Research Determination

Print Date: 5/25/21

Title:

OD2A Technical Assistance Tracking and Assessment for Program Improvement and Impact

Project Id:

0900f3eb81adc70e

Accession #:

NCIPC-OOSST-2/20/20-dc70e

Project Contact:

Pierre Olivier Cote

Organization:

NCIPC/DOP/PPEB/SLTATB

Status:

Project In Progress

Intended Use:

Project Determination

Estimated Start Date:

08/24/2020

Estimated Completion Date:

12/30/2022

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

Determinations
Determination

Justification

Completed

Entered By & Role

3/31/20

Angel_Karen C. (idy6) 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:
Returned with No Decision

3/31/20

Angel_Karen C. (idy6) OMB / PRA

3/31/20

Zirger_Jeffrey (wtj5) ICRO Reviewer

Description & Funding
Description
Priority:

Standard

Date Needed:

03/05/2020

Determination Start Date:

02/20/20

Description:

In 2019, Centers for Disease Control and Prevention (CDC), Division of Overdose Prevention (DOP), awarded funds to 66 states,
territories, and localities to implement the Overdose Data to Action (OD2A) program. OD2A supports recipients#?? efforts to use
opioid morbidity and mortality data to implement data-driven prevention and response efforts across the country. CDC contracted
with ICF to develop a technical assistance (TA) hub (hereafter referred to as the OD2A TA Center) to build knowledge and
strengthen the capacity of the recipients to implement and evaluate surveillance and prevention activities in their jurisdictions. The
OD2A TA Center will streamline and centralize CDC#??s TA response. Evaluating the TA provided to OD2A recipients will ensure
that recipient needs are met and that TA services result in meaningful change. The continuous monitoring and evaluation of TA
provided to recipients will provide feedback to improve subsequent TA events and demonstrate the effectiveness of TA in improving
recipients#?? capacity to implement and evaluate their programs. The evaluation for this project consists of two electronic data
collection instruments (a TA Feedback Form and Annual OD2A TA Center Survey) designed to collect information about TA access,
utilization, and outcomes. The TA Feedback Form will be administered on an ongoing basis to collect immediate feedback following
individual TA encounters and participation in group events such as webinars and in-person trainings. The Annual OD2A TA Center
Survey will be distributed one time each year to assess satisfaction with overall TA provided during the year and the extent to which
TA supported the successful implementation of OD2A strategies. Survey respondents will consist of beneficiaries of TA activities
including OD2A program administrators, staff, evaluators, and partners. ICF will administer and analyze the surveys. CDC will
provide oversight. Surveys are included under additional documentation.

IMS/CIO/Epi-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

Assessment of Chemical Exposure Name:

Not selected

Goals/Purpose

Objective:

The goal of this project is to evaluate and improve the effectiveness of TA provided to OD2A program recipients. Specifically, the
evaluation will gather real-time information to improve ongoing provision of TA and to demonstrate the overall success and impact
of OD2A TA. This evaluation will also assist CDC with future decision making on the type and number of resources allocated for TA
purposes.
The information obtained through the primary data collection tools will allow TA providers to assess OD2A recipients# experience
and utility of knowledge and resources gained through individual TA support, peer-to-peer sessions, and other group trainings.
Additionally, data collection will inquire about further program support needs to inform and modify subsequent training and TA plans.
Ultimately, the evaluation data will inform subsequent rounds of TA and allow TA providers to make necessary adjustments to the
overall TA strategy for continuous quality improvement. This will ensure recipients have the support necessary to implement
strategies that will improve opioid surveillance and prevention policies and practices within their communities.

Does this project include interventions, services, or Not Selected
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:

Not Selected

Activities or Tasks:

New Collection of Information, Data, or Biospecimens

Target Populations to be Included/Represented:

Other - Staff from State, Territorial and Local health departments and their designess working on OD2A

Tags/Keywords:

In alphabetical order- Evaluation Technical Assistance, Overdose Date to Action, Overdose Prevention Technical Assistance,
Overdose Surveillance Technical Assistance, Program Technical Assistance, Sub

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:

Survey

Methods:

The evaluation consists of two web-based surveys with a series of close-ended and open-ended questions. The two web-based
surveys are designed to measure TA access, utilization, and outcomes across all OD2A recipient programs. The two surveys are
the TA Feedback Form and Annual OD2A TA Center Survey. The TA Feedback Form will be used to measure participant
knowledge, intended application, and experience after each TA encounter (e.g., webinar, in-person event, virtual training, direct
consultation). The TA Feedback Form will be administered through Survey Monkey, a web-based platform, following the close of
each TA activity. Staff from funded OD2A jurisdictions that participate in the event will receive an email notification and a link with
instructions for accessing the survey. Two reminder emails will be sent to nonrespondents within two weeks of the initial invitation.
An annual web-based survey with respondents from all OD2A recipients will be conducted to assess satisfaction with overall TA and
the extent to which TA supports informed implementation of OD2A strategies. The Annual OD2A Center Survey will be automated

for each respondent to reflect the TA that has been received or accessed by the OD2A recipient during the year. The survey will be
administered to a combination of up to 10 leadership team members and staff who participated in TA activities from each recipient
location. The Annual OD2A TA Center Survey will also be distributed through a Survey Monkey link emailed to participants.
Respondents will have three weeks to complete the survey.

Collection of Info, Data or Biospecimen:

Participants in TA activities will be emailed a Survey Monkey link to participate in the TA Feedback Form after each TA event;
recipient project leadership and TA participants will be emailed a SurveyMonkey link for the Annual OD2A TA Center Survey in the
fall of each year. The TA Feedback Form will gather OD2A recipient feedback regarding the perceived quality and effectiveness of
different types of TA activities and will take approximately 5 minutes to complete. Survey items include a mix of close-ended
questions using a 5-point Likert scale (e.g. strongly agree to strongly disagree) to rate aspects of the TA provided as well as openended questions to gather detailed feedback about satisfaction and usefulness of the TA encounter and recommendations for
improvement. In addition, the survey asks participants to indicate other TA items to address in the future. The survey closes with a
few demographic items to collect the role/profession and location of the respondent. The Annual OD2A TA Hub Survey will include
both qualitative and quantitative questions to understand recipient experiences with TA supports and understand how OD2A
recipients are using what they learned from TA to improve or inform grant related activities. The survey will take no longer than 15
minutes to complete.

Expected Use of Findings/Results:

The findings from these surveys will enable CDC and program stakeholders to improve delivery of TA and guide decision-making
about future TA resource allocations. To ensure results are usable, ICF will develop an Evaluation and Lessons Learned Report
each year. The report will share program successes, a summary of TA activities, participants, barriers encountered, TA outcomes,
and recommendations for improving TA and sustaining knowledge gains. Additional dissemination channels may include the
monthly progress reports as well as potential conference presentations and/or journal articles for publications of interest to funders
of public health and behavioral health programs and TA providers.

Could Individuals potentially be identified based on
Information Collected?

Yes

Will PII be captured (including coded data)?

No

Is an assurance of confidentiality in place or
planned?

No

Is a certificate of confidentiality in place or planned? No
Is there a formal written agreement prohibiting the
release of identifiers?

No

Funding

Funding Type

Funding Title

Funding #

Original Budget Yr

# Years Award

CDC Contract

Division of Overdose Prevention Technical Assistance Hub

GS00Q140ADU119

2019

4

Budget Amount

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
Population - Minors
Population - Prisoners
Population - Pregnant Women
Population - Emancipated Minors

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 & Staff
Institutions
Name

FWA #

FWA Exp Date

IRB Title

IRB Exp Date

Funding #

ICF Inc. and Subsidiary Organizations

FWA00002349

10/13/25

icf IRB #1

08/14/21

GS00Q140ADU119

Staff
Staff
Member

SIQT
Exp. Date

Henrietta
Kuoh

02/18
/2023

Pierre
Olivier Cote

02/19
/2023

CITI Biomedical
Exp. Date

CITI Social &
Behavioral Exp. Date

03/29/2022

CITI Good Clinical
Practice Exp. Date

Staff Role

Email

Phone

Organization

Program
Lead

ilq7@cdc.
gov

770-4887335

OPIOID OVERDOSE STATE
SUPPORT TEAM

Technical
Monitor

yyc8@cdc.
gov

770-4884752

STATE & LOCAL TECHNICAL
ASSISTANCE TEAM A

Data
DMP
Proposed Data Collection Start Date:

8/24/20

Proposed Data Collection End Date:

12/30/22

Proposed Public Access Level:

Non-Public

Non-Public Details:
Reason For Not Releasing Data:

Other - The information gathered will be used for program quality improvement purposes only.

Public Access Justification:

Information will be collected from stakeholders who oversee, implement, and support the program activities under OD2A, including
state agency administrators, program staff, local health department staff, and evaluators. Data collection will include the TA utility,
preferences, needs, and interests for the optimal delivery of TA content across a diverse group of stakeholders who are directly
involved in building or sustaining opioid surveillance and prevention program activities. The information gathered will be used for
quality improvement purposes only. The dataset will not be made available to the public.

How Access Will Be Provided for Data:

Data will not be released to the public.

Plans for Archival and Long Term Preservation:

The name and work email address of the individuals receiving the email with the survey link will be stored separately from the
survey responses and will be destroyed after administration. The survey data will be destroyed upon project completion.

Spatiality
Country

State/Province

United States

Nebraska

United States

Montana

United States

Missouri

United States

Mississippi

United States

Minnesota

United States

Michigan

United States

Kansas

United States

Iowa

United States

Indiana

United States

Illinois

United States

Massachusetts

United States

Maryland

United States

Maine

United States

Louisiana

United States

Idaho

United States

New York

United States

Hawaii

United States

Georgia

County/Region

United States

Florida

United States

Delaware

United States

Connecticut

United States

Colorado

Baltimore County

United States

California

Chicago City

United States

Arkansas

Broward County, Duval County, Palm Beach County

United States

Arizona

Riverside County, San Diego County

United States

Alaska

Maricopa County

United States

Alabama

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