CLARITY is a study which aims to improve patient care pathways and to ensure that patients with suspected appendicitis receive the appropriate care that they need
| ISRCTN | ISRCTN16757238 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16757238 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 334172 |
| Protocol serial number | RG_24-022 |
| Sponsor | University of Birmingham |
| Funder | Investigator Initiated and funded |
- Submission date
- 20/08/2024
- Registration date
- 03/09/2024
- Last edited
- 16/12/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Appendicitis is a common condition where the appendix, a small part of the bowel, becomes inflamed. If untreated, it usually doesn’t get better on its own, so the appendix is often removed through surgery. However, diagnosing appendicitis can be tricky because its symptoms can resemble other conditions. While doctors use blood tests and scans to help with the diagnosis, the way these are used varies across the UK, leading to some patients being misdiagnosed or undergoing unnecessary surgery. In fact, about 20% of people in the UK who have their appendix removed are found not to have had appendicitis after all, which is much higher than in other European countries.
The CLARITY study aims to improve how doctors diagnose and treat suspected appendicitis. The goal is to reduce unnecessary hospital admissions and surgeries by educating doctors on using the best evidence-based strategies to diagnose appendicitis more accurately.
Who can participate?
This study is focused on doctors, so it does not require patients to participate directly. However, patients with suspected appendicitis will benefit from the improved care pathways being tested.
What does the study involve?
For patients with suspected appendicitis, there won’t be any changes to their care, and they won’t need to attend extra appointments or fill out surveys. The study is testing an educational intervention for doctors, which means the focus is on improving how doctors make decisions about diagnosing and treating appendicitis.
What are the possible benefits and risks of participating?
There are no risks for patients involved in this study since their usual care won’t change. The potential benefit is that the study could lead to better diagnosis and treatment for appendicitis, reducing unnecessary surgeries and hospital stays.
Where is the study run from?
University of Birmingham (UK)
When is the study starting and how long is it expected to run for?
May 2024 to January 2026
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Professor Dion Morton, dion.morton@uhb.nhs.uk
Contact information
Public, Scientific, Principal investigator
Room 31, Fourth Floor
Academic Department of Surgery
University of Birmingham
Heritage Building
Birmingham
B15 2TT
United Kingdom
 ORCID ID |
0000-0001-6784-1689 |
|---|---|
| Phone | +44 (0)1213718910 |
| dion.morton@uhb.nhs.uk |
Scientific
ITM, Heritage Building
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
| ORCID ID |
0000-0001-7458-5644 |
|---|---|
| Phone | +44 (0)7305907886 |
| j.keatley@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre parallel cluster randomized controlled trial with an effectiveness-implementation design |
| Secondary study design | Randomised controlled trial |
| Scientific title | SurgiCaL educAtion to Reduce IncorrecT care pathwaYs and enhance patient outcomes in right iliac fossa pain |
| Study acronym | CLARITY |
| Study objectives | CLARITY is a study which aims to improve patient care pathways and to ensure that patients with suspected appendicitis receive the appropriate care that they need. We will do this by trying to reduce unnecessary admissions for appendicitis in the United Kingdom. CLARITY will test whether educating doctors who diagnose and treat appendicitis prompts them to use the best evidence strategies to diagnose appendicitis correctly. In turn this may enable doctors to reach the correct diagnosis earlier and to use admissions or surgery in patients that require them. |
| Ethics approval(s) |
Approved 29/05/2024, HRA and Health Care Research Wales (Health Research Authority, 2 Redman Place, London, E20 1JQ, United Kingdom; +44 207 104 8000; contact@hra.nhs.uk), ref: 24/HRA/2214 |
| Health condition(s) or problem(s) studied | Improve patient care pathways in patients with suspected appendicitis |
| Intervention | The intervention is the CLARITY accurate diagnosis package, which is made up of three components: the evidence based education programme (EBP), an implementation checklist and local implementation strategies. The EBP is considered the main component of our intervention and will be delivered using a digital education platform to intervention sites. There are two study arms: intervention and control. Randomisation of sites is carried out on Redcap using a 1:1 minimisation algorithm. Intervention arm Sites randomised to the intervention arm receive access to our intervention, the CLARITY evidence-based education programme. Doctors and clinicians within the acute surgical team, are encouraged to carry out the programme in a 4-week training period. This is followed by 8 weeks of data collection, during which routine data will be gathered for all consecutive patients aged 16-39 years who are referred to general surgery with right iliac fossa pain. The follow up is for 30 days, starting from the date of index admission or attendance to hospital. There is no patient level intervention. Control Arm Sites randomised to the control arm do not receive the intervention and continue with their routine practice. They are asked to complete an 8-week data collection period and 30 days follow up. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Non-operative admission rate (NOAR) defined as the proportion of patients admitted overnight with right iliac fossa pain who did not undergo an operation. Measured by review of patient notes at 30 days follow up. Measured by the patient's admission and discharge on different dates without any record of operative intervention during their stay. This excludes patients that are subsequently admitted to hospital with missed appendicitis and readmissions. |
| Key secondary outcome measure(s) |
1. Negative appendicectomy rate (NAR). Defined as the proportion of patients that received a negative appendicectomy measured by review of patient notes at 30 days follow up. |
| Completion date | 16/01/2026 |
Eligibility
| Participant type(s) | Health professional, Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Upper age limit | 39 Years |
| Sex | All |
| Target sample size at registration | 4800 |
| Total final enrolment | 2530 |
| Key inclusion criteria | Patients: 1. Age 16 - 39 years 2. Attending hospital with right iliac fossa pain Health professionals: 1. Members of the acute general surgery team |
| Key exclusion criteria | Patients: 1. Previous appendicectomy 2. Current pregnancy 3. Patients with RIF pain under the care of secondary teams (other than general surgery team) Heath professionals: 1. Doctors and allied health professionals that are not part of the acute general surgical team 2. Members of the general surgical team that are not involved in the diagnostic assessment and management of patients with RIF pain |
| Date of first enrolment | 23/08/2024 |
| Date of final enrolment | 16/11/2025 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
- Wales
Study participating centres
Luton
LU4 0DZ
England
80 Newark Street
London
E1 2ES
England
Boston
PE21 9QS
England
Dalton Lane
Barrow-in-furness
LA14 4LF
England
Caradoc Road
Aberystwyth
SY23 1ER
Wales
Gloucester
GL1 3NN
England
Edinburgh
Lothian
EH4 2XU
Scotland
Bordesley Green
Birmingham
B9 5ST
England
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
England
Derriford Road
Derriford
Plymouth
PL6 8DH
England
Lovely Lane
Warrington
WA5 1QG
England
St Marys Hospital
South Wharf Road
London
W2 1BL
England
Cumberland Infirmary
Infirmary Street
Carlisle
CA2 7HY
England
Williams Avenue
Dorchester
DT1 2JY
England
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
Scotland
Rake Lane
North Shields
NE29 8NH
England
Taunton
TA1 5DA
England
Marlborough Street
Bristol
BS1 3NU
England
Headley Way
Headington
Oxford
OX3 9DU
England
London
SE5 9RS
England
Craigavon
BT63 5QQ
Northern Ireland
Dundee
DD1 9SY
Scotland
Boston
PE21 9QS
England
Merthyr Tydfil
CF47 9DT
Wales
Glasgow
G51 4TF
Scotland
Belvedere Road
Burton-on-trent
DE13 0RB
England
Stoke-on-trent
ST4 6QG
England
Newcastle upon Tyne
NE1 4LP
England
Magdala Avenue
London
N19 5NF
England
Cardiff
CF14 4XW
England
Arrowe Park Road
Upton
Wirral
CH49 5PE
England
Wythenshawe
Manchester
M23 9LT
England
27 Union Walk
Hereford
HR1 2ER
England
Heath Town
Wolverhampton
WV10 0QP
England
Grove Lane
Smethwick
B66 2QT
England
Dumfries
Dumfries and Galloway
DG1 4AP
Scotland
Pontyclun
CF72 8XR
Wales
Larbert
FK5 4WR
Scotland
Fountain Street
Ashton-under-lyne
OL6 9RW
England
Shrewsbury
SY3 8XQ
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | The datasets generated during the study will be stored in a non-publicly available repository (Redcap - https://bistc.redcap.bham.ac.uk/). Our participants are doctors and clinicians with the acute surgical team. The final dataset will comprise the datasets from all eligible patients. The data stored will include details on: - Baseline characteristics - Investigations performed - Clinical management - Clinical outcomes at 30-day follow up. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 2.0 | 07/07/2025 | 16/12/2025 | No | No |
| Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
- ISRCTN16757238_PROTOCOL_V2.0_07Jul2025.pdf
- Protocol file
Editorial Notes
16/12/2025: The following changes were made to the study record:
1. The date of final enrolment was changed from 01/12/2025 to 16/11/2025.
2. The completion date was changed from 30/12/2025 to 16/01/2026.
3. Final enrolment and study participating centres added.
08/10/2024: Contact details updated.
27/08/2024: Trial's existence confirmed by NHS HRA.
