A programme to spread glomerular filtration rate (eGFR) graph surveillance for the early identification, support and treatment of people with progressive chronic kidney disease
| ISRCTN | ISRCTN13701669 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13701669 |
| Secondary identifying numbers | Health Foundation Unique Award Reference Number: 7349 |
- Submission date
- 10/10/2016
- Registration date
- 11/01/2017
- Last edited
- 07/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
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
Contact information
Scientific
SW Thames Renal Unit
St Helier Hospital
Carshalton
SM5 1AA
United Kingdom
Public
Kidney Research UK, Nene Hall
Peterborough
PE2 6FZ
United Kingdom
| Phone | 01733 367 834 |
|---|---|
| Assist@kidneyresearchuk.org |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Study acronym | ASSIST-CKD |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2014 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Pathology laboratories serving 16-20 UK renal units |
| Key inclusion criteria | 1. Patients <65 years with eGFR <50 ml/min/1.73m2 2. Patients >65 years with eGFR <40 ml/min/1.73m2 |
| Key exclusion criteria | Participants not fulfilling inclusion criteria. |
| Date of first enrolment | 31/07/2015 |
| Date of final enrolment | 01/01/2017 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
- Wales
Study participating centres
2 Penventinnie Lane
Treliske
Truro
TR1 3LJ
United Kingdom
Monkscourt Avenue
Airdrie
ML6 0JS
United Kingdom
Upton
Wirral
CH49 5PE
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
Doncaster
DN2 5LT
United Kingdom
Liverpool
L69 3GA
United Kingdom
Town Lane
Kew
Southport
PR8 6PN
United Kingdom
High Heaton
Newcastle-upon-Tyne
NE7 7DN
United Kingdom
Newry
BT35 8DR
United Kingdom
Westcliff-on-Sea
SS0 0RY
United Kingdom
Ulster
BT16 1RH
United Kingdom
45 Bush Road
Antrim
BT41 2RL
United Kingdom
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
Carshalton
London
SM5 1AA
United Kingdom
Surrey
GU2 7XX
United Kingdom
Hull
HU3 2JZ
United Kingdom
Bangor
LL57 2PW
United Kingdom
Derry
BT47 6SB
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Rhuddlan Road
Bodelwyddan
Rhyl
LL18 5UJ
United Kingdom
Heol Maes Eglwys
Morriston
Swansea
SA6 6NL
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Sponsor information
Charity
Nene Hall
Peterborough
PE2 6FZ
United Kingdom
"ROR" |
https://ror.org/02kx7se86 |
|---|
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | 09/01/2017 | 07/01/2022 | Yes | No | |
| Protocol article | 11/04/2017 | 07/01/2022 | Yes | No |
Editorial Notes
07/01/2022: Publication references added.
20/05/2019: The following changes were made to the trial record:
1. The study design was changed.
2. The secondary study design was changed from Stepped wedge randomised to Quasi-experimental study.
3. The interventions were changed.
4. The plain English summary was updated to reflect these changes.
04/04/2017: Internal review.
