A remote intervention to improve medication nonadherence guided by a marker of risk derived from the electronic health records of adolescent transplant recipients.

Improving medication adherence in adolescents who had a liver transplant (iMALT), a prospective, block-randomized, single-blind, controlled multisite study in 13 pediatric transplant centers, used the medication level variability index (MLVI) to identify nonadherent adolescents. It compared a 2-year remote behavioral telemetric intervention (TI) that focused on adherence and addressed barriers to standard of care (SOC). The primary endpoint was the composite incidence of centrally determined (3 masked pathologists) rejection, death, retransplantation, or consent withdrawal. In 148 participants (TI group, n = 72 and the SOC group, n = 76), with a mean age 15.5 years, there were twice as many primary events in SOC (12; 15.8%) compared with TI (6; 8.3%) (relative risk, 0.57; 95% confidence interval, 0.24-1.35; P = .20). All secondary outcomes improved in the TI vs SOC groups. The study was underpowered because iMALT study sites used the MLVI score in clinical care, significantly reducing overall rejections compared with the previous MALT study cohort, where the MLVI score was not used (rejection was observed in 12/76 patients in the iMALT study, SOC vs 13/25 patients in the MALT study; P < .0001). The effect on the primary outcome, therefore, was not statistically significant; thus, the intervention is not evidence-based. MLVI score, an electronic health record-derived behavioral marker, can be used to target interventions to patients with clinically significant nonadherence. ClinicalTrials.Gov, NCT03691220.