Impact of a pharmacist-led, mHealth-based intervention on tacrolimus trough variability in kidney transplant recipients: A report from the TRANSAFE Rx randomized controlled trial

Abstract

Purpose: Nonadherence is a leading cause of death-censored allograft loss in kidney transplant recipients. Strong associations have tied tacrolimus intrapatient variability (IPV) to degree of nonadherence and high tacrolimus IPV to clinical endpoints such as rejection and allograft loss. Nonadherence is a dynamic, complex problem best targeted by multidimensional interventions, including mobile health (mHealth) technologies.

Methods: This was a secondary planned analysis of a 12-month, parallel, 2-arm, semiblind, 1:1 randomized controlled trial involving 136 adult kidney transplant recipients. The primary aims of the TRANSAFE Rx study were to assess the efficacy of a pharmacist-led, mHealth-based intervention in improving medication safety and health outcomes for kidney transplant recipients as compared to usual care.

Results: Patients were randomized equally to 68 patients per arm. The intervention arm demonstrated a statistically significant decrease in tacrolimus IPV over time as compared to the control arm (P = 0.0133). When analyzing a clinical goal of tacrolimus IPV of less than 30%, the 2 groups were comparable at baseline (P = 0.765), but significantly more patients in the intervention group met this criterion at month 12 (P = 0.033). In multivariable modeling, variables that independently impacted tacrolimus IPV included time, treatment effect, age, and warm ischemic time.

Conclusion: This secondary planned analysis of an mHealth-based, pharmacist-led intervention demonstrated an association between the active intervention in the trial and improved tacrolimus IPV. Further prospective studies are required to confirm the mutability of tacrolimus IPV and impact of reducing tacrolimus IPV on long-term clinical outcomes.

Keywords: adherence; kidney transplant; mHealth; tacrolimus; telemedicine.

Figure 1.

Randomization and patient flow in the TRANSAFE Rx study.

Figure 2.

Mean tacrolimus intrapatient variability from baseline to 12 months post randomization, comparing the treatment and control arms. Tac IPV indicates tacrolimus intrapatient variability; CV, coefficient of variation.

Figure 3.

Proportion of patients achieving tacrolimus intrapatient variability of <30% and <40% at baseline and at end of study, comparing the control and treatment arms. The blue bars for each category represent the control group, while the orange bars represent the intervention group. Tac IPV indicates tacrolimus intrapatient variability.