CASE STUDY: Patient Caregiver Liaison
Background
Stiris was awarded a contract to rescue a Phase III Adolescent CNS Rare Disease study being run at sites throughout the United States and Canada. This patient population required ongoing caregiver support. Around the mid-point of the study, we noticed patients and/or their caregivers were having challenges with the burden encountered when participating in a clinical trial.
We worked closely with the Sponsor to design and build a program to help ease the burden and increase the likelihood of patient retention. In addition to supporting the patients already participating in the study, we included a role in our design to help patients enroll in the study.
Challenge
Our Sponsor had been unable to find a vendor who could: 1) help patients find and enroll in the clinical trial, and 2) provide support for patients, and their caregivers, throughout their study journey. The Sponsor asked Stiris to develop a system where patients could have their voice heard, feel valued, and become true collaborators with the Sponsor. The system also needed to help the Sponsor understand the patient journey so they could design clinical trials that are best suited for the patient and their caregivers. Finally, we needed to develop a system that helped with both recruitment and retention.
Solution
We developed the Patient Caregiver Liaison service which had a dedicated Patient Caregiver Liaison (PCL) to facilitate recruitment into the clinical trial, and a Patient Advocate (PA) from the therapeutic area community to facilitate retention. The PCL answers any questions the patient has about the current clinical trial (e.g. What will happen to me? How often do I have to come in? How much time will each visit take? etc.), and about clinical trials in general (e.g. Does the government know about this research?). And when it’s time for the patient to talk with a site about enrolling in the study, the PCL facilitates that introduction and ensures there is a connection between the site and the patient.
Once a patient is enrolled in the study, the support system transfers from the PCL to the PA. The PA’s role is to be a trusted contact for the patients for their questions (e.g. how to prepare for an upcoming site visit – do they need to bring food, how long is the visit, is there handicap parking etc.), comments and concerns. The PA works with the site and the Sponsor to help remove barriers for the patients.
The PCL and PA work closely with the Sponsor and the study Project Manager, sharing lessons learned, feedback and community updates so the leadership team has a deeper and more robust understanding of the disease and the community they are serving.
Results
Of the twenty patients who used the PCL role, 100% of those patients were retained in the trial, and 100% of those who were eligible continued to be enrolled into the open label extension study. While retention was the original challenge, this new role also had a positive impact on enrollment, showing an increase in connecting patients, in the community, with participating sites, leading to an increase in recruitment. Early connections with the PCL and the PA increased the understanding of study participation.
Families were very receptive to the Patient Caregiver Liaison Service. The Patient Advocate reported a decrease in stress for the patients and caregivers who utilized the service. Patients/caregivers voices were heard, and Sites learned how minor adjustments to a visit day (e.g. taking blood work at the end of the visit made the day much easier for the caregiver to manage) could have a large impact on their patients. The Sponsor better understands the full ‘customer’ and the barriers they face, and the community sees the Sponsor as their ‘partner’.