People face many barriers to participation in clinical research. Most don’t even know it could be an option for them. Among those who are aware of clinical research options, many find that scheduling additional medical appointments into an already busy schedule or traveling long distances to a clinical research center can make participation challenging. Those challenges can become even greater if the research participant has a rare condition or is a child.
Addressing some of those challenges is one reason we at Lilly use mobile nursing in several clinical trials. Mobile nursing is when a trained medical professional (for example, a nurse, nursing assistant or lab technician) comes to your home—or any other location that is convenient for you—to conduct the study visit.
I recently sat down with two members of Lilly’s pediatric steering committee, to learn more about their experience implementing in-home visits via mobile nursing for a Lilly pediatric research study.
Tell us about the Lilly clinical trial that implemented in-home site visits.
Actually, we’ve used in-home nursing for several Lilly studies, in kids and adults, across several therapeutic areas.
How did the idea for implementing in-home site visits, or mobile nursing, come to light for these research studies?
Participation in a research study can cause a big impact to families’ schedules. Frequently, parents of children with medical conditions express how busy their lives are with medical appointments, therapies on top of the background of typical family life of work, school, sports, music lessons, etc. For adults, taking time off work can be a burden. Finding time for additional appointments for research needs can be overwhelming. Furthermore, industry research guidelines advise study sponsors to reduce “the emotional and physical burden” and to consider the “convenience of participation” for research participants and their caregivers. When appropriate, an in-home visit from a clinical trial nurse can be a welcomed option.
We know that shared decision making is an important aspect of considering clinical trial participation. How did the introduction of in-home visits impact that conversation between physicians, patients and caregivers?
As a best practice, the Principal Investigators allowed extra time to discuss the mobile nursing option and time for all the people involved to meet and get more comfortable with each other. When a Principal Investigator had a patient who could be eligible for the trial, he or she mentioned the in-home visits as one of the clinical trial options and explained all the details of the visits, who the nurse was and what his/her background was, why the nurse was being introduced and how the mobile nursing vendor was selected. Patients and caregivers were then invited to attend an in-person meeting with the Investigator and mobile nurse at the research center. This meeting provided an opportunity for everyone to become familiar with each other and identify any potential issues before the in-home visits began.
What were the challenges of in-home visits from an operations perspective?
Using a mobile nurse presents a unique set of operational challenges, such as maintaining a consistent flow of two-way communication between research site staff and the mobile nurse, as well as providing additional training for the mobile nurses.
What are your closing thoughts around your experience implementing in-home visits for clinical trials?
Our main goal of introducing the in-home visits was to reduce patient and caregiver burden. We learned that including in-home visits as part of the clinical trials conversation provided flexibility, giving potential participants more options. Mobile nursing is not the right solution for all clinical trials, as the study design and the number of participants play a big role in the success of these types of studies, but we are committed to finding and using these kinds of solutions that work.