Home Visits for Clinical Trials During the COVID-19 Pandemic

The impact of COVID-19 is being felt in emergency rooms and ICUs around the world. Healthcare practitioners are stretched and healthcare systems are already feeling the strain.

Within clinical research, there are many uncertainties around the reallocation of medical resources and the potential impact the outbreak will have on the health of patients and the integrity of trials. Mass travel bans and increasingly complex logistics are also having damaging implications for many study sites and sponsors.

As the global fear rises, so too do the concerns of patients taking part in clinical trials. According to a recent study by Applied Clinical Trials, 29% of sites believe COVID-19 will have a “big” or “extremely big” negative impact on clinical trial recruitment and retention. Patient sentiment, particularly in regards to site visits, is being cited as a key reason for this.

If clinical trials are to continue to run successfully, a different approach is required. If it is no longer feasible for patients to go to the study site, other 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 thought the site visits were stressful compared to 16% who completed the trial.

While these statistics apply to the state of the industry outside of the COVID-19 pandemic, they show how performing home visits during a clinical trial directly boosts engagement, patient sentiment and overall 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 During the COVID-19 Pandemic

The FDA’s new guidance for investigators and institutional review boards recognises the need for amendment of clinical trial protocols during this health crisis. Changes will be dependent on the trial and protocol, and one recommendation was to use alternative locations to clinical sites, such as the patient’s own home.

Having a nurse come to the patient’s home reduces the risk of exposure to the COVID-19 virus, going some way to protect the health of the patient as well as other members of their household.

All nurses will be regularly tested for COVID-19 and take the necessary precautions to ensure they don’t bring the virus into the patient’s home. The nurse will adhere to strict hygiene policies and the appropriate PPE (personal protective equipment) will be provided to the nurse and the patient for use during the visit.

In these uncertain times, it’s important we stay agile and look for innovative solutions. Home health services provide a flexible and safe alternative for the patient to continue to participate in the trial.

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