Special Diabetes Program for Indians Competitive Grant Program

1. SPECIAL DIABETES PROGRAM FOR INDIANS Competitive Grant Program Technical Assistance Meeting Day 1 Recruitment, Screening/Eligibility, Enrollment Special Diabetes Program for Indians Competitive Grant Program

2. SDPI CGP Diabetes Prevention Program Coordinating Center Staff - DP ProgramAlisa Katai DP Project Coordinator 303-724-0288 alisa.katai@uchsc.eduKaren Wilde Rogers DP Data Coordinator 303-724-1422 karen.rogers@uchsc.edu Sandy Janis DP Program Specialist 303-724-0678 sandra.janis@uchsc.edu Melanie Mandelin, MD Clinical Consultant 602-576-1680 meljoy5@cox.net

3. SDPI CGP Diabetes Prevention Program CORE ELEMENTS:RecruitmentCORE ELEMENTS:Screening and Eligibility

4. FIGURE 2: OVERVIEW OF DATA COLLECTION ACTIVITY STEP RECRUITMENT: 1 SCREENING, REGISTRY, RECRUITMENT Ongoing until recruitment goals met BASELINE ASSESSMENTS 2 DP: Within month before beginning curriculum HH: Within month before beginning case management INTENSIVE ACTIVITIES 3 HH: Case management and HGHH Curriculum DP: DPP Curriculum and Lifestyle Coaching FOLLOW - UP ASSESSMENTS (DP ONLY) 4 Within a month of completion of DPP Curriculum AFTER - CORE ACTIVITIES (DP ONLY) Lifestyle Coaching and Reinforcement Activities 4a ANNUAL AFTER INTENSIVE ACTIVITY 5 Anniversary of Baseline Assessment ANNUAL (DECEMBER) Annual reports and Questionnaires 6 ONE TIME TELEPHONE INTERVIEW 7 Selected providers interviewed by CC

5. Overview – What’s in the Core Elements? Core Elements: Recruitment Recruitment (Enrollment) Goals Recruitment Team Reaching people to screen - Settings/Methods/Materials Invitation to Enroll Entry Process - Prepare for Baseline Evaluation – Documentation of Recruitment Activities Core Elements: Screening Inclusion Criteria Who to Screen – Who is at risk for Diabetes? Exclusion Criteria Screening (process) Screening (results) Evaluation – Documentation of Screening Activities SDPI CGP Diabetes Prevention Program Where to find the Core Elements Operations Manual/ Appendices Website: DP Project Materials and Resources

6. SDPI CGP Diabetes Prevention Program Progression of Activities Recruitment: Recruitment (Enrollment) Goals Recruitment Team Who to Screen – Who is at risk for Diabetes? Reaching People to Screen- Settings/Methods/Materials Screening: Screening (Process) Screening (Results) Inclusion Criteria Exclusion Criteria Recruitment: Invitation to Enroll Entry Process - Prepare for Baseline Evaluation Documenting Recruitment and Screening Activities

7. Enrollment Goals 48/year - suggestion for pacing “year” can end in December 144 participants with pre-diabetes have completed curriculum by end of 3 years Enroll a few more to allow for drop-outs This is a GOAL show “good faith effort” of strong recruitment/retention efforts Website/Materials/Resources Grantee Strategies, Challenges, and Solutions TOTW Common Issues/Questions What if I can’t get 48 people through the course by September? Where did goal of 48 come from? SDPI CGP Diabetes Prevention Program

8. Recruitment Team Recruitment Team members Recruiter Project Coordinator, Data Coordinator Educator, Lifestyle Coach Provider (oversight of screening/clinical issues) Other project staff as needed Meetings Monthly first year (at least quarterly thereafter) Purpose Develop and implement Recruitment Plan Review activities, identify successes/challenges problem-solve and modify Plan problem-solve screening issues with individuals Documentation Document monthly meetings - date, topics, attendees minutes encouraged Forms Recruitment Team Meetings Form Common Issues/Questions Confidentiality/Privacy for discussing screening results on individuals What goes in a Recruitment Plan? SDPI CGP Diabetes Prevention Program

9. Who to Screen – Who is at risk for Diabetes? Anyone with at least one risk factor: Family member with diabetes Overweight - BMI ≥ 25 Age ≥ 35 Habitual inactivity Previous Pre-DM diagnosis Gestational diabetes Deliver baby > 9 lbs History of Polycystic Ovarian Syndrome Any other component of Metabolic Syndrome Abdominal obesity/waist: men > 40”, women > 35” Waist/hip ratio: men > 0.9, women > 0.85 Hypertension/blood pressure ≥ 130/85 Low HDL: men < 40, women < 50 High Triglycerides > 150 Fasting plasma glucose ≥100 Website/Materials/Resources IHS Guidelines for Pre-DM and Metabolic Syndrome ADA Risk Test Common Issues/Questions Confidentiality/Privacy when discussing risk factors with individuals SDPI CGP Diabetes Prevention Program

10. Reaching People to Screen –Settings/Methods Settings Community Clinic Methods Community-based activities, events Clinic referrals RPMS / Clinic records Contacts with tribal councils, providers, community – update often Recruitment Plan Website/Materials/Resources Project Materials and Resources RPMS Training Info Forms Recruitment Activities Annual Report Common Issues/Questions Confidentiality/Privacy – RPMS - HIPAA issues What goes into a Recruitment Plan? What works in your community? SDPI CGP Diabetes Prevention Program

11. SDPI CGP Diabetes Prevention Program Reaching People to Screen – Recruitment Materials National project name, logo Common set of recruitment materials Project fact sheet, brochure, newsletter DPP Message of Hope Video Local Materials Local program name, logo (local culture) Brochures, flyers, posters Radio, TV Ads, PSAs Newspaper ads, articles Community Presentations (PowerPoint) Items with project name/logo on them Incentives Use national brochure, newsletter as templates Word of mouth Website/Materials/Resources • CGP Website • Grants Mgmt FAQs • Community Toolbox • Grantee Strategies, Challenges and Solutions • Incentives List • Community-Based Activities List • Meetings Materials • Brochure, Logo • Spotlight newsletter • Other grantees’ materials • IHS Incentives Policy • Technical Assistance Conference Calls • Your Community • Local vendors, artists • focus groups • Community calendar

12. Screening (process) Find people: Community search: provider referral, RPMS/clinic records, self-referral, other Do Screening: Community: Random Fingerstick and ADA Risk Test Positive (either) - refer for OGTT Negative (both) - track for future re-screening Clinic: Referral to project based on history, abnormal labs, risk factors, ADA risk test, provider judgment Confirm for diagnosis: do OGTT Positive and no exclusions - invite to enroll Negative - track for future re-screening Do ADA risk test if not already done Website/Materials/Resources Operations Manual Registry Guidelines Forms Community Screening Worksheet Registry Input Form Excel Registry Common Issues/Questions Confidentiality/Privacy at all times Why do ADA risk test in clinic? Who goes into Excel Registry? SDPI CGP Diabetes Prevention Program

13. Screening (results) Positive Screening - Refer for OGTT Random Fingerstick 100-250 OR ADA Risk test score ≥ 10 Positive OGTT = Pre-Diabetes - ? Invite to Enroll FBG (1st test) 100-125 OR 2-hr (2nd test) 140-199 SDPI CGP Diabetes Prevention Program

14. Screening and Diagnosis (interpreting results) Screening: Random Capillary Fingerstick and ADA Risk Test Normal fingerstick < 100 and ADA test < 10 Abnormal fingerstick 100-250 or ADA test ≥ 10 Possible DM fingerstick > 250 Diagnosis: OGTT (FBG and 2-hr result) Normal FBG < 100 Pre-DM (IFG) FBG 100-125 Possible DM FBG > 125 OR Normal 2-hr < 140 Pre-DM (IGT) 2-hr 140-199 Possible DM 2-hr ≥ 200 SDPI CGP Diabetes Prevention Program

15. Screening - Eligibility Inclusion Criteria Diagnosis of Prediabetes (IFG or IGT) Documented previous diagnosis of Pre-DM Exclusion Criteria Under age 18 Normal Glucose Metabolic Syndrome with No Prediabetes Previous/Current Diagnosis of Diabetes ESRD on Dialysis Provider Judgment on ability to participate: Cancer under treatment Active Alcohol/Substance Abuse Other unusual condition or life situation Current Pregnancy (may start 6 weeks after delivery) Website/Materials/Resources Core Elements Clinical Guidelines Dr. Mandelin Forms Registry Input Form Common Issues/Questions Confidentiality/Privacy in all clinic measures and discussions Why not children? Eligible if on Metformin? Eligible if previous Pre-DM diagnosis, but glucose normal now? What if becomes pregnant during program? SDPI CGP Diabetes Prevention Program

16. Invitation to Enroll Invite to Participate - describe project Administer Informed Consents Participant Signs Consents Consents are Required collecting/submitting personal health data consent for screening not required by IHS National IRB, but may be required locally Common Issues/Questions Confidentiality/Privacy at all times Why consent needed? SDPI CGP Diabetes Prevention Program

17. Consent Forms Consent for Participation in Program Example Participant Consent Form Participant Consent Talking Points HIPAA B Form Example HIPAA B Form Consent for Family Members Example Family Consent Form Participant Consent Talking Points Consents must be signed BEFORE starting baseline or intensive activities Need to make sure that participant really understands the project and what information will be released Website/Materials/Resources Operations Manual Informed Consent Talking Points (participant, family) IRB/HIPAA Training Info Forms Participant Consent Form Family Consent Form HIPAA B Form Common Issues/Questions Confidentiality/Privacy at all times SDPI CGP Diabetes Prevention Program

18. Informed Consent Process Describe Project(group or individual presentation) Enrollment Talking Points Administer Informed Consents describe data to be collected, confidentiality, who sees data, risks/benefits, voluntary nature, contact info emphasize commitments (Participant) Participating in activities – 16 classes, lifestyle coaching visits, exercise, other classes/activities, after-core (Participant and Family Member) Completing assessments and questionnaires time for questions Participant/Family Member Signs Website/Materials/Resources Operations Manual Description of HIPAA B forms Enrollment Talking Points Informed Consent Talking Points (participant, family) IRB/HIPAA Training Info Forms Participant Consent Form Family Consent Form HIPAA B Forms Common Issues/Questions Confidentiality/Privacy during consenting process Timing of family consent Family consent required? What is family member’s commitment to project? Submit consents to CC? SDPI CGP Diabetes Prevention Program

19. Entry Process – After Consents Signed Instructions/Information on next steps Prepare for Baseline If first class of next group starts within 1 month after consenting immediately schedule Baseline activities If first class of next group starts more than 1 month after consenting delay Baseline activities until 1 month before first class of next group Document Recruitment and Screening Activities Document as you go Next Step – Baseline Activities Common Issues/Questions Streamline number of times person comes in for enrollment and baseline activities If longer delay until classes start, what to do with the participant? SDPI CGP Diabetes Prevention Program