Towards rational approaches of health care utilization in complex patients: an exploratory randomized trial comparing a novel combined clinic to multiple specialty clinics in patients with renal disease-cardiovascular disease-diabetes.

BACKGROUND: Optimal utilization of health care resources for patients with chronic conditions is an increasing focus of health care policy researchers and clinicians. Kidney disease, diabetes (DM) and cardiovascular disease (CVD) often coexist within one individual, but current systems are designed to manage individual conditions. We sought to examine if streamlining medical care of complex patients (two or more conditions) is associated with similar, worse or improved outcomes using a randomized controlled study design. METHODS: Patients attending a kidney care clinic (KCC) and at least one other specialty clinic of interest (DM, CVD) were randomly assigned to either the 'combined clinic (CC)' arm, where resources from all three were integrated into one clinic, or to the 'standard care' arm with continued attendance at multiple specialty clinics (MC), including the KCC. The primary outcome was hospitalization rate and sample size was calculated based on non-inferiority. RESULTS: Of 150 subjects enrolled, 11 subjects exited before study commencement: 139 remained for final analysis. Other than older age in the MC group (P = 0.009), the demographics were comparable. Hospitalization rates were not different (95% CI for the difference: 0.013-0.207; P = 0.03). Similar proportions in each group achieved clinical and laboratory targets. Mortality (13%) and dialysis (32%) rates were the same between groups. Differences in the cost of clinic visits alone were $86,400 per year in favor of the CC. CONCLUSIONS: Medical care of complex patients may be delivered in a single combined specialty clinic as compared to multiple disease specific clinics without compromising patient care or important health outcomes, with demonstrable outpatient costs savings.

Evaluation of anemia management by algorithms in patients with chronic kidney disease who are not receiving dialysis.

BACKGROUND: Anemia commonly develops in patients with chronic kidney disease and is strongly associated with adverse clinical outcomes. There are currently no published studies evaluating the efficacy of a nurse-driven anemia-management protocol for patients with chronic kidney disease who are not receiving dialysis. OBJECTIVES: To evaluate the efficacy of an anemia-management protocol in terms of achieving hemoglobin and transferrin saturation levels within the target range, as well as associated utilization of medications, relative to individualized dosing of medications by nephrologists. METHODS: An algorithm for nurse-driven management of anemia was introduced in April 2009 at a kidney function clinic in a large urban centre. The charts of patients with chronic kidney disease who were not undergoing dialysis were reviewed before (July to December 2007) and after (July to December 2009) implementation of the protocol. Patients' data for hemoglobin, transferrin saturation, and doses of iron and erythropoiesis-stimulating agents were collected for each of the 6-month study periods. RESULTS: In total, 390 patients were treated for anemia before and 434 patients after introduction of the protocol. The anemia-management protocol was non-inferior to individualized dosing for maintenance of hemoglobin levels within the target range of 110-120 g/L: percentage of measured levels within target range 33.3% (485/1456) before versus 34.2% (504/1472) after (absolute difference 0.9 percentage points, 95% confidence interval [CI] -2.5 to 4.4). The criteria for non-inferiority were not met for maintenance of transferrin saturation within the target range of 22%-50%: percentage of levels within target range 58.8% (374/636) before versus 56.9% (403/708) after (absolute difference 1.9 percentage points, 95% CI -3.4 to 7.2). There were no statistically significant differences in mean doses of epoetin alfa, darbepoetin, or iron before and after introduction of the protocol. Similarly, there were no statistically significant differences in number of dose changes for epoetin alfa, darbepoetin, or iron. CONCLUSION: The nurse-driven anemia-management protocol was non-inferior to dosing by nephrologists in terms of managing hemoglobin levels. It would be reasonable to use an anemia-management protocol for patients with chronic kidney disease who are not receiving dialysis.

Conservative outpatient renoprotective protocol in patients with low GFR undergoing contrast angiography: a case series.

BACKGROUND: The correct strategy to prevent radiocontrast-induced nephropathy (CIN) in high-risk patients going for cardiac angiography is widely debated in the literature. It is well known that chronic kidney disease (CKD) patients with lower estimated glomerular filtration rates (eGFRs) at baseline are at the greatest risk for a significant loss in kidney function, or even dialysis after a contrast load. For this reason potentially life-saving procedures such as angiography are sometimes withheld or delayed. METHODS: We describe a case series of 31 well-characterized patients with CKD who underwent cardiac or peripheral vessel angiography, and patients with renal artery stenosis (RAS) who underwent angioplasty and stenting. All were treated with a standardized outpatient protocol of withholding their diuretics and angiotensin-converting enzyme (ACE) inhibitors (ACEs)/angiotensin receptor blockers (ARBs) the day prior to and 2 days after the procedure, restarting the diuretic the day after the procedure and the ACE inhibitor/ARB after 2 days. Calcium channel blockers were prescribed for the 2 days prior to and 2 days after the procedure. Patients had bloodwork on days 2-3 and days 7-10 post-procedure. RESULTS: The patients had a mean baseline creatinine of 214 micromol/l (SD = 123), ranging from 87 to 535 micromol/l. This corresponded to a mean baseline eGFR of 34 ml/min (SD = 15.8), ranging from a minimum of 12-59 ml/min. The mean age was 64 +/- 13.8 years; 48% were male and 11 (35.5%) were diabetic. All patients enrolled had a baseline eGFR of less than 60 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) formula. Based on pre-procedure CKD stage, 21 (68%) were stage 3 (eGFR 30-60 ml/min), 5 (16%) were stage 4 (eGFR 15-30 ml/min), and 6 (19%) were stage 5 (eGFR < 15 ml/min). No patient required urgent hemodialysis following their angiography. All patients have had a longitudinal follow up of 26 months, and none developed any change in the rate of progression from prior to procedure. CONCLUSIONS: This case series provides data in support of a conservative, outpatient-based approach for high-risk CKD patients going for cardiac angiography. This protocol warrants further study in randomized control trials.

Stage of chronic kidney disease predicts seroconversion after hepatitis B immunization: earlier is better.

BACKGROUND: Hepatitis B virus (HBV) infection remains a concern in dialysis populations, and vaccination programs have been less successful than those in the general population. Reasons for poor response include malnutrition, uremia, and the generalized immunosuppressive state of patients with chronic kidney disease (CKD). This prospective cohort study evaluated factors impacting on the effectiveness of a vaccination program before dialysis therapy initiation, including level of kidney function. METHODS: All patients receiving care in the Kidney Function Clinic (St Paul's Hospital, Vancouver, Canada) were screened for previous HBV infection or vaccination. Those who were marker negative were administered a standardized hepatitis B vaccination schedule recommended for patients with CKD. The primary outcome measure, seroconversion, is defined as hepatitis B surface antibody titer greater than 10 IU 3 months after completion of the vaccination schedule. RESULTS: The study population of 165 patients included 64% men with a mean age of 60 years, mean serum creatinine level of 3.4 +/- 1.5 mg/dL (300 +/- 133 micromol/L), and median estimated glomerular filtration rate (GFR) of 20 mL/min (interquartile range, 14 to 20). Seroconversion rate was 82%. Multivariate analyses showed the independent predictive value of level of GFR. The model showed that patients with the lowest level of kidney function and who were older and had diabetes were less likely to seroconvert (P < 0.05). CONCLUSION: This is the largest study to show in a well-characterized cohort that patients with higher GFR levels are more likely to respond to hepatitis B vaccination programs with seroconversion, independent of other factors. Future studies will explore specific mechanisms to explain this phenomenon.