior to consenting subjects must 
include the following process to determine inclusion/exclusion criteria:  
 
1) Study staff will work with the PI to determine the methods used in identifying potential subjects for the 
research. For example, this may include creating an Epic Workbench report of patients who are in the 
hospital and meet minimum criteria for the research. 
 
2) Study staff may access medical records of all potential subjects’ identified (i.e., Workbench) to determine 
eligibility criteria using information that already exists in the medical record. During this process, no 
identifiable information may be recorded and any documentation made of a potential subject’s information 
that would disqualify them will be destroyed. 

 
If an eligible patient is not being cared for by the PI, study staff must approach the patient’s provider to 
determine if it is appropriate to proceed with the consent process. 
 
3) If additional testing needs to be done to see whether a patient meets criteria for entry into the study, the PI 
or staff will need to consent the patient first.  
 
4)  If the preparation activity confirms a patient is a possible subject, PI/staff approaches the patient to begin 
the consent process. 
 
2.6 
Describe the steps in your recruitment process. 
 
Not Applicable 
 
1.  Recruiting in the following ways:  identify provider through the HealthPartners Medical Group and Park Nicollet clinic 
system from our internal resources. Identify pediatric and family practice residents, medical students and nursing student. 
We will also be giving presentations about the study at existing meetings for the various groups and interested people at 
these meetings will then proceed starting at Step 3. 
2.  Send invitation e-mail to potentially eligible providers, residents and students. 
3.  Screen for preliminary eligibility. 
4.  During the initial study visit, candidates will review and sign the consent. After the consent has been signed, the 
subject will participate in a survey and two role plays with a trained actor. 
5.  After the initial study visit is complete, the subject will be randomized to either intervention or waitlist control group.    
 
2.7 
Describe any interventions that are used in this study. 
 
Not Applicable 
 
Educational Intervention: The educational intervention will be the online simulation training program. Participants will be 
taught how to use the simulation during a 20 minute orientation session with a research staff person. We will use a 
mastery based approach rather than prescribing an absolute number of hours participants need to play. The criteria are 
as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of 
play, whichever comes first. After the orientation sessions, training sessions will be completed by participants on their 
own. The research team will confirm remote usage, and contact participants by email and phone to prompt usage as 
needed. The research team anticipates that the proposed method will accommodate for participant schedules while still 
ensuring intervention compliance. 
 
Waitlist Control Group: The control group will participate in pre- and post-test assessments of their conversational skills 
with a trained actor.  At the end of the study, the waitlist control group will be allowed to access to the simulation and the 
study team will provide training to participants upon request.  
 
2.8 
Provide a brief, sequential, bullet-point description of the all the data collection activities you will conduct 
from start to finish (e.g., chart review, patient survey, follow-up visits, data pull from the electronic 
medical record, etc.) and who will conduct each. Please see our Example of Data Collection Steps. 
1. Recruitment strategies including working with HealthPartners and Park Nicollet colleagues and the University of 
Minnesota contacts in order to identify candidates. Invitation emails will be sent to invite providers, residents and 
students to participate in the study. 
2. The invitation email will include an initial screening survey for eligibility. Those who are eligible will be scheduled 
for an initial study visit.  
3. Candidate will complete the initial baseline measurement visit where they will review and sign the consent, 
complete a survey, and participate in two role plays with a trained actor. 
4. Subjects are randomized to either the intervention or waitlist control group.  

5. Subjects randomized to the intervention group will complete one 20-minute session with a study staff member 
over the phone to learn about and practice with the simulator. Subjects will then practice with the simulator until 2 
out of the last 3 simulations they have conducted receive a score greater than or equal to 90 percent OR up to 8 
hours of play within the first 10 weeks. Subjects randomized to the control group will not receive any formal 
training beyond what they normally would receive. 
6. All subjects will participate in a follow-up evaluation visit where they will complete a survey and participate in two 
role plays with a trained actor. 
7. The control group will not receive any formal training beyond what they normally would receive during the course 
of the study. The wait list control group will receive access to the online simulation after the follow-up evaluation 
visit. 
2.9 
Provide a timeline for the main study activities.  Please see our Example Timeline 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
Obtain IRB approval 
x 
 
 
 
 
 
 
 
 
 
 
 
Train standardized 
patients 
 
x 
 
 
 
 
 
 
 
 
 
 
Recruitment & 
Baseline Measures 
 
 
x 
x 
x 
x 
x 
 
 
 
 
 
Intervention 
 
 
x 
x 
x 
x 
x 
x 
x 
x 
 
 
Post-Test Measures 
 
 
 
 
 
x 
x 
x 
x 
x 
 
 
Analysis & 
Manuscript Writing 
 
 
 
 
 
 
 
 
 
 
x 
x 
 
2.10 
Describe your plans for ensuring data security 
All study personnel will have completed the human subjects training.  Confidentiality of study data will be ensured by 
assigning a subject identification number to each participant. All data collected in the study will be identified by an arbitrary 
and unique subject identification number only. These data will be entered by identification number into a computerized 
database residing on a user name and password protected file-server to which only the researchers involved in the study 
will have access. No participant data will be individually identified or released to anyone other than the study investigators 
without specific written permission from the study participant. 
2.11. 
List the KEY variables that will be collected to support the study aims outlined in item 1.1. KEY variables 
include those used for: 
1) achieving the study aims (outcomes, predictors, potential confounders),  
2) identifying the study population (for inclusion/exclusion criteria),  
3) describing the study population 
Please see an Example of a Completed Table and an Example Data Dictionary. 
Variable Name 
Data Source 
(patient survey, EMR, 
claims, registry) 
Purpose 
(sample identification,  
description, grouping 
variable, study endpoint, 
predictor, covariate) 
Measurement Scale 
(binary, continuous) 
Demographic characteristics 
Participant survey 
Moderator 
Continuous 
Simulation Score 
Based on role play with a 
standardized patient 
Dependent Variable, 
primary outcome 
Continuous 
Confidence for addressing 
obesity with patients 
Participant survey 
Moderator 
Continuous 

 
2.12 
Provide operational definitions of any variables listed above that aren’t adequately described by the 
variable name above, and provide a brief background of any validated measurement scales listed above. 
The simulation scoring system is tailored for the obesity simulation and is based on the Simmersion team’s prior work 
using a similar standardized patione and scoring approach.( Fleming, M., Olsen, D., Stathes, H., Boteler, L., Grossberg, 
P., Pfeifer, J. & Skochelak, S. (2009). Virtual reality skills training for health care professionals in alcohol screening and 
brief intervention. The Journal of the American Board of Family Medicine, 22(4), 387-398). 
Each participant will complete two role-plays pre-intervention and two role-plays post-intervention. These will be audio-
recorded and labeled only by participant ID. Raters will be blind to condition and any participant identifiers. 
2.13 
If you are collecting data elements besides those listed in Table 2.10 above, provide a justification for 
gathering the additional data.  
N/A 
 
Reminder:  For chart review studies, a data collection form must be uploaded with your application listing variables 
collected and how they are recorded (chart review studies). Provided are links to two example chart review tools: Word 
Chart Review Example and Excel Chart Review Example 
 
 
****3.  ANALYSIS**** 
3.1 
Describe the statistical methods that will be used to address the study aims. For each aim, this will 
usually include: 
 
Description of the sample used for the particular analysis 
 
The variables included in the specific analysis and their role in the analysis 
 
Numeric summaries computed (e.g., mean, standard deviation, proportion, correlation)  
 
A summary of data exploration and presentation activities (e.g., generating scatter plots, summary tables)  
 
Description of statistical tests (e.g., independent samples t-test, Mann-Whitney test), and models constructed (e.g., 
logistic regression) 
Please see our Examples of Statistical Methods. 
Describe here: 
Note:  Please reference the area/pages of an established protocol if you are not writing your own analysis plan.   
The attained effectiveness of the developed computer-based training program will be demonstrated through the analysis 
of relative pre-post changes on measures from the clinical skills assessments with standardized patients, with adjustment 
for baseline clinical skill assessment level. The clinical skills assessment data will be tested for treatment specific 
changes in conversational skills. Expected increases in skill levels will correspond to the skills acquisition 
objectives of the computer-based training simulations. Scores will be assigned to each research subject in the study for 
both pre-test and post-test sessions. To address the primary study aim regarding the efficacy of the simulation 
intervention in enhancing conversational skills, the treatment by time interaction will be quantified using a general linear 
mixed model approach where treatment (Simulation Intervention, Wait List Control) will be a fixed between-subjects effect 
and time a fixed within-subjects effect. Additional exploratory analyses will be conducted to examine if the patterns of 
change are the same across individual characteristics within the sample, such as student versus practitioner status, 
gender, and educational background (nursing, pediatrics, family practice. 
Sample size: 
3.2 
What is the estimated sample size(s) for the primary study analyses (per group for studies with different 
arms or comparison groups)? 
We will be recruiting up to 100 participants, with the goal of enrolling 30 clinicians in practice and 70 clinicians in training. 
Of the 70 clinicians in training the goal is to enroll 35 medical students/residents and 35 nursing students. 
3.3 
The sample size selected was (check all that apply): 

 
Based on data likely to be available during a specific time period (often based on data available in past 
periods) 
X 
To conduct one or more specific analyses with adequate statistical power  
 
To achieve a specified level of precision in one or more key estimates 
 
Other (explain): 
 
3.4 
Explain your choice of the sample size selection you listed above: 
Power Calculation to Estimate Sample Size: Sample size calculations for the study are based on the power to 
detect a significant improvement in scores by the intervention group on the standardized patient assessments.  
Based on our experience with the NIAAA-funded STTR alcohol and screening simulation (Fleming, 2009), both 
groups will have mean scores of 150 out of the possible 300 points, with a standard deviation of 50. The 
control group is expected to show a 0.5(σ) improvement at follow-up due to standard test-retest factors such as 
familiarity.  The intervention group is 
expected to show moderate (1.0 σ) to 
strong (1.1 σ) effect. Sample size and 
power projections are provided in the 
figure below. The graph represents 
the power and sample size 
requirements assuming a moderate 
(1.0 σ) or strong (1.1 σ) effect size in 
the intervention group. Assessment of 
the major hypothesis, assuming 
moderate efficacy, may be achieved 
with an effective sample size of 100 
total subjects (50 per treatment arm) 
and statistical power (1-ß) of 0.70.  If 
the intervention has the expected 
strong effect, we project study power 
(1-ß) to be between 80% and 85% 
with a sample size of 100. 
 
 
 
3.5 Describe your assumptions concerning data available for analysis (e.g. How many subjects will be 
randomized, possibly lost to follow-up or a procedure? What do you expect for survey response rates, and 
how much missing data do you expect?). Include information as it pertains to your study (human or animal). 
See above. 
 
Power analysis 
NOTE: If you are doing a descriptive study (i.e., aside from computing confidence intervals you are not using statistical 
tests, inferential statistical testing for group comparisons, or statistical models), please complete 3.6 and skip 3.7-3.8.   
If you are conducting statistical tests, using statistical inference to compare groups, or are building statistical models, 
please skip 3.6 and complete 3.7-3.8.  Please see our Example Power Analysis. 
 
3.6 
Provide a measure of the precision of your estimates for key study endpoints, (e.g., 95% confidence 
intervals on proportions or means), using actual expected estimates.   
See above. 
 
0.00
0.20
0.40
0.60
0.80
1.00
0
10
20
30
40
50
60
70
Power (1-Beta)
Number of Subjects per Group
Power Curves for Detecting Intervention Effect
Strong Effect Size
Moderate Effect Size

3.7 
What level of differences observed in your primary endpoints would be considered clinically or practically 
significant? 
See above. 
3.8 
What is the power for your primary analysis (and the set of assumptions underlying it: hypothesis 
addressed, expected pattern of effects with justification for these expectations, analysis used, variables 
in the analysis, effect sizes, sample sizes, alpha level, one or two-sided test)? 
See above. 
 
3.9 
What are the limitations of the proposed approach and analysis? 
It is possible our assumptions are incorrect and we won’t have sufficient power to detect and intervention effect. 
 
3.10 
Please name the people who completed the analysis section of this application. 
Laura Humm (Simmersion), Dale Olsen (Simmersion), Michael Fleming (Northwestern) 
 
3.11 
Please name the people who will summarize data and conduct statistical analysis. 
Nancy Sherwood, PhD 
****4.  RESEARCH TEAM**** 
List your study team 
and degrees. 
List what each person will do: 
Identify study subjects; Data 
entry; Chart abstraction; 
Statistical analysis; Study 
recruitment; Interview patients; 
Draft and revise manuscripts  
List each person’s experience 
Explain each person’s previous 
research experience with the tasks 
assigned or what other 
background/experience relates to the 
task they are assigned. 
Time Estimate 
Please estimate 
the number of 
hours or % effort 
each person will 
spend on the study 
Nancy Sherwood, 
PhD 
Oversee all aspects of the 
project including 
communicating to the IRB, 
ensuring methodological 
design compliance, 
supervising personnel and 
completing all data 
collection and statistical 
analysis.  She will also be 
responsible for 
dissemination of study 
results. 
PhD in clinical psychology, extensive 
experience managing research 
studies over a 15 year time period. 
 
5% effort 
Dani Bredeson, BS 
Coordinate recruitment, 
measurement, intervention, 
data collection and IRB 
communication 
Four years of experience at the 
Institute working on recruitment, data 
collection, quality assurance and 
study coordination. 
30% effort 
TBN 
Research Specialist 
Selected personnel will have 
experience working on recruitment, 
data collection and quality assurance 
40% effort 
 
****5.  DISSEMINATION**** 
5.1 
What are your plans for publication, including target journals? 
We will write a primary outcome paper and will consider the following journals: Obesity, Childhood Obesity, American 
Journal of Preventive Medicine 
5.2 
What plans do you have to share results or translate results to care delivery at HP or for HP personnel? 
We will share the results of the trial with the HealthPartners and Park Nicollet pediatrics and family medicine departments. 
 

****6.  ENVIRONMENT**** 
6.1 
Where will the study be conducted? Why is the proposed location appropriate for study? 
The study will be conducted at the University of Minnesota Simulation Center for all providers, students and residents, 
which allows for flexibility and convenience of a centralized location. The Simulation Center also is able to provide 
trained actors and private space for role play simulations as well as privacy for the informed consent process.  
6.2 
How will the results of this study impact the health of HealthPartners members and the community? Be 
specific as to whether and how you see any clinical application as a result of this study. 
The simulation tool could be utilized by the HP and PN medical groups.  
6.3 
Does the treatment strategy (drug or service) proposed in the study commit HP to covering or continuing 
to provide the treatment or program support after the study is completed? 
The treatment strategy does not commit HealthPartners to cover or continue to provide treatment or program support. 
 
****7.  OTHER REVIEW**** 
7.1  
Has this study been submitted for other review and/or received approval/rejection previously, including 
but not limited to: Federal, collaborative agency, previous HealthPartners (rejected), or other funding 
sources (e.g., nonprofit foundation review)? 
 
No 
X 
Yes (Provide dates of submission and status of review [approved, pending, or rejected]) 
 
 
 
The study was submitted to the NIH/CDC and funded by the CDC. The study was funded in 2015, 
and we have been working on revising the simulation in preparation for the randomized trial. 
7.2 Does this study require review by HealthPartners Radiation Safety Officer?  
X 
No 
 
Yes 
Please state that you have spoken to the Radiation Safety Office (651-254-3322) and have their 
support for this study.  
 
 
 
If a research protocol is to involve the use of ionizing or non-ionizing radiation, the principal investigator (PI) should 
contact the Institutional Radiation Safety Officer (RS0) for Regions Hospital and HealthPartners clinics. 
Regions Radiation Safety Office: 651-254-3322. 
Frank E. Zink, Ph.D.,  Radiation Safety Officer for X-Ray Use 
Yuanlin Peng, Ph.D.,  Radiation Safety Officer for Radioactive Materials 
 
****8.  DATA ACCESS REQUEST**** 
These questions must be completed if you are accessing HP/Regions data or if you study involves a 
HealthPartners Institute programmer. You will need to work with an Institute programmer to complete this form. 
Please contact Ann Werner (952-967-5263) or Teri Defor (952-967-7304) for assistance.   
If you are not proposing the access HP/Regions data (e.g. Animal Study), you may check “N/A” below. 
8.1  
What is the name of the programmer helped you complete this section? 
NA 

 
8.2 
Will you need to add a programmer to your study team? 
 
X 
No 
 
Yes 
 
8.3 
Considering your inclusion/exclusion criteria described in 2.3, what specific data will you need? 
NA 
 
8.4 
What years of data are needed? 
NA 
 
8.5 
Will any of the study data be shared or transferred to others within HealthPartners? 
No 
8.6 
Will any study data be shared or transferred to others outside of HealthPartners? 
 
No 
 
Yes - mark which method you will use to share study data: 
[ X  ] E-transfer 
[ X ] Secure website/portal 
[   ] Other secure, encrypted method.  Describe below. 
A de-identified limited dataset will be transferred to study partners after all data is collected for analysis purposes. 
8.7 
Data Sources (please mark all known data sources) 
Mark 
(X) 
Data Source 
Mark 
(X) 
Data Source 
 
EWIS – Claims Data 
 
Registries (chronic condition, disease) 
 
RDW (Research Data Mart) – historical medical, 
dental, state death data 
 
Inpatient Case Management data (i.e., Care 
Guide, Care Partner) 
 
Claims/Mumps/Cache 
 
Paper Medical Chart 
 
EPIC (Electronic Medical Record) 
 
Provider’s own source (own patient’s chart, 
provider or department/hospital registry) 
 
EDR (Electronic Dental Record) 
 
Geriatric department data (i.e., transitional, 
long term care database) 
 
EDR Reporting 
 
Data directly from contracted clinics 
x 
New Subject Survey 
 
VDW (Virtual Data Warehouse) 
 
MEDIPAC System (Regions Billing System) 
 
Consolidated Network Provider (CPN) 
 
Physician Services Department Data 
 
Health Behavior Group Data (e.g., 10,000 
steps, HRA) 
 
MN State Death Data 
 
MN State Birth Data 
 
Misys/Sunquest (Lab production system) 
 
Clarity (Epic Reporting Database) 
x 
Other (Please describe): role play with trained actor score 
8.8 
Exclusion Lists: Institute programmers are required to review and apply the following privacy 
requirements to study patients and their wishes regarding access to medical record information. 

Mark X 
Exclusion List 
 
HealthPartners Institute Exclusion List which excludes persons from all medical research. This should 
be used for all studies. Applies to all data used internally and externally. 
 
Gramm-Leach-Biley Opt-Out List: (if known; sometimes this can be determined after a study starts). 
Applies to identifiable data being sent externally. 
 
Consent for Treatment-Payment-Operations (TPO) Opt-Out List: (if known; sometimes this can be 
determined after a study starts). Applies to identifiable data being sent externally. 
 
8.9 
Data Elements (Please mark all elements that will be used/ accessed during the study): 
Mark 
(X) 
Data Elements 
 
Name 
 
Address 
 
Telephone Number (any) 
 
Fax Number 
 
Certificate/license number (i.e., DEA number, professional license number) 
 
Email address 
 
Device identifier or serial number 
 
URL or IP address (web addresses) 
 
Full face photos, biometric identifiers, or other images 
 
Health Plan beneficiary number (or family contract number) 
 
Date of Birth 
 
Vehicle identification or serial number 
 
Medical Record number (or any personal record identifier) 
 
8.10 
Data Content (Please mark all content areas that apply to your study 
Mark 
(X) 
Data Content 
 
Demographic: age and gender 
 
Health Plan enrollment information (i.e., dates, coverage) 
 
Diagnoses - Medical 
 
Procedures - Medical 
 
Mortality Data 
 
Lab Results 
 
Prescriptions/ Medications 
 
Dates of Service (treatment) 
 
Facility or Provider Identifier / Characteristics (e.g., specialty, FTE, Clinic) 
 
Birth Certificate Data 
 
Pathology / Tissue Type 
 
Financial data 
 
Provider notes 

 
Vitals – height, weight, BP, etc 
 
Social history – tobacco use, etc. 
 
Other Clinical data 
 
Other: please describe:  
****9.  REFERENCES**** 
9.1 
Please list below or attach a list of numbered references to support your literature review in section 1 
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