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

NCT01688141 | Completed Results DMC

• 1 other identifier: Shelton
• Study Type: interventional
• Target: 28,304
• Locations: 1 country
• Sites: 3

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:

1. 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. 2.To foster excellence in CKD care
3. 3.To improve coding of CKD and prevalence on chronic disease registers.
4. 4.To increase interest in, and capacity for primary care research in Northamptonshire.
5. 5.To implement and evaluate a new model of partnership working between primary and secondary care.

Conditions

Chronic Kidney Disease

Keywords

CKD

Outcome Measures

Primary Outcomes (1)

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

  Baseline and 3.5 years

Secondary Outcomes (6)

• Blood Pressure Control

  Baseline and 3.5 years

• Proteinuria

  3.5 years

• Incidence of Cardiovascular Events

  3.5 years

• Other Biochemical Parameters

  3.5 years

• Referrals to Secondary Care and Hospitalisations

  3.5 years

Study Arms (2)

Control

NO INTERVENTION

Usual care

Enhanced Management

ACTIVE COMPARATOR

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

Interventions

Enhanced management OTHER

Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.

Also known as: CKD management

Enhanced Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University Hospitals, Leicester: lead

Study Sites (3)

Leicester General Hospital

Leicester, Leics, LE5 4PW, United Kingdom

Location

University Hospitals Leicester

Leicester, Leics, LE5 4PW, United Kingdom

Location

University Hospitals of Leicester

Leicester, United Kingdom

Location

Related 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.

  PMID: 31097609 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Professor Nigel Brunskill
• Organization: University of Leicester

njb18@le.ac.uk

+44 116 258 8043

Study Officials

• Nigel Brunskill, PhD

  Consultant

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: September 19, 2012
• Study Start: January 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: October 11, 2018
• Last Updated: April 8, 2020
• Results First Posted: April 8, 2020

Record last verified: 2020-03

Locations

GB (3)