FP-00005

Section 1 - Basic information about you and your application:

Title of research project
Improving Wrist Injury Pathways (I-WIP)

Grant Type
The ORUK Inspiration Fund

Research area
Treatment

Duration
12

Start date
January 1, 2024

Have you previously received funding from ORUK?
No.

Profession
Orthopaedic surgeon

Your current job title/position
Consultant Hand Surgeon

Are you an early-career researcher (ECR)? (definition of ECR)
yes

Section 2 - Lay summary

Lay summary:

Wrist injuries are a big and common problem for patients and the NHS. Around 70,000 patients a year in the UK go to hospitals with wrist pain after an injury. Often, when doctors check, the wrist is very painful, but the x-rays look normal. Current guidelines now recommend that this large group of people should have MRI scans (magnetic resonance imaging = very detailed scanning) early on.

When doctors do use MRI scans early on, patients feel less worried, and happier with their treatment. It also saves the NHS money. But our recent survey work tells us that doctors do not often do this – only 13% of UK centres can currently provide early MRI scans for these patients.  We need to understand this complex problem better, before trying to fix it.

This project is part 1 and the aim is to subsequently proceed to part 2. Together these will form a new way of sorting out this complex problem.

Part 1: data gathering to understand the situation

We will visit ten different NHS hospitals to:

• interview staff members working with wrist injuries
• interview patients treated for wrist injuries

The aims of the first part of this project are to find out:

• what helps staff to give good treatment for patients with wrist injuries
• what makes it challenging to provide best quality care
• what is most important to patients who have wrist injury

A key part of any complex intervention is being able to seamlessly monitor outcomes in real time. Therefore, we will develop a custom data platform with our industry collaborators, PRO-MAPP Limited.  The platform will enable each local clinical team to analyse their performance in real time using the bespoke dashboard which will include easy to interpret charts of time to MRI.

We will then analyse this information, and this will guide part 2:

Part 2: turning information into action

This will consist of a series of group workshops. The group will involve our patient representatives, NHS clinicians who treat patients day-to-day and our team of specialist researchers. Together, we will develop a theoretical framework (a way of describing how we think wrist injury pathways work) using the results of part 1. Following this, we will co-produce a complex intervention; this means we will work together as a team to develop a solution.

This project proposal has been written and co-designed with our patient contributors. Patient participants are a vital part of both parts of this project. In Part 1, we will interview patients, so we can understand their experience. Also, patient representatives will form part of the expert group who will have an important role in helping to co-design the complex intervention.

Section 3 - Purpose of research

Purpose of research:

This project consists of one key component with the ultimate aim of developing a complex intervention to address the implementation gap relating to NICE guideline 38.

Specifically, this has two main aims:

1. Explore the barriers and facilitators to delivering early MRI
2. Understand what is most important to patients with a wrist injury

This study shall consist of mixed methods including case study focused ethnography, pathway mapping, and qualitative interviews.  The expert group includes our patient representative, clinical triallists, experts in implementation science, quality improvement and complex intervention development, clinicians, and experienced qualitative researchers.  This component shall also include the development and piloting of a data platform (including bespoke front end and dashboard) with our project partners PRO-MAPP which shall enable local clinical teams to easily gather data and monitor their performance in real time.  Improved situational awareness provided by these data together with training and implementation components in our complex intervention will support frontline teams to improve time to MRI and definitive treatment for patients.

This study will then lead to a second project which will consist of an iterative series of 6 co-design workshops.  Firstly, the group will develop of a theory of change and driver diagrams as informed by the gathered data.  Secondly, the group will co-produce the complex intervention.  The complex intervention developed by this project will then enable us to apply for funding to firstly, test the feasibility of this intervention in the NHS and then secondly, to assess the effectiveness of our complex intervention compared to that of a robust comparator in a pragmatic RCT.

Section 4 - Background to investigation

Background to investigation:

Wrist injuries represent a significant burden to both patients and health care services in the UK.  Around 70,000 patients per year attend Emergency Departments (EDs) or Minor Injuries Units (MIUs) after trauma with significant wrist pain and tenderness on clinical examination and go on to have entirely normal x-rays; these patients are often described as having ‘suspected’ or ‘occult scaphoid fractures’(1).

Early MRI has been consistently proven to be the most sensitive and specific investigation for detecting scaphoid fractures, which means it is unique in being able to confidently rule out the presence of a scaphoid fracture and enable early mobilisation in most patients(2).    The superiority of early MRI translates into an improved patient experience and significantly lower healthcare costs(3,4). This was evidenced in the Scaphoid Magnetic Resonance Imaging in Trauma (SMaRT) trial which compared early MRI to a more traditional pathway of further assessment combined with delayed CT when clinically indicated(3). Trial authors reported substantial cost savings (£266 per patient at six months), as well as benefits in terms of patient satisfaction and experience.  This translates into savings of around £10million/year for the NHS.

Current guidance from the National Institute of Care and Health Excellence (NICE) for acute wrist injuries advises early magnetic resonance imaging (MRI). Although the benefits from early use of MRI scans, and the NICE guidance, are clear, we know from our recent national (UK) survey that MRI scans are underused around the country(5). Only 13% (11 of 87) of centres can provide MRI early for patients and we identified multiple contributing causes for this including limited MRI capacity but also a lack of awareness of the evidence amongst all stakeholders and a lack of integration of services.  We also found that not a single centre had data systems in place which enabled outcomes to be monitored in real time. This implementation gap between what best evidence recommends and what happens in clinical practice is a complex problem that requires further investigation to inform the development of a complex intervention to improve care for this patient group.  NIHR / MRC guidance defines complex problems in healthcare as having multi-factorial, interdependent causes, involving multiple stakeholders and with variability across different, seemingly similar contexts. Complex problems often require complex solutions, to address them, which comprise of multiple components with different mechanisms of action designed to address the various identified root causes.

This project sets to firstly develop a better understanding of this complex problem, across a variety of contexts, and then use this information, together with data about what has worked to address this issue, to develop a complex intervention. Whilst part 2 of this project will develop the intervention, we know it will likely have components such as stakeholder-specific training materials, data monitoring and feedback tools and process-mapping training to support frontline clinicians to effect change locally.  Our complex intervention will be developed in line with the UK Medical Research Council (MRC) guidance for developing and evaluating complex interventions to improve the delivery of health care services(6).

1. Dean BJF, Riley N, Little C, Sellon E, Sheehan W, Burford J, et al. Suspected scaphoid injuries managed by MRI direct from the ED – a single centre prospective cohort study. Bone Jt Open. 2021.  Jun;2(6):447-453
   1. This single centre cohort study provides evidence relating to the incidence of this common problem.
2. Bäcker HC, Wu CH, Strauch RJ. Systematic Review of Diagnosis of Clinically Suspected Scaphoid Fractures. J Wrist Surg. 2020 Feb;9(1):81–9.
   94. This systematic review showed that MRI had the highest sensitivity and specificity for diagnosing scaphoid fractures, which were 94.2 and 97.7%, respectively
3. Rua T, Malhotra B, Vijayanathan S, Hunter L, Peacock J, Shearer J, et al. Clinical and cost implications of using immediate MRI in the management of patients with a suspected scaphoid fracture and negative radiographs results from the SMaRT trial. Bone Joint J. 2019 Jul 31;101-B(8):984–94.
   542. The use of immediate MRI in the management of participants with a suspected fracture of the scaphoid and negative radiographs led to cost savings while improving the pathway’s diagnostic accuracy and patient satisfaction. The mean cost up to three months post-recruitment per participant was £542.40 (sd £855.20, n = 65) for the control group and £368.40 (sd £338.60, n = 67) for the intervention group, leading to an estimated cost difference of £174 (95% confidence interval (CI) -£30 to £378; p = 0.094). The cost difference per participant increased to £266 (95% CI £3.30 to £528; p = 0.047) at six months. Overall, 6.2% of participants (4/65, control group) and 10.4% of participants (7/67, intervention group) had sustained a fracture of the scaphoid (p = 0.37). In addition, 7.7% of participants (5/65, control group) and 22.4% of participants (15/67, intervention group) had other fractures diagnosed (p = 0.019). The use of MRI was associated with higher diagnostic accuracy both in the diagnosis of a fracture of the scaphoid (100.0% vs8%) and of any other fracture (98.5% vs84.6%).
4. Appendix M, Cost-effectiveness analysis: Imaging of suspected scaphoid fractures. [Internet]. 2016. Available from: https://www.ncbi.nlm.nih.gov/books/NBK368138/
   1. NICE have modelled the cost effectiveness of different approaches proving that early MRI results in significant cost savings for the NHS.
5. Dean BJF. The management of suspected scaphoid fractures in the UK: a national cross-sectional study. Bone Jt Open. 2021 Nov;2(11):997–1003.
   1. This national cohort study has shown that a minority of centres have implemented NICE guidance, while the majority do have access to MRI but use it in a more delayed fashion. This is shown in the abstract and Figure below.
6. NIHR/MRC. Developing and evaluating complex interventions: 2021;

 

Section 5 - Plan of investigation

Plan of investigation:

This study shall consist of mixed methods including case study focused ethnography, pathway mapping, and qualitative interviews.  The project has been co-produced with our patient representatives and our expert group, who are critical in the delivery of all aspects of this work.  The expert group includes our patient representative, clinical triallists, experts in implementation science, quality improvement and complex intervention development, clinicians (ED, radiology and orthopaedics), and experienced qualitative researchers.

Data will be collected at 10 NHS sites which shall be purposively sampled by the project team. 10 NHS centres have already agreed to take part in this project, as they have already participated in the background work which supports this application.  Site selection has adopted maximal sampling to ensure a mix of hospitals based upon their use of early MRI, and to reflect the differences in the types of hospital within the NHS overall (e.g. differences in patient volume, the setup of emergency services (ED and MIUs) and type of hospital (district general or teaching)). Our project stakeholders are a diverse population and will include managers, emergency department clinicians, radiologists, radiographers, administrative staff and surgeons.

One to two site visits will take place over the study period (January 2024 to January 2024).  A project setup telephone call will take place to arrange the visit and run through the logistics of the visit.

The first visit shall include pathway mapping small group sessions with stakeholders to explore details such as the emergency services setup locally, the nature of the patient record system and referral processes, the details relating to radiology requests and reports, the logistics of MRI scanning, the nature of local audit data, and the setup of services in terms of funding and management structures.  Detailed document analysis will also take place at the first visit including pathway and training material, as well as job plans.  Case studies and observation with field notes in emergency services and clinics shall also take place at the first visit.  The second visit will include a pathway mapping large group session with stakeholders to finalise pathway details.  Case studies and observation with field notes in emergency services and clinics will also take place at the second visit.  Supplementary data will be collected from the site visits in the form of documents and field notes.

Qualitative data shall be gathered via semi-structured interviews conducted by lead applicant and members of the group with training in qualitative research.  There will be up to 7 semi-structured interviews per site (70 total) including stakeholders involved in the treatment of wrist injury (ED, radiology, management, clinical lead, surgeons, administrative staff, radiographers, plaster room staff etc).  Interviews will be conducted virtually using structured interview guides developed in conjunction with our team member who is an experienced qualitative researcher.  Data will be collected by recording the individual interviews and transcription verbatim.  Qualitative data will be analysed using the reflexive thematic analysis as described by Braun and Clark.  This method is widely used and well recognised with the field of qualitative research, involving the researchers immersing themselves in the research topic and acknowledging their subjectivity.  The staff interviews and patient interviews shall be analysed separately.  This will involve the following stages: 1) familiarising with the data set 2) preliminary coding 3) further development of codes 4) provisional development of themes 5) refinement of themes 6) writing up.  Two members of the research team will be involved in all six stages so certain elements are carried out independently and then reflected upon together, in a way that enables theme development to be natural, evolving and subjective.  The analysis will be undertaken by our team member who is an experienced qualitative researcher (Francine Toye), while the lead applicant also has training and experience in qualitative research.  The data from the site visits will be summarised and presented to the expert group, as shall the initial results from the qualitative interviews.

This shall also include the development and piloting of a data platform at the lead site (including bespoke front end and dashboard) with our project partners PRO-MAPP which shall enable sites to easily gather data and monitor their performance in real time. This will provide the essential ingredient to the model for improvement, as by seeing and acting upon the key real time clinical information, clinical teams will be able to learn and improve their performance.  The custom solution will include:

• Secure logins for staff and project members
• Bespoke front end to allow for the collection and update of requested information
• Bespoke dashboard report and ability to download raw data.
• Database to support the collection and reporting
• Secure Hosting (PRO-MAPP are a Cyber Essentials Plus certified company)
• Management and support during the project.
• Full audited data capture methodology.

The future work (beyond this project) will consist of an iterative series of 6 co-design workshops involving this group of which three will be virtual and three will be face-to-face.  These will be 4-6 weeks apart.  We anticipate each workshop to last half a day, and include three patient representatives, three clinicians, and the five expert group members.  Firstly, the group will develop of a theory of change and driver diagrams as informed by the gathered data.  Secondly, the group will co-produce the complex intervention.  The final complex intervention developed by this project will then enable us to apply for funding to firstly, test the feasibility of this intervention in the NHS and then secondly, to assess the effectiveness of our complex intervention compared to that of a comparator in a pragmatic RCT.

Section 6 - Research environment and resources

Research environment and resources:

The team consists of:

Benjamin Dean	BD	PI who is carrying out site visits, interviews, data analysis and will be leading co-production of the intervention
Matt Costa	MC	Mentor/supervisor providing advice and support for the PI
Tim Stephens	TS	Expert in complex interventions and will be helping with the co-production of the complex intervention
Amy Grove	AG	Expert in implementation and will be involved in both mixed-methods study and co-production of intervention
Liz Baird	LB	Patient representative who is integral in project design and co-production of the intervention
David Beard	DB	Clinical triallist with expertise in intervention development and pragmatic clinical trials who will be involved in co-production of the intervention
Francine Toye	FT	Experienced qualitative research who will be assisting in qualitative project, both in terms of carrying out interviews and data analyis
David Metcalfe	DM	ED clinician and academic providing ED input into co-production phase
Ashley Scrimshire	AS	Orthopaedic surgeon with experience in improvement science and clinical trials who will be involved in the co-production phase
Edward Sellon	ES	Radiologist and academic providing input into co-production phase

 

The development of complex intervention requires a complex mixture of skills which are included within our team.  TS and AS have extensive experience in this emerging area and have a proven track record of leading large national mutli-centre projects. AG and FT have extensive experience in mixed methods research (including qualitative research) which will be invaluable in developing the methodology underlying the complex intervention development.  The variety of clinical expertise within the group will also be important in developing the methodology and intervention (orthopaedics-BD and MC, radiology-ES, EM-DM).  The patient focus will be provided by LB which will enable the new methodology and co-production to be sufficiently patient centred.  The development of a bespoke data platform will be a significant contribution, notably TS has experience of this within the group.

MC and DB will provide general mentorship to the lead applicant BD.  TS has experience in the co-production of interventions and his leadership will be essential in the co-production phase, while his mentorship will be an important aspect of maintaining working relationships during the project.  The clinical expertise within the group (BD, ES, DM, MC, AS) will be vital in using their lived experience in guiding the project to be truly clinically engaged, and this has been invaluable in getting the project to this stage with a large network of engaged NHS centres who have agreed to take part in this project.  Our patient representative LB will also be vital in maintaining effective working relationships with the future patients involved in the co-production phase.

This project has been supported so far by a small pump priming grant from AO UK and the SoECAT is funded by this grant.

Section 7: Research impact

Who will benefit from this research?

This research will lead to benefits for patients, clinicians and the NHS.  Developing a better understanding of the complexity underlying current wrist injury pathways is essential if they are to be improved efficiently for patients of the future.  There is high quality evidence proving that early MRI improves patient outcomes and experience, this project aims to translate this evidence into clinical practice by addressing the current implementation gap.  Not only will patients benefit, but there are also huge potential benefits to clinicians and NHS services.  Early MRI can save the NHS around £10 million per year, while it also has great potential in helping offload the already busy trauma clinics around the UK.

How can your research be translated in real-life?

This research will form the backbone of a second project which will be to co-produce the complex intervention that will be designed to effectively address the implementation gap and enable NHS centres to improve their wrist injury pathways by using early MRI efficiently.  This will consist of an iterative series of 6 co-design workshops involving this group of which three will be virtual and three will be face-to-face.  Firstly, the group will develop of a theory of change and driver diagrams as informed by the gathered data.  Secondly, the group will co-produce the complex intervention.   We will then apply for funding to run a randomised controlled trial testing the effectiveness of this complex intervention in the UK.  Ultimately this is the most robust and efficient manner to improve care for patients with wrist injuries in the UK.

How will your research be beneficial for ORUK and its purpose?

Ultimately this project aims to improve the diagnosis and treatment for patients with wrist injuries in the UK.  This has great potential to improve patient outcomes by aiding the implementation of early MRI, while the way the data gathering includes the patient perspective means that this will be done in a way that better supports patients of the future.  It will also significantly reduce the burden on NHS services by saving money and reduce unnecessary clinic attendances.

This project lies at the interface between clinical medicine and academia, meaning that it will continue to raise more awareness of this important issue. This project is also vital to the lead applicant who is aiming to develop as a future MSK leader in this important area.  While the project will result in an important publication in the field of implementation science, which will translate usefully into other clinical domains.

Section 8: Outreach and engagement

Patient and Public Involvement representatives and groups

Liz Baird and Robin Horton, our lead patient/public representatives, will liaise with their colleagues in the UK Musculoskeletal Trauma PPI Group to disseminate the findings of this project to patients and carers directly through their national network of patient advocacy organisations. They will help generate a plain language summary, explainer video and infographic for patients and the public. These documents will be available in hard copy, podcast, as a blog and formatted for social media. A dedicated trial website, which will be open to all participants and their carers, will have up to date information on progress of the study and subsequently the results. An abstract will be submitted to the annual annual Musculoskeletal Trauma Patient and Public Involvement Meeting, where the lay co-applicants will give a presentation. Posters will also be prepared with input from the broader PPI Group for inclusion at any workshop, focus group or conference where relevant national PPI is involved or discussed.

Social media and traditional news

Research group members will to distribute links to the published study on the social media. This will involve social media sites such as Facebook and Twitter. The research findings will also be sent to relevant stakeholder groups such as the Hand Society (BSSH) and relevant Royal Colleges (Radiology and Emergency Medicine) so they can distribute to members via their newsletters. The work will also be submitted for national presentations at meetings including the British Orthopaedic Association’s and the Hand Society’s.

Co-production of online video and infographic

We shall co-produce a simple online video and infographic with our patient representatives to summarise the research’s findings. This will be posted online and distributed as above via our group’s social media accounts (Oxford Trauma and NDORMS).

Versus Arthritis patient magazine

Members of our current group have links to this magazine and the aim will be to publish a short article to facilitate the dissemination of this work within this community.

Section 9: Research budget

Requested funding from ORUK

University fees (if any)
£0

Salary
£26700

Consumables
£15000

Publications
£3000

Conference attendance
£2000

Other items
£

Total 'requested fund'
£46700



Other items




Other secured funds

Internal funding
£0

Partner (University)
£0

Partner (Commercial)
£0

Partner (Charity)
£10000

Other sources
£0

Total 'other funds)
£10000

Section 10: Intellectual property and testing on animal

Is there an IP linked to this research?
Yes

Who owns and maintains this patent?

Should there be any other outcomes from the research, which are capable of exploitation either by direct adoption into the healthcare service or via commercialisation, I will notify ORUK immediately and discuss these outcomes with the Oxford University Innovations (OUI) team.  IP relating to the protocol, method of findings of the data platform with PRO-MAPP stay with the project owners (research team) and this has been confirmed by PRO-MAPP.

Does your research include procedures to be carried out on animals in the UK under the Animals (Scientific Procedures) Act?
No

If yes, have the following necessary approvals been given by:

The Home office(in relation to personal, project and establishment licences)?


Animal Welfare and Ethical Review Body?


Does your research involve the use of animals or animal tissue outside the UK?
No

Does the proposed research involve a protected species? (If yes, state which)



Does the proposed research involve genetically modified animals?


Include details of sample size calculations and statistical advice sought. Please use the ARRIVE guidelines when designing and describing your experiments.


There should be sufficient information to allow for a robust review of any applications involving animals. Further guidance is available from the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), including an online experimental design assistant to guide researchers through the design of animal experiments.

Please provide details of any moderate or severe procedures


Why is animal use necessary, are there any other possible approaches?


Why is the species/model to be used the most appropriate?