Plain English Summary
Background and study aims
Chronic kidney disease (CKD) is a long-term condition where the kidneys do not work properly. In a healthy person, the kidneys are vital for filtering out the waste products and excess water in the blood, and converting them into urine. In patients suffering from CKD, the kidneys are unable to do this, and so the body is unable to get rid of the waste products building up in the blood. CKD is common, affecting over 10% of the adult population. It is frequently unrecognised since it causes no symptoms in the early stages. CKD often exists together with other conditions, particularly high blood pressure and diabetes. Some people with CKD develop kidney disease that worsens over time (progressive disease). In the most advanced stages, treatment using machines to do the work of the kidneys (dialysis) or transplants are the only way to keep people alive. People with progressive disease who are referred late by their GPs to kidney units treatment have a lower risk of surviving. Late referral is therefore a major, and preventable, cause of harm in these people. Early identification of people with progressive disease would also create opportunities to start treatment to slow disease progression. The aim of this project is to improve the treatment and outcomes of CKD patients at high risk of kidney failure and other complications.
Who can participate?
Patients with chronic kidney disease.
What does the study involve?
Information on each of the participants on pathology computer systems are used to generate a graph of kidney function over time. In cases where the graph shows that kidney function is getting worse, these are highlighted for review by a laboratory scientist. For participants that are identified as being of “high-risk” a paper copy of the graph is sent to the general practitioner with a prompt that further action may be needed. In this way the project takes information already available and highlights trends over time to primary care. The intervention is to be rolled-out sequentially, with renal centres (and their associated pathology laboratories) starting eGFR graph reporting at staggered time points. Four or five renal centres begin the intervention at each step with a six-month interval between steps.
(Removed 20/05/2019: The start time of the program is chosen randomly.)
What are the possible benefits and risks of participating?
Individual patients do not have any additional testing and there are no significant burdens or risks.
Where is the study run from?
22 NHS sites in the UK
When is the study starting and how long is it expected to run for?
September 2014 to December 2017
Who is funding the study?
Health Foundation (UK)
Who is the main contact?
1. Dr Hugh Gallagher (scientific)
2. Ms Rowena Sampson (public)
Assist@kidneyresearchuk.org
Trial website
Contact information
Type
Scientific
Primary contact
Dr Hugh Gallagher
ORCID ID
Contact details
SW Thames Renal Unit
St Helier Hospital
Carshalton
SM5 1AA
United Kingdom
Type
Public
Additional contact
Ms Rowena Sampson
ORCID ID
Contact details
Kidney Research UK
Nene Hall
Peterborough
PE2 6FZ
United Kingdom
01733 367 834
Assist@kidneyresearchuk.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Health Foundation Unique Award Reference Number: 7349
Study information
Scientific title
A programme to spread eGFR graph surveillance for the early identification, support and treatment of people with progressive chronic kidney disease (ASSIST-CKD): stepped wedge implementation and evaluation of an intervention to reduce late presentation for renal replacement therapy
Acronym
ASSIST-CKD
Study hypothesis
The aim of this study is to evaluate the implementation of this intervention across a large population served by a number of UK renal centres using a mixed methods approach.
Ethics approval
The project was considered by the National Research Ethics Service (South East Coast-Surrey) on 16th January 2015 and determined to be service evaluation, not requiring ethical review by an NHS Research Ethics Committee. The project does not involve allocation to different interventions across patient groups; there are no significant risks or burdens to patients; and outcome data are already routinely collected by the UK Renal Registry.
The intervention was introduced as a local quality improvement project in the Heart of England Foundation Trust in 2012. The subsequent fall in late presentation rate has been documented and published. A number of sites, such as the West Midlands Strategic Clinical Network, are routinely introducing the intervention outside this project on the basis of this evidence.
Study design
Current study design as of 20/05/2019:
Quasi-experimental study (changed in Sept 2017)
Previous study design:
Multicentre stepped wedge randomised control study
Primary study design
Interventional
Secondary study design
Quasi-experimental study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Chronic kidney disease
Intervention
Reporting of eGFR graphs by pathology laboratories to primary care. The intervention takes the information on pathology computer systems and automatically generates a graph of kidney function over time for individuals. Graphs where the kidney function is deteriorating are flagged for review by a laboratory scientist – for those patients determined to be “high-risk” a paper copy of the graph is sent to the general practitioner with a prompt that further action may be needed. In this way the project takes information already available and highlights trends over time to primary care. Individual patients do not have any additional testing and there are no significant burdens or risks.
The intervention will be rolled-out sequentially, with renal centres (and their associated pathology laboratories) commencing eGFR graph reporting at staggered time points. The plan is for four or five renal centres to begin implementation at each step with a six-month interval between steps. The time of intervention initiation will be randomised.
UPDATE 20/05/2019:
Randomisation proved extremely difficult to follow, with only very few laboratories being able to activate the intervention in the period they were randomised to. Therefore in September 2017 it was decided to proceed with analysis based on a quasi-experimental design, where the study is not considered ‘experimental’ because of lack of randomisation, but there is still account for control periods, a staggered intervention that allows for more robust analysis of possible confounding time effect, and also the inclusion of more controls (non-participants clusters, never randomised, never started on intervention, areas with no similar interventions).
Intervention type
Other
Phase
Drug names
Primary outcome measure
Incidence of late presentation for renal replacement therapy, defined as any patient first seen by renal services within 90 days of starting renal replacement therapy. These data will aggregate into six-month time periods, two per calendar year (Jan to June; July to December).
Secondary outcome measures
1. The use of temporary vascular access for starting dialysis
2. Estimated Glomerular Filtration Rate (eGFR) measured within two weeks of start of renal replacement therapy (RRT)
3. Mortality at 6 months from start of RRT in new RRT patients
4. The incident rate of end-stage renal disease, measured annually
All outcomes measures are routinely collected by the UK Renal Registry with the exception of vascular access, which is collected annually as part of the Registry’s Multisite Dialysis Access Audit. Routinely collected baseline data will be provided by the UK Renal Registry and baseline referral rates supplied by participating centres. Outcomes will be measured before and during intervention roll-out at each site.
The number of new patient referrals (per quarter) will be recorded as a balancing measure. These data are readily extractable from renal centre appointment systems.
A qualitative evaluation will also be performed with:
1. Semi-structured interviews with laboratory staff, renal centre staff and service commissioners, in order to find out about the drivers and enablers to the intervention being implemented and also to find out what these groups think the effect of the intervention might be
2. Online survey of GPs receiving the intervention, that is, asking GPs how useful the graph is in identifying people at risk of progressive disease, and how helpful it is in providing education about what to do next
3. Focus groups of primary care staff, where questions will examine in more detail the implementation of the intervention (what happens once the graph arrives in the Practice) and what potential difference the graphs make to patient care
Overall trial start date
01/09/2014
Overall trial end date
31/12/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients <65 years with eGFR <50 ml/min/1.73m2
2. Patients >65 years with eGFR <40 ml/min/1.73m2
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Pathology laboratories serving 16-20 UK renal units
Participant exclusion criteria
Participants not fulfilling inclusion criteria.
Recruitment start date
31/07/2015
Recruitment end date
01/01/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Cornwall Hospital NHS Trust
Royal Cornwall Hospital
2 Penventinnie Lane
Treliske
Truro
TR1 3LJ
United Kingdom
Trial participating centre
NHS Lanarkshire Hospitals
Monklands Hospital
Monkscourt Avenue
Airdrie
ML6 0JS
United Kingdom
Trial participating centre
Wirral University Teaching Hospitals NHS Trust
Arrowe Park Hospital
Upton
Wirral
CH49 5PE
United Kingdom
Trial participating centre
Countess of Chester Hospital NHS Foundation Trust
The Countess Of Chester Health Park
Liverpool Road
Chester
CH2 1UL
United Kingdom
Trial participating centre
Doncaster and Bassetlaw Hospitals NHS Foundation Trust
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
Trial participating centre
Liverpool Clinical Laboratories
Aintree University Hospital NHS Trust/Royal Liverpool and Broadgreen University Hospitals NHS Trust
Liverpool
L69 3GA
United Kingdom
Trial participating centre
Southport and Ormskirk Hospital NHS Trust
Southport and Formby District General Hospital
Town Lane
Kew
Southport
PR8 6PN
United Kingdom
Trial participating centre
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Freeman Road
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
Trial participating centre
Southern Health and Social Care Trust
John Mitchel Place
Newry
BT35 8DR
United Kingdom
Trial participating centre
Southend University Hospital NHS Foundation Trust
Prittlewell Chase
Westcliff-on-Sea
SS0 0RY
United Kingdom
Trial participating centre
South Eastern Health and Social Care Trust
Upper Newtownards Road
Ulster
BT16 1RH
United Kingdom
Trial participating centre
Northern Health and Social Care Trust
Services Yard Antrim Area Hospital
45 Bush Road
Antrim
BT41 2RL
United Kingdom
Trial participating centre
Betsi Cadwaladr University Health Board
Wrexham Maelor Hospital
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
Trial participating centre
Epsom and St Helier University Hospitals NHS Trust
Wrythe Lane
Carshalton
London
SM5 1AA
United Kingdom
Trial participating centre
Surrey Pathology Services
Royal Surrey County Hospital NHS Foundation Trust/Ashford and St Peter's Foundation Trust/Frimley Health NHS Foundation Trust
Surrey
GU2 7XX
United Kingdom
Trial participating centre
Hull and East Yorkshire NHS Foundation Trust
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Trial participating centre
Betsi Cadwaladr University Health Board
Ysbyty Gwynedd
Bangor
LL57 2PW
United Kingdom
Trial participating centre
Western Health and Social Care Trust
106 Irish Street
Derry
BT47 6SB
United Kingdom
Trial participating centre
Derby Teaching Hospitals NHS Foundation Trust
Royal Derby Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Trial participating centre
Betsi Cadwaladr University Health Board
Glan Clwyd Hospital
Rhuddlan Road
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Trial participating centre
ABM University Health Board
Morriston Hospital
Heol Maes Eglwys
Morriston
Swansea
SA6 6NL
United Kingdom
Trial participating centre
City Hospitals Sunderland NHS Foundation Trust
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Funders
Funder type
Charity
Funder name
Health Foundation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results of the project will be analysed in 2018. Outputs will be disseminated at national and international meetings and via peer reviewed journals.
IPD Sharing plan:
1. Individual patient level data are stored, which can also be analysed at centre level. The repository name is the UK Renal Registry (UKRR): www.renalreg.org
2. Access to the data will not be limited, except patient or centre identifiable information. The process to access data can be found here: https://www.renalreg.org/about-us/working-with-us/
3. Data are made available to researchers promptly after completion of the approved process including peer review and completion of data sharing agreement as outlined on the UKRR website
Intention to publish date
31/12/2018
Participant level data
Stored in repository
Basic results (scientific)
Publication list