Ensuring quality of in-home trial delivery while reducing participation burden.

Ensuring quality of in-home trial delivery while reducing participation burden.

There are several challenges that hybrid trial models aim to address one challenge is that protocols are increasingly complex & demanding leading to enrollment barriers & retention challenges.

Hybrid trials alleviate these challenges by reducing patient and site burden when participating in a clinical trial.  It’s no easy task but with almost 20 years of experience, there are tips we’d like to share to ensure success.

Through solutions like Home Trial Support, delivering clinical visits to the patient in their own home or alternate location, patients can experience reduced burden in the following ways:

1. Less travel (this saves time but also addresses logistical challenges for rare and pediatric patients)
2. Less cost incurred, not having to pay for things that will not be covered by participation reimbursement
3. Lack of support at site due to understaffed sites or overstretched research staff.

While a hybrid trial addresses these burdens and allows for added convenience, comfort, flexibility and patient choice,  in-home trial solutions needs to ensure quality and safety of delivery as its top priority.

Two specific considerations are Who and Where?

Who?

Who provides care to the patient is incredibly important and only successful when all parties feel they can trust the healthcare professional (HCP).  An HCP conducting an in-home visit needs to be a trained, qualified, and vetted professional.  Our recommendation is to evaluate your vendor’s screening and onboarding process.  Training should be thorough, and work should be continuously monitored, manually or via technology, to reduce risk and avoid issues arising after a home visit.  Connection to the site during a visit is one way to address issues in real time.  Having technology in the home has proven to successfully connect the home visit with the site.

Where?

Where and when the patient wants to be seen should also be considered and have quality and safety implications of their own.  An in-home visit will not be the right solution for every patient or for every visit and the home/remote location may not be appropriate for clinical care (example: when infusions are required, we recommend talking to your vendor’s clinical experts to determine if these visits are an option).  Striking the right balance for each patient and letting them choose where they want to participate will create a more engaged participant.

A trained healthcare professional will be coming into their home, sometimes two for blinding– into their private space, is their space for this? What has been planned for the health and safety of those in the home or location of the visit that are no in the clinical trial?

If participating from an alternative location such as work or school, sometimes necessary access or authorization is required for the HCP.  The desired or required privacy of the patient in this type of location needs to be carefully planned and managed.

We know that patients like the convenience of participating in a flexible trial, we routinely care for patients outside of normal business hours, allowing them to maintain work schedules, child care schedules and reduce their time commitment and cost during their participation.

If you are considering using in-home solutions, we recommend you connect with one of our clinical trial experts to learn more about possible solutions for your patients. Click here to contact an MRN trial specialist.