USING INTERACTIVE VOICE
RESPONSE (IVR) SYSTEMS TO
ASSIST WITH PATIENT
RECRUITMENT
Maddy Lecomte
Business Manager
ClinPhone Group Limited
What is an IVR System?
• Company and protocolspecific pre-recorded voice
prompts
ClinPhone
• User response via the
touch-tone key pad of the
telephone
• Callers input response, data
and receive instructions
based on protocol-specific
algorithms
What is an IVR System?
An IVR System
is NOT ONLY a
randomization system!
ClinPhone•ivr applications
•
Site Management
–
–
–
–
–
•
Site activation
Site suspension
Payment to investigators
Track enrolment (country level/site level)
Control site activities through gatekeeper calls
Patient Management
–
–
–
–
–
–
–
–
–
Pre-screening and pre-qualification
Screening
Eligibility check
Randomization (with patient visit schedule)
Dose calculation
Patient re-supply
Patient tracking
Recording of efficacy/safety data
Code break
ClinPhone•ivr applications
•
Clinical Trial Supplies Management (inventory
and distribution control)
– Trigger level
– Predictive
•
Patient Direct
– Diary cards
– Psychiatric rating scales (HAM-D, HAM-A, Mental Health Screener,
the Leibowitz Social Anxiety Scale, Y-BOCS and WSAS)
– Cognitive functions assessment (reaction, choice reaction, articulatory
working memory task, word recall and recognition)
– Quality of Life questionnaires
– Health Economics questionnaires
•
Reporting
– Batch reports
– Web reports
– Data upload
SCOPE: assist with patient recruitment
•
Pre-qualification & referral to investigators
•
Screening via IVR patient diary cards
•
Assessment of eligibility for subjective
clinical end-points
•
Metrics for screening failures
•
Tracking patients’ compliance during the
study
Benefits of using IVR for pre-screening
• Investigator cost/time saving
• Accelerated recruitment
• Unbiased sample
- Web recruitment biased by age/gender
• Increased patient honesty in sensitive areas
• Globally applicable……languages & 24/7 up-time
• Access of real time demographic, diagnostic and study
management information
• Prevention of baseline score inflation (eg HAM-D)
IVR pre-screening
A patient contact method
• Following direct advertising via radio, TV,
newspaper, magazines, flyers etc.
- USA: common practice
- Europe: becoming accepted
• Following a clinic visit or referral by 1ry physician
• Can be used in combination with a call centre
– Cost-effective alternative to call centre alone
– Initial human interaction to take contact details may be
beneficial
• Can be used on its own
– Standardised medical interviews possible (eg HAM-D) or
pre-qualification followed by recording of patient contact
details
IVR pre-screening
A pre-qualification method
• Diagnosis check
– Psychiatric rating scales like the Mental Health
Screener to screen mood, anxiety, eating disorders
and other substance abuse, to identify potential
patients with evidence of depression)
– Cognitive function assessments
• Disease severity
• Eligibility criteria
• Demographics
Pre-Qualification
Referral
Via TV Advertising
Referral
From Site/community
Record Contact
Info
IVR HAM-D
Eligibility
Fax to closest
study centre
Call Centre
IVR call
Accelerated Recruitment in Depression
study
Centralised screening used in addition to study site activities
TOTAL # contacts
32,763
# Call centre screens
22,994
70%
# Pre-qualified
subjects
7,651
33%
#Pre-qualified
subjects to HAMD
5,755
75%
# Successful with
HAMD (>19)
3,774
66%
# passed on to sites
1,329
35%
Subjects randomised
677
51%(9%)
Accelerated Recruitment in Depression
study
Outcome:
– 394 and 283 subjects randomised on to the protocols
– Protocol 1 fully enrolled in 12 weeks (saved 16 weeks)
– Protocol 2 fully enrolled in 14 weeks (saved 7 weeks)
Baseline score inflation
Case Study:
Supplementary Efficacy Data Collection
Entry Criterion
– Total baseline HAM-D > 19
Study population
– Major depressive disorder
– N = 291
Assessments
– Clinician rated HAM-D: weeks 0, 1, 2, 3, 4, 5, 6, 7, 8
– IVR HAM-D recorded (from office): weeks 0, 1, 2, 3, 4, 5, 6, 7, 8
Clinician
i t
1
i t
2
HV
Ai
M
s
i t
3
0 1 2
0 3
0 4
0 0
V i s
i t
9
D1
7
D1
7
D1
7
0 1 2
0 3
0 4
0 0
i
D
t 1
27 H
pV
Ai
M
s
0 1 2
0 3
0 4
0 0
HV
Ai
M
s
0 10Vist9HAMD17p 20 30 40
0 2 4 6 8 10 12
V i s
i
D
t 1
17 H
c A M
i
D
t 1
27 H
c A M
0 1 2
0 3
0 4
0 0
i
D
t 1
37 H
pV
Ai
M
s
i
D
t 1
37 H
c A M
DeBrota et al.,
NCDEU, 1999
0 2 4 6 8 10 12
0 1 2
0 3
0 4
0 0
0 1 2
0 3
0 4
0 0
i
D
t 1
17 H
pV
Ai
M
s
0 1 2
0 3
0 4
0 0
0 10Vist3HAMD17p 20 30 40
0 5 10 15 20
V i s
Visit 9
Endpoint
HV
Ai
M
s
0 5 10 15 20 25
0 1 2
0 3
0 4
0 0
Visit 3
Randomisation
0 1 2
0 3
0 4
0 0
0 10Vist2HAMD17p 20 30 40
Visit 2
Qualification
0 5 10 15 20
V i s
0 10 20 30 40 50
0 1 2
0 3
0 4
0 0
0 20 40 60
0 10Vist1HAMD17p 20 30 40
Visit 1
Qualification
0 5 10 15 20 25
IVR
0 1 2
0 3
0 4
0 0
HV
Ai
M
s
0 1 2
0 3
0 4
0 0
i
D
t 1
97 H
pV
Ai
M
s
i
D
t 1
97 H
c A M
D1
7
Effect of baseline score inflation
Greater placebo effect
Reduced ability to show treatment related differences
Higher withdrawal rate
IVR screening
A screening method
•
•
•
•
Eligibility criteria
Demographics
Additional diagnosis checks
Run-in treatment allocation
Benefits of using IVR for screening
• Investigator cost/time saving
• Accelerated recruitment
• Unbiased sample
- Web recruitment biased by age/gender
• Lower screening failures
• Tracking of screening failures
• Prediction on when to close pre-screening and screening
period
• Trigger of medication management – more focused supplies
• Increased patient honesty in sensitive areas
• Globally applicable……languages & 24/7 up-time
• Access of real time demographic, diagnostic and study
management information
• Prevention of baseline score inflation (eg HAM-D)
IVR diary cards
Is essential for subjective efficacy data
–
–
–
–
–
Irritable Bowel Syndrome
Sleep depravation
Pain
Sexual dysfunction
Migraine
Also valuable for other indications
–
–
–
–
Asthma
Diabetes
Urinary incontinence
Gastro
Patient Diary Data
Self observations
Observable signs or symptoms
• Incontinence episodes
• Sleep disturbance
• Home peak-flow meter reading
• Escape medication usage
• Health service usage
Subjective symptoms
Primary or secondary endpoint
• Pain severity
• Fatigue severity
• Patient satisfaction
Quality of life
Questionnaire instruments
• Generic instruments (eg SF-12, SF-36)
• Disease-specific instruments
Benefits of using IVR for diary cards
• Investigator cost/time saving
• Accelerated recruitment
• Unbiased sample
- Web recruitment biased by age/gender
• Lower screening failures
• Tracking of screening failures
• Prediction on when to close pre-screening and screening
period
• Trigger of medication management – more focused supplies
• Increased patient honesty in sensitive areas
• Globally applicable……languages & 24/7 up-time
• Access of real time demographic, diagnostic and study
management information
• Prevention of baseline score inflation (eg HAM-D)
Benefits of using IVR for diary cards
• Can build in logic checks and improve the quality of data
• Real-time compliance assessment / real-time alerts in case of
non-compliance / proactive patient follow up, resulting in
improved compliance and lower withdrawal rates
• Tracking of withdrawal & drop-out rates
• Date and time stamp of event
• Integration with other electronic systems (EDC, Medication
Management, Central laboratory)
– Real-time assessment of patient safety
– Study data viewable via a single channel / integrated reports
Improved Data Quality Using eDiaries
Case study
Asthma peak flow meter study
Verschelden et al., 1996. Eur Resp Journal






Subjects (n=20) not informed that data automatically stored
PEF monitoring for 44–131 days (mean = 89 days)
3,482 values expected
1,897 values recorded on paper diary
46% missing
1,533 values recorded electronically
22% invented
90% of written values agreed with those stored
Improved Data Quality Using eDiaries
Summary of paper diary data quality
issues
•
Patients do not complete diaries when
scheduled
Car-park effect
•
Data recorded erroneously
•
Data invented
Patient Adherence/Compliance
Case study:
Irritable bowel syndrome studies
Treatment period:
2 weeks screening + 12 weeks treatment
Number of active patients:
640 IBS patients
System availability:
8040 h out of 8135 h (99% up-time)
Compliance:
Study 1:
Study 2:
Reference:
83%
81%
Harding JP, et al. (1997) Alim Pharmacol Ther; 11:1073-6
Patient Acceptability
How easy was it to use the IVR System? (n=449)
77
15
1
0
Difficult
Very difficult
Neither easy
nor difficult
Easy
7
Very Easy
100
90
80
70
60
% 50
40
30
20
10
0
Patient Acceptability
How easy was it to use the IVR system? (n = 874)
73
Very Easy
Easy
17
8
Neither Easy Nor Difficult
Difficult
Very Difficult
2
0
0
20
40
%
(Subjects had HamD and LSAS assessments)
Katzelnick et al., ACNP 1998
60
80
100
ClinPhone IVRS Diaries: Examples
Indication
Measurements
Patients
Countries
Bronchitis
Symptom diary
800
N. America, S, America.
Pneumonia
Symptom diary
300
N. America, S, America.
Irritable Bowel Syndrome
Symptom diary, Pain scores
800
Europe (7), Australia, New
Zealand.
Irritable Bowel Syndrome
Symptom diary, Pain scores
1000
Far East
Irritable Bowel Syndrome
Symptom diary, Pain scores
450
S. America
GERD
Symptom diary
700
N. America, Europe (8), Australia
Gastro paresis
Symptom diary
500
N. America, Europe (12), Australia
Depression
Cognitive function
800
USA
Depression
Mental Health screener, HAM-D,
Symptom diary, SF-12, Health
economics
1400
USA
Depression
HAM-D
650
N. America
Depression
HAM-D
650
N. America
Pain
Escape medication, Withdrawal
symptoms
500
USA, UK
Migraine
Symptoms
300
N. America
Migraine
Symptoms
300
N. America
Migraine
Symptoms
470
Europe (9)
Contact: Maddy Lecomte
[email protected]
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