Trust in the Transplant Team Associated With the Level of Chronic Illness Management-A Secondary Data Analysis of the International BRIGHT Study.

A trustful relationship between transplant patients and their transplant team (interpersonal trust) is essential in order to achieve positive health outcomes and behaviors. We aimed to 1) explore variability of trust in transplant teams; 2) explore the association between the level of chronic illness management and trust; 3) investigate the relationship of trust on behavioral outcomes. A secondary data analysis of the BRIGHT study (ID: NCT01608477; https://clinicaltrials.gov/ct2/show/NCT01608477?id=NCT01608477&rank=1) was conducted, including multicenter data from 36 heart transplant centers from 11 countries across four different continents. A total of 1,397 heart transplant recipients and 100 clinicians were enrolled. Trust significantly varied among the transplant centers. Higher levels of chronic illness management were significantly associated with greater trust in the transplant team (patients: AOR= 1.85, 95% CI = 1.47-2.33, p < 0.001; clinicians: AOR = 1.35, 95% CI = 1.07-1.71, p = 0.012). Consultation time significantly moderated the relationship between chronic illness management levels and trust only when clinicians spent ≥30 min with patients. Trust was significantly associated with better diet adherence (OR = 1.34, 95%CI = 1.01-1.77, p = 0.040). Findings indicate the relevance of trust and chronic illness management in the transplant ecosystem to achieve improved transplant outcomes. Thus, further investment in re-engineering of transplant follow-up toward chronic illness management, and sufficient time for consultations is required.

Prevalence and Patient-Level Correlates of Intentional Non-Adherence to Immunosuppressive Medication After Heart-Transplantation-Findings From the International BRIGHT Study.

After heart transplantation (HTx), non-adherence to immunosuppressants (IS) is associated with poor outcomes; however, intentional non-adherence (INA) is poorly understood regarding its international variability in prevalence, contributing factors and impact on outcomes. We investigated (1) the prevalence and international variability of INA, (2) patient-level correlates of INA, and (3) relation of INA with clinical outcomes. Secondary analysis of data from the BRIGHT study-an international multi-center, cross-sectional survey examining multi-level factors of adherence in 1,397 adult HTx recipients. INA during the implementation phase, i.e., drug holiday and dose alteration, was measured using the Basel Assessment of Adherence to Immunosuppressive Medications Scale© (BAASIS©). Descriptive and inferential analysis was performed with data retrieved through patient interview, patient self-report and in clinical records. INA prevalence was 3.3% (n = 46/1,397)-drug holidays: 1.7% (n = 24); dose alteration: 1.4% (n = 20); both: 0.1% (n = 2). University-level education (OR = 2.46, CI = 1.04-5.83), insurance not covering IS costs (OR = 2.21, CI = 1.01-4.87) and barriers (OR = 4.90, CI = 2.73-8.80) were significantly associated with INA; however, clinical outcomes were not. Compared to other single-center studies, this sample's INA prevalence was low. More than accessibility or financial concerns, our analyses identified patient-level barriers as INA drivers. Addressing patients' IS-related barriers, should decrease INA.

Frequency of Medication Administration Timing Error in Hospitals: A Systematic Review.

BACKGROUND: Medication administration timing error (MATE) leads to poor medication efficacy, harm, and death. Frequency of MATE is understudied. PURPOSE: To determine MATE frequency, and characteristics and quality of reporting studies. METHODS: A systematic review of articles between 1999 and 2021 was conducted using the Cumulative Index of Nursing and Allied Health Literature, ProQuest, and PubMed databases. Articles were scored for quality using the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) checklist. RESULTS: Initially, 494 articles were screened; 23 were included in this review. MATE was defined as administration beyond 60 minutes before or after the scheduled time in 13 (57%) of the included studies. Measurement procedures included data abstraction, self-report, and observation. Frequency of MATE was 1% to 72.6%. Moderate study quality was found in 78% of articles. CONCLUSION: Research on MATE is characterized by inconsistent definitions, measurements procedures, and calculation techniques. High-quality studies are lacking. Many research improvement opportunities exist.

Defining a new normal: A qualitative exploration of the parent experience during the single ventricle congenital heart disease interstage period.

AIM: To explore parents' experience of transition in the period between the palliative cardiac surgeries (i.e., the interstage period) of an infant with single ventricle congenital heart disease. DESIGN: We conducted an exploratory naturalistic inquiry using a qualitative descriptive approach. METHODS: A purposive sample of 11 parents of children with single ventricle disease was selected among families that participated in an interstage-period parental home monitoring program during the past 2 years. Interviews and field observations were conducted September-October 2019, and data were analyzed for themes. Analysis of data was inductive, although study questions and the interpretation of results were informed by Meleis' transition theory. RESULTS: Parents described the experience of transition in interstage as a striving for normality, a theme that was clustered in subthemes of home, self, and infant. CONCLUSION: Parents' experiences of striving for normality indicated a need for more targeted efforts to address parents' psychosocial needs during the highly stressful interstage transition. IMPACT: This research underscored the complexity of parents' psychosocial support needs on returning home after their child's first palliative surgery. The findings also suggest need for examination of the transition following the second palliative heart surgery, when the home monitoring program is withdrawn. Understanding parent needs will help guide healthcare teams in developing ways to support parents as they adjust to home, self, and child.

SystemCHANGE™ Solutions to Improve Medication Adherence in Kidney Transplant Recipients: A Secondary Data Analysis.

The SystemCHANGE™ intervention has led to great improvements in medication adherence, which is a challenge for nearly one-third of kidney transplant recipients. This secondary data analysis sought to measure the frequency of individual solutions utilized by participants in a previously conducted randomized controlled trial of the SystemCHANGE™ intervention and to determine which classes of solutions had greatest impact on improved medication adherence. Solutions that were significant predictors of improving medication adherence to the 85% or higher level included alarm cues (p ≤ 0.0001), time cues (p = 0.006), restructuring the physical environment (p = 0.048), and social support (p = 0.023). Alarm and time cues, restructuring the environment, and social support were successful solutions largely influenced by personal routine and environment consideration that might be prioritized in future studies when implementing SystemCHANGE™.

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

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.

Recruitment of Older Kidney Transplant Recipients to a Longitudinal Study.

BACKGROUND: Currently, limited information is available regarding selection of the most successful strategies for recruitment of older adult kidney transplant recipients as research participants. OBJECTIVE: The aim of this study was to explore multiple modes of recruitment strategies to enroll older kidney transplant recipients in a 1-year longitudinal study. METHODS: We used a feasibility design to explore the following recruitment methods: face-to-face contact in the transplant clinic, paper flyers placed in the transplant clinic, Facebook, an online transplant newsletter, and a university website listing of research studies. RESULTS: Enrollment was open for 9 months, during which time websites and the Facebook portal were active, 142 newsletters were e-mailed, and 424 patients were approached in the transplant clinic. Among patients approached in the clinic, 12 did not own a smartphone required for the study. The sample consisted of 60 participants (39 men, 21 women), with a mean age of 64.5 ± 4.7 years. Of the participants who enrolled in the study, the largest number (75%, n = 45) was recruited using the face-to-face method in the transplant clinic. The online transplant newsletter was the second-best recruitment source (18%, n = 11). DISCUSSION: Recruitment strategies using face-to-face contact and the online newsletter associated with the transplant clinic organization appeared to be more effective than strategies not associated with the transplant clinic (Facebook and university website). Findings suggest that using a familiar organization communication method to recruit older chronic disease population may be the most beneficial.

Prevalence and Correlates of Cost-Related Medication Nonadherence to Immunosuppressive Drugs After Heart Transplantation: The International Multicenter Cross-sectional Bright Study.

BACKGROUND: Cost-related medication nonadherence (CRMNA) refers to not taking medications as prescribed because of difficulties paying for them. OBJECTIVES: The aims of this study were (1) to assess the prevalence of CRMNA to immunosuppressants in heart transplant recipients internationally and (2) to determine multilevel correlates (patient, center, and healthcare system levels) of CRMNA. METHODS: Using data from the cross-sectional international BRIGHT study, applying multistaged sampling, CRMNA was assessed via 3 self-report items in 1365 patients from 36 heart transplant centers in 11 countries. Cost-related medication nonadherence was defined as any positive answer on any of the 3 items. Healthcare system-level (ie, insurance coverage, out-of-pocket expenditures) and patient-level (ie, intention, perceived financial burden, cost as a barrier, a health belief regarding medication benefits, cost-related self-efficacy, and demographic factors) CRMNA correlates were assessed. Correlates were examined using mixed logistic regression analysis. RESULTS: Across all study countries, CRMNA had an average prevalence of 2.6% (range, 0% [Switzerland/Brazil] to 9.8% [Australia]) and was positively related to being single (odds ratio, 2.29; 95% confidence interval, 1.17-4.47), perceived financial burden (odds ratio, 2.15; 95% confidence interval, 1.55-2.99), and cost as a barrier (odds ratio, 2.60; 95% confidence interval, 1.66-4.07). Four protective factors were identified: white ethnicity (odds ratio, 0.37; 95% confidence interval, 0.19-0.74), intention to adhere (odds ratio, 0.44; 95% confidence interval, 0.31-0.63), self-efficacy (odds ratio, 0.54; 95% confidence interval, 0.43-0.67), and belief about medication benefit (odds ratio, 0.70; 95% confidence interval, 0.57-0.87). Regarding variability, 81.3% was explained at the patient level; 13.8%, at the center level; and 4.8%, at the country level. CONCLUSION: In heart transplant recipients, the CRMNA prevalence varies across countries but is lower than in other chronically ill populations. Identified patient-level correlates are novel (ie, intention to adhere, cost-related barriers, and cost-related self-efficacy) and indicate patient-perceived medication cost burden.

Impact of a SystemCHANGE™ Intervention on Medication Adherence in Older Adults With Heart Failure: A Feasibility Study.

The purpose of the current study was to examine the feasibility and acceptability of a SystemCHANGE™ intervention in improving medication adherence in older adults with heart failure (HF). Adults age ≥50 years with HF who self-administered diuretics were screened for 2 months using electronic monitoring to determine baseline adherence scores. Participants were randomized into the SystemCHANGE™ or attention-control group if adherence scores were <88%. The SystemCHANGE™ intervention focuses on changing the individual's environment by including medication taking into existing routines, receiving support from individuals who impact routines, and using small experiments with feedback. Challenges were noted by participants in using the electronic medication monitor technology during the screening phase. Lessons learned from this study emphasize the need to revise recruitment procedures and include multiple sites. Education and counseling should be adapted to the cognitive level of the participant and address technology challenges. [Journal of Gerontological Nursing, 45(4), 15-19.].

Multilevel factors are associated with immunosuppressant nonadherence in heart transplant recipients: The international BRIGHT study.

Factors at the level of family/healthcare worker, organization, and system are neglected in medication nonadherence research in heart transplantation (HTx). The 4-continent, 11-country cross-sectional Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation (BRIGHT) study used multistaged sampling to examine 36 HTx centers, including 36 HTx directors, 100 clinicians, and 1397 patients. Nonadherence to immunosuppressants-defined as any deviation in taking or timing adherence and/or dose reduction-was assessed using the Basel Assessment of Adherence to Immunosuppressive Medications Scale© (BAASIS© ) interview. Guided by the Integrative Model of Behavioral Prediction and Bronfenbrenner's ecological model, we analyzed factors at these multiple levels using sequential logistic regression analysis (6 blocks). The nonadherence prevalence was 34.1%. Six multilevel factors were associated independently (either positively or negatively) with nonadherence: patient level: barriers to taking immunosuppressants (odds ratio [OR]: 11.48); smoking (OR: 2.19); family/healthcare provider level: frequency of having someone to help patients read health-related materials (OR: 0.85); organization level: clinicians reporting nonadherent patients were targeted with adherence interventions (OR: 0.66); pickup of medications at physician's office (OR: 2.31); and policy level: monthly out-of-pocket costs for medication (OR: 1.16). Factors associated with nonadherence are evident at multiple levels. Improving medication nonadherence requires addressing not only the patient, but also family/healthcare provider, organization, and policy levels.

Report from the American Society of Transplantation Psychosocial Community of Practice Adherence Task Force: Real-world options for promoting adherence in adult recipients.

Starting in 2015, the American Society of Transplantation Psychosocial Community of Practice, with representatives of the Transplant Pharmacy Community of Practice, convened a taskforce to develop a white paper that focused on clinically practical, evidenced-based interventions that transplant centers could implement to increase adherence to medication and behavioral recommendations in adult solid organ transplant recipients. The group focused on what centers could do in their daily routines to implement best practices to increase adherence in adult transplant recipients. We developed a list of strategies using available resources, clinically feasible methods of screening and tracking adherence, and activities that ultimately empower patients to improve their own self-management. We limited the target population to adults because they predominate the research, and because adherence issues differ in pediatric patients, given the necessary involvement of parents/guardians. We also examined broader multilevel areas for intervention including provider and transplant program practices. Ultimately, the task force aims to foster greater recognition, discussion, and solutions required for implementing practical interventions targeted at improving adherence.

The international prevalence and variability of nonadherence to the nonpharmacologic treatment regimen after heart transplantation: Findings from the cross-sectional BRIGHT study.

INTRODUCTION: Heart transplant (HTx) recipients need to follow a complex therapeutic regimen. We assessed the international prevalence and variability in nonadherence to six nonpharmacologic treatment components (physical activity, sun protection, diet, alcohol use, nonsmoking, and outpatient follow-up visits). METHODS: We used self-report data of 1397 adult HTx recipients from the 36-HTx-center, 11-country, 4-continent, cross-sectional BRIGHT study (ClinicalTrials.gov ID: NCT01608477). The nonadherence definitions used were as follows: Physical activity: <3 times/wk 20 minutes' vigorous activity, <5 times/wk 30 minutes' moderate activity, or <5 times/wk a combination of either intensity; Sun protection: not "always" applying any sun protection; Diet: not "often" or "always" following recommended diet(s); Alcohol use: >1 alcoholic drink/d (women) or >2 drinks/d (men); Smoking: current smokers or stopped <1 year before; Follow-up visits: missing ≥1 of the last 5 outpatient follow-up visits. Overall prevalence figures were adjusted to avoid over- or underrepresentation of countries. Between-country variability was assessed within each treatment component via chi-square testing. RESULTS: The adjusted study-wide nonadherence prevalence figures were as follows: 47.8% for physical activity (95% CI [45.2-50.5]), 39.9% for sun protection (95% CI [37.3-42.5]), 38.2% for diet recommendations (95% CI [35.1-41.3]), 22.9% for alcohol consumption (95% CI [20.8-25.1]), 7.4% for smoking cessation (95% CI [6.1-8.7]), and 5.7% for follow-up visits (95% CI [4.6-6.9]). Significant variability was observed between countries in all treatment components except follow-up visits. CONCLUSION: Nonadherence to the post-HTx nonpharmacologic treatment regimen is prevalent and shows significant variability internationally, suggesting a need for tailored adherence-enhancing interventions.

Fathers' Stress in the Neonatal Intensive Care Unit: A Systematic Review.

BACKGROUND: Admission to the neonatal intensive care unit (NICU) is stressful for parents. Nurses often focus on maternal well-being and fail to acknowledge the stress of fathers. Research on fathers' psychological stress is limited. PURPOSE: A systematic review of the literature was completed to examine the extent of psychological stress and types of stressors in fathers with infants admitted to the NICU. METHODS/SEARCH STRATEGY: A search of Ovid MEDLINE, Cochrane Library, PsycINFO, CINAHL, and EMBASE was conducted to identify descriptive and observational studies reporting father-specific stress in the NICU. Studies using observational and descriptive designs, published in English, and reporting father-specific stress outcomes during a NICU admission were eligible for inclusion. Strengthening the Reporting of Observational Studies in Epidemiology guidelines were used for quality assessment. RESULTS: Fifteen studies met inclusion criteria. Fathers find the NICU environment stressful and are more stressed than fathers of full-term, healthy infants. Parental role alteration, infant appearance, NICU environment, and staff communication are stressors. IMPLICATIONS FOR PRACTICE/RESEARCH: By recognizing the extent and types of psychological stress in fathers, nurses can provide better support for fathers in their new role. Younger fathers and those with very low birth-weight premature infants may need additional support and resources. Future research on fathers' stress should include larger sample sizes, diverse populations, and tool development and evaluation.

Quality of Life for Parents of Children With Congenital Heart Defect: A Systematic Review.

BACKGROUND: As survival rates for infants born with severe forms of cardiac defects (congenital heart defect [CHD]) improve, attention is directed to evaluating factors that affect the child's short- and long-term outcomes including parental quality of life (QOL). PURPOSE: The purpose of this review was to identify how parental QOL is affected when having a child with a CHD. Factors that influence parental QOL when having a child with a CHD will also be described. METHODS: A systematic search of CINAHL, EMBASE, PsycINFO, and PubMed databases was performed. Thirty-three quantitative cross-sectional or cohort studies were selected for inclusion and analyzed for quality reporting using Strengthening the Reporting of Observational Studies in Epidemiology guidelines. RESULTS: Heart defect severity, age of child, perceived support, and availability of economic resources were identified as factors affecting parental QOL. Parent gender was related to QOL and family functioning factors. Paternal outcomes were reported in 23 of the 33 studies (70%), with an average father participation rate of 40%. CONCLUSIONS: Having a child with CHD negatively affects parental QOL. Future research should include targeting fathers to improve understanding of their unique perceptions and needs. Longitudinal studies should also describe correlations of parental QOL with their child's developmental outcomes. Efficacy studies testing supportive interventions on outcomes such as improved adjustment and QOL are needed.

An Exploratory Correlational Study in the Use of Mobile Technology Among Adult Kidney Transplant Recipients.

INTRODUCTION: Rapidly growing use of mobile technology provides a platform for self-management of care support for those with chronic conditions. Few studies have explored the characteristics or access patterns of kidney transplant recipients who use mHealth applications (apps) for self-management of care. RESEARCH QUESTIONS: The primary aim of this study was to describe demographics, use, barriers, and perceptions of mobile apps for self-management of care among adult kidney transplants recipients. The secondary aim was to compare blood urea nitrogen, glomerular filtration rate, and number of hospitalizations among mHealth app users, other app users, and non-app users. METHODS: A cross-sectional design was used to administer the Mobile Application Use among Kidney Transplant Recipients Questionnaire. Descriptive statistics, χ2 statistics, and analysis of variance were used for the primary aim and linear regression was used for the secondary aim. RESULTS: The sample included mostly African American males (n = 123, 75.5%) with a mean age of 50 (13.2) years. Knowledge was the greatest barrier reported by the non-app users (mHealth app users 9%, other app users 12%, non-app users, 49%, P < .001). Significantly fewer hospitalizations were found in the mHealth app users compared to other app users (regression coefficient b = -1.2, standard error [SE] = 0.5) and non-app users ( b = -0.9, SE = 0.6), adjusting for patient demographic and clinical characteristics. DISCUSSION: Findings suggest a relationship may exist between mHealth app use and a decrease in the number of hospitalizations following kidney transplantation.

Improvement of Immunosuppressive Medication Adherence Using a SystemCHANGE Intervention: Case Study of an Older Adult Kidney Transplant Recipient.

This article reports a case study of an older adult kidney transplant recipient with poor medication adherence enrolled in an innovative six-month SystemCHANGE intervention that seeks to systematically improve medication adherence by identifying and shaping routines, involving others in routines, and using medication-taking feedback through small, patient-led experiments. Medication adherence increased immediately and was sustained throughout the intervention and maintenance phases. This is the first case study to demonstrate effectiveness of the SystemCHANGE intervention for promoting medication adherence in a kidney transplant recipient. The intervention improved the timing of doses by linking them to a regularly occurring behavior and providing feedback. The SystemCHANGE intervention represents a systems-thinking approach for both provider and patients, and gives healthcare providers the tools needed to assist patients in using habits and routines, and feedback to improve medication taking and timing.

Medication Adherence Interventions for Older Adults With Heart Failure: A Systematic Review.

Medication adherence is crucial in patients with heart failure; however, the rate of medication nonadherence in the heart failure population is 50%, making it a significant problem. The purpose of the current review was to summarize intervention studies designed to improve medication adherence in older adults with heart failure. A search was conducted to locate randomized controlled trials or quasi-experimental studies that tested interventions to improve medication adherence in patients 45 or older with heart failure. Five of eight studies (63%) showed a statistically significant improvement in medication adherence in intervention groups. Five of these six studies used a combination of educational, behavioral, and affective interventions, and focused on medication adherence alone versus multiple health behaviors. Interventions using combined approaches and focusing only on medication adherence show the most promise for future studies. [Journal of Gerontological Nursing, 43(10), 37-45.].

Allopurinol Medication Adherence as a Mediator of Optimal Outcomes in Gout Management.

BACKGROUND: Patient and provider factors, including allopurinol medication adherence, affect gout treatment outcomes. OBJECTIVES: The aim of this study was to examine associations of patient and provider factors with optimal gout management. METHODS: Linking longitudinal health and pharmacy dispensing records to questionnaire data, we assessed patient and provider factors among 612 patients with gout receiving allopurinol during a recent 1-year period. Associations of patient (medication adherence and patient activation) and provider factors (dose escalation, low-dose initiation, and anti-inflammatory prophylaxis) with serum urate (SU) goal achievement of less than 6.0 mg/dL were examined using multivariable logistic regression. Medication adherence was assessed as a mediator of these factors with goal achievement. RESULTS: A majority of patients (63%) were adherent, whereas a minority received dose escalation (31%). Medication adherence was associated with initiation of daily allopurinol doses of 100 mg/d or less (odds ratio [OR], 1.82; 95% confidence interval [CI], 1.20-2.76). In adjusted models, adherence (OR, 2.35; 95% CI, 1.50-3.68) and dose escalation (OR, 2.48; 95% CI, 2.48-4.25) were strongly associated with SU goal attainment. Low starting allopurinol dose was positively associated with SU goal attainment (OR, 1.11; 95% CI, 1.02-1.20) indirectly through early adherence, but also had a negative direct association with SU goal attainment (OR, 0.21; 95% CI, 0.12-0.37). CONCLUSIONS: Medication adherence and low starting dose combined with dose escalation represent promising targets for future gout quality improvement efforts. Low starting dose is associated with better SU goal attainment through increased medication adherence, but may be beneficial only in settings where appropriate dose escalation is implemented.

Merging an Activity Tracker with SystemCHANGE™ to Improve Physical Activity in Older Kidney Transplant Recipients.

Motivational strategies to increase adherence to a long-term physical activity regimen have been unsuccessful for kidney transplant recipients. We propose a theory-based SystemCHANGE™ + Activity Tracker framework. The SystemCHANGE™ + Activity Tracker approach combines small, individual-driven experiments for increasing physical activity with visual feedback from the wireless activity tracker, which enables clients to study their progress in increasing physical activity. The SystemCHANGE™ + Activity Tracker approach is designed to empower kidney transplant recipients to improve and maintain their physical activity behavior.

MAGIC Study: Aims, Design and Methods using SystemCHANGE™ to Improve Immunosuppressive Medication Adherence in Adult Kidney Transplant Recipients.

BACKGROUND: Among adult kidney transplant recipients, non-adherence to immunosuppressive medications is the leading predictor of poor outcomes, including rejection, kidney loss, and death. An alarming one-third of kidney transplant patients experience medication non-adherence even though the problem is preventable. Existing adherence interventions have proven marginally effective for those with acute and chronic illnesses and ineffective for adult kidney transplant recipients. Our purpose is to describe the design and methods of the MAGIC (Medication Adherence Given Individual SystemCHANGE™) trial METHODS/DESIGN: We report the design of a randomized controlled trial with an attention-control group to test an innovative 6-month SystemCHANGE™ intervention designed to enhance immunosuppressive medication adherence in adult non-adherent kidney transplant recipients from two transplant centers. Grounded in the Socio-Ecological Model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-led experiments to change and maintain behavior. After a 3-month screening phase of 190 eligible adult kidney transplant recipients, those who are <85 % adherent as measured by electronic monitoring, will be randomized into a 6-month SystemCHANGE™ intervention or attention-control phase, followed by a 6-month maintenance phase without intervention or attention. Differences in adherence between the two groups will be assessed at baseline, 6 months (intervention phase) and 12 months (maintenance phase). Adherence mediators (social support, systems-thinking) and moderators (ethnicity, perceived health) are examined. Patient outcomes (creatinine/blood urea nitrogen, infection, acute/chronic rejection, graft loss, death) and cost effectiveness are to be examined. DISCUSSION: Based on the large effect size of 1.4 found in our pilot study, intervention shows great promise for increasing adherence. Grounded in the socio-ecological model, SystemCHANGE™ seeks to systematically improve medication adherence behaviors by identifying and shaping routines, involving supportive others in routines, and using medication taking feedback through small patient-lead experiments to change and maintain behavior. Medication adherence will be measured by electronic monitoring. Medication adherence persistence will be examined by evaluating differences between the two groups at the end of the 6-and 12- month phases. Mediators and moderators of medication adherence will be examined. Patient outcomes will be compared and a cost-effectiveness analysis will be conducted. TRIAL REGISTRATION: ClinicalTrials.gov Registry: NCT02416479 Registered April 3, 2015.