Chronic kidney disease (CKD) is a major public health problem with a UK prevalence of 8-10%. The study hypothesis is to ascertain if intensive primary care led disease management programmes for CKD, supported by input from secondary care specialists will slow progression of CKD, improve blood pressure control and reduce cardiovascular events in patients on CKD registers. The investigators have partnered with Nene commissioning, a practice based commissioning group representing approximately 80 GP practices in Northamptonshire, to run this study. This will be a cluster randomised trial of an intensive, secondary care supported, CKD management programme in primary care vs normal CKD care. Randomisation will be at the level of the individual general practice. All general practices associated with Nene commissioning will be invited to participate. Randomisation of practices will be performed by the University of Leicester Clinical Trials Unit and the study will adhere to guidelines for undertaking randomised cluster trials. The aims of the study are: 1. To determine whether reinforcement of best practice in the management of key aspects of CKD care by clinical nurse specialists based in primary care, but with close links to colleagues from secondary care, improves clinical outcomes. 2. To foster excellence in CKD care 3. To improve coding of CKD and prevalence on chronic disease registers. 4. To increase interest in, and capacity for primary care research in Northamptonshire. 5. To implement and evaluate a new model of partnership working between primary and secondary care. The primary outcome measures will be changes in estimated glomerular filtration rate (eGFR). Secondary outcome measures will be blood pressure control, proteinuria, incidence of cardiovascular events,other biochemical parameters, referrals to secondary care and hospitalisations and mortality.
see above
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
28,304
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Leicester General Hospital
Leicester, Leics, United Kingdom
University Hospitals Leicester
Leicester, Leics, United Kingdom
University Hospitals of Leicester
Leicester, United Kingdom
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
Time frame: Baseline and 3.5 years
Blood Pressure Control
Observation of blood pressure control over the study period via blood pressure targets
Time frame: Baseline and 3.5 years
Proteinuria
Proteinuria coding in practices
Time frame: 3.5 years
Incidence of Cardiovascular Events
Observation of incidence of cardiovascular events over the study period
Time frame: 3.5 years
Other Biochemical Parameters
Nature and incidence over the study period
Time frame: 3.5 years
Referrals to Secondary Care and Hospitalisations
Data coillected from secondary care
Time frame: 3.5 years
Mortality
data collected from secondary care
Time frame: 3.5 years
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