Engaging patients in their care, or ‘patient engagement’, has been an important strategy in the broader healthcare industry for years. Whether it is engaging patients after a surgical procedure to reduce the likelihood of complications and hospital readmission – or empowering people to make healthy choices to keep them out of the healthcare system – hospitals, health systems, health plans and employers (as benefit providers) have long been focused on engagement as a key strategy in achieving positive health outcomes.
Today, patient engagement is also becoming an increasingly important component of clinical research. At the most basic level, in an area where patient recruitment and retention are critical to the success of a trial, patient engagement methods are imperative to attract and retain study participants. At the same time, new data sources and the increasing focus on virtual and decentralized trial models is creating a greater focus on the patient, or study participant, and it is making them a direct line of data collection. In these models, the patient takes on a more active role in the study by directly tracking and reporting data and outcomes.
While there are significant benefits of decentralized and hybrid models, there are also key challenges. Participants’ comfort levels with limited or no in-person interactions and concerns about data privacy and security may present concerns. Clinical trial teams need to consider the entire participant experience, including engagement and education. It will be incumbent on clinical trial teams to vet patient technologies and design and build engagement programs that ensure adherence. These challenges may become more complex as outreach expands to underserved populations.
The Role of the Patient Advocate
As patients and patient advocates become more involved in trial designs, a new focus on the patient experience is coming to light. Patient advocates play an important role in research by bringing the patient’s perspective to the investigative and clinical environment. Involving patient advocates in the study design can help uncover potential barriers and challenges in advance, particularly as it relates to remote participation and direct data collection.
Optimizing the Patient Experience
The increasing shift toward hybrid, virtual or decentralized trial models holds multiple promises. By easing the patient burden, these formats can make it easier for people to participate in a trial, increasing recruitment, retention and diversity of study participants. The convenience and comfort of meeting virtually or locally with a healthcare provider improves the patient experience. Incorporating other technologies like telemedicine visits enhances the experience further and likely increases patient adherence at the same time.
An exciting aspect of decentralized trials is the simultaneous emergence of the patient voice. In decentralized trials, the entire patient experience is different. Clinical research teams must redefine patient communications. They must consider how they will support frequent, real-time, and two-way communications. Opportunities for patient engagement traditionally focused on reminders about site visits, etc., may now need to be more focused on ongoing participation, reminders to track or submit data, etc. It’s critical to understand participants bring varying levels of knowledge, cultural differences and language preferences to the study. To address these differences, research teams need to consider health literacy principles when designing communications and / or incorporating patient engagement technologies.
As wearables and other applications are used to capture, track, store, and report data directly from study participants, their role in the data lifecycle becomes more critical. Research teams must validate tools to ensure data quality. They must adequately train patients and caregivers to use the tools properly to ensure data integrity. Furthermore, the ability to easily integrate disparate data sources with other clinical trial systems is key to efficiency and optimal data integrity.
The patient as a more central and active participant in clinical trials opens up a world of possibilities. At the same time, it requires research teams to think more creatively, embrace innovation and create more ‘consumer-centric’ research designs. New technologies, data sources and advanced analytics, coupled with consumer expectations and demand, will push innovation further. Research teams need to be prepared with technology solutions able to meet the demands of the industry – and the participant.
Comprehensive, flexible platforms offer a unique balance of the flexibility and scalability the evolving clinical research industry requires. As the requirements for the suite of tools needed to support new clinical trials designs and patient engagement increase, flexible platforms designed with a robust solution and feature set, while allowing for integrations are critical. A comprehensive native feature set delivers much-needed underlying consistency, while a highly functional API enables integrations with a variety of technology vendors to allow patients to effectively become active participants.