USING INTERACTIVE VOICE RESPONSE (IVR) SYSTEMS TO

ASSIST WITH PATIENT RECRUITMENT

Maddy LecomteBusiness Manager

ClinPhone Group Limited

• Company and protocol-specific pre-recorded voice prompts

• 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?

ClinPhone

An IVR System

is NOT ONLY a

randomization system!

What is an IVR 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 AdvertisingReferral

From Site/community

Record Contact Info

IVR HAM-D

EligibilityFax 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)

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

Baseline score inflation

0 10 20 30 40

05

1015

2025

Visit 1 HAMD17p Visit 1 HAMD17c

Vis

it 1

HA

MD

17p

0 10 20 30 40

010

2030

40

0 10 20 30 40

020

4060

Visit 1 HAMD17c

0 10 20 30 40

05

1015

20

Visit 2 HAMD17p Visit 2 HAMD17c

Vis

it 2

HA

MD

17p

0 10 20 30 40

010

2030

40

0 10 20 30 40

010

2030

4050

Visit 2 HAMD17c

0 10 20 30 40

05

1015

20

Visit 3 HAMD17p Visit 3 HAMD17c

Vis

it 3

HA

MD

17p

0 10 20 30 40

010

2030

40

0 10 20 30 40

05

1015

2025

Visit 3 HAMD17c

0 10 20 30 40

02

46

810

12

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Vis

it 9

HA

MD

17p

0 10 20 30 40

010

2030

40

0 10 20 30 40

02

46

810

12

Visit 9 HAMD17c

DeBrota et al.,NCDEU, 1999

Visit 1Qualification

Visit 2Qualification

Visit 9Endpoint

Visit 3Randomisation

IVR Clinician

Greater placebo effect

Reduced ability to show treatment related differences

Higher withdrawal rate

Effect of baseline score inflation

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

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

Patient Diary Data

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: 83%

Study 2: 81%

Reference: Harding JP, et al. (1997) Alim Pharmacol Ther; 11:1073-6

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Patient Acceptability

How easy was it to use the IVR System? (n=449)

17

0

2

8

73

0 20 40 60 80 100

Very Easy

Easy

Neither Easy Nor Difficult

Difficult

Very Difficult

Katzelnick et al., ACNP 1998

(Subjects had HamD and LSAS assessments)

%

Patient Acceptability

How easy was it to use the IVR system? (n = 874)

ClinPhone IVRS Diaries: Examples

N. America300SymptomsMigraine

Europe (9)470SymptomsMigraine

N. America300SymptomsMigraine

USA, UK500Escape medication, Withdrawal symptoms

Pain

N. America650HAM-DDepression

N. America650HAM-DDepression

USA1400Mental Health screener, HAM-D, Symptom diary, SF-12, Health economics

Depression

USA800Cognitive functionDepression

N. America, Europe (12), Australia500Symptom diaryGastro paresis

N. America, Europe (8), Australia700Symptom diaryGERD

S. America450Symptom diary, Pain scoresIrritable Bowel Syndrome

Far East1000Symptom diary, Pain scoresIrritable Bowel Syndrome

Europe (7), Australia, New Zealand.800Symptom diary, Pain scoresIrritable Bowel Syndrome

N. America, S, America.300Symptom diaryPneumonia

N. America, S, America.800Symptom diaryBronchitis

CountriesPatientsMeasurementsIndication

Contact: Maddy Lecomtemlecomte@clinphone.com