Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial

J Heart Lung Transplant. 2017 May;36(5):499-508. doi: 10.1016/j.healun.2017.01.007. Epub 2017 Jan 6.


Background: Well-designed randomized controlled trials (RCTs) testing efficacy of post-transplant medication adherence enhancing interventions and clinical outcomes are scarce.

Methods: This randomized controlled trial enrolled adult heart, liver, and lung transplant recipients who were >1 year post-transplant and on tacrolimus twice daily (convenience sample) (visit 1). After a 3-month run-in period, patients were randomly assigned 1:1 to intervention group (IG) or control group (CG) (visit 2), followed by a 6-month intervention (visits 2-4) and a 6-month adherence follow-up period (visit 5). All patients used electronic monitoring for 15 months for adherence measurement, generating a daily binary adherence score per patient. Post-intervention 5-year clinical event-free survival (mortality or retransplantation) was evaluated. The IG received staged multicomponent tailored behavioral interventions (visits 2-4) building on social cognitive theory and trans-theoretical model (e.g., electronic monitoring feedback, motivational interviewing). The 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: Of 247 patients, 205 were randomly assigned (103 IG, 102 CG). At baseline, 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 odds of adherence being 5 times higher in the IG than in the CG (odds ratio 5.17, 95% confidence interval 2.86-9.38). This effect was sustained at end of follow-up (similar results for timing adherence). In the IG, 5-year clinical event-free survival was 82.5% vs 72.5% in the CG (p = 0.18).

Conclusion: Our intervention was efficacious in improving adherence and sustainable. Further research should investigate clinical impact, cost-effectiveness, and scalability.

Keywords: heart transplantation; liver transplantation; lung transplantation; medication adherence; randomized controlled trial.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Belgium
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Follow-Up Studies
  • Graft Survival
  • Heart Transplantation / adverse effects
  • Heart Transplantation / methods*
  • Heart Transplantation / mortality
  • Humans
  • Immunosuppressive Agents / administration & dosage
  • Kaplan-Meier Estimate
  • Liver Transplantation / adverse effects
  • Liver Transplantation / methods*
  • Liver Transplantation / mortality
  • Lung Transplantation / adverse effects
  • Lung Transplantation / methods*
  • Lung Transplantation / mortality
  • Male
  • Medication Adherence / statistics & numerical data*
  • Middle Aged
  • Postoperative Care / methods
  • Risk Assessment
  • Survival Rate
  • Tacrolimus / administration & dosage*
  • Time Factors
  • Transplantation Immunology / drug effects
  • Treatment Outcome
  • Young Adult


  • Immunosuppressive Agents
  • Tacrolimus