Home health care has long been utilized in clinical trials. With the increased interest in adopting clinical trial models like decentralized clinical trials (DCTs) that make clinical research easier to conduct in a pandemic-facing world, home healthcare is being revitalized. Sponsors, private health insurers, and health care providers are realizing and embracing the benefits of this approach to collecting data from trial participants.
Home health care relies upon experienced healthcare staff (generally nursing) to visit trial participants at their homes to conduct procedures and collect data. The staff normally have small fridges, freezers, and centrifuges in their cars, which means they can take and temporarily store most biological samples. They can capture the standard vital signs (heart rate, blood pressure, respiratory rate, temperature), record ECGs, and if necessary, transmit these telephonically to a physician for review. They also can conduct basic respiratory measurements and administer many patient reported outcomes. Many of the assessments required in a clinical trial visit schema are attainable with well-trained home health care nurses from a reputable home health company.
For pediatric clinical trials, home health care is a particularly important consideration. Children diagnosed with a chronic condition or rare disease often find they have limited treatment options and potentially detrimental outcomes. Clinical trials are frequently presented as a treatment option and can be perceived as a “light at the end of a tunnel.” However, trial participation involves the entire family and can lead to many logistical and emotional challenges for the child’s care circle.
Typical challenges associated with a schedule of visits to the trial center include loss of parental work time (and earnings) for caregivers, loss of school time for the child, and stress associated with transporting an unwell, possibly apprehensive, child to and from the trial center. In addition, the mental health strains of any healthy sibling(s) may become an issue, as the ill child consumes a greater proportion of the parents’ time and attention. Home healthcare can help to alleviate some of these challenges and improve the participation experience for the whole family.
Home health care can also increase access to treatment options and make clinical research as a care option (CRAACO) a possibility. Geographic distance to the site or time commitment to participation are common barriers preventing participation. Protocols may specify a schedule of events which require assessments to be made or samples to be taken on a frequent basis. In some cases, that may require a journey of some hours to and from the trial center and may entail an overnight stay away from home – a burden which may simply be unsupportable for a family with a seriously ill child. Home health care can enable procedures to be performed and data to be collected in the home setting, making participation attainable.
The Center for Pediatric Clinical Development carefully considers home health care integration when reviewing a schedule of assessments to decrease barriers and burdens to participation. Utilizing home health care in clinical research has many benefits, including decreasing cost associated with travel, greater diversity in participants, engaging a larger patient catchment, and real-time accurate data collection via Electronic Clinical Outcome Assessment (eCOA) & Electronic Patient Reported Outcomes (ePRO)-utilizing technology.
Many Phase II & Phase III clinical trials will evaluate the safety and efficacy of an Investigational Medicinal Product requiring rigorous pharmacokinetic/pharmacodynamic draws, electrocardiograms, distribution and administration of study medications, or even physical exams. Home health care providers are capable of conducting these measurements in the home, and with strategic planning during protocol development, this at-home option can be utilized.
When reviewing a schedule of assessments, it’s important to realize the benefits home health visits can introduce to these families goes beyond just easing the burden. It also removes the risk of exposure to secondary infections by allowing subjects and family members to remain in their home, and it improves their participation experience. An improved experience in turn increases retention and reduces the risk of pediatric subjects being lost to follow-up in longer term studies.
Although home health care has supported clinical trials for well over a decade, IRBs and Ethics Committees may not always be familiar with the range of activities which the staff of these organizations can undertake. These committees may have concerns regarding the conduct of assessments which, traditionally, take place at the study site. They may also be uneasy that trialists are not being seen by the investigator as frequently as in the traditional model. Anticipating these concerns is important— providing information up-front to IRBs and Ethics Committees which describes the qualifications and experience of their staff, as well as explaining how the home healthcare staff interact with staff at the study site, will do much to reduce such concerns. Moreover, clinical research organizations need to work with sites to ensure they understand how home health care functions and that data integrity is not compromised by their utilization.
As Pediatric Strategy Liaisons at PRA, we look at visit schedules over the duration of the study and the impact of participation. We place ourselves as the “Kid in the Room,” assessing aspects for continued engagement of the child/adolescent/teen, the caregivers, and their healthy siblings. We evaluate each visit focusing on the safety of the subjects, collection of endpoints, and modifications to include home health care visits where appropriate.
At the Center for Pediatric Clinical Development, we have the unparalleled expertise and resources needed to run exceptional pediatric trials from start to finish. We’ve tapped into the world’s best pediatric experts across the board to deliver pediatric-focused insights across all aspects of a clinical trial.
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