Fabienne Dobbels1, Leentje De Bleser2, Lut Berben3, Paulus Kristanto4, Lieven Dupont5, Frederik Nevens6, Johan Vanhaecke7, Geert Verleden5, Sabina De Geest8. 1. 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. 2. Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium. 3. Institute of Nursing Science, University of Basel, Basel, Switzerland. 4. AARDEX Group, a WestRock Healthcare Company, Visé, Belgium. 5. Lung Transplant Program, University Hospitals of Leuven, Leuven, Belgium. 6. Liver Transplant Program, University Hospitals of Leuven, Leuven, Belgium. 7. Heart Transplant Program, University Hospitals of Leuven, Leuven, Belgium. 8. Academic Centre for Nursing and Midwifery, KU Leuven, Leuven, Belgium; Institute of Nursing Science, University of Basel, Basel, Switzerland.
Abstract
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.
RCT Entities:
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.
Authors: Cynthia L Russell; Donna Hathaway; Laura M Remy; Dana Aholt; Debra Clark; Courtney Miller; Catherine Ashbaugh; Mark Wakefield; Sangbeak Ye; Vincent S Staggs; Rebecca J Ellis; Kathy Goggin Journal: Am J Transplant Date: 2019-08-20 Impact factor: 8.086
Authors: Geert M Verleden; Lieven Dupont; Jonas Yserbyt; Veronique Schaevers; Dirk Van Raemdonck; Arne Neyrinck; Robin Vos Journal: J Thorac Dis Date: 2017-09 Impact factor: 2.895
Authors: Marie A Chisholm-Burns; Christina A Spivey; Praveen K Potukuchi; Elani Streja; Kamyar Kalantar-Zadeh; Csaba P Kovesdy; Miklos Z Molnar Journal: Nephron Date: 2020-05-20 Impact factor: 2.847
Authors: Milou van Heuckelum; Cornelia H M van den Ende; Anne E J Houterman; Charlotte P M Heemskerk; Sandra van Dulmen; Bart J F van den Bemt Journal: PLoS One Date: 2017-10-09 Impact factor: 3.240