Clinical trial NCT01688141: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: CKD
Lead sponsor: University Hospitals, Leicester
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 28304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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. 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.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Difference in Mean CKD Register Patient eGFRs Between Groups After 3.5 Years of Study
timeFrame: Baseline and 3.5 years
Secondary outcomes:
measure: Blood Pressure Control
timeFrame: Baseline and 3.5 years
measure: Proteinuria
timeFrame: 3.5 years
measure: Incidence of Cardiovascular Events
timeFrame: 3.5 years
measure: Other Biochemical Parameters
timeFrame: 3.5 years
measure: Referrals to Secondary Care and Hospitalisations
timeFrame: 3.5 years
measure: Mortality
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Leicester General Hospital
state: Leics
city: Leicester
country: United Kingdom
facility: University Hospitals Leicester
state: Leics
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester
Study officials:
affiliation: Consultant
name: Nigel Brunskill, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.