Condition category
Digestive System
Date applied
09/09/2019
Date assigned
27/09/2019
Last edited
27/09/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Around 41,000 people are diagnosed with bowel cancer each year. Bowel cancer develops from polyps, which grow slowly on the lining of the bowel. Colonoscopy is the best test to find and remove polyps, before they change into cancer. Polyps are missed for many reasons, including how the endoscopist does the test. Patients of endoscopists who find fewer polyps, are more likely to develop bowel cancer after the test. It is not known how often we should find polyps in the UK, or if feedback of performance will improve how many polyps are found. The researchers hope to improve colonoscopies for all patients in the UK by finding more polyps to prevent bowel cancers. The study will use the National Endoscopy Database (NED) to assess how often doctor and nurse endoscopists currently find pre-cancerous growths in the bowel (polyps) when performing camera tests through the bottom (colonoscopies). They will give feedback to endoscopists and the units they work in about how successful they are at finding polyps compared to others nationally. They want to find out if this makes them better at finding polyps.

Who can participate?
Colonoscopists at participating NHS endoscopy units in the UK

What does the study involve?
NED collects data from every colonoscopy in the UK including if polyps were found and removed. The researchers will look at over 100,000 colonoscopies to work out how often polyps should be found by endoscopists. Participating colonoscopy units are randomly allocated to either receive regular feedback on their colonoscopy performance or to not receive feedback. After a year the researchers will see if receiving feedback improved how many polyps they found. Before and after the study they will interview endoscopists to explore what kind of feedback is most likely to help them, how feedback and behaviour are influenced in endoscopy, and how they can improve feedback further.

What are the possible benefits and risks of participating?
The results will help guide the use of performance data from NED, to improve quality of colonoscopy and performance feedback, benefiting all endoscopists. If colonoscopists are allocated to the feedback group they will receive information, educational material and feedback aiming to improve their own practice. The researchers think this will be incentivising and rewarding as an endoscopist. They do not envisage any risks - this study involves providing colonoscopists with performance data, which will only be shared with the colonoscopist and the endoscopy unit lead (the lead already has access to local performance data). This feedback should only be used as a guide by endoscopy leads, and not for formal competency review.

Where is the study run from?
-

When is the study starting and how long is it expected to run for?
April 2019 to July 2021

Who is funding the study?
Health Foundation (UK)

Who is the main contact?
Mrs Jill Deane
jill.deane@nth.nhs.uk

Trial website

https://www.health.org.uk/programmes/insight-2017/projects/ned-apriqot-%

Contact information

Type

Scientific

Primary contact

Mrs Jill Deane

ORCID ID

Contact details

Research Nurse Offices
Middlefield Centre
University Hospital North Tees
Hardwick
Stockton-on-Tees
TS19 8PE
United Kingdom
+44 (0)1642 624582
jill.deane@nth.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS: 41104

Study information

Scientific title

Automated Performance Reports to Improve Quality Outcomes Trial (APRIQOT) Using the National Endoscopy Database (NED) to evaluate endoscopy performance and reduce unwarranted variation in quality

Acronym

NED: APRIQOT

Study hypothesis

To assess, by means on an RCT, whether regular automated feedback of endoscopist- and endoscopy unit-level colonoscopy performance data reduces unwarranted variation in colonoscopy quality.

Ethics approval

As per HRA approval; REC approval is not required for this study

Study design

Randomised; Both; Design type: Diagnosis, Process of Care, Psychological & Behavioural, Active Monitoring, Other, Qualitative

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Bowel polyps

Intervention

Trial design: Cluster randomised control trial, 1:1 randomisation

Intervention group: monthly automated email including KPI data report to individual endoscopists and to the endoscopy unit leads. The precise content will be determined in the initial stage of the NED-APRIQOT project. Guidance and consensus from the Advisory Group, many members of which have considerable expertise in QA, will be sought regarding content and structure of the KPI reports. In addition, the proposed qualitative work, detailed above, will inform the structure and content of the KPI reports.

KPI data reports will be provided for endoscopy leads, and formatted using the above qualitative work. This will include pooled data for the unit, from all independent endoscopists. This summary statistic will be calculated may include data from colonoscopists who have not consented to partake in the NED APRIQOT study. The endoscopy lead’s report will include detailed KPI reports for all individual endoscopists who are consented into the study, including any action plans. Unit leads will be given information about dealing with underperformance in endoscopy which is their clinical responsibility, based on international expert guidance(Rees et al., 2018) with a link to further resources.

Provisionally, the KPI data report will report on a rolling monthly period, to balance the reports reflection of contemporary practice with its statistical power.

Recipients will be provided with contact details of their endoscopy lead to flag concerns about their performance, and local investigators and the central research team to flag any perceived discrepancy in the accuracy of the feedback data. Local investigators will have local access to assess potential mismatch between NED data and local ERS data.
This can then be fed-back to problem-solve any IT accuracy issues with the research and Weblogik © team. If accuracy is challenged, local units may be asked to provide numerator and denominator data for the period in question which can be checked and compared centrally.

Comparator group: No KPI report; access to NED website available, but optimal detection KPI not displayed. This is the current feedback available to all endoscopists nationally, and reflects current endoscopic practice.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Mean value of optimal detection KPI in the 2 study arms, measured at 12 months

Secondary outcome measures

Measured at 9 months in both arms:
1. Percentage of endoscopists above minimum standard for optimal detection KPI
2. Percentage of endoscopists above target standard for optimal detection KPI
3. mean value of optimal proximal detection KPI
4. Percentage of endoscopists above minimum standard for optimal proximal detection KPI
5. Percentage of endoscopists above target standard for optimal proximal detection KPI
6. Change over time in optimal detection KPI during the 9-month trial
7. Change over time in optimal proximal detection KPI during the 9-month trial
8. Subgroup analysis of endoscopists in the intervention group who access learning resource materials on the NED website during the trial
9. Subgroup analysis of endoscopists in the control group who access the basic NED website during the trial
10. Mean value in other colonoscopic KPIs (caecal intubation rate, terminal ileal intubation rate, rectal retroversion rate, colonoscopy withdrawal time, polyp retrieval success, patient comfort, bowel preparation quality)

We shall also perform a nested study to correlate the opadKPI with both adenoma detection rate (ADR) and serrated polyp detection rate (SDR). This will be performed by asked each trial centre to review polyp histology from all independent colonoscopies within a specific 3-day period of the trial. We estimate that this will amount to 20-40 procedures per centre, totaling approximately 1500 procedures.

Overall trial start date

08/04/2019

Overall trial end date

01/07/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Endoscopy units: NHS endoscopy units in the UK that perform at least 600 colonoscopies per annum
2. Endoscopists: All consenting independently-practising colonoscopists within a trial endoscopy unit
3. Colonoscopy data): All colonoscopy data from trust-employed independent endoscopists at participating endoscopy units

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 480; UK Sample Size: 480

Participant exclusion criteria

1. Endoscopy units:
1.1. Independent sector and private sector endoscopy units
1.2. Endoscopy units performing fewer than 600 colonoscopies per annum
1.3. Endoscopy units without express support for the RCT from the endoscopy lead
1.4. Endoscopy units without express support for the RCT from the trust’s R&D team
1.5. Those units not participating in valid accurate data-uploading to NED
2. Endoscopists:
2.1. Non-consenting colonoscopists
2.2. Colonoscopists in non-independent (supervised) training (NB – trainees who are performing colonoscopies independently can participate)
3. Colonoscopy data:
3.1. Procedures performed by trainee endoscopists in non-independent (supervised) training
3.2. Procedures where an independent endoscopist was acting as a trainer
3.3. Procedures performed by endoscopists who are not employed by that trust
3.4. Procedures performed by endoscopists who are not anticipated to remain in the trust for the duration of the RCT

Recruitment start date

01/10/2019

Recruitment end date

10/10/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Aintree University Hospital
Lower Lane
Liverpool
L9 7AL
United Kingdom

Trial participating centre

Airedale NHS Foundation Trust
Airdale Hospital Skipton Rd Steeton
Keighley
Keighley
United Kingdom

Trial participating centre

Ashford & St Peter's NHS Trust
Ashford Hospital London Road Ashford Surrey
Ashford
TW15 3AA
United Kingdom

Trial participating centre

Barts Health
The Royal London Hospital Whitechapel Rd Whitechapel
London
E1 1BB
United Kingdom

Trial participating centre

Basildon & Thurrock University Hospitals NHS Foundation Trust
Basildon University Hospital Nethermayne
Basildon
SS16 5NL
United Kingdom

Trial participating centre

Bedford Hospital NHS Trust
Bedford Hospital Kemston Rd
Bedford
MK42 9DJ
United Kingdom

Trial participating centre

Bradford Teaching Hospitals NHS Foundation Trust
Bradford Royal Infirmary Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

Brighton & Sussex University Hospitals NHS Trust
The Royal Sussex County Hospital Barry Building Eastern Rd
Brighton
BN2 5BE
United Kingdom

Trial participating centre

Cambridge University Hospitals
Addenbrooke's Hospital Hills Rd
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

County Durham & Darlington Hospitals
Bishop Auckland Hospital Cockton Hill Rd
Bishop Auckland
DL14 6AD
United Kingdom

Trial participating centre

Dorset County Foundation
Dorset County Hospital Williams Ave
Dorchester
DT1 2JY
United Kingdom

Trial participating centre

East & North Herts NHS Trust
Lister Hospital Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom

Trial participating centre

East Kent University Hospitals Trust
Queen Elizabeth the Queen Mother Hospital St Peter's Rd
Margate
CT9 4AN
United Kingdom

Trial participating centre

East Sussex Healthcare NHS Trust
Eastbourne District General Hospital Kings Dr
Eastbourne
BN21 2UD
United Kingdom

Trial participating centre

Frimley Park Hospital
Portsmouth Rd
Frimley
GU16 7UJ
United Kingdom

Trial participating centre

Gloucestershire Hospitals NHS Foundation Trust
Cheltenham General Hospital Sandford Rd
Cheltenham
GL53 7AN
United Kingdom

Trial participating centre

Guy's and St Thomas' NHS Foundation Trust
St Thomas' Hospital Westminster Bridge Rd
London
SE1 7EH
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Good Hope Hospital Rectory Rd
Sutton Coldfield,
B75 7RS
United Kingdom

Trial participating centre

Hampshire Hospitals NHS Foundation Trust
Royal South Hants Hospital Brintons Terr
Southampton
SO14 0YG
United Kingdom

Trial participating centre

Isle of Wight NHS Primary Care Trust
St Mary's Hospital Parkhurst Rd
Newport
PO30 5TG
United Kingdom

Trial participating centre

James Paget University Hospital
Lowestoft Rd Gorleston
Great Yarmouth
NR31 6LA
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Lancashire Teaching Hospitals NHS Trust
Royal Blackburn Teaching Hospital Haslingden Rd
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

London North West / St Mark's
St Mark's Hospital Watford Rd
Harrow
HA1 3UJ
United Kingdom

Trial participating centre

Maidstone Hospital & Tunbridge Wells Hospital
Maidstone Hospital Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom

Trial participating centre

North Bristol NHS Trust
Southmead Hospital Southmead Rd Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Trial participating centre

North Cumbria NHS Foundation Trust
Cumberland Infirmary Newton Rd
Carlisle
CA2 7HY
United Kingdom

Trial participating centre

North Tees & Hartlepool NHS Trust
University Hospital of North Tees Hardwick
Stockton on Tees
TS19 8PE
United Kingdom

Trial participating centre

Sheffield Teaching Hospital NHS Foundation Trust
Northern General Hospital Herries Rd
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Northumbria Healthcare NHS Foundation Trust
North Tyneside General Hospital Rake Ln
North Shields
NE29 8NH
United Kingdom

Trial participating centre

Nottingham University Hospitals NHS Trust
Queen’s Medical Centre Derby Rd
Nottingham
NG7 2UH
United Kingdom

Trial participating centre

Pennine Acute Hospitals NHS Trust
The Royal Oldham Hospital Rochdale Rd
Oldham
OL1 2JH
United Kingdom

Trial participating centre

Royal Berkshire NHS Foundation Trust
Royal Berkshire Hospital London Rd
Reading
RG1 5AN
United Kingdom

Trial participating centre

Royal Devon and Exeter Hospital - Tiverton and Axminster Hospitals
Wondford Hospital Barrack Rd
Exeter
EX2 5DW
United Kingdom

Trial participating centre

Royal United Hospital Bath
Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Salford Royal Hospital Stott Ln
Salford
M6 8HD
United Kingdom

Trial participating centre

Sherwood Forest Hospitals NHS Foundation Trust
King's Mill Hospital Mansfield Rd
Sutton-in-Ashfield
NG17 4JL
United Kingdom

Trial participating centre

Shrewsbury & Telford Hospital NHS Trust
Royal Shrewsbury Hospital Mytton Oak Rd
Shrewsbury
SY3 8XQ
United Kingdom

Trial participating centre

South Devon Healthcare NHS Foundation Trust
Torbay Hospital Newton Rd
Torquay
TQ2 7AA
United Kingdom

Trial participating centre

South Warwickshire General Hospitals NHS Trust
Warwick Hospital Lakin Rd
Warwick
CV34 5BW
United Kingdom

Trial participating centre

St George's University Hospitals NHS Foundation Trust
St Georges Hospital Blackshaw Rd Tooting
London
SW17 0QT
United Kingdom

Trial participating centre

St Helens & Knowsley Teaching Hospitals
St Helen's Hospital Marshalls Cross Road
St. Helens
WA9 3DA
United Kingdom

Trial participating centre

Taunton and Somerset NHS Trust
Musgrove Park Hospital, , Somerset, TA1 5DA
Taunton
TA1 5DA
United Kingdom

Trial participating centre

The Dudley NHS Foundation Trust
Russells Hall Hospital Pensnett Rd
Dudley
DY1 2HQ
United Kingdom

Trial participating centre

The Princess Alexandra Hospital
Hamstel Rd
Harlow
CM20 1QX
United Kingdom

Trial participating centre

The Rotherham NHS Foundation Trust
Rotherham General Hospital Moorgate Road
Rotherham
S60 2UD
United Kingdom

Trial participating centre

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Royal Bournemouth Hospital Castle Lane East, ,
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

The Royal Liverpool & Broadgreen Trust
The Royal Liverpool Hospital Prescot St
Liverpool
L7 8XP
United Kingdom

Trial participating centre

The Royal Wolverhampton NHS Trust
New Cross Hospital Wolverhampton Rd Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Queen Elizabeth Hospital Birmingham Mindelsohn Way Edgbaston
Birmingham
B15 2GW
United Kingdom

Trial participating centre

University Hospitals Coventry & Warwickshire
University Hospital Coventry Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

West Herts Hospital NHS Trust
Watford General Hospital Vicarage Rd
Watford
WD18 0HB
United Kingdom

Trial participating centre

West Sussex Hospital
Spitalfield Lane
Chichester
PO19 6SE
United Kingdom

Trial participating centre

Wye Valley Trust - Hereford and Ross
Hereford County Hospital Union Walk
Hereford
HR1 2ER
United Kingdom

Trial participating centre

Yeovil District Hospital NHS Foundation Trust
Yeovil District Hospital Higher Kingston
Yeovil
BA21 4AT
United Kingdom

Trial participating centre

York Teaching Hospital
The York Hospital Wigginton Road
York
YO31 8HE
United Kingdom

Sponsor information

Organisation

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Sponsor details

c/o Aaron Jackson
Newcastle Joint Research Office
Level 1 Regent Point
Newcastle-Upon-Tyne
NE3 3HD
United Kingdom
+44 (0)1912825789
aaron.jackson@nuth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Charity

Funder name

Health Foundation; Grant Codes: 695428

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Peer reviewed scientific journals
2. Internal report
3. Conference presentation
4. Publication on website

IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. The study utilises the National Endoscopy Database [NED] data set which is overseen by JAG/RCP London (https://www.thejag.org.uk/ or https://www.rcplondon.ac.uk]. This dataset does not contain any patient identifiable data. For the NED:APRIQOT trial; a data download from NED is being provided to the research team lead by Newcastle University (the sponsor) as per data sharing agreement. The participants (endoscopists and clinical endoscopy leads) are consenting to the data sharing as part of the informed consent process.

Intention to publish date

01/07/2022

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/09/2019: Trial's existence confirmed by the NIHR.