Embedding an Education Intervention about Shared Decision Making into an RCT: Ensuring competency and fidelity.

Objective: To describe the outcomes of training nephrology clinicians and clinical research participants, to use the Best Case/Worst Case Communication intervention, for discussions about dialysis initiation for patients with life-limiting illness, during a randomized clinical trial to ensure competency, fidelity to the intervention, and adherence to study protocols and the intervention throughout the trial. Methods: We enrolled 68 nephrologists at ten study sites and randomized them to receive training or wait-list control. We collected copies of completed graphic aids (component of the intervention), used with study-enrolled patients, to measure fidelity and adherence. Results: We trained 34 of 36 nephrologists to competence and 27 completed the entire program. We received 60 graphic aids for study-enrolled patients for a 73% return rate in the intervention arm. The intervention fidelity score for the graphic aid reflected completion of all elements throughout the study. Conclusion: We successfully taught the Best Case/Worst Case Communication intervention to clinicians as research participants within a randomized clinical trial. Innovation: Decisions about dialysis are an opportunity to discuss prognosis and uncertainty in relation to consideration of prolonged life supporting therapy. Our study reveals a strategy to evaluate adherence to a communication intervention in real time during a clinical study.

Opportunities to Improve Shared Decision Making in Dialysis Decisions for Older Adults with Life-Limiting Kidney Disease: A Pilot Study.

Background: Lack of awareness about the life-limiting nature of renal failure is a significant barrier to palliative care for older adults with end-stage renal disease. Objective: To train nephrologists to use the best case/worst case (BC/WC) communication tool to improve shared decision making about dialysis initiation for older patients with limited life expectancy. Design: This is a pre-/postinterventional pilot study. Setting/Subjects: There were 16 nephrologists and 30 patients of age 70 years and older with estimated glomerular filtration rate (eGFR) <20 mL/min per 1.73 m2 in outpatient nephrology clinics, in Madison, WI. Measurements: Performance of tool elements, content of communication about dialysis, shared decision making, acceptability of the intervention, decisions to pursue dialysis, and palliative care referrals were measured. Results: Fifteen of 16 nephrologists achieved competence performing the BC/WC tool with standardized patients, executing at least 14 of 19 items. Nine nephrologists met with 30 patients who consented to audio record their clinic visit. Before training, clinic visits focused on laboratory results and preparation for dialysis. After training, nephrologists noted that declining kidney function was "bad news," presented dialysis and "no dialysis" as treatment options, and elicited patient preferences. Observer-measured shared decision-making (OPTION 5) scores improved from a median of 20/100 (interquartile range [IQR] 15-35) before training to 58/100 (IQR 55-65). Patients whose nephrologist used the BC/WC tool were less likely to make a decision to initiate dialysis and were more likely to be referred to palliative care. Conclusions: Nephrologists can learn to use the BC/WC tool with older patients to improve shared decision making about dialysis, which may increase access to palliative care.

Dialysis access venous stenosis: treatment with balloon angioplasty 30-second vs. 1-minute inflation times.

Percutaneous balloon angioplasty is the standard of care in the endovascular treatment of dialysis access venous stenosis. The significance of balloon inflation times in the treatment of these stenoses is not well defined. Our objective was to examine the outcomes of 30-second vs. 1-minute balloon inflation times on primary-assisted patency of arteriovenous fistulae and grafts. Using a prospectively collected vascular access database, we identified a total of 75 patients referred for access dysfunction during a 5-year period. These patients received 223 interventions (178 with 30-second inflations and 45 with 1-minute inflations). We compared primary-assisted patency during the subsequent 9 months across groups defined by inflation times. Demographics and baseline characteristics were similar across groups. Immediate technical success and patency in the first 3 months were similar across groups (hazard ratio [HR] = 0.86; 95% confidence interval [CI]: 0.34-2.20). After 3 months, however, a 1-minute inflation time was associated with greater incidence of access failure (adjusted HR [aHR] = 1.74; 95% CI: 1.09-2.79). Other predictors of access failure included age over 60 (aHR = 1.02; 95% CI: 1.01-1.04), central location of the lesion (aHR = 2.49; CI: 1.27-4.89), and three or more prior procedures (aHR 2.48; CI: 1.19-5.16). Our data suggest that shorter balloon inflation times may be associated with improved longer term access patency, although the benefit was not observed until after 3 months. Given the increasing demands of maintaining access patency in the era of the National Kidney Foundation Kidney Disease Outcomes Quality Initiative and Fistula First, the role of angioplasty times requires further study.

Initial vascular access type in patients with a failed renal transplant.

BACKGROUND AND OBJECTIVES: Permanent hemodialysis vascular access is crucial for RRT in ESRD patients and patients with failed renal transplants, because central venous catheters are associated with greater risk of infection and mortality than arteriovenous fistulae or arteriovenous grafts. The objective of this study was to determine the types of vascular access used by patients initiating hemodialysis after a failed renal transplant. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: Data from the US Renal Data System database on 16,728 patients with a failed renal transplant and 509,643 patients with native kidney failure who initiated dialysis between January 1, 2006, and September 30, 2011 were examined. RESULTS: At initiation of dialysis, of patients with a failed transplant, 27.7% (n=4636) used an arteriovenous fistula, 6.9% (n=1146) used an arteriovenous graft, and 65.4% (n=10,946) used a central venous catheter. Conversely, 80.8% (n=411,997) of patients with native kidney failure initiated dialysis with a central venous catheter (P<0.001). Among patients with a failed transplant, predictors of central venous catheter use included women (adjusted odds ratio, 1.75; 95% confidence interval, 1.63 to 1.87), lack of referral to a nephrologist (odds ratio, 2.00; 95% confidence interval, 1.72 to 2.33), diabetes (odds ratio, 1.14; 95% confidence interval, 1.06 to 1.22), peripheral vascular disease (odds ratio, 1.31; 95% confidence interval, 1.16 to 1.48), and being institutionalized (odds ratio, 1.53; 95% confidence interval, 1.23 to 1.89). Factors associated with lower odds of central venous catheter use included older age (odds ratio, 0.85 per 10 years; 95% confidence interval, 0.83 to 0.87), public insurance (odds ratio, 0.74; 95% confidence interval, 0.68 to 0.80), and current employment (odds ratio, 0.87; 95% confidence interval, 0.80 to 0.95). CONCLUSIONS: Central venous catheters are used in nearly two thirds of failed renal transplant patients. These patients are usually followed closely by transplant physicians before developing ESRD after a failed transplant, but the relatively low prevalence of arteriovenous fistulae/arteriovenous grafts in this group at initiation of dialysis needs to be investigated more thoroughly.

The effect of buttonhole cannulation vs. rope-ladder technique on hemodialysis access patency.

The rope-ladder (RL) technique is the most common technique used for cannulation of arteriovenous fistulae (AVF). Buttonhole cannulation (BHC), or constant-site technique, is recommended by the National Kidney Foundation's Kidney Disease Outcome Quality Initiative (NKF/KDOQI) vascular access guidelines. We compared outcomes of primary patency, episodes of bacteremia, access blood flow (Qa), and quality of life (QoL) scores between RL and BHC patients. Using a prospectively collected, vascular access database, a total of 45 prevalent dialysis patients using BHC were compared with 38 patients using the RL technique over a median of 12 months (inter-quartile range: 4-27 months). The two groups did not differ significantly in demographics except that diabetes was more common in those using BHC as compared to rope-ladder (69% vs. 34%; p = 0.002). Risk factors associated with lack of primary patency were age (hazards ratio [HR] = 1.02 per decade; 95% CI: 1.00-1.03; p = 0.04) and female gender (HR = 1.92; 95% CI: 1.08-3.40; p = 0.03). Use of the buttonhole technique was not associated with improved primary patency (HR = 1.22, 95% CI: 0.65-2.28; p = 0.53). Episodes of bacteremia and mean scores from KDQOL-36 did not differ significantly between the groups. This study demonstrates for the first time that BHC use is not associated with improved access patency.

Concentrated heparin lock is associated with major bleeding complications after tunneled hemodialysis catheter placement.

Vascular access complications, including thrombosis, are associated with significant patient morbidity and mortality. Currently, up to 60% of new patients and 30% of prevalent patients are using a catheter for dialysis. To prevent interdialytic catheter thrombosis, these devices are routinely locked with concentrated heparin solutions. Several recent studies have elucidated the potential for abnormal coagulation markers (aPTT) that may arise from this practice. This abnormal elevation in aPTT may be explained by significant early and late leakage from the catheter that occurs after performing a catheter lock. To date no study has evaluated the impact of this practice, or the elevation in aPTT that may result from it, on bleeding complication rates. We conducted a retrospective analysis comparing bleeding rates in subjects who received concentrated heparin catheter lock (5000 u/cc) [group 1, n = 52] to those who received citrate or dilute heparin catheter lock (1000 u/cc) [group 2, n = 91] immediately after tunneled hemodialysis catheter insertion. Baseline characteristics did not differ between the groups except for the preprocedure INR, which was higher in the postpolicy group compared with the prepolicy group (1.29 vs. 1.21, p = 0.04). Results from logistic regression analyses revealed that the likelihood of a composite bleeding event in group 1 was 11.9 times that of a composite bleeding event in group 2, p = 0.04. Concentrated heparin (5000 u/ml) is associated with increased major bleeding complications posttunneled catheter placement compared with low-dose heparin (1000 u/ml) or citrate catheter lock solution, p = 0.02. Given the findings of this study, a randomized controlled trial comparing the safety and efficacy of common anticoagulation lock solutions is warranted.