A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease
NCT ID: NCT01688141
Last Updated: 2020-04-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28304 participants
INTERVENTIONAL
2010-01-31
2018-10-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Usual care
No interventions assigned to this group
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.
Enhanced management
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Interventions
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Enhanced management
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* eGFR \< 60 ml/min/1.73m2
18 Years
ALL
No
Sponsors
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University Hospitals, Leicester
OTHER
Responsible Party
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Principal Investigators
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Nigel Brunskill, PhD
Role: PRINCIPAL_INVESTIGATOR
Consultant
Locations
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Leicester General Hospital
Leicester, Leics, United Kingdom
University Hospitals Leicester
Leicester, Leics, United Kingdom
University Hospitals of Leicester
Leicester, , United Kingdom
Countries
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References
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Major RW, Brown C, Shepherd D, Rogers S, Pickering W, Warwick GL, Barber S, Ashra NB, Morris T, Brunskill NJ. The Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease (PSP-CKD) Study: A Cluster Randomized Trial in Primary Care. J Am Soc Nephrol. 2019 Jul;30(7):1261-1270. doi: 10.1681/ASN.2018101042. Epub 2019 May 16.
Other Identifiers
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Shelton
Identifier Type: -
Identifier Source: org_study_id
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