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

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.

Keywords: clinical research/practice; clinical trial; health services and outcomes research; immunosuppressant; immunosuppression/immune modulation; kidney transplantation/nephrology.

FIGURE 1

Participant flow diagram

FIGURE 2

Random intercept model of SystemCHANGE™ and patient education interventions. AC, attention control group; SC, SystemCHANGE™ group

FIGURE 3

Patient outcome data. AC, attention control group; SC, SystemCHANGE™ group. Study Phase 1 was baseline; phase 2 was 6 mo and phase 3 was 12 mo. There are two depths of shaded areas in the upper figures. The 95% confidence interval bands are displayed as shaded area around each line. Lightly shaded areas pertain to the line that is closest. In both trend plots, the dotted line and the solid lines are close enough to each other such that each line’s shaded area overlaps to form the darker shaded areas