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The ability to carry out clinical trial visits in a patient’s home, workplace or location of choice is still an uncommon concept. However, mobile trained research nurses can expand on this idea by conducting ‘off-site’ study visits.
Mobile research nurses completing ‘off-site’ study visits is still an uncommon, unfamiliar concept to many. Having the ability to carry out clinical trial visits in the comfort of a patient’s home, workplace or location of their choice comes with certain challenges and negative preconceptions. However, the reality is it can open up opportunities for patients to receive potentially life changing treatment previously out of reach, while expanding the patient population available for recruitment into clinical trials.
The challenge for adopting mobile research nursing is often the fear of the unknown: are the nurses qualified for this; can the required procedures be carried out; is there suitable oversight; is the patient’s safety at risk; is it expensive? Some investigators also appear less willing to ‘share’ the patient with an external vendor such as a mobile research nursing vendor.
This is somewhat of a short-sighted view. Offering the service will increase the number of patients that are willing and able to participate that wouldn’t otherwise be able to, the increased level of attractiveness to participate in the trial will result in increased patient recruitment and retention, compared with the number that may have been enrolled without the ability to offer a mobile research nursing service. Offset this against the cost of mobile research nursing and it becomes very appealing.
Mobile trained research nurses are not medical doctors and are not there to replace them. However, many of the visits in a trial protocol are of a routine nature and do not require specialist equipment or medical assessment. There are many protocols which would be more easily recruited into and patient retention would be improved by writing in the flexibility of off-site visits.
Illingworth’s Research nurses were contracted to provide mobile research nurses to assist three sites conducting a Duchenne Muscular Dystrophy (DMD) study. The long treatment period and need for weekly clinic visits caused a higher than expected and desired dropout rate. One of the sites had enrolled a patient called Peter.
Peter is six years old, goes to school and lives on the Isle of Man. He has Duchenne Muscular Dystrophy (DMD), a condition that gradually causes the muscles to weaken, leading to an increasing level of disability. His parents are his carers and he has a brother and a sister. Peter has been enrolled into a clinical trial and the closest center is Great Ormond Street in London. This involves him flying into London for his visits. One of his parents must accompany him while the other parent ensures his brother and sister continue with their routine while still going to work themselves. Every time Peter has a clinical trial appointment, he misses a day of school and his parent a day from work. The study involves Peter and his parent attending the hospital for a trial visit every week for at least two years.
In many instances, especially in orphan diseases, pediatrics and chronic, debilitating diseases, patients and their carers will enroll regardless of the inconvenience involved, often through desperation. In cases such as these, mobile research nursing can reduce the inconvenience the patient his family has to go through and allows them to carry on their usual family routine as best as possible.
Research nurse profiles
What makes the difference when conducting visits outside of the clinical environment? The nurses. Illingworth Research nurses are not only registered general nurses but also highly experienced clinical trial nurses, working on clinical trials on an ongoing basis with many years of clinical experience. This ensures that they have the experience necessary to provide a quality service outside of the typical clinic environment.
Nurse selection is decided based on experience in the therapeutic area and geographical location to the patient. This same process is applied globally to large multicenter trials. In the case of Peter, a research nurse local to his home provided the support to conduct three out of four visits within the home setting, therefore removing the need for frequent travel and associated costs.
Part of the study team
The research nurse is not an isolated contractor performing services remotely, but an integral part of the study team. Every research nurse is approved by the relevant hospital and is named on the delegation of duties log at the study site, meets the team in advance of any study activities so that they are able to build up a rapport, undergoes pre-study training and attends the site initiation visit, maintaining strong communication with the investigators.
Meeting the patient
Patients are informed about the possibility of off-site visits during informed consent, explaining how it will work for them, the locations available such as at home, at their place of work or school in the case of aediatric patients. The choice of taking up the use of mobile research nurses is entirely the patient’s and is not mandatory. However, more often than not, when this additional degree of flexibility is offered, it is accepted by the patient and family.
Peter was enrolled and his parents were interested in off-site visits due to the frequency of visits to London and the associated inconvenience. The Illingworth Research nurse met them at site to discuss arrangements for future visits such as location (home or school), access, preferred time of visit, requirements (such as a space for the nurse to work), names of the family members and pets if important to the them, provide reassurance of the procedures and develop a relationship with Peter and his family.
Off-site visit preparations
Communication is key. A handover call is made with the investigator site team before each off-site visit to discuss adverse events to follow up, changes in concomitant medications and any other important visit details such as rotation of injection site location.
Peter’s family was called to confirm the time of the visit, (a visit in the morning to avoid too much time off school was preferred) and remind them of any relevant restrictions.
The safety of the research nurse is as much a priority as the patient. Illingworth operates a check in/out system where the nurse logs their location, transport details and expected visit duration with the team prior to entering the property. Checking back in after leaving the property when the visit is complete lets the team know they are safe and heading to the next visit location.
The research nurse handles all the visit requirements such as liaising with pharmacy and courier to deliver Investigational Medicinal Product (IMP) to the nurse at the visit location (following chain of custody practices), brings all the necessary equipment such as temperature and blood pressure monitors, centrifuges for blood sample preparation, and transfer of the sample to courier for refrigerated or dry ice delivery to the laboratory.
During the visit
The nurse attends the visit and makes the patient feel comfortable, which is much easier to do in the familiar surroundings of their own home, even more so with children. Although performed outside of the clinic environment, the visit procedures occur as they would do at the study site. Serious adverse events are reported to the investigator immediately and appropriate action taken where necessary.
Continuity is important to ensure that the protocol is followed and there is no change in the level of quality when working off-site.
IMP is administered or supervised by the research nurse who remains with the patient for a set amount of time after dosing (usually 30 minutes) to identify any reactions. During this time, source data can be checked and sample preparation can take place. When all procedures are complete, the next visit is arranged.
The impact of the visit on Peter’s life is obvious, he was comfortable, relaxed, with his family and disruption to their lives is minimal. After the visit, Peter can go to school, his parents can go to work and they all continue a normal life. The costs involved with flying two people in and out of London are gone and Peter and his family are happy to continue taking part in the study.
Following the visit
A courier collects samples and the nurse disposes of sharps and clinical waste appropriately. Data can be entered directly on to EDC, or paper CRFs can be scanned to Illingworth or site for entry and original copies returned by courier.
Our client approached us with this trial as there was a problem with subject retention. Our mobile research nurses were offered and, after two years of the service becoming an option, not one child had dropped out of the trial. In addition to this, Peter was able to have three quarters of his visits performed at home instead of flying to London every week.
Participation in clinical trials can be difficult, emotionally and physically for many patients, preventing enrolment and impacting on retention. Why not try a different approach and bring the trial to the patient?
By Helen Springford, Vice President of Strategic Development and Peter Allan, Research Nursing Project Manager at Illingworth Research Group Limited.