NED: APRIQOT study of performance feedback emailed to endoscopists and endoscopy unit lead clinicians through the National Endoscopy Database (NED) on the endoscopists’ detection of polyps
| ISRCTN | ISRCTN11126923 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11126923 |
| Secondary identifying numbers | CPMS: 41104 |
- Submission date
- 09/09/2019
- Registration date
- 27/09/2019
- Last edited
- 20/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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?
The Newcastle Upon Tyne Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
April 2019 to November 2022
Who is funding the study?
Health Foundation (UK)
Who is the main contact?
Simon Sinclair
simon.sinclair1@nhs.net
Contact information
Scientific
Middlefield Building
University Hospital Of North Tees
Hardwick Road
Stockton
TS19 8PE
United Kingdom
| Phone | +44 (0)1642 624582 |
|---|---|
| simon.sinclair1@nhs.net |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study acronym | NED: APRIQOT |
| Study objectives | 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(s) | As per HRA approval; REC approval is not required for this study |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 08/04/2019 |
| Completion date | 30/11/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 480; UK Sample Size: 480 |
| Total final enrolment | 546 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 21/11/2019 |
| Date of final enrolment | 30/11/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Liverpool
L9 7AL
United Kingdom
Skipton Rd
Steeton
Keighley
Keighley
United Kingdom
London Road
Ashford
Surrey
Ashford
TW15 3AA
United Kingdom
Whitechapel Rd
Whitechapel
London
E1 1BB
United Kingdom
Nethermayne
Basildon
SS16 5NL
United Kingdom
Kemston Rd
Bedford
MK42 9DJ
United Kingdom
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Barry Building
Eastern Rd
Brighton
BN2 5BE
United Kingdom
Hills Rd
Cambridge
CB2 0QQ
United Kingdom
Cockton Hill Rd
Bishop Auckland
DL14 6AD
United Kingdom
Williams Ave
Dorchester
DT1 2JY
United Kingdom
Coreys Mill Lane
Stevenage
SG1 4AB
United Kingdom
St Peter's Rd
Margate
CT9 4AN
United Kingdom
Kings Dr
Eastbourne
BN21 2UD
United Kingdom
Frimley
GU16 7UJ
United Kingdom
Sandford Rd
Cheltenham
GL53 7AN
United Kingdom
Westminster Bridge Rd
London
SE1 7EH
United Kingdom
Rectory Rd
Sutton Coldfield
B75 7RS
United Kingdom
Brintons Terr
Southampton
SO14 0YG
United Kingdom
Parkhurst Rd
Newport
PO30 5TG
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Haslingden Rd
Blackburn
BB2 3HH
United Kingdom
Watford Rd
Harrow
HA1 3UJ
United Kingdom
Hermitage Lane
Maidstone
ME16 9QQ
United Kingdom
Southmead Rd
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom
Newton Rd
Carlisle
CA2 7HY
United Kingdom
Hardwick
Stockton on Tees
TS19 8PE
United Kingdom
Herries Rd
Sheffield
S5 7AU
United Kingdom
Rake Ln
North Shields
NE29 8NH
United Kingdom
Derby Rd
Nottingham
NG7 2UH
United Kingdom
Rochdale Rd
Oldham
OL1 2JH
United Kingdom
London Rd
Reading
RG1 5AN
United Kingdom
Barrack Rd
Exeter
EX2 5DW
United Kingdom
Bath
BA1 3NG
United Kingdom
Stott Ln
Salford
M6 8HD
United Kingdom
Mansfield Rd
Sutton-in-Ashfield
NG17 4JL
United Kingdom
Mytton Oak Rd
Shrewsbury
SY3 8XQ
United Kingdom
Newton Rd
Torquay
TQ2 7AA
United Kingdom
Lakin Rd
Warwick
CV34 5BW
United Kingdom
Blackshaw Rd
Tooting
London
SW17 0QT
United Kingdom
Marshalls Cross Road
St. Helens
WA9 3DA
United Kingdom
Taunton
TA1 5DA
United Kingdom
Pensnett Rd
Dudley
DY1 2HQ
United Kingdom
Harlow
CM20 1QX
United Kingdom
Moorgate Road
Rotherham
S60 2UD
United Kingdom
Castle Lane East,
Bournemouth
BH7 7DW
United Kingdom
Prescot St
Liverpool
L7 8XP
United Kingdom
Wolverhampton Rd
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom
Vicarage Rd
Watford
WD18 0HB
United Kingdom
Chichester
PO19 6SE
United Kingdom
Union Walk
Hereford
HR1 2ER
United Kingdom
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Wigginton Road
York
YO31 8HE
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Aaron Jackson
Newcastle Joint Research Office
Level 1 Regent Point
Newcastle-Upon-Tyne
NE3 3HD
England
United Kingdom
| Phone | +44 (0)1912825789 |
|---|---|
| aaron.jackson@nuth.nhs.uk | |
| Website | http://www.newcastle-hospitals.org.uk/ |
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 31/03/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in non-publicly available repository |
| Publication and dissemination plan | 1. Peer reviewed scientific journals 2. Internal report 3. Conference presentation 4. Publication on website |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 15/05/2024 | 20/05/2024 | Yes | No |
Editorial Notes
20/05/2024: Publication reference added.
10/11/2022: The intention to publish date was changed from 30/11/2022 to 31/03/2022.
11/07/2022: The following changes were made to the trial record:
1. The overall end date was changed from 01/07/2021 to 30/11/2022.
2. The intention to publish date was changed from 01/07/2022 to 30/11/2022.
3. The recruitment end date was changed from 31/03/2020 to 30/11/2020.
4. The plain English summary was updated to reflect these changes.
5. The total final enrolment was added.
05/08/2021: The study contact has been updated and the plain English summary has been updated accordingly.
08/04/2020: Due to current public health guidance, recruitment for this study has been paused.
28/01/2020: The recruitment end date was changed from 31/12/2019 to 31/03/2020.
14/11/2019: The following changes have been made:
1. The recruitment start date has been changed from 01/10/2019 to 21/11/2019.
2. The recruitment end date has been changed from 10/10/2019 to 31/12/2019.
09/09/2019: Trial's existence confirmed by the NIHR.
