Attachment 2 HSR Determination

Print Date: 2/6/23

Title:

Evaluation on Impact and Effectiveness of Pilot Project This is a T.E.S.T.

Project Id:

0900f3eb8209a272

Accession #:

CPR-PIB-1/24/23-9a272

Project Contact:

Lauren R Finklea

Organization:

CPR/DSLR/PIB

Status:

Pending Clearance

Intended Use:

Project Determination

Estimated Start Date:

02/14/2023

Estimated Completion Date:

01/01/2025

CDC/ATSDR HRPO/IRB Protocol #:
0920-1154

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

2/6/23

Garcia_Albert D. (asg9) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement
Other - Program improvement

Description & Funding
Description
Priority:

Standard

Date Needed:

02/14/2023

Determination Start Date:

01/24/23

Description:

The Centers for Disease Control and Prevention (CDC) designed This is a T.E.S.T (Tabletop Exercise Simulation Tool) to teach
emergency preparedness and response partners who may be involved in population monitoring about Community Reception
Centers (CRCs) and expand their understanding of how to respond to a radiation incident. The goal of the tool is to facilitate
cooperation between different partner agencies that would respond to a radiation emergency, train staff on their roles and
responsibilities, and provide a Homeland Security Exercise and Evaluation Program (HSEEP) aligned exercise design that mimics
real world issues that may arise, such as staff fatigue, public anxiety, and hazards. CDC NCEH and CPR leadership has expressed
interested in 1) expanding the current version of TEST to other emergencies such as pill dispensing, vaccination, and natural
disasters, 2) evaluating how the pilot version of test is performing at creating an engaging environment for public health and
emergency partners, and 3) developing a virtual version pending evaluation results. This project will focus on task 2 # evaluating
This is a T.E.S.T. Video of overview of tool found here: This is a T.E.S.T. Playthrough - YouTube https://www.youtube.com/watch?
v=ZMxNmIxGSJQ

IMS/CIO/Epi-Aid/Lab-Aid/Chemical Exposure
Submission:

No

IMS Activation Name:

Not selected

Primary Priority of the Project:

Not selected

Secondary Priority(s) of the Project:

Not selected

Task Force Associated with the Response:

Not selected

CIO Emergency Response Name:

Not selected

Epi-Aid Name:

Not selected

Lab-Aid Name:

Not selected

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

The purpose of this project is to evaluate the pilot version of TEST to determine the effectiveness of this tool and how it impacts
/improves emergency preparedness public health capacity. The evaluation will also evaluate how TEST improved learning
outcomes from exercise participants through measuring retention levels with the Kirkpatrick Model. Goals following the evaluation
are: # Improved evidence for using game design to develop innovative learning models in emergency preparedness # Enhanced
training for workforce development based on different learning styles # Framework for experiential learning and gamification for CDC
/Public Health trainings # Improved cohesion with public health response partners Needs and Priorities: Recent emergency
responses such as the pandemic and natural disasters have highlighted that there is a significant need for cross sector collaboration
and training. A training needs assessment for public health workforce development showed 38% of the workforce felt that there
were significant gaps in skills and opportunities for form cross sectoral partnerships. Frameworks exist for federal, state, and local

governmental agencies to exercise and plan together such as FEMA#s HSEEP program. Often exercises are in the form of tabletop
exercises which are discussion based in nature, or functional exercises which focus on components of planning, not all aspects at
once. It#s been identified that these exercises can lack in engagement and realistic restrictions on resource yielding both a missed
opportunity for training and identification of potential gaps in plans. Providing an engaging and realistic training environment that
fosters cross agency collaboration and truly stresses decision makers is key to building a better prepared emergency response
workforce. This aligns with CPR#s mission #Evaluating, designing, developing, and maintaining documents, tools, and resources to
strengthen recipient readiness.#

Objective:

The purpose of this project is to evaluate a new training product, #This is a T.E.S.T.# (TEST), developed by the Centers for Disease
Control and Prevention (CDC) to determine how this product has benefited state and local emergency planning partners and if there
are other ways in which the product can be leveraged and improved to further enhance state and local preparedness. # Evaluate
training effectiveness in achieving intended training outcomes: o Improving emergency preparedness plans o Improving cross
sector partnerships o Understanding current and predicted throughput capacity o Simulation of resource constraints # Identify
options for implementing TEST which best promote emergency preparedness planning and coordination with cross sector
personnel to enhance PHEP capabilities # Identify areas for improvement of development and implementation of TEST

Does this project include interventions, services, or Yes
policy change work aimed at improving the health of
groups who have been excluded or marginalized and
/or decreasing disparities?:
Project does not incorporate elements of health
equity science:

Not Selected

Measuring Disparities:

Not Selected

Studying Social Determinants of Health (SDOH):

Not Selected

Assessing Impact:

Not Selected

Methods to Improve Health Equity Research and
Practice:

Not Selected

Other:

This is a T.E.S.T. was designed to facilitate discussion among preparedness planners with a focus on improving planning for those
with access and functional needs. Facilitated discussion will promote equitable response and decrease disparities.

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - State and local public health emergency planners and partner agencies

Tags/Keywords:

Radiation ; tabletop ; Exercise

CDC's Role:

Activity originated and designed by CDC staff, or conducted at the specific request of CDC, or CDC staff will approve study design
and data collection as a condition of any funding provided ; CDC employees or agents will obtain data by intervening or interacting
with participants ; CDC employees or agents will obtain or use anonymous or unlinked data or biological specimens ; CDC
employees will participate as co-authors in presentation(s) or publication(s)

Method Categories:

Focus Group; Observation; Survey
Intervention being Evaluated: This is a TEST (Tabletop Exercise Simulation Tool) is a collaborative serious game that combines
pedagogic approaches and game-based learning models. Implementation: This is a TEST will be implemented by performing
exercises with STLT partners. These exercises will follow similar formats to other exercises such as tabletop exercises where the

Methods:

tool will be used, followed by discussion and debriefing. Exercises will follow FEMA#s HSEEP principles. This is a TEST will also be
implemented at conference workshops that are open to public health and emergency management personnel. Target participants:
STLT agencies that would be involved in radiation emergency response and planning. Agencies include but are not limited to
emergency management, fire/hazmat, law enforcement, public health, hospitals and healthcare, volunteer organizations,
environmental health, and radiation control. Design: Due to the level of resources required and participation needed to facilitate an
exercise, sites will be determined based on those who volunteer after the approved promotional email is shared or those who
request technical assistance through normal CDC channels for exercise assistance. Sites will be asked to have previously
conducted tabletop exercises in the past 2 years and engage at least 3 agencies to ensure cross sector participation for gameplay.
The call for participation will be open to all state and local governmental agencies across the United States. Likely a mix of local and
state partners will participate in each exercise. Due to the timelines of the project, a minimum of 5 exercise sites will be selected
with the potential for up to 15 sites. Each site will need to ensure at least 20 participants. Ideally, it is preferred that a combination of
decision makers and emergency response staff participate in the exercise. Due to other priorities, it may be unrealistic to integrate
decision makers and leaders. For conference implementation, participants who choose to voluntarily register for the workshop will
be included in the evaluation. Conferences will promote workshops through their channels. Project team anticipates at least 1
conference workshop and up to 5 conference workshops for the evaluation. Evaluation Methods: survey (posttest and 1 and 3
month follow up) and focus group interviews. Posttest survey will determine knowledge and attitude level change and reducing
implicit bias of the subjective nature of perceived learning. Feedback will be grouped based on agency status to further evaluate
how gamification may be accepted in different fields. Both qualitative and quantitative methods will be used to compliment the
complexity of the game. Data will be electronically collected where participants will remain anonymized. During the exercise,
participants will be provided the link to the evaluation survey. Due to the nature of exercises, the host site (not CDC) will collect
names and emails of participants (as this is a requirement for exercise credit for CDC/FEMA). Follow-up electronic survey will be
conducted for participants 1/3 months following exercise to determine level of continued collaboration and if action has been taken
based on gaps identified in planning. Participant list from the exercise will be used to email participants the follow up survey link.
Focus groups will be conducted within 3 months following exercises. Voluntary participation only.

Collection of Info, Data or Biospecimen:

Survey- STLT participants, given option to provide name and email if they would like to be followed up with. Participants will be
given a link to do the electronic survey. Name and email will not be retained. Focus groups- During focus groups, the facilitator will
take notes on main themes and feedback, but no PII will be collected.

Expected Use of Findings/Results and their impact:

Dissemination: Evaluation findings will be shared via presentations, publications, and other appropriate dissemination methods both
internally to CDC and externally to agency partners. Preliminary results will be disseminated through a manuscript where evaluation
and emergency response experts will provide feedback and review. Final findings will be presented with a briefing document and
presentation to CDC leadership to assist with decision making on further development of the project. Presentations will be made at
conferences and on webinars to share findings with external stakeholders. Impact: This project proposes to provide a realistic
training experience that is engaging, stressful, and fosters cross sector collaboration among preparedness partners. Widespread
implementation of this project will result in well-trained, well-prepared staff for emergency response. This may lead to reduction in
lives lost and better outcomes during an emergency.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

Yes

Does CDC have access to the identifiers (including
coded data)?:

Yes

Is this project covered by an Assurance of
Confidentiality?

No

Does this activity meet the criteria for a Certificate

No

of Confidentiality (CoC)?
Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding Type

Funding Title

Other-CDC Staff Time

FTE Staff Time

Funding #

Original Budget Yr
2023

HSC Review

HSC Attributes
Quality Assurance / Improvement

Yes

Other - Program improvement

Yes

Regulation and Policy
Do you anticipate this project will be submitted to
the IRB office

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

# Years Award

Budget Amount
0.00

Population - Pregnant Women

Protocol Page #:

Population - Emancipated Minors

Protocol Page #:

Suggested level of risk to subjects
Do you anticipate this project will be exempt
research or non-exempt research

Requested consent process waviers
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Alteration of authorization under HIPPA Privacy
Rule

No Selection

Requested Waivers of Documentation of Informed Consent
Informed consent for adults

No Selection

Children capable of providing assent

No Selection

Parental permission

No Selection

Consent process shown in an understandable language
Reading level has been estimated

No Selection

Comprehension tool is provided

No Selection

Short form is provided

No Selection

Translation planned or performed

No Selection

Certified translation / translator

No Selection

Translation and back-translation to/from target
language(s)

No Selection

Other method

No Selection

Clinical Trial
Involves human participants

No Selection

Assigned to an intervention

No Selection

Evaluate the effect of the intervention

No Selection

Evaluation of a health related biomedical or
behavioral outcome

No Selection

Registerable clinical trial

No Selection

Other Considerations
Exception is requested to PHS informing those
bested about HIV serostatus

No Selection

Human genetic testing is planned now or in the
future

No Selection

Involves long-term storage of identfiable biological
specimens

No Selection

Involves a drug, biologic, or device

No Selection

Conducted under an Investigational New Drug
exemption or Investigational Device Exemption

No Selection

Institutions & Staff
Institutions
Institutions yet to be added .....

Staff
Staff
Member

SIQT
Exp. Date

Amy
Schnall

08/02
/2025

Fuyuen
Yip

Lauren
Finklea

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

Staff Role

Email

Phone

Organization

CoInvestigator

ghu5@cdc.
gov

7704883422

HEALTH STUDIES

08/27
/2024

CoInvestigator

fay1@cdc.
gov

770488-9

DIVISION OF ENVIRONMENTAL HEALTH
SCIENCE AND PRACTICE

07/27
/2024

Principal
Investigator

lna8@cdc.
gov

7704880703

PROGRAM IMPLEMENTATION BRANCH

08/21/2025

CITI Good Clinical
Practice Exp. Date

Data
DMP
Proposed Data Collection Start Date:

2/14/23

Proposed Data Collection End Date:

6/3/24

Proposed Public Access Level:

Public

Public Access Justification:

Aggregated data will be made available in the published manuscript and can be posted through CDC github or other CDC data
sharing platforms. Aggregated data will have no PII. Allowing persons to access aggregated data will lend credibility to the
evaluation Raw data will be available to CDC staff performing the evaluation. This data will only be used for performing evaluation
and an aggregated form will be made available for the public. Names and contact information will be removed.

How Access Will Be Provided for Data:

Public data will be accessed through either publication manuscript website as supplemental information or through the CDC gihub
portal or other data sharing platforms approved through CDC. Data will be in the form of an excel file and PDF. Raw data will be
held internally on shared Teams folders with only access for CDC staff.

Plans for Archival and Long Term Preservation:

Public Data # Long term archival will be through manuscript publication and/or github or other CDC data repositories. Raw Data #
Data will be saved on CDC shared drives and only accessible to CDC staff. As data is for training/tool evaluation, no data is
anticipated to be sensitive or can be used in a negative way against participants. PII will not be kept. PII is only used to reach out to
participants. Those who said they would like to be contacted and provide their name and email as voluntary consent, that data will
be excluded in saved files following completion of the evaluation.

Spatiality

Spatiality (Geographic Locations) yet to be added .....

Dataset
Dataset
Title

Dataset
Description

Dataset yet to be added...

Data Publisher
/Owner

Public Access
Level

Public Access
Justification

External
Access URL

Download
URL

Type of Data
Released

Collection
Start Date

Collection End
Date

Supporting Info
Current

CDC Staff
Member and
Role

Date Added

Description

Supporting Info Type

Supporting Info

Finklea_Lauren
(lna8)
Project Contact

01/31/2023

Attachment d with comments
addressed

Other

Attachment D_Focus Group Script_blm_comments
addressed.docx

Finklea_Lauren
(lna8)
Project Contact

01/31/2023

Attachment C with Comments
addressed

Other

Attachment C_Follow Up Survey
Questions_blm_comments addressed.docx

Finklea_Lauren
(lna8)
Project Contact

01/31/2023

gen ic template with comments
addressed

Other

GenICRequestTemplate_TEST_blm_comments addressed.
docx

Finklea_Lauren
(lna8)
Project Contact

01/31/2023

Updated and clean version of
attachment C

Other

Attachment C_Follow Up Survey Questions_clean.docx

Finklea_Lauren
(lna8)
Project Contact

01/31/2023

Updated version Attachment B

Other

Attachment B_Immediate Post Exercise Survey
Questions_clean.docx

Finklea_Lauren
(lna8)
Project Contact

01/31/2023

updated and clean gen ic template

Other

GenICRequestTemplate_TEST_Clean.docx

Finklea_Lauren
(lna8)
Project Contact

01/31/2023

Updated and clean version of
attachment D

Other

Attachment D_Focus Group Script_clean.docx

Finklea_Lauren
(lna8)
Project Contact

01/31/2023

Attachment B with comments
addressed

Other

Attachment B_Immediate Post Exercise Survey
Questions_blm_comments addressed.docx

Maddox_Brandy
(ftn6)
Branch
Approver
Projects

01/30/2023

Reviewer Feedback/Edits on
Attachment C Follow up survey
questions

Other

Attachment C_Follow Up Survey Questions_blm.docx

Maddox_Brandy
(ftn6)
Branch
Approver
Projects

01/30/2023

Reviewer feedback/edits on
Attachment B _Immediate Post
Survey Questions

Other

Attachment B_Immediate Post Exercise Survey
Questions_blm.docx

Maddox_Brandy
(ftn6)
Branch
Approver
Projects

01/30/2023

Reviewer feedback/edits on
Attachment D Focus Group Script

Other

Attachment D_Focus Group Script_blm.docx

Maddox_Brandy
(ftn6)
Branch
Approver
Projects

01/30/2023

Feedback/edits on Gen IC
Request Template

Other

GenICRequestTemplate_TEST_blm.docx

Current

Finklea_Lauren
(lna8)
Project Contact

01/24/2023

Request for genIC Approval CDC
/ATSDR Formative Research and
Tool Development 0920-1154

Other-Generic IC Package Form

GenICRequestTemplate_TEST.docx

Current

Finklea_Lauren
(lna8)
Project Contact

01/24/2023

This is the information that will be
send out in DSLR update for
recipients to volunteer to host the
tool for exercising and evaluation.

Participant Information Form

Attachment A_Participant Information.docx

Current

Finklea_Lauren
(lna8)
Project Contact

01/24/2023

These are the questions we would
like to use for 1 and 3 month follow
up.

Other-Follow Up Survey

Attachment C_Follow Up Survey Questions.docx

Current

Finklea_Lauren
(lna8)
Project Contact

01/24/2023

Template of the survey we would
like to implement for immediate
follow up after exercising with
TEST.

Other-Immediate Survey Form

Attachment B_Immediate Post Exercise Survey Questions.
docx

Current

Finklea_Lauren
(lna8)
Project Contact

01/24/2023

Focus group script for CDC staff to
use to interview participants.

Other-Focus Group Script

Attachment D_Focus Group Script.docx