Bringing It All Back Home: Collaborating to Bring Clinical Trials Home for Patients.

Bringing It All Back Home: Collaborating to Bring Clinical Trials Home for Patients.

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This article was written by Hellina Birru, MD, Michelle Deville, RN, and Heather Fitzhugh-Boehm, RN.


Two MedStar Health teams come together to bring research opportunities to patients at home, expanding access, and making participation more convenient. 

 

Clinical trials give patients a chance to have early access to advanced treatments for severe conditions. Traditionally, participating in clinical trials often requires patients to go to a hospital or attend several clinic visits for treatment. This can be challenging for those juggling multiple obligations, limited transportation, or difficult symptoms, so we’re bringing the research to them!


A collaboration between MedStar Health Home Care and MedStar Health Research Institute (MHRI) is increasing patient access and making research participation possible for more people. 


We’re working together to bring clinical trials to the patient’s door, expanding access to the latest treatments, and advancing science to benefit the health of our patients and communities. 


Specially trained nurses expand access to trials. 

When we discuss participating in clinical trials with our patients, many ask if there is an option to do so from home. We’re excited that, in some cases, we can now say “yes.”


In this exciting partnership, MedStar Health Home Care nurses get trained in research by completing the on-line Collaborative Institutional Training Initiative (CITI) training program. In addition to this mandatory training for research staff, they get specialized training on specific trial protocols from MHRI experts. 


When MedStar Health Home Care nurses visit the home of an enrolled research participant, they carry out the trial protocols for that visit, which can include:

  • Assessing vital signs (i.e., pulse, blood pressure, temperature, and respiratory rate)

  • Screening for any symptoms and recording adverse events

  • Checking on any changes in medications

  • Administering the medication being studied or teaching participants how to take the drug themselves

  • Drawing a sample of blood for laboratory testing

Usually, a home visit lasts 30-45 minutes. That’s much quicker than the commute to the clinic for many of our participants. 


Related reading: Research: At-home Therapy Via Smart Speaker Can Help Cancer Survivors Solve Insomnia.


Easier for patients, better for research.

MedStar Health Research Institute has been working to decentralize clinical trials since 2018, using digital tools such as e-consents or telehealth visits, communication, and monitoring. 


Our current trial is studying a new treatment for advanced heart failure, which causes symptoms like shortness of breath, chest pain, fatigue, and nausea. This condition can make it challenging to leave the home. All participants are patients of the MedStar Heart and Vascular Institute Advanced Heart Failure Program


When you consider how physically taxing it can be for some patients to visit a facility and how much time the round-trip journey can take, getting a visit from a home care nurse can be a lifeline to advanced care. Depending upon the type of research, appointments may be weekly, monthly, or across years of monitoring to learn how their condition responds to treatment over time. The convenience of home-based research can mean the difference between participating in a clinical trial or not. 


Related reading: Collaborative Research Project Explores New Device to Measure Pain.


This partnership is improving research, too. It helps us enroll more trial participants by offering them more convenient options. It is accessible so we can help—and study—patients with limited mobility or challenging symptoms. Plus, we can stick to our protocols more effectively, resulting in better data and fewer patients leaving studies because of time-consuming requirements. 


Home-based visits allow us to reach more patients by making the process more accessible and flexible. This will enable patients who live in rural or underserved areas to participate without needing to travel long distances to a clinical site. It’s especially important for patients who may face logistical or financial barriers and those with limited mobility and challenging symptoms.


This partnership is just starting to grow, and preliminary feedback has been overwhelmingly positive from participants, nurses, and researchers. Moving forward, we intend to develop this program for more clinical trials, expanding access to more patients who could benefit and deepening our understanding of the best treatments.


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