When Trials Stumble, Mobile Research Nursing Lends a Helping Hand

Jules Moritz

While participation in clinical research offers potential access to promising new treatments, it can also be a challenge for patients due to the burden of trial appointments and the need to travel to a clinical research site that may be far from home. These challenges can become overwhelming, especially if the study participant is seriously ill or is a child. For many study participants, in-home visits from a clinical trial nurse may be a welcome alternative to on-site visits. These in-home visits may also benefit sponsors as they can enhance recruitment and retention without sacrificing data quality, all while increasing patient centricity.

Bringing the trial to the patient

Industry guidelines advise sponsors to reduce the emotional and physical burden of study participation and to consider the convenience of participation for both patients and their caregivers.¹ With mobile research nursing, a nurse goes to that patient’s home —or any other location that is convenient for the patient—to conduct off-site visits and perform study-related assessments and data collection. These off-site visits ease the burden of study participation by allowing clinical trial obligations to be completed in the comfort of the home and at the convenience of the patient and their caregivers. Bringing the trial to the patient also offers the opportunity to strengthen study engagement, especially if the patient is visited regularly by the same nurse who is familiar with their health and circumstances.

Value of mobile research nursing

• Increased patient pool.According to the Deloitte Center for Health Solutions, more than 70% of all clinical trial participants live more than two hours away from the clinical research site. The need to travel long distances for frequent follow-up visits may deter eligible patients from enrolling in a study. Offering the attractive option of off-site visits with a mobile research nurse expands the patient population available for recruitment by making study participation accessible even for those with limited mobility and those who do not live near a clinical research site.
• Reduced patient burden. Even the most motivated clinical trial patients may find traveling to sites inconvenient or difficult, especially if they feel unwell. The COVID-19 pandemic and associated travel restrictions have made site visits even more challenging. With mobile research nursing, clinical research visits can be performed where and when it best suits patients and their caregivers.

At Illingworth, we augment our mobile research nursing services with patient concierge services that help patients get to site visits when they are required to do so. These services, which may include travel bookings, expense reimbursements, and other customized features, are uniquely configured to take into account the patient’s specific needs and limitations.

• Enhanced retention. Reducing the burden of trial participation often goes hand in hand with improving retention. In fact, one survey of clinical trial participants found that 38% of those who dropped out of a study did so because they found site visits to be stressful.² Mobile research nursing contributes to reductions in patient stress without compromising study design or data quality. Indeed, throughout the COVID-19 pandemic, mobile research nursing has enabled patients to continue to participate in clinical trials even when sites were locked down.
• Completeness and quality of datasets. When they need to travel long distances to sites, patients may be exposed to conditions that affect their ability to perform certain physical assessments. Even the disruption of typical routines can impact data quality as patients may become fatigued or exposed to other illnesses while traveling. Mobile research nursing can alleviate these confounding factors by eliminating the need to travel or rearrange daily life activities. In addition, mobile research nursing visits enable site staff to assess the safety of their patients at timepoints when they might not otherwise be able to due to scheduling conflicts or unforeseen circumstances, such as the current coronavirus public health emergency.
• Increased patient centricity. Over the past two decades, there has been a significant shift within the clinical research industry regarding inclusion of off-site data acquisition options. This is due, in part, to increasing emphasis on patient-centricity and wider acknowledgement of the patient as a partner in clinical trials—not just as a participant. Researchers today are more likely to engage with patient advocacy groups, and what they are hearing is that patients welcome the opportunity to participate in clinical trials as long as the experience is not overly burdensome. Mobile research nursing helps address that need.

Taken together, the benefits associated with mobile research nursing can help sponsors complete trials on time, with improved recruitment and retention and increased patient and caregiver satisfaction. When the cost of mobile research nursing is balanced against the cost of dropouts and delays, having the ability to offer in-home visits may be appealing to all stakeholders.

Impact of the COVID-19 pandemic

With the emergence of COVID-19 and the associated site closures and travel restrictions, many clinical trials came to a halt. Sponsors of existing studies that did not have off-site capabilities turned to mobile research nursing as an option to keeping studies on track. In turn, mobile research nursing providers were tasked with adapting their processes and procedures to ensure the safety of both their nursing staff and study participants. This agility and flexibility in times of uncertainty is invaluable for keeping studies moving forward.

Bringing hope into the home

Patients are surrounded by caregivers and families whose lives are also impacted by participation in a clinical trial. On-site visits can put stress on a patient’s support network in terms of time away from home, school, work, and potentially lost wages. In many cases, such as rare diseases, pediatrics, and conditions with limited treatment options, patients and their caregivers will enroll in clinical trials regardless of the inconvenience involved. Participation, however, takes its toll over time.

Technological advances, such as electronic patient reported outcomes, wearables, and telemedicine, have broadened the spectrum of procedures that can now be performed off-site or in the home. With technology, the number of clinical trials that could be conducted with the option of mobile research will continue to increase.

Having a nurse come to the patient eliminates the time a patient, and in some cases their family, would otherwise have to spend traveling and sitting in waiting rooms. Altogether, it makes the mechanics of clinical trial participation less disruptive to a patient’s family life, as well as to their educational and professional lives. Moreover, mobile research nursing offers the patient-centric features of customization and personalization of the clinical trial experience, delivering care in a manner that reflects a patient’s individual preferences and personal situation.

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Integrating with site staff

Mobile research nurses are an extension of the team at the study site. A best practice for integration with site staff is to have every nurse approved by the site and named on the delegation of duties log. As these nurses will be performing activities on behalf of the site, it is important for the nurses to engage and build strong relationships with site staff. In-person meetings with site staff are optimal, as this creates opportunities for the mobile research nurses to share their background and expertise. It is also critical to establish a consistent flow of communication between site staff and the mobile research nurses throughout the course of the study.

Another best practice that can help make the clinical trial experience seamless for study participants is for principal investigators (PIs) to discuss the mobile research nursing option and explain how in-home visits will work. Keep in mind that it is entirely up to the patient whether to opt in for mobile research nursing.

A rigorous onboarding process is also essential to successful integration. In an ideal situation, the study participants and their families are invited to meet the mobile research nurse at the clinical research site in advance of the first in-home visit so everyone can become familiar with each other. Of course, adjustments should be made when patients/families cannot travel to the site for these introductory meetings, for example, in the time of a pandemic.

Close communication between the mobile research nurse and the site team to discuss details of the upcoming visit, such as adverse events to follow up on and changes to medication, enhances the quality of care and the nurse’s role as an extension of the site team. Further examples include handling all visit requirements, coordinating with the pharmacy and the courier delivery of the investigational product to the visit location, bringing all equipment necessary to perform the required assessments, and transferring any samples to a courier for delivery to the laboratory. If any serious adverse events are noted, the nurse must immediately report them to the PI and take appropriate action where necessary.

Selecting a mobile research nursing partner

For those exploring mobile research nursing as part of their clinical development plans, here are a few key questions to ask a potential mobile research nursing provider:

1. How are nurses identified?

Look for providers who offer registered nurses with not only many years of clinical experience, but also specific clinical trial experience in your therapeutic area of interest. You should also ask if the mobile research nursing provider can serve all the geographies where off-site visits may be needed.

2. How are nurses trained to conduct the assessments specified in the protocol in an off-site setting?

The mobile research nursing provider should also have a robust onboarding and training process. In addition to being thoroughly trained in good clinical practice, mobile research nurses should be trained in study-specific procedures.

3. How does the company ensure the quality of the data captured by the mobile research nurse?

Ask about the mobile research nursing provider’s standard operating procedures and the processes they utilize to oversee their nursing staff. Ideally, the provider will prepare and train all nurses on a home care manual that explains all the procedures to be performed at each specific time point. Ongoing data reviews to ensure accurate completion of source documentation with feedback to the nurses enhance data quality and good documentation practices.

The provider should be able to demonstrate a high level of nurse oversight, comprehensive training approach that ensures their nurses can function independently in the field, and a commitment to only hiring nurses who are eager to be integrated into the on-site trial team and dedicated to patient safety and patient centricity.

Conclusion

Fewer than 10% of clinical trials are completed on time. Many studies simply get shelved due to incomplete enrollment. Consequently, study sponsors are continually searching for ways to overcome obstacles in recruitment and retention.

For many, reducing patient and caregiver burden related to clinical trial participation is a top priority.

The rise of mobile research nursing using highly trained practitioners with a diverse skill set harkens back to the bygone doctor’s house call, when care was home-based. Whether at home, school, work, or elsewhere, mobile visits reduce patient and caregiver requirements, providing flexibility and giving study participants more control while addressing key issues for sponsors.

References

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use: “Addendum to ICH E11: Clinical Investigation of Medicinal Products in the Pediatric Population,” Aug. 18, 2017. Available at https://database.ich.org/sites/default/files/E11_R1_Addendum.pdf.
2. Forte Research: “Retention in Clinical Trials: Keeping Patients on Protocols,” Jan. 23, 2020. Available at https://forteresearch.com/news/infographic/infographic-retention-in-clinical-trials-keeping-patients-on-protocols/.

Jules Moritz, COO, Illingworth Research Group Ltd