A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease

Study Overview
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Brief Summary
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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: 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. To foster excellence in CKD care To improve coding of CKD and prevalence on chronic disease registers. To increase interest in, and capacity for primary care research in Northamptonshire. 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
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see above

Official Title
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A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Enhanced management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: measurement of serum creatinine eGFR < 60 ml/min/1.73m2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care | |
| Active Comparator: Enhanced Management<br>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. | Other: Enhanced management<br>* Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.<br>* Other names: CKD management;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study |  | Baseline and 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood Pressure Control | Observation of blood pressure control over the study period via blood pressure targets | Baseline and 3.5 years | 
| Proteinuria | Proteinuria coding in practices | 3.5 years | 
| Incidence of Cardiovascular Events | Observation of incidence of cardiovascular events over the study period | 3.5 years | 
| Other Biochemical Parameters | Nature and incidence over the study period | 3.5 years | 
| Referrals to Secondary Care and Hospitalisations | Data coillected from secondary care | 3.5 years | 
| Mortality | data collected from secondary care | 3.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD