PRAGUE—A multifactorial intervention using a polydrug and lifestyle treatment strategy with nurse practitioner (NP) support can improve management of some cardiovascular (CV) risk factors and reduced the number of physician visits by patients with chronic kidney disease (CKD).

Arjan van Zuilen, MD of the Department of Nephrology and Hypertension at University Medical Center Utrecht in Utrech, Netherlands, presented findings of the MASTERPLAN (Multifactorial Approach and Superior Treatment Efficacy in Renal Patients with the Aid of Nurse Practitioners) study at the 48th Congress of the European Renal Association-European Dialysis and Transplant Association.

The investigators undertook the study to see if the multifactorial, guideline-based intervention with the added support of specialized nurse practitioners to augment physician visits would reduce CV risk, slow progression of kidney disease, and improve quality of care. The multi-center, randomized, controlled clinical trial enrolled patients with an estimated glomerular filtration rate (eGFR) of 20-70 mL/min/1.73m2 between 2004 and 2005.

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Investigators randomly assigned 393 patients to a traditional physician-care control group and 395 to the multifactorial interventional group (IG). Researchers follow-up patients through 2010. NPs used flowcharts to address risk factors requiring drug and/or lifestyle modification. The primary endpoint of the trial was the composite of CV death, myocardial infarction, and stroke.

At baseline, the study arms were well matched for demographic, clinical, and laboratory parameters. One difference between groups was a history of CV disease, accounting for 25% of the patients in the control group compared with 34% in the IG.

The multifactorial intervention with NP support was not associated with any difference in the incidence of the primary composite endpoint of CV death, myocardial infarction, and stroke nor in any secondary endpoints of the risk of the individual components or the risk of end-stage renal disease in the IG compared to the control group.

After five years of follow-up, patients in both groups had an improvement in most laboratory parameters and an increased use of risk-reducing drugs, with the IG showed greater improvements than controls. Those patients had significantly greater decreases in systolic and diastolic blood pressure, LDL cholesterol, proteinuria, and prevalence of anemia. The IG patients used significantly more statin drugs, aspirin, and active vitamin D, but the two arms did not differ significantly in the use of ACE inhibitors and angiotensin receptor blockers, which were used by at least 80% of the participants in each arm.

The two arms showed no difference in any lifestyle risk factors, including body mass index, daily sodium excretion as an indicator of sodium intake, or physical activity. Smoking had declined in both groups.

The intervention was associated with a significantly higher annual number of participant health care visits (7.2 vs. 4.7) but fewer visits to the physician (2.8 vs. 3.7).

Study underpowered

Dr. van Zuilen explained there were too few events to power the study to show any potential difference in the primary outcome between the IG and control groups. In both groups, 8.9% of patients reached the primary endpoint. Risk factors were well controlled in both groups, so the inter-group differences were small, and it would have required far more participants to be able to show any differences if they occurred.

Dr. van Zuilen concluded that the multifactorial intervention with NP support was associated with improved CV risk factors but not lifestyle factors. If NPs adhere to established guidelines for risk factor reduction they “at least can perform as well as the physician” and can alleviate big patient loads.

Johannes Mann, MD, Director of the Department of Nephrology at Munich General Hospitals in Germany, who moderated the session, commented to Renal & Urology News that MASTERPLAN was an important study because in absolute terms the NP intervention was effective in reducing the primary outcome of CV death, myocardial infarction, and stroke. The study showed “what health care workers can do aside from [using] devices and drugs and so forth, and this is a field that is certainly under-investigated to a huge extent because there is no financing,” he said.