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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Enhanced management
Sponsored by
University Hospitals, Leicester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring CKD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Leicester General Hospital
  • University Hospitals Leicester
  • University Hospitals of Leicester

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

Enhanced Management

Arm Description

Usual care

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.

Outcomes

Primary Outcome Measures

Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2009
Last Updated
March 24, 2020
Sponsor
University Hospitals, Leicester
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1. Study Identification

Unique Protocol Identification Number
NCT01688141
Brief Title
A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease
Official Title
A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals, Leicester

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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: 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
see above

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
CKD

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28304 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Enhanced Management
Arm Type
Active Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Enhanced management
Other Intervention Name(s)
CKD management
Intervention Description
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
Primary Outcome Measure Information:
Title
Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
Time Frame
Baseline and 3.5 years
Secondary Outcome Measure Information:
Title
Blood Pressure Control
Description
Observation of blood pressure control over the study period via blood pressure targets
Time Frame
Baseline and 3.5 years
Title
Proteinuria
Description
Proteinuria coding in practices
Time Frame
3.5 years
Title
Incidence of Cardiovascular Events
Description
Observation of incidence of cardiovascular events over the study period
Time Frame
3.5 years
Title
Other Biochemical Parameters
Description
Nature and incidence over the study period
Time Frame
3.5 years
Title
Referrals to Secondary Care and Hospitalisations
Description
Data coillected from secondary care
Time Frame
3.5 years
Title
Mortality
Description
data collected from secondary care
Time Frame
3.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: measurement of serum creatinine eGFR < 60 ml/min/1.73m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nigel Brunskill, PhD
Organizational Affiliation
Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leicester General Hospital
City
Leicester
State/Province
Leics
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
University Hospitals Leicester
City
Leicester
State/Province
Leics
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
University Hospitals of Leicester
City
Leicester
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31097609
Citation
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.
Results Reference
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A Primary-Secondary Care Partnership to Prevent Adverse Outcomes in Chronic Kidney Disease

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