150 likes | 420 Views
How Is Every Diabetic Counts (EDC) Like a Clinical Trial?. What makes EDC work?Beneficiary recruitmentProvider recruitmentAn intervention (EDC)Date collectionData submission. How Is EDC Like a Clinical Trial? (con't). What makes a clinical trial work?Subject recruitmentPrincipal Investigator recruitmentAn intervention (study protocol)Data collectionData submission.
E N D
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