SDPI Healthy Heart Project SDPI Competitive Grant Program Technical Assistance Meeting October 23-24, 2006 Tucson, AZ Core Elements: Recruitment and Screening – Required Activities

SDPI Healthy Heart Project OVERVIEW – What we will cover in this session Recruitment and Screening  Recruitment Core Elements  Screening and Eligibility Core Elements  Overview of materials/Information available to assist you with recruitment activities  Process for “consenting” a participant Core Elements: Recruitment and Screening – Required Activities

SDPI Healthy Heart Project RECRUITMENT CORE ELEMENTS RECRUITMENT CORE ELEMENTS  Recruitment Goals  Recruitment for Intensive Activities Recruitment Team Recruitment Team Lead RecruiterLead Recruiter Other Intensive Activity Team membersOther Intensive Activity Team members Settings for Recruitment Settings for Recruitment Methods of Recruiting Participants Methods of Recruiting Participants Core Elements: Recruitment – Protocol/Required Activities

SDPI Healthy Heart Project Core Elements: Recruitment – Protocol/Required Activities  Marketing Materials for Recruitment Common project name, design Common project name, design Common set of recruitment materials Common set of recruitment materials Basic message – Fact Sheet Basic message – Fact Sheet Types of materials Types of materials Use of Incentives for recruitment activities Use of Incentives for recruitment activities

SDPI Healthy Heart Project Core Elements: Recruitment – Protocol/Required Activities  Process to help interested individuals at risk for diabetes participate in screening process Identification of interested individuals Identification of interested individuals Develop screening plan Develop screening plan Screen for eligibility Screen for eligibility  Invitation to participate Informed Consent Informed Consent  Entry/Enrollment process Information/Instructions on next steps Information/Instructions on next steps Appointment for baseline assessment Appointment for baseline assessment

SDPI Healthy Heart Project SCREENING CORE ELEMENTS   Participation in Intensive Activities Eligibility Diagnosis of Diabetes NOT Eligible Metabolic Syndrome Prediabetes Normal Glucose Core Elements: Screening and Eligibility – Required Activities

SDPI Healthy Heart Project Identification of Individuals for Screening for Diabetes:  Identify individuals at risk for diabetes  Exclude individuals from participation in this project with the following diagnoses/conditions: Pregnancy Pregnancy Active Alcohol or Substance Abuse Active Alcohol or Substance Abuse ESRD on Dialysis ESRD on Dialysis Current Cancer Diagnosis – with restrictions Current Cancer Diagnosis – with restrictions Other Other Core Elements: Screening and Eligibility – Required Activities

SDPI Healthy Heart Project Screening and Diagnosis  Screening may occur during community events/activities or in the clinic – the specific screening activities differ based on the site: Community events/activities Community events/activities Clinical settings Clinical settings Core Elements: Screening and Eligibility – Required Activities

SDPI Healthy Heart Project  Recruitment and Screening Activities – the Abridged Version of what you need to do: Get information about individuals who may be interested in participating (community event, RPMS, clinic referral) Get information about individuals who may be interested in participating (community event, RPMS, clinic referral) Fill out appropriate information on Registry Input Form and enter contact information into Registry Fill out appropriate information on Registry Input Form and enter contact information into Registry Invite individuals to learn more about the project (presentation, meeting, 1:1, etc.) Invite individuals to learn more about the project (presentation, meeting, 1:1, etc.) Screen for diabetes as necessary Screen for diabetes as necessary Complete Consenting Process and set appointments for screening physical exam/baseline activities Complete Consenting Process and set appointments for screening physical exam/baseline activities Core Elements: Recruitment and Screening

SDPI Healthy Heart Project  Process for “Consenting” a participant Describe the project (group or individual presentation) Describe the project (group or individual presentation) Enrollment Talking PointsEnrollment Talking PointsEnrollment Talking PointsEnrollment Talking Points Ask if individual is still interested in becoming a participant Ask if individual is still interested in becoming a participant Informed Consent Talking PointsInformed Consent Talking PointsInformed Consent Talking PointsInformed Consent Talking Points Emphasize the longevity and commitment needed for the project – monthly case management visits, filling out baseline and annual questionnaires Emphasize the longevity and commitment needed for the project – monthly case management visits, filling out baseline and annual questionnaires Stress the nature of it being “more intensive” than regular care and that they will need to commit themselves to that (monthly visits, special activities, etc.) Stress the nature of it being “more intensive” than regular care and that they will need to commit themselves to that (monthly visits, special activities, etc.) Need to make sure that participant really understands the project including HIPAA and what information will be released Need to make sure that participant really understands the project including HIPAA and what information will be released Core Elements: Recruitment and Screening

SDPI Healthy Heart Project  Information to assist with enrollment activities The documents below can be found on the Coordinating Center Website under Data Collection/Forms/: The documents below can be found on the Coordinating Center Website under Data Collection/Forms/: or under Forms, Step 1, of the SDPI Operations Manual Registry Input Form – Enrollment Talking PointsRegistry Input Form – Enrollment Talking Points Informed Consent Process Talking PointsInformed Consent Process Talking Points The document listed below can be found on the Coordinating Center Website under Resources/Other Resources: The document listed below can be found on the Coordinating Center Website under Resources/Other Resources: BrochureBrochure Core Elements: Recruitment and Screening

SDPI Healthy Heart Project RECAP  Recruitment and Screening Recruitment Core Elements Recruitment Core Elements Screening and Eligibility Core Elements Screening and Eligibility Core Elements Recruitment and Screening Activities Recruitment and Screening Activities Process for “consenting” a participant Process for “consenting” a participant Overview of materials/Information available to assist you with recruitment activities Overview of materials/Information available to assist you with recruitment activities Core Elements: Screening and Eligibility – Required Activities