Rationale and design of the MASTERPLAN study: Multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners.
BACKGROUND
Chronic kidney disease (CKD) is an established risk factor for cardiovascular disease (CVD). In addition, patients with renal disease are exposed to a myriad of risk factors that increase their risk even further. The treatment of risk factors in these patients is paramount to reducing cardiovascular risk and for attenuating renal failure progression. It is well known that lifestyle interventions are difficult, and that medical treatment targets are seldom met. A multifactorial approach with the aid of nurse practitioners has shown to be beneficial for achieving treatment goals and reducing events in patients with diabetes mellitus and with heart failure. We propose that this will also hold for the CKD population.


METHODS
A multicenter randomized clinical trial will be performed to study whether intensive medical care delivered by a nurse practitioner and a nephrologist will reduce cardiovascular risk compared to care provided by the nephrologist alone. The acronym MASTERPLAN describes the study: Multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners. Eight hundred patients will be randomized to physician care or nurse practitioner support. For all patients the same set of guidelines and treatment goals will apply. Both groups will receive treatment according to current guidelines and have access to specific cardioprotective medication. Nurse practitioners will intensify therapy by promoting lifestyle intervention, and meticulous implementation of relevant guidelines. Patients will be followed-up for 5 yrs after baseline. Primary endpoints are all-cause mortality, cardiovascular morbidity and cardiovascular mortality.
Van Zuilen
Arjan D
AD
Department of Nephrology and Hypertension, University Medical Center Utrecht-The Netherlands. a.vanzuilen@azu.nl
Wetzels
Jack F M
JF
Blankestijn
Peter J
PJ
Bots
Michiel L
ML
Van Buren
Marjolijn
M
Ten Dam
Marc A G J
MA
Kaasjager
Karin A H
KA
Van De Ven
Peter J G
PJ
Vleming
Louis-Jean
LJ
Ligtenberg
Gerald
G
Ligtenberg
Gerry
G
D002908:Chronic Disease; D003695:Delivery of Health Care; D006801:Humans; D007674:Kidney Diseases / Q000628:therapy*; D015337:Multicenter Studies as Topic; D009722:Nurse Practitioners; D010820:Physicians; D016032:Randomized Controlled Trials as Topic; D012107:Research Design