Case Study: OIC Daily ePRO Diary Cost Savings

How our ePRO applications provided technology solutions and cost savings

Highlights

  • BYOD – low device cost, high level of user satisfaction
  • eSource – virtually eliminates monitoring and data queries
  • Overall Cost Savings over proprietary handheld devices
  • ePRO Daily Voice diary mode of validated paper instrument
  • High diary compliance, greater than 85%
  • Statistically verified migration from paper to voice-telephone mode of data collection

Objectives

  • To utilize an easy-to-use universally accessible application.
  • To increase diary compliance and collect higher quality data in real-time, with resource, time and cost benefits for the overall study.

Statistics

  • Opioid-Induced Constipation (OIC) Study
  • Phase II
  • 20 sites in the US
  • 100 subjects

Test Diagnostic / Study Design:

Subjects were to be evaluated for changes in frequency and type of bowel movements using a validated Bristol Stool Scale-based daily diary. One measure of efficacy relied on daily diary data collected directly from subjects. Eligible subjects were randomized to placebo or investigational material, received treatment, and completed daily diaries for 12 weeks.

Challenges

  • Improving Daily Diary compliance
  • Reducing time and resource-intensive data monitoring and correction process
  • The need for a cost-effective system for subjects to use reliably and easily; Paper v. Bring Your Own Device Phone (BYOD) v. Proprietary electronic handheld device
  • Migration of validated paper Bristol Stool Scale instrument to unbiased interactive voice-phone modality
  • Patient engagement, with user-friendly mode for contemporaneous and time-tracked data entry

IVRCC Solutions to Meet Challenges

Subjects completed a 2 week run-in period of daily diaries to determine whether they would meet the level of diary compliance required to meet eligibility criteria for enrollment into the study.

Both validated paper diary and IVRS (interactive voice-phone) modes of the questionnaire were administered daily to all subjects during the 14-day run-in period.  Subjects were randomized to entering data using one of the modes first, followed by the other mode.  

Subjects were supplied with a laminated color picture card of the Bristol Stool Scale (BSS) to use as an easy reference during each phone call to the system. The reference card duplicated the paper diary’s standard depiction of the scale.

On the 10th day of the run-in period, the system asked subjects about the ease of use of the IVRS compared to the paper collection mode: “When using the telephone to record your bowel movements, how easy was it to understand and follow instructions? Please rate how easy it was using a scale of 1 to 5, with 1 being very difficult and 5 being very easy.” Statistical bias analysis was performed to compare data collected via each mode.

Why was IVRCC the right choice for this study?

Subjects answered the satisfaction survey during the 2-week run-in period and indicated that ease of use of our voice system was very high. When comparing diary responses collected during the run-in mode test period, analysis of the data confirmed that there was no statistical bias between data collected by each modality (paper versus voice accompanied by picture card).

To further optimize diary compliance, we sent subjects automated email and/or SMS text reminders to inform them when daily contact with the system was required. Diary Compliance across all sites and subjects averaged greater than 85% for IVRS collected diaries.

The client compared the costs of our BYOD system with two other bids which collected data from subjects using proprietary handheld devices. With our IVR system, patients use their own phone or smartphone for daily diary collection, which saved the client several hundred thousand dollars. The other two bids were approximately 3.5 times more than our IVR system due to the added cost of deploying proprietary devices.

The benefits of higher compliance and higher quality trackable data far outweighed the initial cost of building the IVRCC e-Source phone diary system, compared to using paper diaries.

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