A randomized controlled trial comparing Dried Blood Spot sampling to venous sampling for Therapeutic Drug Monitoring in tacrolimus using kidney transplant patients: a cost minimization analysis.

Rationale: Immunosuppressants such as Tacrolimus are successfully applied in solid organ transplantation to prevent allograft rejection. Therapeutic drug monitoring (TDM) is important in the clinical follow-up of immunotherapy receiving transplant patients to balance between subtherapeutic and toxic effects of these drugs. Outpatients receiving immunotherapy need to travel to the hospital on a regular basis for follow-up and to have their blood samples taken and analyzed. With the use of Dried Blood Spots (DBS), capillary blood is obtained through a fingerprick with a lancet and is applied to a sampling card. This method is patient friendly and allows patients to sample at home and sent the DBS card to the laboratory by mail. This saves patient transportation costs and time and possibly visits to the policlinic. To date, no studies have investigated the costs and effects of DBS in clinical use. Providing evidence for the cost-effectiveness of DBS may lead to a more widespread use of this technology and thus cost savings and an increase of the quality of care for the transplant patient.
Objective: To determine the difference in the amount (average per patient) of clinical check-ups performed in the hospital for the DBS and the non-DBS group and perform a cost minimization analysis.
Study design: Prospective, randomized controlled trial.
Study population: Tacrolimus using patients aged 18 years and older who are still hospitalized after receiving a kidney transplantation in the UMCG who are able to use the DBS sampling method and speak Dutch.
Intervention (if applicable): Randomization, performing a fingerprick at home, filling in a questionnaire.
Main study parameters/endpoints: Amount of patient visits (average per patient) to the policlinic of the UMCG for a scheduled check-up as reported in the Electronic Patient Dossier (EPD).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The potential benefit of this study is the possibility to prove the cost-effectiveness of a new, patient friendly and efficient method of blood sampling for TDM in transplant patients. Patients will receive standard care in either group and will have to undergo little extra proceedings. From the patients’ perspective, only the training in DBS, the application of a fingerprick instead of venous blood sampling and filling in a questionnaire will be extra to the received care. There is no risk associated with either of these proceedings.

To determine the difference in the amount (average per patient) of clinical check-ups performed in the hospital for the DBS and the non-DBS group and perform a cost minimization analysis.

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Using Dried Blood Spots prior to scheduled check-up with phycisian.