The Science of Engagement in Clinical Trial Subject Enrollment

July 30, 2013
Moe Alsumidaie

Applied Clinical Trials

Accessing and engaging patients is a very difficult task in today’s environment, as there is a bombardment of numerous media vehicles, including digital media, with varying intensities that penetrate patients’ senses, emotions, and thoughts.

Accessing and engaging patients is a very difficult task in today’s environment, as there is a bombardment of numerous media vehicles, including digital media, with varying intensities that penetrate patients’ senses, emotions, and thoughts.  But, how do we determine which medium is best for a diabetic patient compared to a multiple myeloma patient? And how do we successfully recruit and enroll the subject in a clinical trial?

I recently ran across the 19 Elements of Engagement, and I was intrigued by the concept that there is a science behind engaging patients.  After reviewing these elements, I started asking myself, which of these elements can we best leverage in clinical trial subject enrollment? The following three elements stood out the most:

Access:
Access is associated with how easy it is to acquire something, and patients’ attention tends to veer towards the most convenient engagement option.  Scientifically, the brain attempts to achieve the highest reward in the most efficient manner.  In clinical trial subject engagement, accessing patients is a crucial hurdle that study teams need to overcome in order to reach and recruit patients, hence, determining the most appropriate medium to implement engaging tools is key towards recruitment success.

According to the literature, patients are 5 times more likely to visit pharmacies than their primary and specialty physicians [1].  Moreover, patients exhibit familiarity and associate trust with healthcare professionals and related environments, which attribute towards environmental familiarity and maximizing engagement.  Implementing engaging campaigns at physical locations, such as pharmacies, is one of many ways in which study teams could access and engage patients, however, it is important for study teams to understand patient behavior and geolocation in order to access patients and yield favorable enrollment results.

Desire:
Desire is associated with addressing a need that is felt as lacking. It is a subconscious effect that sometimes is the result of having a need that has been missing for a long time, such as pain relief, energy, and social acceptance.  Scientifically, when the brain is presented with stimuli that address these lacking needs, the brain reacts immediately and positively by releasing dopamine.
In clinical trial subject recruitment communications, we sometimes use desire in an unethical manner to attract patients towards clinical trial enrollment, nevertheless, such use results in veering subjects away from clinical trial participation.  While it is important to attract a patient’s attention, it is important for study teams to not only educate patients about the process of clinical trials, but also neither to over-exaggerate the benefits of clinical trials nor make any promises or guarantees. 

For instance, when I worked at the study site, I ran across many campaigns with flyers that exhibited images of overly happy people enjoying their lives. Unfortunately, these campaigns were misleading as we were faced with the reality of patients who had high expectations of getting better by participating in a clinical trial, but, were disappointed and chose not to enroll during the consenting process when we explained the risks and benefits of the clinical trial; we observed that patients were disappointed and they felt that their trust was violated.
Patients that suffer from severe medical ailments are far from the imagery of healthy and happy people that were on these flyers. Study teams need to practice caution by understanding their target audience and setting realistic expectations by developing appropriate subject recruitment content and training study staff on how to best present potential risks and benefits of clinical trials.

Respect:
Respect is associated with the achievement of shared goals, and the feeling is developed by recognizing and rewarding this achievement. Scientifically, this behavior stems from the psychology of reciprocity and mirroring, as people tend to follow those who set directives, which fosters motivation and belonging.
Subject recruitment does not stop at the patient; it particularly involves interactions at the study site, and if study sites are not involved, subject enrollment initiatives fail. To elaborate, when I was working at the sponsor overseeing large Phase III clinical trials, I was assigned to a clinical trial that experienced sluggish subject enrollment. We conducted surveys and analytical assessments, and we uncovered that many study sites were not paying attention to our clinical trial because of competition from other clinical trials.  Moreover, after conducting analytical assessments, we were able to determine that there was a significant relationship between medical chart review frequency and high enrollers.

We implemented a campaign that raised awareness by re-branding the study’s image and implementing contests to engage study sites. In addition, we executed training programs, regular communications, and toolkits to engage study sites.  Naturally, clinical trial subject enrollment rates increased.
Clinical trials are highly dynamic in nature, and each clinical trial requires specific expertise and customized campaigns to reach patients and engage study sites.  Simply implementing one solution towards all clinical trials will not result in maximizing engagement and result in subject enrollment campaign failure. Which of these elements best applies towards your clinical trial?

[1] Getz, Kenneth. Impact of In-Pharmacy Education on Patients’ Knowledge and Attitudes about Clinical Trials.  Tufts University School of Medicine, January 2013

 

By Moe Alsumidaie, VP Analytics & Clinical Affairs, DNA Clinical Communications.  Moe Alsumidaie can be reached here. If you are interested in joining the discussion, apply to the Breakthrough Solutions in Clinical Trials & Healthcare Group