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

NHS Trust

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: Enhanced management

Study type: Interventional

Funder types: Other

Identifiers

NCT01688141

Shelton

Details and patient eligibility

About

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.

Full description

see above

Enrollment: 28,304 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• measurement of serum creatinine
• eGFR < 60 ml/min/1.73m2

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28,304 participants in 2 patient groups

Control

No Intervention group

Description:

Usual care

Enhanced Management

Active Comparator group

Description:

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.

Treatment:

Other: Enhanced management