ACRIN – RA Education SessionFall 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

Determining What Follow-up is Due

• Site Database

• ACRIN Ops Tool

• Wait for Overdue Reports

National Lung Screening Trial (NLST) ACRIN 6654

• Long-term follow-up – 8+ years

• 6 Month Interval Follow-up Form (F2)

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

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

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

ACRIN 6654 – NLSTDHMC

Analysis of Phone Contacts

• 576 enrolled

• 15% random sample – N=87

• Time points 3.0 – 5.5

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

F2 Forms Completed

0

10

20

30

40

50

60

70

80

90

# F2's due 87 87 87 87 64 24

# F2's completed 86 86 86 86 64 24

T 3.0 T 3.5 T 4.0 T 4.5 T 5.0 T 5.5

Follow-up Calls Made

0

5

10

15

20

25

30

35

40

1 2 3 4 5 6 7 8 9 10+

Number of Calls Made to Completion of F2

Nu

mb

er

of

Part

icip

an

ts S

uccessfu

lly

Co

mp

leti

ng

F2

T 3.0

T 3.5

T 4.0

T 4.5

T 5.0

Number of Calls Made to Successful Completion of Follow-up

T 3.0 T 3.5 T 4.0 T 4.5 T 5.0 T 5.5

Total

Calls

203 223 161 172 134 47

Range 1 – 7 1 – 15 1 – 7 1 – 18 1 – 11 1 - 7

Mean 2.33 2.56 1.85 1.97 2.09 1.95

S.E. .15 .21 .12 .21 .18 .32

S.D. 1.45 1.96 1.14 2.05 1.50 1.57

Response to CallsT 3.0 – 5.5 (N=436)

38% N.A./1st Attempt

27% Calls Returned

35% Calls NotReturned

Mean Number of CallsCT vs. CXR

0 0.5 1 1.5 2 2.5

T 3.0

T 3.5

T 4.0

T 4.5

T 5.0

T 5.5

CXR Mean # Calls

CT Mean # Calls

Average Number of WorkdaysFirst to Last Contact

0

2

4

6

8

10

12

14

T 3.0 T 3.5 T 4.0 T 4.5 T 5.0 T 5.5

Follow-up Time Point

Wor

kday

s

Average Number WorkdaysFirst to Last Contact

T 3.0 T 3.5 T 4.0 T 4.5 T 5.0 T 5.5

Mean 10.49 9.78 7.72 5.88 6.59 5.79

Range 1-86 1-110 1-73 1-53 1-50 1-28

S.E. 1.64 1.60 1.45 1.0 1.1 1.49

1 S.D. 15.32 15.00 13.64 9.39 8.87 7.31