There is a new trend afoot in “patient engagement,” related not only to clinical trials, but also to healthcare today.
A plethora of conferences, articles, webinars and discussions purport the importance of this concept as if we had never thought of the idea before. The question before us might be: is this simply another catchy way to describe patient recruitment and/or retention? Is it just an attempt to repurpose customer service principles? Or is it something in between? In any case it is important to consider this more fully, as investigative sites are the only direct connection between the trial and the patient and definitely affect the patient’s decision to enroll in a trial and sustain his/her involvement.
Patient engagement in the true sense, as it relates to trials, is being looked at as a paradigm shift—that patient input should be included throughout the product development lifecycle, and patient involvement should be the new gold standard in product development. As we take the concept a step further, consider a recent article describing the practice of including potential trial participants in the development of protocols. This notion makes sense, to the point that we might ask ourselves why this is not standard practice and, indeed, why it is not standard practice to involve sites in protocol development as well.
More importantly, an evaluation of trial participants’ perceptions of clinical trials—why they enter, why they stay and their experiences—is of critical importance. Perhaps this is, in part, the missing link as to why 80% of trials see delays related directly to patient involvement, and why this statistic has not changed significantly over the last decade or more.
Today’s consumers of clinical trials are exposed to multiple levels of entry to healthcare, pay-for-service models and health and wellness delivery locations on every corner. Take the Walgreens approach to capturing the consumer through a theme formulated around the “corner store” concept, and the new Neighborhood Walmart stores. Even the multi-billion-dollar beauty business is challenged with the market being flooded with home-care delivery devices, such as lasers, and the commoditization of what previously were physician-centric services. Therefore, how do we expect to compete for attention in the clinical trial arena?
A few areas to consider in the delivery of services at the site level are location, hours of operation and evaluation of the needs of our “customers.” While we can’t pick up and move a site to demographically fit a particular population, we can take the study to the patients in some cases—collecting data remotely, changing clinic hours to weekends and evenings and structuring block enrollment strategies to meet the needs of both staff and patients. If we don’t begin more robustly employing these principles, we might miss the opportunity to reach our target populations.
Are you evaluating the patient experience in your setting and implementing feedback from a practical, as well as philosophical, perspective? Brief survey data will quickly reveal your scorecard on staff communication, access to care and satisfaction with the clinical trial process. This data is telling and can be used to help customize and assure the patient of the quality of interaction to expect. Visit walgreens.com for an example of the “scorecard” parameters for patient engagement as related to the company’s perspective on customer satisfaction.
In summary, every activity—from choosing to take on a study to ascertaining and evaluating the participants’ experiences—should become a routine consideration for managing a patient engagement strategy matrix. The ability to thoughtfully evaluate this concept arguably could be one of the most important factors in your site’s growth and, perhaps, its competitive edge. Take the element of the patient experience and the importance this plays in entry and completion of a trial. Can you honestly say you believe this is the most important element of trial success and that you focus on methods to improve the patient experience often? In the high-tech, low-touch lives we lead, relationships still are the common denominator in consumer satisfaction.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas. Email comments and questions to email@example.com.
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