Project Determination

Print Date: 12/12/24

Title:

Evaluating Content and Usability of CDCs Clinical Heat Guidance Amendment 1

Project Id:

0900f3eb8249c338

Accession #:

-NCEH-2/12/24-049a4

Project Contact:

Laura C Seeff

Organization:

NCEH/ATSDR

Status:

Pending Regulatory Clearance : Amendment

Intended Use:

Project Determination

Estimated Start Date:

01/06/2025

Estimated Completion Date:

02/01/2026

CDC/ATSDR HRPO/IRB Protocol #:
OMB Control #:

Determinations

0920-1154

Determination

Justification

Completed

Entered By & Role

12/12/24

Ding_Yan (Shirley) (yad6) CIO HSC

12/12/24

Ding_Yan (Shirley) (yad6) CIO OMB / PRA

12/12/24

Zirger_Jeffrey (wtj5) ICRO Reviewer

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Quality Assurance / Improvement

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 6/13/23
OMB Expiration date: 6/30/26

Description & Funding
Description
Priority:

Standard

Date Needed:

12/20/2024

Priority Justification:
CDC Priority Area for this Project:

Readiness and Response

Determination Start Date:

11/19/24

Description:

The impact of heat on our health has been included as one of the priority risks associated with CDC#s 2024 priority - #Readiness
and Response to Health Threats.# Extreme heat presents a growing concern as the frequency and intensity of extreme heat events
continue to increase each year, with the heat season beginning earlier each year. Extreme heat is associated with increased
morbidity and mortality for all persons, and particularly among certain more sensitive populations. Public health heat resilience
planning has not traditionally engaged the healthcare delivery system, a system well positioned to help protect those most at risk
from heat. In addition, clear and simple guidance has not been widely available for clinicians, patients, and the general public to
enable planning ahead for heat protection before the start of the heat season. In response to this public health need, in April 2024,
CDC released first-ever heat-related clinical guidance to help clinicians counsel patients on preventing health harms from heat for
individuals at increased risk from heat, such as children with asthma, pregnant women, and adults with cardiovascular disease, and
for the general public. A pilot project was approved in April 2024 to obtain feedback from 9 CHC clinicians on the materials prerelease and refine the materials accordingly. This amendment seeks approval to conduct a survey of all 1,496 CHCs across the
nation on their use of the clinical heat guidance since the April 2024 release during summer 2024, the hottest summer ever
recorded. Approval of this project will allow CDC to: 1. Assess how and to what extent CHCs have used CDC#s new clinical heat
guidance. 2. Assess the content and usability of the clinical heat guidance in supporting CHC efforts to reduce the impact of heat on
their patients# health. 3. Identify barriers, facilitators, and areas of need and support for CHCs in using CDC#s new clinical heat
guidance.

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

No

Submission:
IMS Activation Name:

Not selected

Submitted through IMS Clearance Matrix:

Not selected

Primary Scientific Priority:

Not selected

Secondary Scientific Priority (s):

Not selected

Task Force Responsible:

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 goal of this overall initiative is to reduce the impact of heat on the health of patients. The specific goal associated with this
amendment request is assess content and usability of the heat guidance that was released in April 2024 through survey the nations
1,496 CHCs on their use of the guidance. The purpose of the data collection is to: 1. Assess how and to what extent CHCs have
used CDC#s new clinical heat guidance. 2. Assess the content and usability of the clinical heat guidance in supporting CHC efforts
to reduce the impact of heat on their patients# health. 3. Identify barriers, facilitators, and areas of need and support for CHCs in
using CDC#s new clinical heat guidance.

Objective:

The objective of this project is to gain an understanding of the perceived effectiveness and utility of CDC#s clinical heat guidance
and support the development and improvement of future clinical heat guidance materials and products.

Does your project measure health disparities among Yes
populations/groups experiencing social, economic,
geographic, and/or environmental disadvantages?:
Does your project investigate underlying
contributors to health inequities among populations
/groups experiencing social, economic, geographic,
and/or environmental disadvantages?:

Yes

Does your project propose, implement, or evaluate
an action to move towards eliminating health
inequities?:

Yes

Activities or Tasks:

Programmatic Work

Target Populations to be Included/Represented:

Healthcare Provider

Tags/Keywords:

Extreme Heat ; Anticipatory Guidance

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 is NOT a recipient or provider of private data, specimens, materials or services ; CDC is providing funding

Method Categories:

Survey

Methods:

CDC/NCEH will work with the National Center for Farmworker Health (NCFH) and the National Association of Community Health
Centers (NACHC) to survey the nation#s 1,496 Community Health Centers on their use of CDC#s heat guidance released April
2024 designed for help clinicians reduce the impact of heat in the health of their patients. CDC, in partnership with NCFH and
NACHC, will administer a 37-question CDC and NCFH-designed survey to clinicians and non-clinicians at CHCs for content and
usability testing of CDC#s Clinical Heat Guidance. This evaluation will use qualitative and quantitative data collection methods to
assess the design and use of CDC#s web-based heat guidance materials. Additionally, the survey will gather audience knowledge,
attitudes, and beliefs (KABs), perceptions of campaign asset products, and clinic and clinician specialty characteristics. NCFH/CDC
will deploy the electronic survey over a three-week period to capture responses about CDC#s heat and health guidance. A target
sample size of 1000 of the total 1,496 CHCs was informed by the parameters required to achieve a margin of error of 5% or less at
a 95% confidence interval for 33 percent of the overall sample. The estimated proportion of survey respondents who are familiar
with the materials being tested is one in three (33%). With a sample size of 1,000, 330 respondents are estimated to be familiar with
the CDC materials. Among these 330 respondents, the margin of error is 4.76%, given an overall sample size of 1,000 and a
universe of 1,496 health centers. G*Power was used to calculate an a priori sample size for additional power analysis needed to
assess the message effects and variances in scores within each of two groups: those familiar with the resources and those
unfamiliar with the resources. To conduct t-tests to detect a moderate effect size (?=0.2), with 95% confidence (? =0.05), a
minimum sample size of 262 (for the familiar group) or approximately 845 survey participants will be needed. Due to the likelihood
of having some missing data on some questions, this number was rounded up to 1,000 participants needed. Each participant will
acknowledge consent prior to beginning the survey response.

Collection of Info, Data or Biospecimen:

Feedback on the guidance will be collected via a survey to clinicians and non-clinician clinic staff at the nation#s 1,496 CHCs,
targeting a sample size of 1,000.

Expected Use of Findings/Results and their impact:

Information obtained will be used to gain an understanding of the perceived effectiveness and utility of CDC#s clinical heat guidance
and support the development and improvement of future clinical heat guidance materials and products.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

Budget Amount

CDC Contract

Project Management for Environmental Issues

GS00F045DA

2021

1

135000.00

HSC Review

HSC Attributes
Quality Assurance / Improvement

Yes

Regulation and Policy
Do you anticipate this project will require review by
a CDC IRB or HRPO?

No

Estimated number of study participants

Population - Children

Protocol Page #:

Population - Minors

Protocol Page #:

Population - Prisoners

Protocol Page #:

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 HIPAA 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

Will you be working with an outside Organization or Institution? Yes
Institution

FWA #

FWA Exp Date

Funding

Guidehouse LLP

FWA00028885

08/28/28

GS00F045DA - GS00F045DA

Institution

Funding Restriction Percentage

Funding Restriction Reason

Funding Restriction Amount

Funding Restriction has been Lifted

Guidehouse LLP

Institution

Institution Role(s)

Institution
Project Title

Guidehouse
LLP

Intervening or Interacting with Human Subjects; Providing Technical Assistance; Obtaining, Storing or Transferring NonIdentifiable Private Information or Non-Identifiable Biospecimens; Recruiting Subjects

Institution

Regulatory Coverage

Guidehouse LLP

IRB Review is Not Required

Institution

Registered IRB

Institution
Project
Tracking #

IRB Review Status

IRB Registration Exp. Date

IRB Approval Status

Guidehouse LLP

Institution
Guidehouse LLP

IRB Approval Date

IRB Approval Exp. Date

Relying Institution IRB

Prime
Institution

Staff
Staff
Member

SIQT
Exp.
Date

CITI
Biomedical
Exp. Date

CITI Social &
Behavioral Exp.
Date

CITI Good Clinical
Practice Exp. Date

Ambarish
Vaidyanathan

08/28
/2026

12/30/2022

12/30/2022

12/30/2022

Laura Seeff

Staff Role

Email

Phone

Organization

Project
Coordinator

dvq3@cdc.
gov

7704883997

CLIMATE AND HEALTH
BRANCH

08/31
/2026

Project
Coordinator

lvs3@cdc.
gov

4046397063

OD

Paul
Schramm

08/02
/2026

Project
Coordinator

imw3@cdc.
gov

770488-6

DIVISION OF
ENVIRONMENTAL HEALTH
SCIENCE AND PRACTICE

Shubhayu
Saha

04/17
/2026

Project
Coordinator

hsf5@cdc.
gov

7704880783

CLIMATE AND HEALTH
BRANCH

11/26/2021

11/28/2021

CITI Good Laboratory
Practice Exp. Date

Data
DMP
Proposed Data Collection Start Date:

1/6/25

Proposed Data Collection End Date:

1/24/25

Proposed Public Access Level:

Public, Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - Since the survey is collecting information to inform program evaluation, and not public health outcomes, the raw data
themselves are #non-public#

Public Access Justification:

Data will be both public and non-public. The survey collecting program evaluation data that will help us improve customer service for
heat guidance users. De-identified aggregate level data from the data collection will be shared publicly in reports and publications in
an effort to highlight lessons learned, barriers to use of guidance, and best practices.
Data will be collected via an online survey (see Attachment 1 # Survey Instrument and Attachment 2 # Programmed Survey) in a
Qualtrics platform Fedramp approved and hosted by the National Association for Community Health Centers, a subcontractor to the
CoAg recipient. Respondents will be recruited through a notification (see Attachment 3 # Recruitment Email) to the respondent

How Access Will Be Provided for Data:

Plans for Archival and Long Term Preservation:

universe (see Attachment 6 # Respondent Universe) via email. The email notification will explain: # The purpose of the data
collection, and why their participation is important; # Instructions for participating; # Method to safeguard their responses; # That
participation is voluntary; # The expected time to complete the instrument; # Contact information for the project team; and #
Information on how to receive token of appreciation with email address. The email notification will include a survey link, where each
participant will submit responses. The survey will be fielded for up to 3 weeks to ensure respondents have sufficient time to
respond. Participants will receive up to one reminder email each week (i.e., up to three emails in total) (see Attachments 4 and 5).
Survey invites will be sent to all CHCs to either the CMO or the CEO, who will be instructed to identify the staff person most
knowledgeable or familiar with the topic (which could be the initial CMO or CEO recipient themselves) with guidance to complete the
survey if relevant to the recipient and to send the survey to complete and distribute to any other relevant staff to complete. Survey
responses will be tracked by census region towards a total response of 1,000 surveys. Regions will be closed before the 3-week
period if necessary if responses reach 1,000. Survey respondents will receive an electronic gift card in compensation for their time
to complete the survey. Emails for recipients to receive the e-gift will be provided by respondents will be encrypted, stored in a
separate data base from the survey results, and destroyed as soon as e-gift cards are sent. After the raw survey data are
downloaded from the Qualtrics platform, the project team will use MS Excel software for data processing and cleaning, and SPSS
statistical software for the analysis. Each variable will be clearly named and labeled, and each will be properly identified by type (e.
g., Likert-type variables designated as interval variables). The data set cleaning procedures will include independent review of data
set creation to ensure accuracy. The data will be password protected and stored in a secure environment maintained by the
contractor.
An encrypted and de-identified data set will be made available to CDC after the initial data analysis is conducted in early 2025 by
the cooperative agreement recipient, so that CDC may be able to link survey results on use of CDC heat guidance to weather data
(looking at hottest months of the year) and use of the CDC-NOAA HeatRisk tool. Once available, a link to the archived data with a
description of when, how and by whom the data can be accessed will be shared, in compliance with all laws, regulations, and rights
regarding data storage, privacy, and long-term preservation.

Spatiality
Country

State/Province

County/Region

United States

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

Zirger_Jeffrey
(wtj5)
ICRO Reviewer

12/12/2024

NOA 0920-1154 (2023)

Notice of Action

NOA 0920-1154_2023.pdf

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

Recruitment flyer

Participant Information Form

Attachment 7. Recruitment Flyer.png

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

Recruitment and reminder emails

Participant Information Form

Attachments 4-6 - Recruitment, Reminder and Final
Reminder Emails_11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

participant worksheet for non
physicians

Other

Att 11 Worksheet non-physician users.pdf

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

participant worksheet - physicians

Other

Att 10 Worksheet physician users.pdf

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

Survey Instrument

Data Collection Form

Attachment 1. CDC Clinical Heat Guidance Survey
Instrument, Heat Eval for GenIC 1154 - 11.15.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

example of programmed survey

Data Collection Form

Attachement 3. Example of Programmed Survey Heat and
Health Eval - for GenIC 1154 -11.18.24.PNG

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

Programmed Survey

Data Collection Form

Attachment 2. Programmed CDC-Heat_Guidance Survey
Flow - for Heat Eval GenIC 1154 - 11.18,24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

SSB for Eval of CDCs Clinical
Heat Guidance - GenIC1154

Paperwork Reduction Act Form

SSB - for CDC Clinical Heat Guidance Eval - GenIC 1154
-11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

SSA for Eval of CDCs Clinical
Heat Guidance - GenIC 1154

Paperwork Reduction Act Form

SSA - for CDC Clinical Heat Guidance Eval - GenIC 1154
- 11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

Recruitment flyer

Participant Information Form

Attachment 7. Recruitment Flyer.png

Seeff_Laura C.

Attachments 4-6 - Recruitment, Reminder and Final

(lvs3)
Project Contact

Current

12/06/2024

Recruitment and reminder emails

Participant Information Form

Reminder Emails_11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

participant worksheet for non
physicians

Other

Att 11 Worksheet non-physician users.pdf

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

participant worksheet - physicians

Other

Att 10 Worksheet physician users.pdf

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

Survey Instrument

Data Collection Form

Attachment 1. CDC Clinical Heat Guidance Survey
Instrument, Heat Eval for GenIC 1154 - 11.15.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

example of programmed survey

Data Collection Form

Attachement 3. Example of Programmed Survey Heat and
Health Eval - for GenIC 1154 -11.18.24.PNG

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

Programmed Survey

Data Collection Form

Attachment 2. Programmed CDC-Heat_Guidance Survey
Flow - for Heat Eval GenIC 1154 - 11.18,24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

SSB for Eval of CDCs Clinical
Heat Guidance - GenIC1154

Paperwork Reduction Act Form

SSB - for CDC Clinical Heat Guidance Eval - GenIC 1154
-11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

12/06/2024

SSA for Eval of CDCs Clinical
Heat Guidance - GenIC 1154

Paperwork Reduction Act Form

SSA - for CDC Clinical Heat Guidance Eval - GenIC 1154
- 11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

SSA

Paperwork Reduction Act Form,
0.1260 Request to End Review of
Human Research Studies

SSA - for CDC Clinical Heat Guidance Eval - GenIC 1154
- 11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

Recruitment flyer

Participant Information Form

Attachment 7. Recruitment Flyer.png

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

Recruitment and reminder emails

Participant Information Form

Attachments 4-6 - Recruitment, Reminder and Final
Reminder Emails_11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

participant worksheet for non
physicians

Other

Att 11 Worksheet non-physician users.pdf

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

participant worksheet - physicians

Other

Att 10 Worksheet physician users.pdf

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

Survey Instrument

Data Collection Form

Attachment 1. CDC Clinical Heat Guidance Survey
Instrument, Heat Eval for GenIC 1154 - 11.15.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

example of programmed survey

Data Collection Form

Attachement 3. Example of Programmed Survey Heat and
Health Eval - for GenIC 1154 -11.18.24.PNG

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

Programmed Survey

Data Collection Form

Attachment 2. Programmed CDC-Heat_Guidance Survey
Flow - for Heat Eval GenIC 1154 - 11.18,24.docx

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

SSB for Eval of CDCs Clinical
Heat Guidance - GenIC1154

Paperwork Reduction Act Form

SSB - for CDC Clinical Heat Guidance Eval - GenIC 1154
-11.18.24.docx

Seeff_Laura C.
(lvs3)
Project Contact

11/19/2024

SSA for Eval of CDCs Clinical
Heat Guidance - GenIC 1154

Paperwork Reduction Act Form

SSA - for CDC Clinical Heat Guidance Eval - GenIC 1154
- 11.18.24.docx

Green_Donata
(dqg7)
Project Contact

02/14/2024

Draft Heat and Health pregnant
people guidance

Other

DRAFT Heat and Health Pregnant People Guidance.docx

Green_Donata
(dqg7)
Project Contact

02/14/2024

Draft moderators guide

Other

Draft Moderators Discussion Guide Heat_Health.docx

Green_Donata
(dqg7)
Project Contact

02/14/2024

Draft Heat and Health Asthma
guidance

Other

DRAFT Heat and Health Asthma Guidance.docx

Green_Donata
(dqg7)
Project Contact

02/14/2024

Draft Heat and Health CVD
guidance

Other

DRAFT Heat and Health CVD Guidance.docx

Green_Donata
(dqg7)
Project Contact

02/14/2024

One pager description of the
moderators guide and the
discussion session format.

Other

Pilot Heat and Health Initiative One Pager (Description of
Guide and Session Format).docx

Green_Donata
(dqg7)
Project Contact

02/14/2024

One pager of the description of the
moderators guide and the
discussion group format.

Other

Pilot Heat and Health Initiative Project Determination
Consent Form.docx