SS Part B_12 19 2014

CDC Diabetes Prevention Recognition Program

Revision

OMB No. 0920-0909

Supporting Statement: Part B

Program official/project officer: Russell Sniegowski, MPH (NCCDPHP/DDT/OD)

Centers for Disease Control and Prevention

Division of Diabetes Translation

Telephone number: 770-488-5033

Fax number: 770-488-8634

Email address: [email protected]

September 11, 2014

Updated December 19, 2014

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

1A Authorizing Legislation Public Law 111-148

1B Authorizing Legislation PHSA

2A Federal Register Notice

2B Summary of Public Comments

2B American Association of Diabetes Educators

2B America’s Health Insurance Plans

2B American Medical Association

2B Healthcare Leadership Council

2B San Juan Regional Medical Center

2B Weight Watchers International, Inc.

2B Wisconsin Division of Public Health

2B YMCA of the USA

3 DPRP Standards 2014

4A DPRP Application Form and Instructions (screenshot)

4B DPRP Homepage (screenshot)

4C DPRP Confirmation Page (screenshot)

4D DPRP Confirmation Email

4E DPRP Application Acceptance Email

4F DPRP Application Rejection Email

5A Data Dictionary: Evaluation Data Elements (updated 2014)

5B Data Dictionary: Evaluation Data Elements (previously approved by OMB 2011)

5C DPRP Data Web Application (screenshot)

5D(1) Data Reminder Email (4 weeks prior to due date)

5B(2) Data Reminder Email (2 weeks past due)

5D(3) Loss of Recognition Email (Failure to Send in any Data at 18 Months)

5D(4) Progress Report

5D(5) Evaluation report

5D(5) Evaluation Report (Determination of Full Recogniton)

5D(6) Loss of Recognition Email (Failure to Meet Standards)

5D(7) Notification of Achievement of Full Recognition

6 Overview of Changes

Section B. Collections of Information Employing Statistical Methods

Statistical methods are not used to select respondents. Respondents (organizational entities offering a type 2 diabetes prevention lifestyle intervention and seeking recognition by DPRP) self-select by applying for recognition.

1. Respondent Universe and Sampling Methods

The potential respondent universe is any organizational entity in the United States desiring DPRP recognition of its type 2 diabetes prevention lifestyle program. We anticipate 350 applicant organizations per year and 1,200 recognized organizations (annualized) submitting evaluation data during the 3-year OMB approval period.

Calculating the Burden for Submitting the Process/Evaluation Data

OMB Year	Previously Recognized Programs	Programs Recognized This Year	Total Recognized Programs	Burden Per Data Submission	Submissions Per Year	Burden Per Year
Year 1	500	350	850	1 hour	1	850 hours
Year 2	850	350	1,200	1 hour	1	1,200 hours
Year 3	1200	350	1,550	1 hour	1	1,550 hours
Total for 3 years			3,600			3,600 hours
Annualized Total			1,200			1,200 hours

2. Procedures for the Collection of Information

For organizations approved after 12/1/2014 (pending OMB approval)

DPRP will be administered according to the CDC Diabetes Prevention and Recognition Program: Standards and Operating Procedures (DPRP Standards) (Attachment 3). Any organization with the capacity to deliver a lifestyle intervention meeting DPRP Standards may apply for recognition. Organizations seeking recognition complete and submit an online application form (Attachment 4A) which includes organization contact information, the curriculum to be used and the mode of delivery. The DPRP application form is located on the DPRP Web site (www.cdc.gov/diabetes/prevention/recognition) (Attachment 4B), and may be submitted at any time.

After submitting the application form, the organization sees a confirmation Web page (Attachment 4C) and receives a confirmation e-mail (Attachment 4D). When the applicant indicates that they are using the CDC-preferred curriculum, DPRP staff notify the applicant by e-mail of the outcome of the application within 15 working days. When the applicant indicates that they are using an alternative curriculum, DPRP staff review the alternative curriculum along with the application. In this case, DPRP staff notify the applicant by e-mail of the outcome of the application within 30 working days.

When an organization’s application has been reviewed and accepted, DPRP sends an e-mail to the organization’s contact person indicating that the organization has been awarded pending recognition status (Attachment 4E). This e-mail includes the unique organization code assigned by DPRP, the organizations’s effective date (the first day of the month following DPRP approval) which determines the due date for evaluation data submissions, and the e-mail address to which evaluation data are to be submitted. At the same time, the organization is listed in the DPRP Registry. When organization’s application is not accepted, DPRP notifies the applicant by e-mail (Attachment 4F). These acceptance/rejection email messages are individualized to reflect specific issues associated with acceptance/rejection (curriculum used, reason(s) for rejection, etc.).

When an application for recognition is approved, the organization will have pending recognition status and may begin offering classes on or after the application approval date. An organization should begin delivering sessions to participants within six months of its effective date. Thus, there should be at least six months of participant data in the organization’s first 12-month data submission (12 months after the effective date).

Evaluation data is transmitted to DPRP by the organization every 12 months in accordance with DPRP Standards (Attachment 3). To minimize the burden on applicant organizations and to ensure the quality and utility of the data, each evaluation data transmission consists of a single data file submitted via a DPRP web application (Attachment 5C). Detailed specifications for the evaluation data file are contained in DPRP Standards Data Dictionary: Evaluation Data Elements (Attachment 5A).

The DPRP Standards require organizations to submit evaluation data to DPRP every 12 months from the organizations’ effective dates (the 1st day of the month following the approval of an organization’s application). This allows for timely data analysis and provides opportunities for applicant organizations to receive interim feedback on its progress in meeting recognition requirements over the course of a complete lifestyle change program. Data may be submitted at any time during the month of the effective date. Organizations failing to submit complete and acceptable data in the month in which it is due or failing to report attendance in a 12-month period will lose recognition and must wait 12 months before re-applying.

The first annual data submission (12 months post-effective date) must include one record for each session attended by each participant during the preceding year (if organizations choose to allow a participant to attend sessions for longer than 12 consecutive months then only the first 365 days of data per participant should be reported to the DPRP). The first data submission must also include records for any sessions attended between the approval date and the effective date. After the first (12 month) data submission, CDC will provide the organization with an interim progress report (PR).

Recognition status is initially assessed 24 months after the organization’s effective date, and the organization receives full recognition status if it has demonstrated program effectiveness by achieving all of the remaining requirements described in DPRP Standards. These recognition requirements are assessed based on data from all of the lifestyle interventions (each having duration of 1 year) that were delivered in their entirety by the organization during the 24-month period.

If, after 24 months the applicant organization has not achieved all of the requirements for full recognition, it continues in pending recognition status for an additional 12 months. During this period, DPRP continues to provide technical assistance to the organization to help it achieve full recognition. A 36-month evaluation will be performed, based on data from participants who attended their first session at least one year but not more than 2 years before the submission due date. If the organization is not successful in achieving full recognition at the end of this period (36 months after its effective date), it loses recognition and must wait 12 months before it may reapply for recognition

Fully recognized organizations continue to submit evaluation data every 12 months and are reevaluated every 12 months, but do not reapply for recognition. Organizations failing to meet all the standards for full recognition for two consecutive years will lose recognition and must wait 12 months before reapplying for recognition. An organization that does not report attendance during any 12-month period will receive notice of Loss of Recognition (LOR) and may be required to wait 12 months before re-applying for recognition.

Four weeks prior to the data due date, DPRP will send an e-mail reminder to the organization’s contact person regarding the data submission requirement and data due date (Attachment 5D(1)). The first data submission is due on the anniversary of the organization’s effective date. The effective date is the first day of the month following the application approval date. This date determines the organization’s data submission, evaluation, and recognition timeline. It also determines the timing of future data submission reminders, which are sent to the organization approximately 2 weeks after each due date (Attachment 5D(2)). Data may be accepted at any time during the month of the effective date month.

Organizations failing to submit data in the month in which it is due or consistently submitting incorrect data (e.g., in an incorrect format) will lose recognition. Notification of loss of recognition is made by e-mail (Attachment 5D(3)).

For organizations approved prior to 12/1/2014 (pending OMB approval)

Organizations recognized prior to the effective date of the 2014 standards, especially those having submitted evaluation data, cannot reasonably be expected to comply with the new standards immediately, as doing so would be disruptive and detrimental to organizational operations and performance. Thus, a transition plan was developed to help facilitate the transition from the previously approved data elements in the 2011 DPRP Standards (OMB Control Number 0920-0909, expiration date: November 30, 2014) (Attachment 5B) to the revised data elements in the 2014 DPRP Standards (Attachment 5A). The organizations covered under the transition plan will, because of the change in the frequency of data submissions (from every six months to every 12 months), have a single data submission due between the effective date of the 2014 standards (approximately 12/1/2014) and 11/30/15. Organizations wishing to do so (e.g., while in the process of adapting their data systems) may, for this single data submission, submit the previously approved data elements. The previously approved data elements

(Attachment 5 B) includes all of the data elements to be submitted by organizations approved after 12/1/2014, except for “Participant State,” and also includes the following: Core Group Code, Location Code, Lifestyle Coach ID, Session Type and Session ID.

For more deailed information on the transiton plan, see Attachment 3 DPRP Standards: Appendix F: Transition Plan for Organizations Recognized Prior to December 1, 2014.

DPRP correspondence related to receipt/non-receipt of data, data issues (missing or miscoded data), technical assistance and recognition/failure to achieve recognition is personalized and the content must be individualized to address one or more specific issues or organizational needs and/or whether the organization is covered by the transition plan. Thus, it is not feasible to include templates for every reason that an organization might be contacted by the DPRP. Sample correspondence is included for review as follows: data reminder email (4 weeks prior to due date) (Attachment 5D(1), data reminder email (2 weeks past due date) Attachment 5D(2), loss of recognition for failure to submit data Attachment 5D(3), progress report Attachment 5D(4), evaluation report (Attachment 5D(5), loss of recognition for failure to meet standards (Attachment 5D(6), and achievement of full recognition (Attachment 5D(7)).

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

CDC designed this information collection to minimize the burden to respondents and to the government, to maximize convenience and flexibility, and to ensure the quality and utility of the information collected. One hundred percent of the information submitted to DPRP is submitted electronically, as is specified in DPRP Standards.

Periodically, CDC provides training, through platforms that include webinars, to organizations that have questions or may be encountering challenges in providing CDC the required information within the required timeframes. The frequency and nature of these sessions are based on both demand and issues that emerge that are shared by multiple organizations.

The online application form and instructions (Attachment 4A), complete specifications for the evaluation data elements and instructions for their transmission (Attachment 5A), and DPRP Standards are posted on the DPRP Web site (www.cdc.gov/diabetes/prevention/recognition) (Attachment 4B). Potential applicants are encouraged to read and carefully review all of this information before applying for recognition.

Participation by organizations is strictly voluntary. Organizations may withdraw from DPRP at any time by not transmitting evaluation data or for stating reasons specific to the organization. No additional withdrawal notification is required. Organizations that do not transmit evaluation data as required do not achieve and maintain full recognition. As a courtesy, CDC sends e-mails to remind recognized organizations of data submission due dates four weeks before and two weeks after data is due (Attachment 5D(1), Attachment 5D(2)).

4. Tests of Procedures or Methods to be Undertaken

Prior to receiving initial OMB approval, a DPRP workgroup comprised of internal and external members, which included representatives from potential respondent organizations, met for approximately one year. During this time, the workgroup provided input on required data elements, frequency of transmission to CDC and on the application form and instructions. A hard copy of the DPRP application form was pilot tested with seven individuals, three CDC employees and four staff of potential applicant organizations. Feedback was reviewed by DPRP staff and the DPRP Standards (Attachment 3) and the online application form (Attachment 4A) were revised as deemed appropriate.

Several programmatic changes suggested by potential applicants and recognized organizations, received over the lifetime of the National Diabetes Prevention Program, have been incorporated into the revised DPRP Standards (Attachment 3). These programmatic changes resulted in the need for changes to the data elements being collected (Attachment 5A). Two additional data elements have been added (program delivery mode in the application form and Participant State in the evaluation data). Also, the coding for the Participant Diabetes Determination has been simplified to eliminate the need for confirmation of the type of blood test used for participant eligibility (reducing the number of required responses from five to three). Finally DPRP is eliminating the following data elements that have proven to be problematic to ogranizations, have not proven useful for analyses or would not be applicable to both in-person and virtual delivery modes: Core Group Code, Location Code, Lifestyle Coach ID, Session Type and Session ID.

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

Staff in CDC’s DDT (CDC personnel and contractors) developed and maintain the DPRP Web site, including the online application form and the web application [program] for data submission. All data management, analysis, and reporting are performed at CDC by DDT staff and on-site contractors. The individuals listed below were consulted on all statistical aspects of DPRP. DDT staff will be responsible for DPRP data collection and data analysis.

Ann Albright, PhD, RD

Director

Division of Diabetes Translation

Centers for Disease Control and Prevention

Phone: 770-488-5000

Elizabeth Ely, MS

Mathematical Statistician

Division of Diabetes Translation

Centers for Disease Control and Prevention

Phone: 770 488-8086

Email: [email protected]

Deborah B. Rolka, MS

Statistics Team Lead

Division of Diabetes Translation

Centers for Disease Control and Prevention

Phone: 770-488-8395

E-mail: [email protected]

Russell Sniegowski, MPH

Coordinator, Diabetes Prevention Recognition Program

Division of Diabetes Translation

Centers for Disease Control and Prevention

Phone: 770-488-5033

E-mail: [email protected]

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