© 2009 Perceptive Informatics. A PAREXEL ® Company IVRS Feasibility Sue Rizzo, RN 24 May 2010.

© 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


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



Uses of IVR?

Uses of IVR?


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


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ePRO Studies by Data Type


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


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


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


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



Patient experience with IVR

Patient experience

with IVR



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


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)


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Questions?


© 2009 Perceptive Informatics. A PAREXEL ® Company IVRS Feasibility Sue Rizzo, RN 24 May 2010.

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