The Value of Patient-Designed Clinical Trial Navigator Solution

Discover how personalized patient navigator solutions can increase patient engagement, satisfaction, retention and more.

“Patient-centric” is used frequently to describe today’s clinical trial and health care landscape. The industry applauds that point of view and strives to include a patient-centric approach in all aspects of clinical trial designs. However, when it comes to supporting complex trials with multiple participation barriers, there is a need to go beyond what the industry envisions to increase centricity through patient navigator solutions and hear feedback directly from patients.

We surveyed 500 patients across the world to explore what they find most burdensome about clinical trial participation. The results uncovered personal and professional patient engagement insights and ways to deliver a measurable impact and minimize the burdens they face. Patient centricity has become more than a key consideration. It’s now an imperative and will likely have a material impact on the success of a clinical trial.

Patient centricity benefits the patient while reducing site burden

A key takeaway that patients shared was the need for more personal, targeted support, primarily delivered through patient navigator solutions. This 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 navigator solution apart is providing patients with a more personalized approach. With one phone call, a patient can reach an informed, engaged resource who can answer trial questions, offer reassurance, make travel arrangements and more. The patient navigator delivers on enhanced personal connectivity and empathetic support throughout their study — two key considerations patients are seeking.

Including patient feedback in the design of building a patient navigator program is critical to increase patient retention. This is especially important in very complex trials, when excessive travel might be required, or the patient’s medical condition might impair mobility.

Patient insights underscored four core areas for building an effective patient navigator retention program:

1. Support for patients and their caregivers, proactively reaching our and providing answers to non-medical questions. Agents can assist patients in working with travel vendors, as well.
2. Training through a device and/or app to support protocol requirements.
3. Reminders for site and home-health appointments, diaries, lab tests and other protocol requirements.
4. Education on the disease state and regular reinforcement.

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

Four success stories demonstrate how incorporating patient navigator services enhances patients’ experiences and keeps them engaged in their studies.

1. Travel services: A patient in a rare disease trial contacted her navigator expressing concern about her ability to travel to her appointments, as she and her husband shared a vehicle. The navigator solved the immediate need by scheduling a car service and escalated a recommendation for rental car services to the sponsor to overcome the ongoing barrier to participation. Ultimately, the navigator was able to obtain sponsor approval for a rental vehicle for the patient’s travel to her study appointments, and she remained in the trial.
2. Adverse event identification: A patient called his navigator stating that he had been experiencing severe nausea while on treatment and would need to leave the trial. The navigator expressed empathy for the participant’s symptoms, and then offered to transfer the participant to his clinical trial site. The navigator connected 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 navigator 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 navigator identified the need for follow-up reminder calls. After three additional engagements, the patient was comfortable self-completing the diary regularly via the app. However, the navigator remained in touch to ensure that the patient remained engaged and in compliance.
4. Protocol adherence support: A patient based in the U.S. informed his navigator agent that he would be traveling internationally and was concerned about not being able to use the e-diary app while traveling. The navigator reassured the patient that the app would be accessible internationally and provided him with the toll-free number for his navigator in the event he needed support. To ensure continuity with the site, the navigator also proactively contacted the site to notify them of the patient’s travel plans in case of an unplanned reporting delay. Ultimately, the patient was able to fulfill his e-diary reporting requirements while traveling and was grateful for the support. One example of patient engagement, satisfaction and retention is a rare disease study conducted by the PPD™ clinical research business of Thermo Fisher Scientific. Patients had idiopathic recurrent pericarditis in which the primary endpoint was a daily patient-reported outcome (PRO). The biopharmaceutical company running the study felt that given the considerable patient burden, they should realistically expect a 30% patient dropout rate. A trained patient navigator 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.

Patient navigator solutions can deliver significant benefits for patients and trials, including:

• Reduced site burden: Studies with extensive management demands due to trial complexity or frequent office visits can use patient navigator services to reduce the number and volume of administrative activities.
• Decreased patient burden: Trials that recruit very ill patients or those with ambulatory concerns can turn to patient navigator to reduce stressors and ease patient burden.
• Increased 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 navigator to engage and retain patients.
• Maintained patient-reported outcomes (PROs): Protocols that require extensive patient experience tracking and feedback, quality of life questionnaires, or device training can benefit from patient navigator support.
• Supported remote trials: Decentralized trials that employ virtual site and home-health visits can keep technology from becoming overwhelming by employing patient navigator services.

Decreasing patient burden and increasing trial retention is a direct result of soliciting insights from patients. Implementing patient and caregiver support, training, regular reminders and education can ensure an enhanced patient experience and increased engagement. Sponsor that create more personalization through patient navigator solutions can increase patient engagement, satisfaction, retention and more.