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Incorporating Home Visits In Clinical Trials

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nurse taking a patient's blood pressure in a home setting
Patient Centricity

When the COVID-19 pandemic hit, the impact was immediately felt in emergency rooms and ICUs (intensive care units) around the world. Healthcare practitioners became even more stretched within healthcare systems that were already feeling the strain.

The biggest impact on the clinical research industry has been uncertainty around the reallocation of medical resources and the potential impact of the outbreak on the health of patients and the integrity of trials. Mass travel bans and increasingly complex logistics brought damaging implications for many study sites and sponsors. 

As global fear rose, so too did the concerns of patients taking part in clinical trials. According to a recent study by Applied Clinical Trials, 29% of sites said COVID-19 would have a “big” or “extremely big” negative impact on clinical trial recruitment and retention. Patient sentiment, particularly in regards to site visits, was cited as a key reason for this. And it’s not over yet. 

As restrictions begin to ease around the world, there remains uncertainty around the prospect of a second wave of the virus. If clinical trials are to continue to run successfully in this new landscape, a different approach is required. If it is no longer feasible for patients to visit study sites, alternatives such as home health services must be considered. 

What Are Home Health Services?

Home Health services take the clinical trial to the patient by conducting visits in the home. This reduces the number of visits to study sites and significantly lessens the burden on patients and their families. 

A recent Forte Research study on retention in clinical trials found 38% of patients who dropped out of a study early felt site visits were stressful compared to 16% who completed the trial.

Performing home visits during a clinical trial can boost retention, while also lessening the resource burden on clinical sites, allowing them to recruit more patients or run more trials.

How Does Home Health Care Work? 

Home health services provide patients with the same high quality, expert service they receive from the clinic, just in the comfort of their own home. 

Patients are in control, and the nurse contacts the patient directly to schedule appointments. The nurse will then go to the patient’s home, perform the required treatment, care and relevant tests, document any findings, then ship any specimens to the designated laboratory.

Home Health Services Following The COVID-19 Pandemic

The FDA’s new guidance for investigators and institutional review boards recognises the need for amendment of clinical trial protocols beyond this health crisis. Changes will be dependent on the trial and protocol, and one recommendation has been to use alternative locations to clinical sites, such as the patient’s own home. Until COVID-19 has a vaccine, these recommendations will likely remain in place.

Having a nurse come to the patient’s home reduces the risk of exposure to the virus and subsequent infection, going some way to protect the health of the patient as well as other members of their household. 

All our nurses will continue to be regularly tested for COVID-19 and take the necessary precautions to ensure they don’t bring the virus into the patient’s home. 

In the continuation of these uncertain times, it’s important we stay agile and look for innovative solutions. Home health services provide a flexible and safe alternative for patients to continue participating in trials. 

Nurses can come to patients on their terms, and visits will generally be quicker in the patient’s home than on-site. This boosts the overall patient satisfaction, keeps them safe, and ensures the continuation of the trial.