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

This session will cover the regulatory requirements for conducting the National Lung Screening Trial (NLST), including institutional IRB and sponsor guidelines, as well as local, state, and federal guidelines. It will also discuss the process for determining what follow-up is due, using site databases and the ACRIN Ops Tool. The advantages of phone contact for follow-up and retention will also be highlighted, including the ability to establish rapport, clarify information immediately, and provide study updates to participants. An analysis of phone contacts in the NLST at Dartmouth-Hitchcock Medical Center will be presented, including the number of successful follow-ups, average number of calls, and differences between CT and CXR arms.

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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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