Establishing Evidence for the Future of Kidney Disease Education

The provision of kidney disease education for those at-risk, and especially for those with chronic kidney disease (CKD), is a necessary and important part of clinical care; CKD specific education facilitates informed shared decision-making and promotes optimal self-care —both essential to preventing progression of kidney disease and ameliorating its complications.1 Like any intervention, patient focused education requires an ongoing commitment of resources. These resources include personnel, time, financial support, physical space, and emotional dedication of clinical and research champions to develop, deploy and maintain education efficacy. Yet, within any clinical practice setting, there exist competing demands for resources. Thus, identifying strategies that are most likely to influence outcomes is critical. Because of the heterogeneous and complex nature of education programs in kidney disease, there are few informative comparisons that we can make among education interventions in order to determine which are best. But there may be an opportunity to learn from the research and clinical experience of our colleagues in other chronic diseases, for example, multidisciplinary professionals who provide comprehensive diabetes self-management education. Not only are these programs successful, they have led to the establishment of national standards to support quality diabetes education.2 [Summary of the study (design, participants, and numerical data for key outcomes: 1–2 p] In this issue of AJKD Lopez-Vargas et al present a systematic review of the characteristics and outcomes of randomized and non-randomized trials of educational interventions for patients across the spectrum of pre-dialysis CKD.3 The review did not include interventions in patients receiving dialysis or with a kidney transplant. Searching four indexing databases along with an additional supplementary hand search, the authors found a total of 26 studies meeting their inclusion criteria. Approximately 50% were trials, with a total of 5,403 participants. A formal meta-analysis could not be performed, but a descriptive assessment allowed the authors to identify commonly reported features. To evaluate the interventions, the authors drew from a taxonomy similar to other reviews performed for diabetes education programs. For each study they described the educational setting (one-to-one, group), delivery method (face-to-face, telephone, written), frequency, quantity and duration of the encounters, content and the type of provider(s), and who delivered the intervention.4 All interventions included face-to-face teaching; 54% included education in a group, most provided written materials (77%), and 50% incorporated goal-setting. The frequency and duration of contact was highly variable. Similarly, content varied, with the most common education interventions covering nutrition education (62%). Least common was management of psychosocial issues (15%). The majority of interventions utilized nurses (73%) or nephrologists (69%) as primary educators, although all disciplines were represented. Education intervention effect was heterogeneous on the outcomes measured including knowledge, self-care behaviors, quality of life, and a variety of clinical measures including mortality. Interventions most often associated with significant improvements were group teaching sessions, with family and patient peer participation, goal setting, and repeated follow up over time (e.g. monthly sessions for 6+ months). Bias tempered all findings and this appeared to be primarily due to the lack of randomization and the inherent difficulty in ‘blinding’ providers and/or patients to the interventions. Strengths of this review include its characterization of current kidney disease education programs and the provision of some novel information we can use in research and practice. The information from this review also provides a foundation building metrics to define and ascertain outcomes in future education programs. However, evaluation of any education program should also include an assessment of the process of integrating education into practice. Can an education intervention be sustained in a real-world setting, or does it require significant clinical or resource redesign that is not sustainable on a permanent basis? Information about process implementation evaluations is needed and could enhance our understanding and provide additional information for future work. In addition, interventions may change due to participant, educator or organizational needs. Participants may drop out or decline participation if an intervention unexpectedly contributes to anxiety or misunderstanding or if it leaves a patient uncomfortable– by identifying previously unrecognized skill gaps. The review identified and provided only information on studies where education was face-to-face. Moreover, many of the interventions were time-intensive with nearly 1/3 of the sessions taking 30 minutes or longer. Again, these factors suggest that the resources necessary to deliver and maintain education interventions that have been tested, may not be able to be supported in ‘real-world’ practice. A real opportunity exists for research to help us better understand not only how to implement education interventions but how to sustain them in clinical practice in the future. One commonly used framework that could help support process evaluation is RE-AIM (www.re-aim.org).5,6 The first step, “R”, stands for Reach. Reach is the number, proportion and representativeness of individuals who ultimately participate in the education intervention. “E” represents efficacy or effectiveness and is the influence of the intervention on important outcomes including unexpected adverse events and costs. The next step, Adoption, signifies the number, proportion and representativeness of settings and people who are willing to initiate an intervention. This may include organizations with respective personnel expertise and availability to fulfill the program requirements. Implementation is the consistency in educational delivery across the organization. Lastly, Maintenance at the level of the individual represents the long-term impact of the intervention. Suggested strategies for each of the RE-AIM steps are shown in Table 1. Qualitative methods such as interviews or focus groups can augment this process evaluation so that current education interventions can evolve over time to maximize their impact on outcomes and efficiency within the health setting. Table 1 RE-AIM Framework Strategies for Efficacy and Effectiveness trials Through process evaluation we may be able to identify reasons why some interventions did not consistently demonstrate an affect on outcomes. Only one of 9 education intervention studies in this review showed an improved estimated glomerular filtration rate (eGFR).3 Lack of associations reported in the review appears consistent with a similar observation in the SHARP trial, where patient educational attainment was not associated with kidney disease progression.7 As the authors point out, lack of an association may be due to enrolling patients with less severe CKD, or because study timelines were too short to observe changes in renal function. It may also be that these educational interventions were more directly linked with proximal outcomes such as kidney knowledge, perceptions of the severity of kidney disease, self-efficacy or other factors driving self-care behaviors. These pathways may ultimately affect kidney disease morbidity and mortality through these intermediate steps, and there may not be an independent affect of the education program.8 This systematic review identified significant concerns about potential bias in the education intervention studies primarily related to randomization and blinding of study personnel. The suggestion that researchers performing the outcome assessment are blinded to the participant’s assignment is critical, but additional layers are needed to enhance the quality and rigor of education and behavior research. Participants should be not be privy to the details of the randomization, assignment, procedures and study hypotheses.9 Research staff that deliver the intervention should be blinded to the study hypotheses and outcome assessment. The principal investigator should not be involved with participants and should remain unaware of the outcome assessment until the study’s conclusion. Even the statistician should be blinded to the details of the intervention delivery, although could be permitted to know study hypotheses and outcome assessments. At each of these levels, blinding should be considered and included through completion of the intervention. This systematic review by Lopez-Vargas et al is an original and significant contribution to what we already know about kidney disease education research. The detailed description of the magnitude and variation of a wide variety of outcomes serve as initial comparators for other trials, and also provide methodology for future outcome assessment. It confirmed previous cautions related to potential bias, and offers strategies to minimize this in forthcoming programs. The taxonomy applied in this study can inform the design of a novel intervention by specifying each of the designated characteristics during initial study design. Alternatively it could be used to review a program currently in progress. Adding process evaluation is critical to further strengthen our assessments of interventions and fully realize their potential to optimize health. Once these steps are in place, we can better advance nephrology towards national standards for kidney disease education.