A Medication Adherence Promotion System to Reduce Late Kidney Allograft Rejection: A Quality Improvement Study.

Abstract Rationale and Objective Adolescent and young adult kidney transplant recipients have high risk of rejection related to suboptimal adherence. Multi-component interventions improve adherence in controlled trials, but clinical implementation is lacking. We describe an initiative to reduce allograft rejection using evidence-based adherence promotion clinical strategies. Study Design Interrupted time series. Setting and Participants Kidney transplant recipients cared for at Cincinnati Children’s Hospital ≥1 year post-transplant and taking ≥1 immunosuppressive medication from 2014 through 2017. Quality Improvement Activities The following interventions were implemented over 14 months: 1) adherence promotion training for clinical staff, 2) EHR-supported adherence risk screening, 3) systematic assessment of medication adherence barriers, 4) designation of specific staff to address adherence barriers, 5) shared decision-making with the patients to overcome adherence barriers, 6) follow-up to assess progress, 7) optional electronic medication monitoring. Outcomes Primary Outcome: Late acute rejection. Process measures: barriers assessments performed, barriers identified, number of interventions performed. Secondary outcomes/balancing measures: de novo DSA, biopsy rate, rejections per biopsy. Analytical Approach Time series analysis using statistical process control, evaluated patient-days between acute rejections as well as monthly rejections per 100 patient-months before and after implementation. To control for known rejection risk factors including changes in treatment and case mix, multivariable analyses were performed. Results The monthly rejection rate fell from 1.61 rejections/100 patient-months in the 26-months pre-implementation to 0.88 rejections/100 patient-months in the 22-months post-implementation. In multivariable analysis, MAPS was associated with a 50% reduction in rejection incidence (IRR 0.50, 95% CI: 0.27-0.91, p=0.02). DSA and time since transplant were also associated with rejection incidence (IRR 2.27, p=0.02 and IRR 0.87, p=0.02, respectively) Limitations A single center study. Potential confounding by unmeasured variables. Conclusions Clinical implementation of evidence-based adherence-promotion strategies was associated with a 50% reduction in acute rejection incidence over two years.