1. New Dataset Overview July 28, 2009 SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1

2. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 Overview Purpose/Goals Timeline / Pilot Year Plan Original Forms vs. New Forms IRB/HIPAA Implications

3. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 New Dataset Purposes/Goals To monitor the ongoing effectiveness of the diabetes prevention and CVD risk reduction interventions that the grant programs implement. To ensure accountability of the grant programs, while at the same time allowing the programs to focus their energies on providing services rather than on a costly and labor-intensive data collection effort. To guide dissemination, implementation, and evaluation of future program development.

4. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 New Dataset Purposes/Goals The New Datasets will meet these goals by limiting the data collection to only the data elements necessary to: Evaluate the intermediate outcomes of the diabetes prevention and CVD risk reduction interventions among SDPI participants, such as weight, exercise, diet, smoking, blood pressure, lipid levels, and glycemic measures. Evaluate the long-term outcomes of the interventions among SDPI participants, i.e., prevention of diabetes and reduction of cardiovascular disease.

5. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 SDPI Demonstration Projects: Transition to the new datasets Year 5Year 6 July - Sept, 2009Jan - March, 2010Oct - Dec, 2009July - Sept, 2010April - June, 2010 ONE YEAR PILOT OF NEW DATASETS Implement new dataset, obtain grantee input, revise August 1, 2009July 31, 2010 New Participants: Transition Participants: Original Participants: Use new forms Switch to new forms after 1st annual assessment Switch to new forms Participant Groups: Enrolled on or after 8/1/2009 Enrolled prior to 8/1/2009 with no annual assessment by 7/31/09: Enrolled prior to 8/1/2009 with at least one annual assessment by 7/31/09:

6. C1 – Comprehensive Assessment Form (combined DP and HH) C2 – Comprehensive Participant Questionnaire (combined DP and HH) P1 (the previous I2) P2 (the previous I3) M1 SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 Original Forms vs. New Forms Participant Baseline Assessment B1 Participant Baseline Questionnaire B2 Family Baseline Questionnaire B3 Participant Follow-up Assessment F1 Participant Follow-up Questionnaire F2 Family Follow-up Questionnaire F3 Participant Annual Assessment A1 Participant Annual Questionnaire A2 Family Annual Questionnaire A3 Mid-Year Assessment Form M1 Participant Attendance Form I2 Individual Retention Form I3 Recruitment Team Meetings Form R3 Team Meetings Form I1 Recruitment Activities Annual Report AD1 Retention Activities Annual Report AD2 Provider Annual Questionnaire AD3 Organization Annual Questionnaire AD4 Community Annual Questionnaire AD5 After-Core Activities Annual Report AD6 SAE Original FormsNew Forms

7. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 Original Forms vs. New Forms Assessments Original Assessment FormsNew Assessment Form B1 - Participant Baseline Assessment F1 - Participant Follow-Up Assessment A1 - Participant Annual Assessment M1 - Mid-Year Assessment C1 - Comprehensive Baseline, Post-DPP Class, and Annual Assessment; combined HH and DP M1 - Mid-Year Assessment

8. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 Original Forms vs. New Forms Questionnaires Original QuestionnairesNew Questionnaire B2 - Participant Baseline Questionnaire F2 - Participant Follow-Up Questionnaire A2 - Participant Annual Questionnaire C2 - Comprehensive Baseline, Post-DPP Class, and Annual Questionnaire; combined HH and DP

9. Recruitment Team Meetings Form R3 Team Meetings Form I1 Recruitment Activities Annual Report AD1 Retention Activities Annual Report AD2 Provider Annual Questionnaire AD3 Organization Annual Questionnaire AD4 Community Annual Questionnaire AD5 After-Core Activities Annual Report AD6 SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 Original Forms vs. New Forms Annual December Forms

10. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 Participant Attendance and Retention Forms Old I2/I3 FormsNew P1 and P2 Forms I2 - Individual Attendance Form I3 - Individual Retention Form P1 – Participant Attendance Form; Simplified P2 – Participant Retention Form; Simplified * P1 always submitted at Post-DPP Class and Annual Assessment * P2 sent with P1 if a participant is becoming inactive OR becoming active after being inactive Original Forms vs. New Forms

11. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 Original Forms vs. New Forms New Forms Chart Program VisitDPHH BaselineC1 C2 C1 C2 Ongoing (Attendance)P1.DP1.H Post-DPP ClassC1 C2 - AnnualC1 C2 C1 C2 Mid-YearM1.D- As needed (Retention)P2.DP2.H

12. Three Participant Groups: Who Uses Which Form? Transition Group Original Group New Group Participants enrolled prior to August 1, 2009, with at least one annual assessment by July 31, 2009, will use the new forms as of August 1, 2009. Participants enrolled prior to August 1, 2009, with no follow-up and/or annual assessment by July 31, 2009, will remain on the old forms through the completion of their first year annual assessment, then switch to the new forms. Participants enrolled on or after August 1, 2009, will use the new forms only. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1

13. SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 IRB/HIPAA Implications IRB Original Evaluation o IHS National IRB decision letter dated September 23, 2005 stated that this initiative fully meets the definition of a public health assessment and does not require IRB approval nor monitoring. o Nonetheless, some programs were required to obtain approval from their local IRB or other approving authority. New Data Collection o Much reduced in depth and breadth and tailored specifically to measure the projects’ intermediate and long-term outcomes. o Conclusion is that IRB approval and monitoring is not required. o Recommendation is to consult with your local approving authority for requirements.

14. IRB/HIPAA Implications HIPAA SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 HIPAA B disclosure form is required and must be signed by each participant HIPAA Violations occur when Protected Health Information (PHI) is sent to the Coordinating Center

15. Submitted Forms through June 2009 SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1

16. DP Assessments through June 2009 SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 187 3 rd Annual 695 2 nd Annual 1413 1 st Annual 2118 Follow-Up (Post-DPP Class) 3344 Baseline Assessments 2149 Active Participants

17. HH Assessments through June 2009 SPECIAL DIABETES PROGRAM FOR INDIANS Demonstration Projects: Year 5 Meeting 1 234 3 rd Annual 830 2 nd Annual 1681 1 st Annual 3214 Baseline Assessments 2375 Active Participants