A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease
- Conditions
- Chronic Kidney Disease
- Interventions
- Other: Enhanced management
- Registration Number
- NCT01688141
- Lead Sponsor
- University Hospitals, Leicester
- Brief Summary
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.
- Detailed Description
see above
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28304
- measurement of serum creatinine
- eGFR < 60 ml/min/1.73m2
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Management Enhanced management Practices randomised to the intervention group will be offered an enhanced level of CKD disease management led by clinical nurse specialists based on an intervention previously piloted in high risk patients. Here, high risk patients identified will be invited to a CKD clinic for tailored management of bp and proteinuria and referral as needed.
- Primary Outcome Measures
Name Time Method Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study Baseline and 3.5 years
- Secondary Outcome Measures
Name Time Method Incidence of Cardiovascular Events 3.5 years Observation of incidence of cardiovascular events over the study period
Other Biochemical Parameters 3.5 years Nature and incidence over the study period
Blood Pressure Control Baseline and 3.5 years Observation of blood pressure control over the study period via blood pressure targets
Proteinuria 3.5 years Proteinuria coding in practices
Mortality 3.5 years data collected from secondary care
Referrals to Secondary Care and Hospitalisations 3.5 years Data coillected from secondary care
Trial Locations
- Locations (3)
University Hospitals of Leicester
🇬🇧Leicester, United Kingdom
Leicester General Hospital
🇬🇧Leicester, Leics, United Kingdom
University Hospitals Leicester
🇬🇧Leicester, Leics, United Kingdom