“Human intervention by properly trained medical professionals remains a key element in ensuring data consistency and integrity, as well as protocol compliance. It also plays a role in patient retention, as the bond that often exists between the mobile research nurses, the patients and their caregivers is a powerful tool in keeping patients compliant and participatory,” says Ellen Weiss, VP In-home Solutions, Decentralized Clinical Trials at PCM Trials.
The value of mobile research nurses with vulnerable populations
A large percentage of clinical trials involve participants from what is termed vulnerable populations. In the clinical sense, vulnerable can be defined many different ways, including people with:
• Cognitive declines, including Alzheimer’s and other forms of dementia
• Nervous system disorders which limit mobility or dexterity, such as Parkinson’s, Rett syndrome and Angelman Syndrome
• Speech/communications challenges that affect patients who have suffered from strokes, Huntington’s disease, autism or similar disorders
All of these attributes could limit a participant’s ability to understand or accurately use some technology. This and other population also often have dexterity challenges to successfully rely solely on technological solutions. Having a nurse in the home regularly who has been trained on the specific protocols of the trial can help aid understanding and proper use of any technology.
Mobile research nurses prove invaluable in situations where access issues limit use of technology
The FDA continues to push for greater diversity in clinical trials. In extreme cases, promising drugs have been denied approval because the FDA deemed that the trial participants did not adequately represent the real-world patient who needs and could most benefit from the trial drug.
Some trials specifically seek to include participants in remote rural areas, including harder-to-find populations like those in Amish communities, as well as people in urban lower income neighborhoods where access to technology is limited. In areas like these, it is difficult, if not impossible, to consistently deploy devices or video chat with participants. Visits by mobile research nurses, however, can take place regardless of a participant’s access to or use of technology.
Sometimes even the best-intentioned technologies can fail due to human behaviors. Such is the case of a participant who switches the wearable from the right wrist to the left, giving off contradictory results. Or the participant who gives it to his spouse to wear for a day so he can take a break from routine physical activities without being “outed” by the device. And we have all heard about the young trial participant who attached his wearable on his dog just to see how it works. Even if the story turns out to be slightly exaggerated, one can easily see many limitations of overreliance on technology alone.
In many successful decentralized trials, a trained mobile research nurse has served as the eyes and ears of the principal investigators to help spot irregularities and ensure patients are complying with specified protocols without deviation.
Complex, high-risk trials benefit from trained onsite professionals
With many trials involving the infusion of drugs, blood draws or the collection of various other bodily fluids, such as urine and saliva, it’s important for a qualified nurse to be in the home to help ensure patient safety and protocol adherence. In addition, a nurse in the home can confirm that patients are storing drugs correctly and that the home is properly prepared for the various procedures. The technology does not yet exist to safely or adequately perform many of the tasks of these trials at home.
Human intervention by properly trained medical professionals remains a key element in ensuring data consistency and integrity, as well as protocol compliance. It also plays a role in patient retention, as the bond that often exists between the mobile research nurses, the patients and their caregivers is a powerful tool in keeping patients compliant and participatory
Wearables and other types of AI-driven devices have come a long way in their ability to monitor various vital signs. The reality, however, is that there are other changes that could significantly impact trial data that cannot be monitored by technological devices. This includes changes in a patient’s demeanor, family interactions and living environment, to name just a few. All of these could affect the patient’s ability or willingness to continue participating in the trial.
Mobile research nurses, like those employed by PCM Trials, get to know the participants they visit, as well as their families and ongoing caregivers. PCM Trials, in particular, consistently schedules the same primary or secondary nurse to participants so they get to know each other and establish a valuable comfort level.
In one case, a PCM Trials nurse discovered that a participant who was mentally declining due to Alzheimer’s had lost her spouse, who had served as the primary caregiver. The trial site was not aware of the spouse’s death. It was the PCM nurse who stepped in and provided additional assistance to the participant so that she could safely and comfortably remain in the trial and continue complying with the various protocols.
Without a doubt, technology is evolving such that it represents a viable option for some aspects of decentralized trials. The degree to which it is relied upon is largely based on the demographics of the patient population and the complexity of the procedures required. Due to the nuances of human behaviors and the potential for misunderstanding and noncompliance, as well as the need to create personal bonds that aid in patient retention, mobile research nurses continue to prove valuable and necessary whether they are used exclusively or complemented with the use of technology.
