December 9, 2020 PAP-Q4-20-CL-013
With mobile research nursing, a skilled nurse goes to a study participant’s home or other convenient location to conduct off-site visits and perform study-related assessments and data collection. Off-site visits lighten the burden of participation by allowing clinical trial obligations to be completed in the comfort of a familiar environment and at the convenience of the patient and their caregivers. These visits can also enhance retention and strengthen provider–participant rapport, particularly if the patient is visited routinely by the same nurse who is already familiar with their situation.
Pandemic-related site closures and travel restrictions caused many clinical trials to come to a halt. Even as sites reopened, patients and their caregivers may have been reluctant to go to clinical sites for fear of COVID-19 exposure. Mobile research nursing enables clinical research visits to be performed in a way that circumvents these obstacles — an attractive option in almost any study, as a majority of clinical trial participants live more than two hours away from designated clinical research sites.1 By reducing or eliminating the need for long-distance travel, sponsors can expand the recruitment pool by making study participation accessible and attractive to those with limited mobility or who live far away from a site.
Mobile research nurses serve as an extension of the on-site study team and perform activities — including data collection — on behalf of the site. As such, selection of a mobile research nursing partner that is an appropriate fit for the study is critical. Importantly, mobile nursing is not a generic solution. Sponsors may want to seek out providers who offer licensed nurses with both clinical skills and trial experience in their therapeutic area of interest or to understand whether the provider has nurses in all the geographies covered by the study, how the provider trains nurses on the protocol and associated procedures, and what processes the provider uses to ensure the quality of the data captured by their nurses.
To ensure seamless integration with site staff, a best practice is to have every nurse approved by the site and named on the delegation of duties log, as these nurses perform activities on behalf of the site. It is critical for the nurses to build strong relationships with site staff and to establish a cadence of consistent communication. While in-person meetings with site staff are the ideal method for onboarding mobile research nurses, this practice has been adapted during COVID-19 to accommodate video conferencing as an alternative.
In a recent survey of clinical trial participants, 38% of those who dropped out of a study said they did so because site visits were stressful.2 Offering the option of off-site visits with a mobile research nurse can help to alleviate that stress by minimizing disruption of normal, daily routines. In addition to making study participation less disruptive for patients and their caregivers, mobile research nursing visits make it possible for site staff to assess the safety of their patients at more frequent, predictable timepoints, even if unforeseen circumstances — such as a global pandemic — arise.
The recommended approach for making the clinical trial experience seamless for study participants is for sponsors to include the option of mobile research nursing in the protocol and for principal investigators to explain the logistics of off-site visits. If the patient opts in, there would ideally be an onboarding process that gives the patient and their caregivers an opportunity to meet the assigned mobile research nurse in advance of the first visit, either in person or via telephone.
Before each visit, the mobile research nurse and the site team should connect to discuss details of the upcoming visit, including assessments to be performed, adverse events to follow up on, or medication changes to be made. The mobile research nursing team handles all the requirements of the visit, from coordinating with the pharmacy and the courier for delivery of the investigational product to bringing the necessary equipment for assessments to the off-site visit and transferring any samples to a courier for delivery to a lab. If a serious adverse event is noted during the visit, the nurse must immediately report it to the principal investigator and take any appropriate action.
Study recruitment and retention can be challenging, even outside the context of a public health emergency. Clinical trials often involve vulnerable populations who are most at risk from exposure to COVID-19, which further magnifies the obstacles of enrollment and ongoing study participation.
Just as sponsors have needed to adapt in response to pandemic-related challenges, mobile research nursing providers have been tasked with developing processes to protect both their nurses and the patients and caregivers they visit. In addition to mobilizing COVID-19 response teams, developing detailed safety protocols and symptomatology checklists for both nurses and patients has been crucial. An effective approach is to contact the patient and their caregivers the day before a scheduled visit to perform a symptom check. Having the nurses also perform a symptom check on themselves before the visit helps to ensure all parties involved in the visit remain safe. To limit unnecessary face-to-face contact, visits should also be preceded by phone calls between the nurse and the patient or caregiver to discuss the details of the visit.
It is recommended that nurses wear full personal protective equipment (PPE) at all visits, including face masks, gowns, and gloves, and all are supplied with disinfectant products for use during visits. Even more rigorous standards should be adhered to when the nurses are visiting with patients for extended periods of time, interacting with vulnerable patients, or performing procedures, such as pulmonary function tests, that increase exposure risk. Ensuring adherence to these heightened security precautions requires extensive training and situational testing. Strict policies regarding quarantining nurses who have been exposed to patients or other individuals with symptoms or confirmed diagnosis of COVID-19 are essential and should follow country-specific regulations for isolation and monitoring.
So long as COVID-19 remains a concern, it is incumbent upon mobile research nursing providers to continue to monitor what health agencies around the world are saying and to continually adapt their standard operating procedures so that nurses and patients and caregivers feel safe at every visit.
This year of unparalleled uncertainty underscores the importance of proactively planning for unforeseen circumstances in every clinical trial. Clinical trials are the culmination of years of research and development, and they are resource-intensive endeavors. While sponsors of ongoing trials have successfully integrated mobile research nursing into existing protocols to keep their studies moving forward, sponsors of upcoming trials may benefit from incorporating the option of off-site visits at the outset to help future-proof (and pandemic-proof) their studies.
“Virtual Clinical Trials: A New Model for Patient Engagement.” The National Academies of Science, Engineering, and Medicine. 2 Aug. 2019. Web.
“Retention in Clinical Trials: Keeping Patients on Protocols.” Forte Research: 23 Jan. 2020. Web.
In 2020, Jules Moritz joined Illingworth Research Group as COO. She has more than 30 years of clinical research experience, having started at bedside as study coordinator in a major academic hospital in Philadelphia. Jules has held positions of increasing responsibility in academic research, pharmaceutical companies, and CROs. She has worked in a number of therapeutic areas, including a concentration in rare disease and pediatric research. She is committed to increasing "patient-centricity" across the biopharma therapy development cycle.