NCT01688141

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 28,304 (actual)
• Sponsor: University Hospitals, Leicester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
OTHER	Enhanced management	Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-01-01
• Completion: 2018-10-11
• First posted: 2012-09-19
• Last updated: 2020-04-08
• Results posted: 2020-04-08

Locations

3 sites across 1 country: United Kingdom