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

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. Clinical Trial Registration: NCT02416479.

SUBMITTER: Russell CL

PROVIDER: S-EPMC7179766 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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

Russell Cynthia L CL Hathaway Donna D Remy Laura M LM Aholt Dana D Clark Debra D Miller Courtney C Ashbaugh Catherine C Wakefield Mark M Ye Sangbeak S Staggs Vincent S VS Ellis Rebecca J RJ Goggin Kathy K

American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons 20190820 1

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. Ei ...[more]

PMID: 31291507

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Project description: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™) trialWe 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.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.ClinicalTrials.gov Registry: NCT02416479 Registered April 3, 2015.

Project description:BackgroundDespite numerous interventions targeting medication adherence in patients with uncontrolled hypertension, practice-based trials in Latino patients are scant.ObjectiveTo evaluate the effect of a systems-level adherence intervention, delivered by medical assistants (MAs), versus a comparison condition on medication adherence and blood pressure (BP) in 119 hypertensive Latino patients who were initially non-adherent to their antihypertensive medications.Study designRandomized control trial.ParticipantsPatients (50% women; mean age, 61 years) were recruited from April 2013 to August 2015 in a community-based practice in New York.InterventionSystems-level approach that included an office system component built into the electronic health record and a provider support component consisting of nine MA-delivered health coaching sessions for improving medication adherence. The comparison group received the standard health coaching procedures followed at the clinic.Main outcome measuresThe primary outcome was rate of medication adherence measured by an electronic monitoring device (EMD) across 6 months. The secondary outcomes were self-reported medication adherence measured by the eight-item Morisky Medication Adherence Scale (MMAS-8) and BP reduction from baseline to 6 months.Key resultsAdherence as measure by EMD worsened for both groups (p = 0.04) with no between-group difference (- 9.6% intervention and - 6.6% control, p = 0.66). While systolic BP improved in both groups, the difference between groups was not significant (- 6 mmHg in intervention vs. - 2.7 mmHg in control, p = 0.34). In contrast, the intervention group had a greater improvement in self-reported adherence (mean change 1.98 vs. 1.26, p = 0.03) when measured using the MMAS-8.ConclusionsAmong Latinos with poorly controlled BP who were non-adherent to their antihypertensive medications, a systems-level intervention did not improve adherence as measured by EMD nor blood pressure. However, many patients reported challenges to using the EMD. Improvements in self-reported adherence suggest that this measure captures different aspects of adherence behavior than EMD.Clinical trial registrationNCT03560596.

Project description:BackgroundOrgan transplantation is the most effective treatment for patients with end-stage organ failure. It has been actively carried out all over the world. Recently, eHealth interventions have been applied to organ transplant patients. This systematic review and meta-analysis aimed to evaluate the effects of eHealth interventions for improving medication adherence in organ transplant patients as compared to usual or conventional care alone.MethodsWe searched MEDLINE via PubMed, Excerpta Media dataBASE (EMBASE), the Cochrane Register Controlled Trials, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), PsycINFO, and six domestic Korean databases to identify randomized controlled trials (RCTs) published up to April 17, 2020. Two reviewers independently selected relevant studies and extracted data. The quality and bias of the identified studies were assessed. To estimate the effect size, a meta-analysis of the studies was performed using the Cochrane Collaboration software Review Manager 5.3. PRISMA guidelines were followed. When statistical heterogeneity was greater than 80%, narrative synthesis was performed.ResultsOf the 1,847 articles identified, seven RCTs with a total of 759 participants met the inclusion criteria. The risk of bias assessment showed that the blinding of participants and personnel was high. In six studies, medication adherence (effect size = -0.18-1.30) and knowledge scores were not significantly different between those receiving eHealth interventions and the controls.ConclusionsOur findings suggest that eHealth interventions were similar to standard care or advanced care for improving medication adherence, and they faired equally well for improving medication knowledge. Therefore, eHealth interventions can be used for medication adherence of organ transplant patients. More research is needed to provide well-designed eHealth intervention to improve the medication adherence and knowledge of organ transplant patients.Protocol registration numberCRD42017067145 16/05/2017.

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

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

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