Non-Research Determination 2022

Print Date: 4/1/22

Title:

Million Hearts Hospitals & Health Systems Recognition Program

Project Id:

0900f3eb81ec140a

Accession #:

NCCDPHP-MHT-3/18/22-c140a

Project Contact:

Jessica Barnett

Organization:

NCCDPHP/DHDSP/OD/MHT

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

12/01/2022

Estimated Completion Date:

11/30/2025

CDC/ATSDR HRPO/IRB Protocol #:
0920-1274

OMB Control #:

Determinations
Determination

Justification

Completed

Entered By & Role

3/28/22

Redmond Leonard_Joan (jrl3) CIO HSC

Not Research / Other
HSC:
Does NOT Require HRPO
Review

45 CFR 46.102(l)
Program Evaluation
Quality Assurance / Improvement

PRA:
PRA Applies

ICRO:
PRA Applies

OMB Approval date: 11/25/19
OMB Expiration date: 11/30/22

3/29/22

Still-LeMelle_Terri (cse6) OMB / PRA

3/30/22

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

03/30/2022

Determination Start Date:

03/18/22

Description:

Million Hearts# is a national initiative to prevent 1 million heart attacks and strokes by 2027. The purpose of the Million Hearts#
Hospital & Health Systems Recognition program is to recognize institutions working to systematically improve the cardiovascular
health of the population and communities they serve through a focus on Building Healthy Communities, Optimizing Care, Focusing
on Health Equity, and Supplemental Programs and Innovations. Hospitals and health systems will self-nominate through an online
portal confirming that they are: a.)Committed to implement strategies that promote cardiovascular health b.)Provide documentation
of current strategies that they are implementing in order to promote cardiovascular health c.) Provide documentation of current
strategies that they are implementing in order to promote cardiovascular health and provide data that shows positive health
outcomes as a result of those strategies being implemented. Nominations will be reviewed using predetermined criteria to ascertain
that they meet the eligibility criteria. The determinations by the review group will be reviewed by an expert panel of judges.
Recognized designees will participate in the development of a success story product to be shared broadly with the public health and
clinical audiences. CDC staff members have developed the application criteria, data collection instruments, and selection criteria.
Data will be stored by CDC on a secure CDC file system. This data will be stored on a secure server that will be password
protected. CDC's Million Hearts# team and its funded partner (The National Association for Chronic Disease Directors) will have
access to this data. Data will not be shared with any other entities, and will be stored for 3 years. The objective of this program is to
identify and recognize hospitals and health systems that work to improve cardiovascular health in a narrative or documentary
format. No individual patient level data will be collected, only practice level summary data. No generalizable knowledge will emerge
from this project. A manuscript is not planned at this time. Selected hospitals and health systems will be recognized through webbased platforms.

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 the Million Hearts# Hospital & Health Systems Recognition program is to recognize institutions working to
systematically improve the cardiovascular health of the population and communities they serve through a focus on Building Healthy
Communities, Optimizing Care, Focusing on Health Equity, and Supplemental Programs and Innovations.

Objective:

The objective of this program is to identify and recognize hospitals and health systems that work to improve cardiovascular health in
a narrative or documentary format.

Does this project include interventions, services, or No
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:

Million Hearts will recognize hospitals and health systems that are using strategies to focus on priority populations such as pregnant
and postpartum women, people from racial/ethnic minority groups, people with lower incomes and people who live in access
deserts.

Activities or Tasks:

Programmatic Work

Target Populations to be Included/Represented:

Businesses ; Healthcare Provider

Tags/Keywords:

Awards and Prizes

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

Method Categories:

Individual Interviews (Qualitative)

Methods:

Applicants to the Million Hearts Hospitals & Health Systems Recognition program will voluntarily submit an application attesting to
the Million Hearts strategies that they commit to implement, are currently implementing or have been implementing and achieved
results. CDC and it's funded partner (National Association of Chronic Disease Directors) will review the application data and
conduct a qualitative interview with the highest-achieving applicants.

Collection of Info, Data or Biospecimen:

Applicants will submit an application through a web-based portal. Qualitative interviews with the highest-achieving applicants will be
held by phone.
Million Hearts will recognize the work and strategies used by select hospitals and health systems and promote their work through

Expected Use of Findings/Results and their impact:

web-based platforms in narrative or documentary format.

Could Individuals potentially be identified based on
Information Collected?

No

Funding

Funding Type

Funding Title

Funding #

CDC Cooperative Agreement

CSTLTS- MH-NACDD MH Recognition Program

HSC Review

HSC Attributes
Program Evaluation

Yes

Quality Assurance / 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 #:

Original Budget Yr

# Years Award

Budget Amount

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

Judith
Hannan

08/25/2023

Data

CITI Biomedical
Exp. Date

CITI Social & Behavioral
Exp. Date

CITI Good Clinical
Practice Exp. Date

Staff Role

Program
Official

Email

Phone

Organization

770-4884572

DIVISION OF HEART DISEASE AND
STROKE PREVENTION

DMP
Proposed Data Collection Start Date:

12/1/22

Proposed Data Collection End Date:

11/30/25

Proposed Public Access Level:

Public

Public Access Justification:

Million Hearts will release promotional narratives to highlight strategies that applicants attest they are using to address heart
disease and stroke. This recognition program aims to recognize and disseminate strategies that institutions are using to
successfully address heart disease and stroke prevention.

How Access Will Be Provided for Data:

Data will be stored by CDC on a secure CDC file system. This data will be stored on a secure server that will be password
protected. CDC's Million Hearts# team and its funded partner (The National Association for Chronic Disease Directors) will have
access to this data. Data such as the applicant's contact information will not be shared with any other entities, and will be stored for
3 years.

Plans for Archival and Long Term Preservation:

Data will be stored for 3 years and then archived.

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