A study aiming to reduce diagnostic delays of motor neurone disease within primary care in the UK using an automated electronic red flag alert tool
| ISRCTN | ISRCTN72734793 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72734793 |
| Integrated Research Application System (IRAS) | 351043 |
| Central Portfolio Management System (CPMS) | 66185 |
| Sponsor | University of Sheffield |
| Funders | Motor Neurone Disease Association, LifeArc |
- Submission date
- 18/11/2025
- Registration date
- 02/03/2026
- Last edited
- 02/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Motor neurone disease (MND) is a rare, incurable condition affecting about 5,000 UK people. It causes muscle weakness over time, making it harder for people to move, speak, and swallow, and eventually leads to difficulty breathing. Because MND is rare, general practitioners (GPs) may not always recognise it right away, leading to delays in diagnosis. On average, it can take 9 to 27 months from first symptoms to a confirmed diagnosis.
To help GPs identify MND earlier, the MND Association and the Royal College of General Practitioners (RCGP) developed the MND Red Flag Tool in 2014. This tool lists common signs and symptoms that may indicate MND, helping GPs decide when to refer patients to specialists more quickly. The MND Alert system builds on this tool as an automated aid that can be added to patient electronic health records in GP practices. It scans patient records for Red Flag Tool signs linked to MND and sends notifications to GPs when these signs are detected, helping them identify possible cases earlier and make faster referrals. Currently, the MND Alert system can detect symptoms recorded as codes in patient records, but some important information may be written in free-text notes, such as in consultation letters. To ensure nothing is missed, some patient records may need additional manual review.
This study has two stages: (1) implementing the MND Alert system in GP practices for 6 months and (2) evaluating how well it works and if GPs find it helpful. In stage 1, the MND Alert system will be used in routine GP patient consultations. In stage 2, we will interview GPs from the participating practices to understand their experiences with the tool and assess how effective and practical it is for everyday clinical use.
Who can participate?
GPs at participating sites in South Yorkshire
What does the study involve?
The tool will alert the GP during consultations to service users who may have MND-related symptoms. GPs will be invited to participate in a 60-minute semi-structured interview to explore the acceptability and usability of the MND Alert toolkit.
What are the possible benefits and risks of participating?
GPs may find it beneficial to participate in a study that aims to develop a toolkit to speed up the diagnosis of MND. There are no risks of participating.
When is the study run from?
Sheffield Institute for Translational Neuroscience (SITraN) (UK)
When is the study starting and how long is it expected to run for?
August 2025 to March 2026
Who is funding the study
1. Lifearc (UK)
2. MND Association (UK)
Who is the main contact?
Cara Gates, c.gates@sheffield.ac.uk
Contact information
Scientific
Sheffield Institute for Translational Neuroscience (SITraN)
School of Medicine and Population Health
385a Glossop Road
Sheffield
S10 2HQ
United Kingdom
| L.Knox@sheffield.ac.uk |
Principal investigator
Sheffield Institute for Translational Neuroscience (SITraN)
School of Medicine and Population Health
385a Glossop Road
Sheffield
S10 2HQ
United Kingdom
 ORCID ID |
0000-0002-1269-9053 |
|---|---|
| Phone | +44 (0)114222295 |
| c.j.mcdermott@sheffield.ac.uk |
Scientific, Public
Sheffield Institute for Translational Neuroscience (SITraN)
School of Medicine and Population Health
385a Glossop Road
Sheffield
S10 2HQ
United Kingdom
| c.gates@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomized study |
| Secondary study design | Non randomised study |
| Scientific title | Motor Neuron Disease (MND) Alert: a mixed-method feasibility and acceptability pilot study |
| Study acronym | MND Alert |
| Study objectives | There are two stages in this study, each with its own research question: Stage 1: MND Alert implementation Can the MND Alert toolkit help GPs identify early signs of MND in patients' health records? Stage 2: MND Alert evaluation Is the MND alert toolkit useful and acceptable for GPs in their everyday practice? |
| Ethics approval(s) |
Approved 29/05/2025, Health and Care Research Wales (Floor four, North, Welsh Government Offices, Crown Building, King Edward VII Avenue, Cardiff, CF10 3NQ, United Kingdom; +44 (0)2920230457; HCRW.approvals@wales.nhs.uk), ref: 24/NE/0231 |
| Health condition(s) or problem(s) studied | Motor neurone disease |
| Intervention | We will conduct a mixed-methods study to test the MND Alert toolkit in up to 30 GP practices. The aim is to see if this automated alert system can help identify potential cases of MND in patient records over a 6-month period. We want to find out if using the alert system and assessment tools can help reduce delays in diagnosing MND. Once the toolkit is in place, it will trigger an alert when it detects signs or symptoms related to MND in a patient's record. The toolkit will generate reports that include both pseudonymised and identifiable data; however, the identifiable data will only be used within the GP practices for verification. After this verification, GP practices will share only the pseudonymised data with the central research team through secure emails. This data will include unique row numbers that correspond to individual patients, which researchers will use to access patient records during case note reviews. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
There are no secondary outcome measures |
| Completion date | 31/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 20 |
| Key inclusion criteria | Stage 1: MND Alert implementation GP practices: 1. Located in South Yorkshire 2. Willing to integrate the MND Alert toolkit into their electronic health records 3. Using either the SystmOne or EMIS Web clinical information systems 4. Consenting to share pseudo-anonymised patient data generated through the implementation of the MND Alert toolkit 5. Willing to provide researchers access to complete patient records for conducting case note reviews of patients who triggered an alert 6. Willing and able to regularly provide feedback and share monthly pseudo-anonymised data generated through the MND Alert toolkit with the central research team Stage 2: MND Alert evaluation 1. English-speaking individuals who can provide informed consent 2. GPs from participating practices 3. GPs willing to participate in semi-structured interviews to share their experiences with the MND Alert toolkit 4. Individuals with access to a telephone or video-calling service (if semi-structured interviews are conducted remotely) |
| Key exclusion criteria | Stage 1: MND Alert implementation GP practices: 1. Located outside of the NHS South Yorkshire ICB region 2. Unwilling or unable to integrate the MND Alert toolkit into their electronic health records 3. Not using either the SystmOne or EMIS Web clinical information systems 4. Not consenting to share pseudo-anonymised patient data generated through the implementation of the MND Alert toolkit 5. Unwilling or unable to provide researchers access to complete patient records for conducting case note reviews of patients who triggered an alert 6. Unwilling or unable to regularly provide feedback and share monthly data generated through the MND Alert toolkit with the central research team Stage 2: MND Alert evaluation 1. GPs unwilling to participate in semi-structured interviews to share their experiences with the MND Alert toolkit |
| Date of first enrolment | 20/08/2025 |
| Date of final enrolment | 30/03/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Broom
Rotherham
S60 3EW
England
Sheffield
S5 8AL
England
Rotherham
S65 1DA
England
Sheffield
S1 2PJ
England
290 Main Road
Sheffield
S9 4QH
England
Sheffield
S9 1WN
England
Gardens Lane
Conisbrough
Doncaster
DN12 3JW
England
Sheffield
S3 7SF
England
Doncaster
DN5 8DA
England
Powell Street
Worsbrough
Barnsley
S70 5NZ
England
Sheffield
S6 4GQ
England
Sheffield
S6 4FA
England
151 Burngreave Road
Sheffield
S3 9DL
England
Sheffield
S14 1PQ
England
Greasbrough
Rotherham
S61 4RB
England
Sheffield
S11 7BJ
England
Sheffield
S6 3QW
England
Sheffield
S2 3AJ
England
Sheffield
S9 5DH
England
Oughtibridge
Sheffield
S35 0FW
England
Beighton
Sheffield
S20 1HQ
England
Swallownest
Sheffield
S26 4WD
England
Sheffield
S10 1GN
England
Spa Pool Road
Askern
Doncaster
DN6 0HZ
England
Owlthorpe
Sheffield
S20 6PD
England
5-9 Skelton Lane
Woodhouse
Sheffield
S13 7LY
England
900 Chesterfield Road
Sheffield
S8 0SH
England
Rotherham
S61 1AH
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Liam Knox (L.knox@sheffield.ac.uk). Type of data: anonymised interview data or analysis of interviews, practice-level based on Alert Tool usage, suggest qualitative patient-level data from case notes is neither appropriate nor useful to be made available. When the data will be available and for how long: Anonymised data will be kept for at least five years and will be available after the completion of the study. For what types of analyses: secondary analysis of interviews. Interview participant consent will be taken for data sharing (when anonymised). Consent not obtained from patients to access records and view consultation details (this was approved via CAG), therefore it is not appropriate to share this data. |
Editorial Notes
18/11/2025: Study's existence confirmed by the NIHR.
