SystemCHANGE: An Intervention for Medication Change in Adult Kidney Transplant Patients

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.

Secondary Aim (Sec):

SA: To examine the patterns of medication adherence in adult KT recipients in both groups.

Research question (RQ): When does the intervention become effective (e.g., what "dose" is
needed)? RQ: What is the pattern of decay in adherence over time in both groups?

Exploratory Aims (EA):

EA1: To determine whether the intervention is more effective than the control in decreasing
poor health outcomes (e.g. increasing creatinine/BUN, infection, acute/chronic rejection,
graft loss, death, hospitalizations, length of hospital stay, and healthcare appointments).

Hypothesis: At one year, there will be differential levels of poor outcomes, with the
intervention demonstrating lower levels of poor outcomes than the control.

EA2: To evaluate the role of potential mediators and moderators of medication adherence and
health outcomes in adult KT recipients in the intervention and those in the control.

Hypothesis: Incorporating potential mediators and moderators of the intervention (e.g.,
nonwhite ethnicity, perceived social support, perceived health status, personal systems
behavior) will increase the medication adherence variance explained by the intervention.

EA3: To determine if the intervention is cost-effective. Hypothesis: The cost-effectiveness
ratio for the intervention will be less than for the control.

Each year, 35.6 KT recipients per 100 are non-adherent with their medications, which is the
primary cause of post-transplant morbidity. Thus, the need for effective interventions is
compelling: Decreasing transplant complications from MNA will reduce costs and make
additional kidneys available to those waiting for transplants by reducing the number of KT
recipients who must rejoin the organ list. This project builds on our research team's
previous adherence work, including a SystemCHANGE 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.

Inclusion Criteria:

1. age 18 years or older,

2. prescribed at least 1 immunosuppressive medication taken twice a day,

3. functioning KT (not on dialysis),

4. has received a kidney-only transplant,

5. agreement from the transplant physician and nephrologist that individual is able to
participate in the study,

6. able to speak, hear, and understand English as determined by the ability to
participate and comprehend conversation about potential inclusion in the study,

7. able to open a MEMS cap as assessed by the Research Assistant (RA) asking if there is
any problem with opening pill bottle caps,

8. able to administer immunosuppressive medications to self,

9. has a telephone or has access to a telephone,

10. has no cognitive impairment as determined by a score of 4 or greater on the 6-item
Telephone Mental Status Screen Derived from the Mini-Mental Status Exam,

11. has no other diagnoses that may shorten life span, such as metastatic cancer,

12. is not currently hospitalized,

13. receives post-transplant care by the Missouri or Tennessee transplant programs.

Exclusion Criteria: