new dataset overview july 28, 2009 special diabetes program for indians demonstration projects: year...

New Dataset Overview

July 28, 2009

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


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.


SDPI Demonstration Projects: Transition to the new datasets

Year 5 Year 6

July - Sept, 2009 Jan - March, 2010Oct - Dec, 2009 July - Sept, 2010April - June, 2010

ONE YEAR PILOT OF NEW DATASETS

Implement new dataset, obtain grantee input, revise

August 1, 2009 July 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:

• 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


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 Forms New Forms


Original Forms vs. New FormsAssessments

Original Assessment Forms New 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


Original Forms vs. New FormsQuestionnaires

Original Questionnaires New 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

• 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


Original Forms vs. New FormsAnnual December Forms


Participant Attendance and Retention Forms

Old I2/I3 Forms New 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


Original Forms vs. New FormsNew Forms Chart

Program

Visit DP HHBaseline C1

C2C1C2

Ongoing (Attendance) P1.D P1.H

Post-DPP Class C1C2

-

Annual C1C2

C1C2

Mid-Year M1.D -As needed (Retention) P2.D P2.H

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.



IRB/HIPAA ImplicationsIRB

• 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 Collectiono 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.

IRB/HIPAA ImplicationsHIPAA


• 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

Submitted Forms through June 2009


DP Assessments through June 2009


2149 Active Participants

HH Assessments through June 2009


2375 Active Participants

new dataset overview july 28, 2009 special diabetes program for indians demonstration projects: year...

Documents

new datasets year

new participants

new forms participant

indians demonstration

new forms switch

year pilot of new datasets

annual assessment switch

diabetes prevention