Background and objectives People receiving hemodialysis to treat kidney failure need a vascular access (a fistula, a graft, or a central venous catheter) to connect to the blood purification machine. Higher rates of access complications are considered the mechanism responsible for the excess mortality observed among catheter or graft users versus fistula users. We tested this hypothesis using mediation analysis. Design, setting, participants, & measurements We studied incident patients who started hemodialysis therapy from North America, Europe, and Australasia (the Dialysis Outcomes and Practice Patterns Study; 1996–2011). We evaluated the association between access type and time to noninfectious ( e.g. , thrombosis) and infectious complications of the access (mediator model) and the relationship between access type and time-dependent access complications with 6-month mortality from the creation of the first permanent access (outcome model). In mediation analysis, we formally tested whether access complications explain the association between access type and mortality. Results Of the 6119 adults that we studied (mean age =64 [SD=15] years old; 58% men; 47% patients with diabetes), 50% had a permanent catheter for vascular access, 37% had a fistula, and 13% had a graft. During the 6-month study follow-up, 2084 participants (34%) developed a noninfectious complication of the access, 542 (8.9%) developed an infectious complication, and 526 (8.6%) died. Access type predicted the occurrence of access complications; both access type and complications predicted mortality. The associations between access type and mortality were nearly identical in models excluding and including access complications (hazard ratio, 2.00; 95% confidence interval, 1.55 to 2.58 versus hazard ratio, 2.01; 95% confidence interval, 1.56 to 2.59 for catheter versus fistula, respectively). In mediation analysis, higher mortality with catheters or grafts versus fistulas was not the result of increased rates of access complications. Conclusions Hemodialysis access complications do not seem to explain the association between access type and mortality. Clinical trials are needed to clarify whether these associations are causal or reflect confounding by underlying disease severity.
Chronic kidney disease (CKD) affects 30 million Americans. Early management focused on blood pressure (BP) control decreases cardiovascular morbidity and mortality. Less than 40% of patients with CKD achieve recommended BP targets due to many barriers. These barriers include a lack of understanding of the implications of their diagnosis and how to optimise their health.This cluster randomised control trial hypothesises that the combination of early primary care CKD education, and motivational interviewing (MI)-based health coach support, will improve patient behaviours aligned with BP control by increasing patient knowledge, self-efficacy and motivation. The results will aid in sustainable interventions for future patient-centric education and coaching support to improve quality and outcomes in patients with CKD stages 3-5. Outcomes in patients with CKD stages 3-5 receiving the intervention will be compared with similar patients within a control group. Continuous quality improvement (CQI) and systems methodologies will be used to optimise resource neutrality and leverage existing technology to support implementation and future dissemination. The innovative approach of this research focuses on the importance of a multidisciplinary team, including off-site patient coaching, that can intervene early in the CKD care continuum by supporting patients with education and coaching. We will test impact of BP control when clinician-delivered education is followed by 12 months of MI-based health coaching. We will compare outcomes in 350 patients with CKD stages 3-5 between intervention and control groups in primary care. CQI and systems methodologies will optimise education and coaching for future implementation and dissemination. This study was approved by the University of Michigan Institutional Review Boards (IRBMED) HUM00136011, HUM00150672 and SITE00000092 and the results of the study will be published on ClinicalTrials.gov, in peer-reviewed journals, as well as conference abstracts, posters and presentations. NCT04087798.
