© 2009 perceptive informatics. a parexel ® company ivrs feasibility sue rizzo, rn 24 may 2010
TRANSCRIPT
© 2009 Perceptive Informatics. A PAREXEL® Company
IVRS Feasibility
Sue Rizzo, RN
24 May 2010
2© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
Alphabet soup:
What is ePRO?
What is IVRS?
© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
3© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
What is ePRO?
electronic Patient Reported Outcomes Describes any patient self reported assessment or diary,
symptom questionnaire, scale, or HRQL instrument Alternative to paper collection of patient reported data Modes of collection include:
– IVR (Interactive Voice Response)
– IWR (Interactive Web Response)
– Handheld device (PDA or Tablet)
– Desktop computer
Interactive Voice Response (IVR)
Telephone is interface to a computerized system via touch tone technology
Caller hears prompts Caller key their responses Data stored directly to central database
Central Database(Source)
Toll Free Toll Free
DATA DATA
© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
5© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
Uses of IVR?
Uses of IVR?
© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
ePRO Experience
Asthma Allergy Attention Deficit Hyperactivity
Disorder Pneumonia GERD Gastro paresis Depression Breast pain Migraine Insomnia
Sexual dysfunction Osteoarthritis Irritable bowel syndrome Parkinson’s disease Women’s health Ulcerative colitis Post herpetic neuralgia Neuropathic pain Anxiety (GAD, SAD) Bronchitis Oncology
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280+studies 80countries 100K+patients 10K+sites
© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
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ePRO Studies by Data Type
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Primary 27%
Secondary 20%
Eligibility 6%
Other 16%
Safety Alone 2%
Exploratory 2%
Secondary & Other 1%
Primary & Other 7% Primary & Secondary 19%
Adult + Elderly76%
Elderly2%
Adult + Paediatric
1%All4%
Adult13%
Paediatric4%
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ePRO Studies by Target Population
Meacham et. al., ISPOR, 2008© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
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ePRO Studies by Assessment Frequency
Other17%
Baseline+4%
Monthly3%
Screening+8%
Daily + Weekly 6%
Weekly7%
Screening Alone4%
Daily43%
Twice Daily8%
Meacham et. al., ISPOR, 2008© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
10© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
Mean vs. Median Compliance
0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%90.0%
100.0%
Young
Adult
Elderly
Male
Female
<8 Assess
>8 Assess
Fibromyalgia
Osteoarthritis
PHN
Mean MedianMeacham et. al., ISPOR, 2008
© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
Do reminders make a difference?
SMS Texts– Those who consented were 3.44% (n=8) and 23.97 (n=33) more
compliant for dx1 and dx2 respectively
– No apparent correlation between lack of consent and timeliness of making scheduled call
– Only 22% consented; affect of countries and demographics unknown
Outbound calls:– Seem to/no to have an impact in x% of the time…
Too early to make a judgment
11© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
Achieving High Compliance
Quality user instruction manuals (site and patient) Set expectations with sites Alert sites to non-compliant patients Alert patients directly via SMS text messaging or outbound
calls Consider a compliance threshold during the run-in period Don’t lose sight of patient burden
– Avoid unneeded complexity / duration
12© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
13© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
Patient experience with IVR
Patient experience
with IVR
© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
14© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
Interaction with IVR
Patient interacts directly with the system in a confidential manner
Direction is given as to frequency of required calls Training system is available to help with comfort level of
patient Site provides patient with a secure envelope which contains
an access code – Site maintains patient record, system does not record patient
details (i.e. name, personal information)– Patient chooses their own PIN– Combination of supplied access code and patient’s PIN allows
access to the system
15© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
Interaction with IVR
Patient makes calls as directed (i.e. daily, weekly, etc.) Reports are provided to sites to assist with tracking of
compliance Non-compliance can be handled in different ways:
– Site personnel follows up directly with patient– SMS message is sent to patient automatically as a reminder– Outbound calls can be made from system with an automated
message for patient– Call centers can be utilized to follow up similar to site follow up
above It is important to take patient confidentiality into account with
the above measures
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Our experience with IVR ePRO
Adult and elderly patients able and willing to use IVR ePRO– Elderly patients almost always more compliant
Disorder (except for those not practical e.g. Schizophrenia) has not been shown to be an influencing factor on compliance
Even more severely ill patients can use IVR ePRO A burden of twice daily, 5 minute calls for 8-12 weeks has
been shown to be acceptable e.g. eszopiclone Patients are more compliant with routine reporting (daily or
weekly)
© 2009 Perceptive Informatics, Inc. A PAREXEL® Company
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Questions?
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