Efficacy of a medication adherence enhancing intervention in transplantation: The MAESTRO-Tx trial.
- Dobbels F Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium; Institute of Nursing Science, University of Basel, Basel, Switzerland. Electronic address: fabienne.dobbels@kuleuven.be.
- De Bleser L Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium.
- Berben L Institute of Nursing Science, University of Basel, Basel, Switzerland.
- Kristanto P AARDEX Group, a WestRock Healthcare Company, Visé, Belgium.
- Dupont L Lung Transplant Program, University Hospitals of Leuven, Leuven, Belgium.
- Nevens F Liver Transplant Program, University Hospitals of Leuven, Leuven, Belgium.
- Vanhaecke J Heart Transplant Program, University Hospitals of Leuven, Leuven, Belgium.
- Verleden G Lung Transplant Program, University Hospitals of Leuven, Leuven, Belgium.
- De Geest S Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium; Institute of Nursing Science, University of Basel, Basel, Switzerland.
- 2017-02-07
Published in:
- The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation. - 2017
heart transplantation
liver transplantation
lung transplantation
medication adherence
randomized controlled trial
Adult
Aged
Belgium
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Follow-Up Studies
Graft Survival
Heart Transplantation
Humans
Immunosuppressive Agents
Kaplan-Meier Estimate
Liver Transplantation
Lung Transplantation
Male
Medication Adherence
Middle Aged
Postoperative Care
Risk Assessment
Survival Rate
Tacrolimus
Time Factors
Transplantation Immunology
Treatment Outcome
Young Adult
English
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.
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.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.healun.2017.01.007
- PMID 28162931
- Persistent URL
- https://sonar.rero.ch/global/documents/150064
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