One of the most perplexing aspects of a clinical trial is patient recruitment, as it often is difficult to find not only the desired number of subjects but also the appropriate patient population. This challenge can seem magnified during a holiday season, when many potential patients are traveling or are preoccupied with other seasonal events.
But there are many ways to plan strategy to keep recruitment momentum high. These include making reasonable accommodations for patients during the holiday season, establishing a block-enrollment strategy and increasing communication with patients to keep them involved in the study.
Holiday seasons bring hectic calendars and it often can be challenging to retain patients if they cannot make adequate time in their schedules. Opening an hour earlier or extending afternoon hours during weekdays could greatly impact the number of patients brought in during these otherwise difficult times. Consider opening for a few hours on weekends if your clinic does not already. During the screening process, discuss potential conflicts with subjects and be proactive about minimizing them. Perhaps they are unable to find child care during working hours and it would be easier for them to come in for a visit later in the afternoon or early evening.
If your site has enough personnel and is equipped to provide hourly child care, consider offering it at no cost to your patients while they attend appointments. If your site is located in a busy shopping center, parking could be an issue during this time of year and could cause many patients to avoid the area altogether. Get in touch with the parking lot owner and negotiate spaces dedicated to your patients.
During appropriate studies—for example, an acne study with little exclusion criteria—it may be beneficial to adopt a block-enrollment strategy. Many sites use this method when investigators have limited schedules and are only available on certain days of the week. Rather than schedule patients throughout the week, a block of time can be devoted to a particular study. All patients for that study can be seen during the scheduled block, allowing the site to meet its desired weekly goal while working around seasonal constraints. Committing a certain day/time to a particular study will allow research staff the ability to maximize time and energy spent recruiting for a specific trial.
Of course, once patients are enrolled in a study, it is important to keep them actively engaged. The subject’s awareness of the study opportunity and the extent to which they feel appreciated is a key factor in recruitment and retention. The holidays are a great opportunity to remind patients how much they are appreciated through simple initiatives such as sending a greeting card. A newsletter is an effective way to keep patients informed of any new information and provide educational materials should they become available.
During an acne study, a Research Across America site used its newsletter to focus on patient retention during the holiday season. This proactive enrollment initiative helped ensure follow-up visits were conducted as scheduled (see Figure 1). While the number of new subjects enrolled dropped slightly during the month of December, the site still was able to maintain momentum during the recruitment phase and exceed its overall enrollment goal.
Communication with patients should be regular; it needs to go beyond appointment reminders and scheduling calls. The relationship between the site and patient also depends on how responsive the site is to each subject’s needs, as well as the nature and frequency of communication.
A site should establish open, two-way communication with patients to foster trust and an ongoing relationship. It should call them between visits to make sure they are able to comply with the protocol and offer any helpful information. Nurturing relationships with patients could help them be more inclined to communicate any issues and reschedule visits if necessary, decreasing the likelihood of their not showing up for a scheduled appointment.
When accepting a new study, it is critical to adopt proactive enrollment strategies early in the beginning. Plan ahead for any holiday hour changes, closings and staff vacations, and be prepared to adapt accordingly. While this may seem like a basic approach to patient recruitment, during the hustle and bustle of the holiday season many of these simple strategies often are overlooked as sites struggle to simply keep up.
In any situation, it always is helpful to take a step back and analyze the big picture before zooming in on the details. Remember the basics of patient recruitment and make sure the systems that have been put in place are still being followed closely to minimize the complications that could come up during the holiday season.
Jeffrey Adelglass, M.D., F.A.C.S., is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multidiscipline CRO. Email comments to firstname.lastname@example.org.
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