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ACRIN – RA Education Session Fall 2008 THE LONG HAUL & FOLLOW-UP

ACRIN – RA Education Session Fall 2008 THE LONG HAUL & FOLLOW-UP. Suzanne B. Lenz, MA – CCRP Dartmouth-Hitchcock Medical Center Lebanon, NH. Know Regulatory Requirements. Institutional IRB Sponsor Local, state, federal guidelines Informed consent Authorization to collect PHI.

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ACRIN – RA Education Session Fall 2008 THE LONG HAUL & FOLLOW-UP

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  1. ACRIN – RA Education SessionFall 2008THE LONG HAUL & FOLLOW-UP Suzanne B. Lenz, MA – CCRP Dartmouth-Hitchcock Medical Center Lebanon, NH

  2. Know Regulatory Requirements • Institutional IRB • Sponsor • Local, state, federal guidelines • Informed consent • Authorization to collect PHI

  3. Determining What Follow-up is Due • Site Database • ACRIN Ops Tool • Wait for Overdue Reports

  4. National Lung Screening Trial (NLST)ACRIN 6654 • Long-term follow-up – 8+ years • 6 Month Interval Follow-up Form (F2)

  5. National Lung Screening Trial (NLST) ACRIN 6654 Dartmouth-Hitchcock Medical Center (DHMC) • Site database + ACRIN Ops Tool • Follow-up and retention through phone contact • Approximately 96 participants/month • Network with other RAs at site

  6. ACRIN 6654 – NLSTDHMC Advantages of Phone Contact • Direct contact 2 times/year • Establish rapport & on-going relationship • Ability to clarify information immediately • Provide study updates to participants • Participants can ask questions

  7. ACRIN 6654 – NLSTDHMC Advantages of Phone Contact • Gauge participants’ feelings • Adjust follow-up methods • Participant doesn’t see lengthy forms • Cost effective at our site

  8. ACRIN 6654 – NLSTDHMC Analysis of Phone Contacts • 576 enrolled • 15% random sample – N=87 • Time points 3.0 – 5.5

  9. ACRIN 6654 – NLSTDHMC Analysis of Phone Contacts • Number of successful follow-ups • Average number of calls by time point • How many participants return site calls • Average # of days from 1st to last contact • Difference over time • Difference between CT and CXR arms

  10. F2 Forms Completed

  11. Follow-up Calls Made

  12. Number of Calls Made to Successful Completion of Follow-up

  13. Response to CallsT 3.0 – 5.5 (N=436)

  14. Mean Number of CallsCT vs. CXR

  15. Average Number of WorkdaysFirst to Last Contact

  16. Average Number WorkdaysFirst to Last Contact

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