Applying the Principles of Clinical Trial Management to the Every Diabetic Counts Program

1. Applying the Principles of Clinical Trial Management to the Every Diabetic Counts Program Tom Pianta, MPT Project Director, 7.1 QualityNet December 2009

2. How Is Every Diabetic Counts (EDC) Like a Clinical Trial? What makes EDC work? Beneficiary recruitment Provider recruitment An intervention (EDC) Date collection Data submission

3. How Is EDC Like a Clinical Trial? (con�t) What makes a clinical trial work? Subject recruitment Principal Investigator recruitment An intervention (study protocol) Data collection Data submission

4. What Techniques Work in Clinical Trial Management That Help Achieve the Goals of EDC? For subject/beneficiary recruitment: Physician referral Physician relationship building Advertising: print, radio, PSAs News stories, newsletters

5. What Techniques Work in Clinical Trial Management That Help Achieve the Goals of EDC? (con�t) For Principal Investigator/Provider recruitment: Physician relationship management

6. What Techniques Work in Clinical Trial Management That Help Achieve the Goals of EDC? (con�t) Study protocol (DEEP) A defined process/intervention In EDC, educational process will not be as well defined as a clinical trial protocol

7. What Techniques Work in Clinical Trial Management That Help Achieve the Goals of EDC? (con�t) Data collection and submission Defined data points collected at scheduled points of time across the continuum of the trial/contract

9. What Techniques Work in Clinical Trial Management That Help Achieve the Goals of EDC? (con�t) Quality assurance Data reviewed by more than one person prior to acceptance and entry Time management Pharma and CMS define time periods for submissions and monitor their timeliness and completeness

10. How Did DFMC/DFDC Apply These Principles to 7.1? Project Director defined the project in terms of this process at its onset A structured process put in place for: site recruitment physician relationship management beneficiary recruitment and retention data collection and submission

11. Site Recruitment and Physician Relationship Management Initiated the External Relationship Management Team (ERMT) Meets weekly to provide strategy for PP recruitment and report results Always reviews what QICs can bring PPs that will improve patient care quality and be beneficial to them Created a �call universe� strategy for QICs: which PPs to visit, frequency of visits, messages to deliver

12. Beneficiary Recruitment and Retention  Regular follow up with PPs to collect �beneficiary cards��recruitment cards that allow beneficiaries to sign up for classes Posters, literature placed in senior housing, PP offices, etc. CHWs designated to follow up with enrolled beneficiaries to ensure they attend classes/complete EDC

13. Beneficiary Recruitment and Retention (con�t)

14. Beneficiary Recruitment and Retention (con�t) Initiated the Data Management Team Meets weekly to review: Data submissions (quality checks) Data collection processes (best practices) IQC portal Any other data issues that may come up (RIR calculations, PPRs, etc.)

15. Results Applying clinical trial protocol-type structure to EDC resulted in: Improved staff satisfaction Improved data quality Increased beneficiary recruitment Increased access to PPs

16. Questions? Tom Pianta 410-872-9636 piantat@dfmc.org