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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01688141
• Other study ID #: Shelton
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: October 11, 2018

Study information

• Verified date: March 2020
• Source: University Hospitals, Leicester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

see above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28304
• Est. completion date: October 11, 2018
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• measurement of serum creatinine

• eGFR < 60 ml/min/1.73m2

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Enhanced management
Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.

Locations

Country	Name	City	State
United Kingdom	Leicester General Hospital	Leicester	Leics
United Kingdom	University Hospitals Leicester	Leicester	Leics
United Kingdom	University Hospitals of Leicester	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
University Hospitals, Leicester

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study		Baseline and 3.5 years
Secondary	Blood Pressure Control	Observation of blood pressure control over the study period via blood pressure targets	Baseline and 3.5 years
Secondary	Proteinuria	Proteinuria coding in practices	3.5 years
Secondary	Incidence of Cardiovascular Events	Observation of incidence of cardiovascular events over the study period	3.5 years
Secondary	Other Biochemical Parameters	Nature and incidence over the study period	3.5 years
Secondary	Referrals to Secondary Care and Hospitalisations	Data coillected from secondary care	3.5 years
Secondary	Mortality	data collected from secondary care	3.5 years