Activities & Operations

Home nursing in DCTs

One way of decentralising a study visit in a clinical trial is for a nurse or other healthcare professional (HCP) to visit a participant at their home or another community location (for example, their workplace) to perform trial related activities. Such home nurse visits could either be conducted by nurses from the clinical trial site or by contracting home nurse service providers. Home nurses play an important role in DCTs, with activities ranging from delivery of medication, administration of medication, sample collection, or other trial assessments and interventions. As such, it is important to evaluate experiences and perspectives on their involvement in DCTs.

Recommendations

Develop industry-wide templates for contracting with sites utilising external home nurse services., especially to clarify the delegation of tasks and oversight of home nurses and data sharing, which should account for both regulatory and site-specific requirements.

Assess site experience, processes and use of internal or external nursing resources to ensure the appropriate level of support and training required to reduce oversight risks. Ensure investigators are comfortable integrating external home nurses into their practice as part of the site initiation visit. Less experienced sites should be provided with with clearly written communication and oversight plans with the home nurses.

Schedule site staff and home nurse training to allow time for setting up processes, and supplement with refresher modules as close as possible to the first expected visit to reduce knowledge loss and maintain familiarity.

Implement strict access control for any digital platforms used for transmitting participant contact information to home nurses and home nursing service providers, including audit trails and clear user role assignments.

Establish a clear definition of roles and responsibilities for all home nursing activities in the PI oversight documentation and ensure these are signed off before the first visit is scheduled. Ensure all stakeholders, including couriers and IMP providers have written instructions/training and have clarity with regards to each other’s roles.

How Trials@Home reached these recommendations

Home nursing was included in the RADIAL trial in the hybrid arm where a home nurse (external provider in most cases, site nurses in some cases) visited the participants at the mid-term trial visit to collect a blood sample and monitor vitals. At the end of the trial the sites were interviewed via the site satisfaction survey, qualitative interviews, and follow up interviews to probe them on the home nursing experience amongst other topics. Furthermore, we investigated patient preference regarding the use of decentralised trial visits, including home nursing visits, and interviewed people living with type 2 diabetes on their attitudes.

Further reading

Publications

Selecting and Preparing Clinical Sites for the Successful Conduct of Decentralized Clinical Trial Activities–Findings From the Trials@Home RADIAL Proof-of-Concept Trial

Lipinska, et al
Clinical Pharmacology & Therapeutics
2025
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