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

March 24, 2020 updated by: University Hospitals, Leicester

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

see above

Study Type

Interventional

Enrollment (Actual)

28304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Leicester, United Kingdom
        • University Hospitals of Leicester
    • Leics
      • Leicester, Leics, United Kingdom, LE5 4PW
        • Leicester General Hospital
      • Leicester, Leics, United Kingdom, LE5 4PW
        • University Hospitals Leicester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual care
Active Comparator: 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.
Other: Enhanced management
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Other Names:
  • CKD management

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals, Leicester

Investigators

  • Principal Investigator: Nigel Brunskill, PhD, Consultant

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

October 11, 2018

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

September 14, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Actual)

April 8, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shelton

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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