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

Discussion

This is the first fully powered RCT designed to test the SystemCHANGE™ intervention to improve and maintain MA in kidney transplant recipients, an exemplar population of chronically ill adults. Study sample MNA rates were consistent with prior reports in the kidney transplant population.[1] Immunosuppressive MA improved dramatically during the first month of the SystemCHANGE™ intervention and was sustained through the 6-month intervention. The improvement was sustained until month 12 of the maintenance phase, which has not been achieved in other MA intervention studies with kidney transplant patients.[21,34]

This shows the potential to deliver the intervention less frequently; perhaps once in the clinical setting followed by less frequent, periodic "boosters" delivered over the telephone or by a smartphone application though the frequency of these must be further tested, perhaps using adaptive interventions, multiphase optimization strategies (MOST), and Sequential Multiple Assignment Randomized Trial (SMART) designs.

The SystemCHANGE™ intervention is an innovative approach because it moves away from blaming the patient for poor MA. Rather than focusing on education and motivation, the SystemCHANGE™ intervention taught patients to use person-level quality improvement strategies to link adherence to established daily routines, environmental cues, and supportive people. This is consistent with other multicomponent intervention studies that have improved MA in transplant recipients.[35,36]

Consistent with the theoretical framework, successful SystemCHANGE™ solutions involved changes in the environment that supported MA. Successful solutions involved setting cell phone alarms and placing medications next to objects in the environment of daily routines such as close to the coffee pot, television remote control, toothbrush, or car keys. Other people in the environment who may "touch" the medication taking processes were also involved in supporting the solutions. Ultimately, medications were in the right place at the right time so that medication taking was effortless.

The SystemCHANGE™ approach involves a key component of using MA data from EM to develop and track solution effectiveness. Though EM alone has shown marginal success in improving MA,[37] when combined with SystemCHANGE™ the medication execution taking and timing details provide actionable information for improvement and effectiveness tracking.[38]

The MAGIC study findings are clinically meaningful. The difference between the median MA score of the SystemCHANGE™ group (0.91) and the attention control group (0.67) at 6 months is 0.24. This means for an individual with the common MNA pattern of taking the morning dose on time and the evening dose late, using our previously published approach for scoring twice daily dosed medications, this translates into taking the morning dose on time and the evening dose on time.[4] Another common MNA pattern is missing medications, particularly in the evening.[27,33] An improvement in MA score of 0.24 can be translated into a clinical improvement of not missing a dose that was previously missed every other day. This same clinical significance holds for the 12-month maintenance endpoint where the difference between the median MA score of the SystemCHANGE™ group (0.77) and the attention control group (0.60) at 12 months is 0.17.

The SystemCHANGE™ intervention also appeared to produce robust effects when delivered by different RAs. During the MAGIC study due to RA attrition, four different RAs delivered SystemCHANGE™ without any observable fluctuation in study participants' involvement in SystemCHANGE™ activities. Training was provided as previously described and all SystemCHANGE™ participants received 100% of the "dose" of the SystemCHANGE™ components. Although there was variation in timing of the 6 monthly intervention "doses" that ranged from 100% at baseline to a low of 62% at month 5, this variation did not have an impact on the efficacy of the intervention. This observation further supports the consideration of an intervention with less frequent intervention and instead, periodic boosters, which enhances sustainability. The MAGIC study had very high participant retention rates for a 12-month study. There are several possible explanations. Both groups received a $20 monthly gift card throughout the phases. Additionally, the RAs developed relationships with the participants through the home visit and monthly phone calls during the intervention phase. Although payments are not clinically practical, the collaborative relationship between providers and patients can be established and maintained.

The MAGIC study sample was 61% African American, which is much higher than the overall kidney transplant population. The 2017 United Network of Organ Sharing national data indicate that only 27% of individuals receiving a kidney transplant were African American.[31] In contrast, the sample was similar to national data on other demographics such as gender, and of note, nonwhite ethnicity, a risk factor for immunosuppressive MNA. Thus, generalization of the MAGIC study results is particularly important in regard to this high-risk group as well as being beneficial for individuals who may be at lower risk but still struggle with MA.[1]

This study was not powered for clinical outcomes; however, the trends for renal function for the SystemCHANGE™ group were in the anticipated direction, which is consistent with other studies testing MA intervention to improve outcomes.[35,39] With immunosuppressive MA, recipients may be at higher risk for infections due to increased immunosuppression. This trend also seemed to be supported by our data.

The study has several limitations including the low intervention recruitment rate, the use of EM, and the amount of in-person visit time. Recruitment was planned to see how many MNA participants would accept the intervention. This step resulted in a pool of willing participants who evidenced poor MA at the same rate usually observed in our prior work and the literature. The dropout rate was nearly identical between groups, which indicates lack of participant interest in addressing MA rather than intervention intensity. The EM was used because it provides critical actionable MA details of initiation, implementation (medication taking and timing), and persistence, which guided development of successful MA SystemCHANGE™ solutions.[40] The EM may have influenced MA though the first month of MA data during the screening phase was dropped to reduce the Hawthorne effect. Additionally, the attention control intervention cannot be considered standard of care. Consequently, the effect of the intervention may in fact be larger than that measured in the study when compared to standard care with no EM monitoring. To reduce in-person visit time, future alternatives should be explored including delivery by videoconferencing technology, video self-instruction, and/or lay providers, reducing clinical staff implementation burden.[41]

In conclusion, the SystemCHANGE™ intervention is efficacious for improving immunosuppressive MA for adult kidney transplant recipients. Improvement occurs within 2 months upon intervention initiation with sustained improvement over the 6 months of intervention and 6-month of maintenance. Outcomes also appear to trend in the direction of improvement. This robust intervention could be applicable to other patient populations and dosing regimens. However, the efficacy in other populations must be tested. The next study's goal will be to test effectiveness of the intervention in kidney transplant recipients in the clinic setting.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....