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