Improving medication adherence and outcomes in adult kidney transplant patients using a personal systems approach: SystemCHANGE™ results of the MAGIC randomized clinical trial

Am J Transplant. 2020 Jan;20(1):125-136 doi: 10.1111/ajt.15528.
Abstract

This study determined if a SystemCHANGE™ intervention was more efficacious than attention control in increasing immunosuppressive medication adherence and improving outcomes in adult kidney transplant recipients during a 6-month intervention phase and subsequent 6-month (no intervention) maintenance phase. The SystemCHANGE™ intervention taught patients to use person-level quality improvement strategies to link adherence to established daily routines, environmental cues, and supportive people. Eighty-nine patients (average age 51.8 years, 58% male, 61% African American) completed the 6-month intervention phase. Using an intent-to-treat analysis, at 6 months, medication adherence for SystemCHANGE™ (median 0.91, IQR 0.76-0.96) and attention control (median 0.67, IQR 0.52-0.72) patients differed markedly (difference in medians 0.24, 95% CI 0.13-0.30, P < .001). At the conclusion of the subsequent 6-month maintenance phase, the gap between medication adherence for SystemCHANGE™ (median 0.77, IQR 0.56-0.94) and attention control (median 0.60, IQR 0.44-0.73) patients remained large (difference in medians 0.17, 95% CI 0.06-0.33, P = .004). SystemCHANGE™ patients evidenced lower mean creatinine and BUN at 12 months and more infections at 6 and 12 months. This first fully powered RCT testing SystemCHANGE™ to improve and maintain medication adherence in kidney transplant recipients demonstrated large, clinically meaningful improvements in medication adherence. Clinical Trial Registration: NCT02416479.

CET Conclusion
Reviewer: Mr Simon Knight, Centre for Evidence in Transplantation, The Royal College of Surgeons of England.
Conclusion: This interesting RCT investigates the use of a behavioural intervention (SystemChange) to improve medication adherence following renal transplantation. Patients were randomized to intervention or control, and the authors demonstrate a significant improvement in adherence following the intervention, which importantly is preserved for 6 months after the intervention is complete. Interventions that demonstrate sustained improvement in adherence in transplant recipients are far and few between, so these findings are important. However, it is not clear from this study how easy it would be to implement the intervention outside of the trial setting as it is quite resource intensive. Whilst the intervention effect was sustained in patients for 6 months after completion, this was with a stipend and continued electronic pill monitoring. It is possible that the effect will reduce over time outside of a trial. A pragmatic real-world trial in more centres would help to answer some of these outstanding questions.
Methodological quality
Jadad score 3
Allocation concealment YES
Data analysis PER PROTOCOL
Study Details
Aims: The objective of this study was to determine if a SystemCHANGETM intervention was more efficacious than attention control in increasing immunosuppressive medication adherence and improving outcomes in adult kidney transplant recipients during a 6-month intervention phase and a subsequent 6-month (no intervention) maintenance phase.
Interventions: Patients were randomly assigned to a 6 month SystemCHANGETM intervention or a no intervention, maintenance phase. The SystemCHANGETM approach taught patients to use person-level quality improvement strategies to link adherence to established daily routines.
Participants: There were 89 kidney transplant patients which participated in this study.
Outcomes: Primary outcome was assessed as the average 6-month immunosuppressive medication adherence rate, which was defined as doses taken on time/total doses as measured by the Medication Event Monitoring System SmartCap® (MEMSCap™). The secondary outcome was adherence of immunosuppressive medication at 12 months.
Follow Up: 12 months
Metadata
Publication type: Randomized Controlled Trial, Randomised Controlled Trial
Organ: Kidney
Language: English
MeSH terms: Female; Follow-Up Studies; Humans; Immunosuppressive Agents; Kidney Failure, Chronic; Kidney Transplantation; Male; Medication Adherence; Middle Aged; Patient Care Team; Patient Compliance; Prognosis; 0 (Immunosuppressive Agents)