Efficacy of a medication adherence enhancing intervention in transplantation: The maestro-tx trial

Background Well-designed RCTs testing the efficacy of adherence-enhancing interventions on post-transplant medication adherence and clinical outcomes remain scarce. Methods This RCT enrolled adult heart, liver and lung transplant patients who were > 1 year post-transplant and on tacrolimus twice daily (convenience sample) (visit 1). After a 3 months run-in period, patients were randomized 1:1 to the intervention or control group (visit 2), followed by a 6 months intervention (visit 2-4) and a 6 months adherence follow-up period (visit 5). All patients used electronic monitoring (EM) for 15 months for adherence measurement, generating a daily binary adherence score per patient. Five years clinical event-free survival (mortality or re-transplantation) post-intervention was evaluated. The intervention group (IG) received staged multicomponent tailored behavioral interventions (visit 2-4) building on the social cognitive theory and trans-theoretical model (e.g. EM feedback, motivational interviewing). Control group patients (CG) received usual care and attended visits 1-5 only. Intention-to-treat analysis used generalized estimating equation modeling and Kaplan Meier survival analysis. Results Out of 247 patients consenting, 205 were randomized (103 IG; 102 CG). At baseline, the average daily proportions of patients with correct dosing (82.6% IG; 78.4% CG) and timing adherence (75.8% IG; 72.2% CG) were comparable. The IG had a 16% higher dosing adherence post-intervention (95.1% IG; 79.1% CG; p< 0.001), resulting in the odds of adherence to be 5 times higher in the IG than in the CG (OR=5.17; 95% CI= 2.86-9.38). This effect sustained at end of follow-up (similar results for timing adherence). Five years clinical event-free survival was 82.5% in the IG versus 72.5% in the CG (p= 0.18). Conclusion Our intervention was efficacious in improving adherence and sustainable. Further research should investigate its clinical impact, cost-effectiveness, and scalability.