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

SDPI CGP Diabetes Prevention Program Coordinating Center Staff - DP Program Alisa Katai DP Project Karen Wilde Rogers DP Data Sandy Janis DP Program Melanie Mandelin, MD Clinical

SDPI CGP Diabetes Prevention Program CORE ELEMENTS: Recruitment CORE ELEMENTS: Screening and Eligibility

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

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

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 EvaluationDocumenting Recruitment and Screening Activities

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

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

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

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

SDPI CGP Diabetes Prevention Program 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 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

Screening (process) 1.Find people: –Community search: provider referral, RPMS/clinic records, self-referral, other 2.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 3.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

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

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

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

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

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

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

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