Abstract
BackgroundAmong 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™) trialMethods/DesignWe 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.DiscussionBased 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 registrationClinicalTrials.gov Registry: NCT02416479 Registered April 3, 2015
Highlights
Introduction of SystemCHANGETMOverview-challenges of medication taking, focus on routines and conducting small experiments to improve medication taking, review 4 steps of SystemCHANGETM, and discuss how Research Assistant (RA) will guide Pp through the process of improvement.Review of electronic medication RA guides Pp’s review of MEMS report details; Pp’s personal MEMS report reviewed from screening phase. self-monitoring report Goal settingRA discusses Pp’s medication taking goals; encouraged to have goal of 100 % medication adherence.Determining Process Owners RA assists Pp in identifying important people in medication taking process using Important People worksheet.Lifestyle RoutinesRA assist Pp in identifying lifestyle routines using the Life Routines worksheet
We hypothesize adult kidney transplant recipients participating in the SystemCHANGETM intervention will have higher immunosuppressive MA rates than those participating in the attention control at the completion of intervention and maintenance phases
Overview-challenges of medication taking, focus on routines and conducting small experiments to improve medication taking, review 4 steps of SystemCHANGETM, and discuss how RA will guide Pp through the process of improvement
Summary
This is the first fully-powered, randomized, controlled trial to determine the effectiveness of a SystemCHANGETM intervention in increasing medication adherence in adult kidney transplant recipients. We need a paradigm shift from focusing on medication adherence patient knowledge, attitudes, beliefs, and behavioral skills to the patient’s personal environment and daily routines that influence MA [68] If this SystemCHANGETM intervention is found to be effective in kidney transplant patients, other chronically ill populations known to have medication nonadherence (those with hypertension, diabetes, TB, asthma, epilepsy) may immediately benefit from this approach while trials are conducted to confirm findings across populations. The need for effective interventions is compelling: Decreasing transplant complications from medication nonadherence will reduce costs and make additional kidneys available to those waiting for transplants by reducing the number of kidney transplant recipients who must rejoin the organ list This project builds on our research team’s previous adherence work, including a SystemCHANGETM intervention pilot study that addresses Healthy People 2020 initiatives of reducing chronic kidney disease complications, disability, death, and costs by optimizing transplant medication adherence and increasing the number of patients who receive a transplant [70]. Author details 1School of Nursing and Health Studies, University of Missouri-Kansas City, Health Sciences Building 2407, Kansas City, MO 64108, USA. 2Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH 44106, USA. 3Department of Advanced Practice and Doctoral Studies, 920 Madison, #924, Memphis, TN 38163, USA. 4Department of Internal Medicine, University of Kansas Medical Center, 4043 Wescoe, MS 1037 3901 Rainbow Blvd, Kansas City, KS 66160, USA. 5Health Services and Outcomes Research, Children’s Mercy Hospitals and Clinics, University of Missouri - Kansas City Schools of Medicine and Pharmacy, 2401 Gillham Road, Kansas City, MO 64108, USA
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