The Value of Patient-Designed Clinical Trial Concierge Service

In this blog, Paul Biedenbach (vice president, operations, medical communications at PPD) discusses how personalized patient concierge services can increase patient engagement, satisfaction, retention and more.

Patient-centric. These two words are used frequently to describe today’s clinical trial and healthcare landscape. The industry not only applauds that point of view but also strives to include a patient-centric approach in all aspects of clinical trial designs. When it comes to supporting complex trials with multiple participation barriers, however, there is a need to go beyond what the industry envisions to increase patient centricity. The need means hearing directly from patients themselves for their insights. To help the industry with this challenge, we asked 500 global patients what they find most burdensome about clinical trial participation. These insights led us to uncover personal and professional ways to engage patients to deliver a measurable impact and minimize the burdens they face. In the post-pandemic world, patient centricity has become more than a key consideration — it’s now an imperative and will likely have a material impact on whether a clinical trial is successful.

What patients shared was the need to build more personal, targeted support, primarily delivered through patient concierge services. True to how it sounds, patient concierge service provides many aspects of one-on-one support needed to keep a patient in a study while feeling positive about his or her experience. While today’s clinical trial landscape includes technologies to add efficiency and convenience, what sets a patient concierge service apart is providing patients with a more personalized approach. Just one phone call allows a patient to reach an informed, engaged resource who can answer trial questions, offer reassurance, make travel arrangements and more. The patient concierge service delivers on what patients are seeking — enhanced personal connectivity and empathetic support throughout their study. Patient centricity adds benefit for the patient and simultaneously reduces a site’s administrative burden.

What did patients share directly about their trial experiences?

“I’m clear now on what the plan is. Thank you.”

The inspiration to include patient feedback in the design of building a patient concierge program was born out of a desire to increase patient retention, especially in the case of very complex trials when excessive travel might be required or the patient’s medical condition might impair mobility.

Patient insights highlighted four core areas for building an effective patient concierge program:

• Support: Being there for patients and their caregivers, proactively outreaching and providing answers to non-medical questions. Agents can assist patients in working with travel vendors, as well.
• Training: Device and/or app training to support protocol requirements.
• Reminders: Appointments (site and home-health related), diaries, lab tests and other protocol requirements.
• Education: Disease state education/reinforcement.

For biopharmaceutical companies and the sites supporting their trials, an effective patient concierge program delivers the entire patient journey with in-depth insights, outcomes and trends — all of which can inform future efforts.

“Thank you for handling all of this for me.”

The quotes included throughout this article aren’t gratuitous — they’re genuine patient feedback to reinforce every day that a personalized approach makes a real difference. To illustrate the point more explicitly, here are three success stories that incorporate patient concierge services to enhance patients’ experiences and keep them engaged in their studies:

1. Travel services: At the beginning of the pandemic, a clinical trial participant in Italy wanted to drop out of her trial, stating that she was “already at high risk of infection and did not want to risk exposure to COVID-19.” On the patient’s behalf, her concierge worked with the travel vendor to cancel her existing site visit plans and set up alternate remote visits. The clinical trial participant did not drop out of the study, nor did she miss any visits. She completed the study to its end.
2. Adverse event identification: A patient called his concierge stating that he had been experiencing severe nausea while on treatment and would need to leave the trial. The concierge expressed empathy for the participant’s symptoms, and then offered to transfer the participant to his clinical trial site. The concierge was able to connect the participant with the site for care and adverse event reporting.  As a result, the patient’s treatment was adjusted, and he remained enrolled in the study.
3. E-diary reminders: A site called and asked the concierge to reach out to a patient regarding the use of her electronic diary app. The participant was having trouble making diary entries required by the protocol. After some basic troubleshooting, the concierge identified the need for follow-up reminder calls. After three additional engagements, the patient was comfortable completing the diary regularly on her own via the app. However, the concierge remained in touch to ensure that the patient remained engaged and in compliance.

“I’ll be sure to call if we run into any more problems.”

Patient concierge services are not needed for every patient or every trial. But they can deliver significant benefits in circumstances when a customer seeks to:

Reduce site burden: Studies with extensive management demands due to trial complexity or frequent office visits can use patient concierge services to reduce the number and volume of administrative activities.

Decrease patient burden: Trials that recruit very ill patients or those with ambulatory concerns can turn to patient concierge to reduce stressors and ease patient burden.

Increase retention: Trials in which retention is at risk because of limited patient populations (i.e., rare diseases), multiple appointments and/or complex medication routines can use patient concierge to engage and retain patients.

Maintain patient-reported outcomes (PROs): Protocols that require extensive patient experience tracking and feedback, quality of life questionnaires, or device training can benefit from patient concierge support.

Support remote trials: Decentralized trials that employ virtual site and home-health visits can keep technology from becoming overwhelming by employing a patient concierge.

“I feel much more prepared now. Thank you.”

The appreciation from patients and sites alike is rewarding. But, the real reason to solicit insights from patients and create patient concierge service is to decrease the patient burden and increase trial retention.

One example is a rare disease study of patients with idiopathic recurrent pericarditis in which the primary endpoint was a daily PRO. The biopharmaceutical company running the study felt that given the considerable patient burden, they should realistically expect a 30% patient drop-out rate. A trained patient concierge team, however, was able to identify the risks to missed future site visits and address them by providing special travel arrangements and home-health visits. As a result, the actual study dropout rate was only 1.6% with a 10% or less non-compliance rate on daily dairy collection. The added utilization of a dynamic protocol design increased flexibility for patient care without delays that would normally be present in a more rigidly written protocol.

That’s an example of patient engagement, satisfaction and, ultimately, retention. That’s truly a patient-centric result.