Ss-b_0920-15anc_09-02-2015

Formative and Summative Evaluation of the

National Diabetes Prevention Program

Existing Collection Without an OMB Control Number

Supporting Statement: Part B

Program Official/Project Officer: Stephanie Gruss, PhD, MSW

Centers for Disease Control and Prevention

National Diabetes Prevention Program

Telephone number: 770-488-8173

Fax number: 770-488-4639

Email address: Inf6@cdc.gov

September 2, 2015

Table of Contents

Section B Collections of Information Employing Statistical Methods

B.1 Respondent Universe and Sampling Methods

B.2 Procedures for the Collection of Information

B.3 Methods to Maximize Response Rates and Deal with No Response

B.4 Tests of Procedures or Methods to Be Undertaken

B.5 Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data

Attachments

Attachment 1a Authorizing Legislation for the National Diabetes Prevention Program

Attachment 1b Authorizing Legislation for the Public Health Service Act

Attachment 2 National DPP RE-AIM Framework

Attachment 3a Spreadsheet for National DPP Intervention Sites

Attachment 3b Spreadsheet for National DPP Grantees

Attachment 3c Glossary of Terms for Completing National DPP Spreadsheets

Attachment 4 Introductory/Invitation E-Mail

Attachment 5 Reminder E-Mail

Attachment 6 Thank You E-Mail

Attachment 7 IRB Letter

Attachment 8a Federal Register Notice

Attachment 8b Public Comments and CDC Response

Section B. Collection of Information Employing Statistical Methods

B1. Respondent Universe and Sampling Methods

The Centers for Disease Control and Prevention (CDC) funds 6 National Diabetes Prevention Program (National DPP) grantees across 35 states. Each grantee is responsible for scaling and sustaining evidence-based lifestyle change programs for individuals at risk of developing type 2 diabetes. Using electronic Excel data collection spreadsheets, grantees have the opportunity to submit to CDC data on program-level characteristics, strategies, barriers, and facilitators (Attachments 3a and 3b). CDC will collect this data annually and distribute all supporting communication (Attachments 4 to 6). We anticipate a response rate of 100%. The respondent universe is based on 6 National DPP grantees:

1. American Association of Diabetes Educators,

2. America’s Health Insurance Plans,

3. Black Women’s Health Imperative,

4. National Association of Chronic Disease Directors,

5. OPTUM- a UnitedHealth Group, and

6. YMCA of the USA

Each grantee is working with multiple sites. For 2015, the estimated number of sites is 110. This number is expected to increase in 2016 and 2017.

Table B.1-1.Estimated Sample Size

	2015	2016	2017	Annualized
National DPP Grantee	6	6	6	6
National DPP Intervention Site	110	120	130	120

Information will be collected from each grantee and each intervention site. No sampling methods are employed.

B2. Procedures for Collection of Information

Information will be collected annually. Shortly following Office of Management and Budget (OMB) approval, CDC’s National DPP Evaluator/Statistician, Kunthea Nhim, DrPH, MPH, will:

• send an introductory/invitation e-mail to grantees (Attachment 4) along with the attachments of the Excel spreadsheet for the National DPP Intervention Sites (Attachment 3a), the Excel spreadsheet for the National DPP Grantees (Attachment 3b), the Glossary of Terms (Attachment 3c), and Instruction for Form Completion on page 2 of spreadsheets. This e-mail will inform respondents of the spreadsheets and encourage participation in the assessment.

• send a reminder e-mail to those grantees who have not completed the spreadsheet by December 1 (Attachment 5).

• follow up with grantees that have not responded to both the introductory and reminder e-mails via phone call or e-mail to give an overview of the proposed data collection and address any potential questions or concerns grantee respondents may have.

Each grantee will be responsible for completing a grantee-level data collection spreadsheet in addition to distributing site-level data collection spreadsheets to their intervention sites, and collecting and compiling the spreadsheets from their sites. The final spreadsheet to be submitted to CDC include grantee’s responses and one tab per intervention site’s responses. Following submission of the data collection spreadsheets, Dr. Nhim will send grantees an e-mail thanking them for their participation in the assessment (Attachment 6).

Upon receiving completed spreadsheets, CDC will share these via a secure file transfer site with the National DPP’s evaluation contractor, who will then analyze the data and provide feedback to each grantee in the form of an annual assessment reports per each grantee and an annual cross-grantee, de-identified, aggregate assessment report.

B3. Methods to Maximize Response Rates and Deal with Nonresponse

Participation in the National DPP assessment has a clear benefit to grantees, who submit the data collection spreadsheet in order to receive data-driven technical assistance from CDC and individualized feedback in the form of annual assessment reports per each grantee and an annual cross-grantee, de-identified, aggregate assessment report. As such, we anticipate a high rate of response and significant cooperation on this CDC assessment from grantee program directors and project coordinators. In order to increase rates of participation, we will also employ introductory e-mails, follow up reminder e-mails, and additional follow up phone calls if needed.

B4. Tests of Procedures or Methods to Be Undertaken

The spreadsheet is based on the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) evaluation framework (see Attachment 2) referenced in the FOA and lessons learned from technical assistance activities conducted in Years 1 and 2. The RE-AIM framework identifies pertinent questions around process and outcome measures for monitoring grantee’s activities and progress. In Year 1, the six grantees provided qualitative information to CDC about activities at their intervention sites. CDC and the grantees used the qualitative reports and the RE-AIM framework to define the data elements to be used for process evaluation. A prototype of the instrument was fielded in Year 2. The Year 2 responses allowed CDC and grantees to further refine the process indicators, data items, and response options needed to accurately characterize their program implementation activities. The information collection for Years 3, 4, and 5 (Attachments 3a and 3b) is based on these initial developmental activities.

B5. Individuals Consulted on Statistical Aspects and Individual Collecting and/or Analyzing Data

The spreadsheets will be reviewed by CDC staff with expertise in National Diabetes Prevention Program implementation and assessment. This includes the CDC National DPP Acting Team Lead, Stephanie Gruss, PhD, MSW, the CDC National DPP Evaluator/Statistician, Kunthea Nhim, DrPH, MPH, and CDC-designated evaluation contract staff.

The grantee and site program-level information will be analyzed by the National DPP Evaluation Contractor, while the aggregated de-identified site-level outcomes will be analyzed by the CDC National DPP Evaluator/Statistician. The evaluation contractor will receive regular guidance and feedback from CDC throughout the analysis process. This assessment effort will result in several dissemination products, including annual grantee assessment reports, annual cross-grantee assessment reports, and at least one manuscript.

Table B.5-1 Staff Responsible Data Collection and Analyses
Name	Affiliation	Telephone	E-mail
Stephanie Gruss, PhD, MSW	CDC COR Level II	770-488-8173	inf6@cdc.gov
Kunthea Nhim, DrPH, MPH	CDC Evaluator/ Statistician	770-488-0912	xmh8@cdc.gov
Deborah Porterfield, MD, MPH	National DPP Evaluation Contract Manager	919-843-6596	dporterfield@rti.org
Sara Jacobs, PhD	National DPP Evaluation Contract Statistician	770-407-4951	sjacobs@rti.org

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