Empathetic Technology: The Key to Improving Clinical Study Recruitment, Enrollment and Retention
The solution to the inherent challenges of clinical study recruitment and retention is the implementation of digital tools that offer end-to-end support for unique patient journeys, are intuitive to use, and are clearly impactful and valuable.
Introduction
Patient recruitment, enrollment, and retention in clinical trials remain among the most vexing and time-consuming processes, with a reported 80 percent of U.S.-based clinical trials failing to meet enrollment timelines1 and an overall clinical trial dropout rate of 30 percent.2
While patients struggling with symptoms and side effects cobble together tools to help themselves navigate their demanding and time-consuming clinical trial journey, study sites and sponsors seek solutions to give more patients access and satisfy the need for diversity and equity in trials, as well as government mandates on the collection and handling of patient data.
The solution for these challenges is the creation and of comprehensive digital tools that provide end-to-end support for the patient journey, from identification of the right study, through enrollment and one that anticipates patient needs throughout the treatment journey.
Patient Recruitment/Retention Challenges
Founded in 2014, StudyKIK is a technology and patient recruitment/retention company that aims to improve and streamline the clinical trial lifecycle to offer a better experience for patients, sites, and sponsors through technologies that are interconnected. Based on its expertise, inherent challenges in clinical trial recruitment, enrollment, and retention include:
The real and perceived complexity of the treatment protocols. For example, technical terminology for the nonscientist can be overwhelming, contributing to feelings of anxiety and reluctance that may already be heightened because of the medical condition alone.3
Time and scheduling. Clinical trials require frequent medical visits, all of which carry their own burdens of time, travel considerations, and other related pressures for participants to work out. The time demands can be a significant factor in the decision of whether to participate, particularly for individuals with pre-existing health conditions and/or other life responsibilities.4
Expense: Clinical study participation may also mean patients face additional expenses related to transportation, childcare, or missed work. And the task of filing reimbursement paperwork adds to that burden.5
The burden on caregivers: Patients cite the demands on their extended circle of caregivers and concerns about the safety/security of their data as being a deterrent to participation in studies.6
Limited access: Rural and poor populations face challenges related to geographical barriers and have limited access to healthcare facilities and research sites. The challenges of transportation can further compound these difficulties, making it especially taxing for patients in more rural areas.7 According to a recent McKinsey survey, approximately 70 percent of patients live 2+ hours from their research site.
An End-to-End Solution that Marries Technology and Human-Centered Design
CarePackage is the comprehensive support system that StudyKIK has created to address these challenges. CarePackage leverages technology and human-centered design to streamline the clinical trial lifecycle, enhance recruitment, and improve retention efforts.
CarePackage is a unifying force in the patient journey. It offers a comprehensive support system that includes crucial features, including transportation assistance, remote visit solutions, and reimbursement management.
It is one single platform for patient interactions, replacing the disjointed experience of unrelated apps and notes, to enhance convenience, communication, and overall trial satisfaction while also improving retention rates. Human-centered design tactics, which make products intuitive and pleasurable for the user, were employed to create tools that take complex treatment protocols and break them down into digestible, easy-to-understand information regardless of the person’s familiarity and ease with digital technology.
For example, EaseConsent is a resource that transforms complex protocols into a repository of clear, patient-friendly consent documents that can be used to obtain consent either on-site or remotely, ensuring a heightened level of patient understanding. It allows patients to annotate consent forms and schedule virtual visits for any questions, fostering a deeper sense of comprehension, and thus, engagement.
In parallel, mobile applications serve as centralized hubs for essential study resources and information, placing critical details at participants’ fingertips.
TeleCare uses remote monitoring tools to enable virtual check-ins and data collection, minimizing the need for in-person visits. Technology also facilitates communication between participants and their research team. Mobile applications provide a direct and convenient channel for participants to ask questions, report any concerns, or receive updates about the trial. This enhances their overall experience and continues to foster a sense of empowerment in the healthcare journey.
StudyCash streamlines the process of submitting receipts. Consider the convenience of capturing a quick snapshot of your receipt and uploading it directly to the device you carry with you every day, compared to the task of logging into various portals and manually inputting each receipt. This is a more practical and compelling option.
CarePackage also addresses the concerns about accommodating the circle of caregivers and family, regardless of how expansive. StudyKIK’s PatientConnect mobile app incorporates features like the Support Network, which ensures the patient’s designated support person receives all pertinent information during active treatment, from appointment reminders to medication dosage notifications. By extending support to include their caregiver, CarePackage creates an environment of comprehensive care and assistance. This eases the patient’s journey, while offering invaluable support to those who play a crucial role in their well-being.
Simultaneously, on the provider side, Patient Engage fosters fast-track recruitment and provides an ongoing stream of actionable data. The Support Hub enables personalized patient outreach with appointment reminders, surveys, and more. Study Capture provides recruitment, retention, and diversity data all in one repository, increasing efficiencies and supporting a holistic approach to reporting and analysis.
StudyKIK’s Inclusive, Equitable Approach
CarePackage was created via StudyKIK’s ongoing efforts to identify, engage, and retain a diverse range of study participants. It leveraged its network of more than 2,000 patient communities by conducting targeted outreach and digital marketing campaigns designed to ensure that motivated and qualified individuals from various backgrounds are represented in clinical trials.
Another facet of StudyKIK’s mission to create an end-to-end solution was to address accessibility and inclusivity across all communities.It underscores the pivotal role that technology has in overcoming these barriers, enabling equitable access to healthcare resources for individuals regardless of their geographic location or economic circumstances.
Furthermore, CarePackage places a deliberate focus on diversity, equity, and inclusion (DE&I). Its advanced analytics provide sponsors with enhanced visibility into the demographic composition of their studies. This diversity data reporting empowers sponsors with a clear and detailed understanding of the demographic makeup of their patient populations, ensuring that representation is both meaningful and inclusive.
Achieving diversity in studies can be a significant challenge, as certain demographic groups, particularly minority populations, are often underrepresented. This lack of diversity can limit the generalizability of study findings to broader populations.
On the patient side of the equation, health equity is a crucial consideration in clinical trials. Health equity requires actively working with the intent to reduce disparities in access. This may include the use of digital tools that facilitate participation for marginalized and underserved populations. For example, user-friendly mobile apps can provide transportation options and streamline reimbursement processes, removing logistical barriers that may have otherwise hindered involvement.
By leveraging technology, we aim to ensure that all individuals, regardless of background or socioeconomic status, have equal opportunities to benefit from the advancements in medical research.
New Expectations
Digital technology is ubiquitous, crossing demographic, socioeconomic, and geographic boundaries. That said,younger generations of patients have a different relationship with digital technology than older generations, one in which they have more expectations from a tool they’ve grown up using and incorporated into all facets of their lives.
Simultaneously, the generational digital divide that once existed has narrowed. More people, regardless of age, rely heavily on smartphones for various aspects of their lives, including communication, access to information, and task management.
This surge in mobile reliance and the demographic difference in expectations from the technology all influenced the design of CarePackage. It also made it obvious to StudyKIK that human-centered design principles were essential in the creation of a unifying end-to-end solution that keeps people engaged and connected.
The needs of clinical trial sites are far from one-size-fits-all. They can vary day to day, study to study, and are influenced by location, treatment approach, and the variabilities of each disease they seek to treat. Their needs are as diverse as the patient populations hoping to support the development of new life-saving therapies.
Human-centered design recognizes these differences and embraces empathy, seeking to streamline the patient/user’s journey and ways to enhance it. As part of this process, StudyKIK engaged in provider roundtables and patient panels to comprehensively assess the existing ecosystem of tools. This research allowed the company to glean insights into specific needs, ensuring that solutions are effective, as well as aligned with how patients and clinical trial sites engage with technology day to day.
The company identified several key points that became integral to CarePackage’s development. Among them was a call for a unified platform facilitating seamless patient interactions, reducing site burden, and eradicating the necessity for multiple vendors, effectively replacing the previously disjointed experience. CarePackage aims to enhance convenience, communication, and overall trial satisfaction while simultaneously boosting retention rates. Additionally, it addresses the crucial components of the clinical trial journey including patient engagement, streamlined consent processes, personalized support services, telecare capabilities, and in-depth data capture.
Navigating the complexities of clinical trials can lead to fragmented experiences, impacting not only patients but also research sites. To address these challenges, CarePackage is dedicated to offering a unified solution. With ‘One Platform. One Connected Journey’, we streamline all aspects of the trial journey from recruitment to retention, providing a comprehensive and cohesive experience for patients, sites, and sponsors alike.
The Community Response
Feedback from patients, sites, and sponsors who have implemented CarePackage has been overwhelmingly positive. The consolidation of study resources, from recruitment through retention, and the availability of comprehensive study data within a single platform have proven to be highly efficient and productive. This adaptability and efficiency have garnered praise from users, affirming the transformative impact of CarePackage in optimizing the clinical trial experience.
Our versatile team showcases agility and can quickly adapt to meet the distinct needs of various studies. This spans a spectrum of activities, ranging from creating innovative recruitment strategies involving digital advertising, to developing custom mobile applications for better patient retention. The seamless integration of these comprehensive solutions across every touchpoint makes for an elevated, human-focused experience for patients, sites, and sponsors alike.
Conclusion
StudyKIK, a leader in clinical trial management technologies with solutions focused on patient recruitment and retention, aims to fill the unmet need in clinical study recruitment, enrollment, and retention with CarePackage, its new comprehensive platform that integrates the company’s services to provide a seamless, end-to- end-solution for both patients and industry. Using human-centered design tactics ensured that CarePackage is a cohesive end-to-end platform that provides an impactful and supportive experience during the treatment journey.
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