Masterplan: multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners

This randomized study addresses the question if intensified treatment (multiple targets, nurse practitioner assistance) of patients with chronic kidney disease (CKD) decreases the number of cardiovascular events. The study started in February 2004.The projected time of follow-up was 5 years. The study was closed in July 2010. Enrollment In total 793 patients were included in 9 participating centers (range 64 to 104 per center). Five patients had to be excluded from the analysis. Patients were randomised to receive nurse practitioner support added to physician care (intervention group) or physician care alone (control group). Baseline-evaluation Control group 393 patients, intervention group 395 patients. Mean age of the 788 participating patients is 59 years, 68% is male, mean estimated glomerular filtration rate is 38 ml/min/1.73m2. All baseline variables were balanced between the two groups apart from a history of cardiovascular disease (33% in intervention group; 25% in control group). We defined 11 treatment goals for patients with CKD based upon then current guidelines. Approximately two-third of the patients did not achieve 4 or more treatment-goals. Importantly, treatment center proved an independent predictor. We separately analysed BP control and adjusted for potential confounders more extensively. Center was also independently associated with BP. We conclude that physician characteristics are an important factor to explain this phenomenon. Evaluation of treatment efficacy after two years At 2 yrs patients in the intervention group as compared to the control group had lower systolic and diastolic BP, LDL-cholesterol and increased use of ACE-inhibitors, statins, aspirin and vitamin D. The intervention had no effect on smoking cessation, body weight, exercise or sodium intake. We conclude that in both groups, aspects of the quality of care improved, most prominently within the first year after inclusion in the study. Life style interventions were not effective. The differences between centers disappeared in the intervention group. Effect on cardiovascular outcome. During a median follow-up of 4.8 years, mean BP remained lower in the intervention group. Significant improvements were found for LDL cholesterol, proteinuria, anaemia, and use of vitamin D, aspirin and statins. No differences were found for smoking, body weight, sodium intake, physical activity. Intensive control did not reduce the rate of the composite endpoint (myocardial infarction, stroke, or cardiovascular death) (22.9/1000 person-years versus 25.5/1000 person-years; hazard ratio 0.90 [95% CI 0.59, 1.38], p = 0.63). No differences were found in secondary event outcomes, including end stage renal disease. We conclude that a strategy of intensified support by nurse-practitioner care in CKD patients improved some risk factor levels, but did not significantly reduce the rate of our primary cardiovascular endpoint. These findings may be partly explained by the increased care in the control group as a result of the conduct of the trial, the small differences between the groups, the lower than expected event rate, and the lack of successful life style changes. Nonetheless we feel that nurse practitioners can play a valuable role in the care for CKD patients by taking over a proportion of the visits