SystemCHANGE: An Intervention for Medication Adherence in Transplant Recipients

SPECIFIC AIMS For adult kidney transplant (KT) patients, the leading predictor of rejection, kidney loss, death and their attendant costs is immunosuppressive medications nonadherence (MNA). An alarming one-third of KT recipients experience this preventable problem. According to meta-analysis, predictors of MNA are nonwhite ethnicity, poorer social support and poorer perceived health. Patients' most frequent barrier to adhering to immunosuppressive medication is forgetting. 9 Even minor deviations from adherence have shown negative effects, though the precise extent of poor outcomes stemming from nonadherence is not clear. Traditionally, intervention studies aimed at boosting adherence target cognition (knowledge, attitudes, beliefs) and behavioral skills. However, these have proven marginally effective for individuals with acute and chronic illnesses and ineffective for adult KT recipients. In a sample of KT recipients, we propose to test the innovative and successful SystemCHANGE intervention, which is grounded in the socio-ecological model. This approach is a paradigm shift in behavioral interventions because it seeks to redesign the system of the interpersonal environment and daily routines linked to health behavior, rather than to alter individuals' efforts to change their behavior. Using a four-pronged, patient-centered approach, we will (1) assess individual systems (including important others who shape medication taking), how they influence medication taking and their proposals for improving medication adherence, (2) implement the proposed individual systems solutions for improving adherence, (3) track adherence data, and (4) evaluate adherence data through small experiments. In our pilot study, this intervention yielded a large effect size of 1.4.

This study's innovation lies in its use of a socio-ecological model known as SystemCHANGE, which differs greatly from previous cognitive and behavioral skills-focused interventions for improving medication adherence. This will be the first rigorous evaluation of SystemCHANGE with a diverse sample of KT recipients and long-term follow up. This study presents a unique opportunity to evaluate moderators and mediators of adherence and has potential, based upon pilot work, to have immediate "dose" impact. As such, it could hold great promise as an intervention that translates very well into practice settings. Our 6-month SystemCHANGE intervention (also referred to as "intervention") seeks to enhance adherence to immunosuppressive medication among adult KT recipients who are non-adherent. The study is a randomized controlled trial with an attention-control intervention (also referred to as "control") to determine persistence of medication adherence behavior change and differences in adherence between the two groups during the 6-month maintenance phase.

Primary Aim (PA):

PA: To determine whether the intervention is more effective than control in increasing medication adherence in adult KT recipients at the completion of the intervention and maintenance phases.

Hypothesis: Adult KT recipients participating in the intervention will have higher immunosuppressive adherence rates than those participating in the control at the completion of intervention and maintenance phases.