Case Study

 

Built-in Patient Engagement with IRT

Patient engagement remains a perennial topic in the ongoing discussion about improving patient retention in clinical trials. It sounds like an obvious choice, but to do it effectively and consistently across investigator sites requires systems that provide centralized communications, with mechanisms that allow blinded information exchange with patients. YPrime’s IRT+ integrates patient communication features with standard IRT functionality, eliminating the need for additional systems and interfaces at the sponsor and site level.

How it Works

When a patient is screened using IRT+, the email is securely stored and can be used for several event-specific and timely follow-up communications, including:

  • Instructional emails triggered by individual visits (i.e., dosing instructions)
  • Newsletters, information about managing their condition, access to visit schedules
  • Information about clinical research, the sponsor and patient support programs
  • Ad-hoc updates, which can be tailored to any immediate need during study conduct
  • Post-study updates, such as information about study results or treatment approval
  • Content can be dynamically populated by specific triggers, ensuring timeliness and relevance to study participants

The versatility of the IRT+ patient communication feature can support clinical studies of all types. It also provides ongoing touchpoints when there are several months between visits, periods when patients are most likely to drop out of a study.

YPrime recently partnered with Lupin Research Inc. to create newsletter functionality in their IRT+ system to support COPD patients enrolled in a clinical study. The patient newsletter is currently distributed via email at key milestones, including screening and randomization. Newsletter features highlight a mix of topics relevant to this patient population, including disease management, medication-specific information, instructions for using electronic clinical outcome assessment (eCOA) devices, among other study-specific updates.

“The ad-hoc feature is particularly useful for this study,” said Carrie Lewis, Associate Director of Clinical Operations at Lupin. “It has allowed our team to promptly address issues that arise during study conduct, such as e-diary compliance. The reminders have been an effective retention tool.”

At the site level, study coordinators also see clear benefits.

“The patient newsletters were very informative and a useful tool in updating the subjects on the flow of the trial. Having this patient communication feature enhances the task of study communications from site staff,” said Sharon Duarte, Research Director at Northeast Medical Research Associates, a participating study site.

While the study is ongoing, there is a remarkable correlation between the newsletter and patient retention. Based on early data collected, the impact of the patient newsletter has cut the early termination rate in half. Most important, feedback collected directly from patients affirmed the value of this simple, yet highly effective patient engagement approach. So far, the data speak volumes:

  • 86% of 21 patients surveyed found the newsletter useful
    • 90% of the same patient group surveyed preferred the email format
    • 86% of patients were interested in receiving post-study updates
    • 90% of patients recommended the sponsor include patient newsletters in future studies