A Mobile Domiciliary Phlebotomy Service to Support Patients With Rare Disease and Screening Study Recruitment in the UK

Objective: This study evaluated the feasibility and impact of a home-based phlebotomy service to support patient recruitment for a screening study of aromatic L-amino acid decarboxylase (AADC) deficiency in the UK during the COVID-19 pandemic.

Methods: Three external nursing services were assessed for their capabilities to provide a mobile phlebotomy service to take blood samples from patients in their own home. Ashfield Healthcare was appointed to provide the service following appropriate training on the protocol in April 2021. Two remote consent options were developed for patients and their caregivers: a witnessed verbal consent process and a postal consent process.

Results: A process flow for recruiting, consenting, and collecting blood samples via the mobile phlebotomy service was developed. 47% of recruited patients have been screened using the mobile phlebotomy service, with principal investigators (PIs) agreeing that these patients could not have entered the study without this remote option. Feedback from investigators, caregivers, and providers has been very positive.

Conclusions: The ability to provide a phlebotomy service at home improved patient recruitment to the study and reduced potential exposure to COVID-19 while also reducing the burden on overstretched hospital resources. Study participants and their caregivers experienced less anxiety, as they were seen in their own homes and at a time of their choosing. This flexibility also decreased the workload for the PIs and limited the impact on their clinical time and that of the hospitals. Moving forward, this methodology can also be applied to other disease areas and research projects.
Keywords: Rare Diseases, Genetics