Home Health to Play Increasingly Important Role in Clinical Research

While the coronavirus has ravaged the nation’s aging population and stretched the U.S. health care system to its limits, every cloud has its silver lining.

For home health care providers, one silver lining comes in the form of increased recognition and expanded opportunities. Agencies are seeing higher levels of service demand, fewer recruitment and workforce issues and a heightened ability to divert patients away from skilled nursing facilities.

While those provider opportunities have been covered by the media, another has flown somewhat under the radar: participation in clinical trials.

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Clinical trials are research studies that use a group of participants to test health-related treatments or interventions. Historically, those studies have occurred mostly in centralized settings.

In light of the COVID-19 emergency, however, home health providers have been presented with the chance to participate in such research.

Home Health Care News recently connected with Firma Clinical Research CEO Michael Woods to discuss the growing opportunities for providers to participate in the space.

Firma Clinical Research is a contract research organization that provides outsourced research services to pharmaceutical and biotech companies. It specializes in drug development efforts, helping by offering advanced in-home patient visits, data management and biostatistics, medical writing, regulatory consulting, clinical pharmacology and clinical operations.

Woods told HHCN the future of clinical trials will be decentralized, with home-based care providers set to play an important role in making it all possible.

You can find that conversation below, edited for length and clarity.

HHCN: How common are home-based clinical trials currently?

Woods: Home health visits are used frequently today when there are mobility, transportation or distance issues, especially with older adults, children and people with disabilities. In addition, more procedures associated with studies are being performed in the home.

As a result, Firma’s Home Trial Service is seeing more sponsors using home health visits to enhance the clinical trial experience.

What has the clinical trial landscape looked like historically?

Typically, clinical trial visits involved the participant going to where the study principal investigators were practicing – in hospitals, clinics or physician offices. Some patients traveled long distances to participate in a clinical trial.

But as society in general is adapting to online interactions and home-based services, research studies are implementing new ways of engaging patients through telemedicine and home visits.

What specific opportunities do you think exist to do clinical trials in home health care? For example, are there any particular opportunities you see or do you think all trials could be done in the home?

An opportunity for sites using home health services is to reduce the patient burden. For patients whose conditions are caregiver intense, such as rare … disease patients, easing the burden and cost of travel through home health visits is helping to improve participation and retention. Including home health visits in a study can extend the reach of a site by hundreds of miles.

Firma’a Home Trial Service deploys and trains home health nurses who are local to research participants.

[Firma’s Home Trial Service works with outside home health agencies. It does not have its own home health line.]

Why does home health make sense for clinical trials, and why haven’t we seen it as a popular clinical trial setting in the past?

Billions of dollars were spent in the past to recruit patients to studies. Patient recruitment remains difficult, but the focus now is on enhancing the patient experience through the entire study.

In addition to the ease of home health, it also offers a safety advantage for patients who perceive risk with going to a hospital, clinic or physician office during a disease outbreak.

A Firma Home Trial Service visit occurs with personal protective equipment and social distancing to minimize the risk of disease transmission. A nurse or phlebotomist communicates in advance with each research participant to ensure visit expectations are understood and to gain the risk perspective of the participant.

What would this mean for home health providers and their patients?

Firma’s Home Trial Service is experiencing greater demand for our home health services. Plus, we are seeing the blurring of the line between home health care and home health research visits.

There is new focus on informed consent for research, which minimizes any therapeutic misconceptions.

What would home health providers have to do to get involved with a clinical trial? Would there be financial upsides?

More visits can mean better margins. But home health visits also support study success by helping to enhance clinical trial participation and retention, which in turn results in the more rapid collection of data necessary for the development of a drug or device.

If a home health provider is interested in supporting clinical trials, I recommend reaching out to a local university or research institution to explore a partnership for home-based health services.

What are your predictions for the future?

Where economically feasible, decentralized and patient-centric clinical trials will include an integration of home health and telemedicine.

Firma’s Home Trials Service is prepared to see an increasing number of health services and procedures conducted in the home, as equipment for procedures improves and becomes more mobile.

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