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- Title
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.
- Authors
Fleming, James N; Gebregziabher, Mulugeta; Posadas, Aurora; Su, Zemin; McGillicuddy, John W; Taber, David J
- 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.
- Subjects
CONFIDENCE intervals; KIDNEY transplantation; FISHER exact test; MANN Whitney U Test; TREATMENT effectiveness; RANDOMIZED controlled trials; DRUGS; DESCRIPTIVE statistics; CHI-squared test; PATIENT compliance; DATA analysis software; TRANSPLANTATION of organs, tissues, etc.; TACROLIMUS; TELEMEDICINE; PATIENT safety; SECONDARY analysis
- Publication
American Journal of Health-System Pharmacy, 2021, Vol 78, Issue 14, p1287
- ISSN
1079-2082
- Publication type
Article
- DOI
10.1093/ajhp/zxab157