Improving Medication Adherence and Outcomes in Adult Kidney Transplant Patients Using a Personal Systems Approach

SystemCHANGE Results of the MAGIC Randomized Clinical Trial

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

Disclosures

American Journal of Transplantation. 2020;20(1):125-136. 

In This Article

Abstract and Introduction

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.

Introduction

The high rate of immunosuppressive medication nonadherence (MNA) in kidney transplant recipients[1] is associated with poor outcomes and staggering costs of over $33 000 per patient in the 3 years posttransplant.[2,3] Short-term kidney transplant outcomes have improved, yet long-term outcomes continue to languish, in part due to poor medication adherence (MA). Numerous systematic reviews and meta-analyses have reported the efficacy of MA interventions in the acute and chronically ill general population.[4–11] Multicomponent interventions are associated with the greatest effect sizes; however, even with multicomponent interventions, effect sizes in meta-analyses remain small.[7] A majority of interventions, when used, are guided by psychological theories that focus on enhancement of knowledge through education, attitude through counseling, and behavior through skills training.[4,12] Benefits of these interventions are limited and preoccupied with intention and motivation.[12,13] Most transplant intervention studies focused only on motivation and intention have equally disappointing MA results.[14–21]

Bronfenbrenner's Socio-Ecological Model (SEM)[23] and Deming's Plan-Do-Check-Act (PDCA) model[22] provide the foundation for the SystemCHANGE™ approach, which harnesses reliable person-centered systems that people have already established—daily routines, environment, and important others—as possible system-based solutions evaluated to support MA using person-level quality improvement strategies. The SystemCHANGE™ intervention is implemented at the individual, micro- (immediate environmental setting of family, peers, health services, workplace), meso- (interrelations between family, health care provider, employer), and exolevels (outside of the person's immediate setting but affecting the functional setting).[23]

SystemCHANGE™ was developed by incorporating the PDCA cycle into Bronfenbrenner's SEM.[26] The quality improvement movement, using root-cause analysis, successfully used the PDCA cycle as a framework improving processes within an organizational system.[22] The SystemCHANGE™ approach applies quality improvement methods at a personal level, not the organizational system level, using the following steps.[22] In the "Plan" step, a problem such as MNA is defined and possible causes and solutions are hypothesized. During the "Do" step, MA solutions are implemented. The "Check" step evaluates the results of the plan and a decision is made about whether MA has been achieved. The "Act" step identifies what was learned in the "Check" step and further MA solutions are implemented if needed. The successful solution is then standardized. An unsuccessful change informs a new PDCA cycle.

Using the SystemCHANGE™ approach, we guided the individual to conduct a "small experiment" where we (1) assessed the medication systems (including other people important for medication taking, eg, spouses, adult children), how the systems influence medication taking, and possible solutions for improving MA; (2) implemented the proposed solutions for improving MA; (3) tracked MA data with electronic medication (EM); and (4) evaluated MA data[24,25] We found a nearly fourfold greater effect size in a pilot study using the SystemCHANGE™ intervention to improve immunosuppressive MA compared to previous adherence interventions.[26]

The aim of this study was to ascertain whether a SystemCHANGE™ intervention was more effective than an attention control intervention in increasing immunosuppressive MA in adult kidney transplant recipients at the completion of a 6-month intervention and a subsequent 6-month maintenance (no intervention) phase. The hypothesis was that adult kidney transplant recipients who participated in the SystemCHANGE™ intervention would have a higher immunosuppressant MA rate than those in the attention control group at both time points. The exploratory aim was to determine whether the SystemCHANGE™ intervention was more effective in improving health outcomes (eg, creatinine/BUN, infections, acute and chronic rejections, kidney failure, death). An attention control intervention, which included providing patient education materials focused on health-related activities, was designed to make the interventions received by the two groups as similar as possible except for the SystemCHANGE™ intervention and to provide attention to the control group to decrease attrition.

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