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Scaphoid FractureI-WIPNCT05835440

Improving Wrist Injury Pathways (I-WIP) Study

An observational study of Scaphoid Fracture and Wrist Injuries, run by University of Oxford at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Wrist injuries represent a considerable problem for both patients and the NHS. Around 70,000 patients per year in the UK attend hospitals with serious wrist pain after an injury, only to find that their x-ray is considered to be 'normal'. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Scaphoid Fracture, Wrist Injuries
How many people
70 participants
Where
1 siteUnited Kingdom
Study dates
1 Aug 2023to May 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: For aim 1, the staff stakeholders (NHS staff) shall be identified using snowballing sampling starting with the local QI project lead and the aim is to undertake up to 40 staff stakeholder interviews (maximum of 4 at each site). For aim 2, we will undertake up to 30 patient participant interviews recruited from trauma clinics (3 at each site). As explained above, patient participants shall be sampled purposively to achieve a diversity in terms of gender and age.

Who may be able to join

  • All participants are willing and able to give informed consent for participation in the study (including audio recording of interview). Where possible we shall use translation services to enable those who might not adequately understand various forms of information to take part
  • For staff stakeholders (NHS staff) - Any staff member involved in regular delivery or management of Wrist Injury Pathways (e.g. manager, nurse practitioner, physiotherapist, surgeon, administrative staff, radiologist, radiographer, emergency department clinician). This staff member must be deemed to be integral in the day to day running and/or overall management of the pathway.
  • For patients:
  • Male or female aged over 18 years of age
  • Being treated for a traumatic wrist injury with a normal initial X-ray

Who cannot join

  • Learning difficulty

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site, 1 recruiting
  • OUH NHS TRust

    Oxford, Oxon, OX3 7LD

    Gail Lang, 01865741155, gail.lang@ndorms.ox.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: Improving Wrist Injury Pathways (I-WIP): a Qualitative Study

Wrist injuries represent a considerable problem for both patients and the NHS. Around 70,000 patients per year in the UK attend hospitals with serious wrist pain after an injury, only to find that their x-ray is considered to be 'normal'. The National Institute of Care and Health Excellence (NICE) advises that these patients should be given MRI (magnetic resonance imaging) scans early on, within 2 weeks. Early MRI gives patients the best care, by picking up the serious injuries requiring early treatment and by helping reassure those without serious injuries to get back to activities quickly. This saves the NHS staff time and money by reducing unnecessary clinic attendances. Although these benefits from early use of MRI scans, and the NICE guidance, are clear, it is know from our recent national (UK) survey that only 11 of the 87 UK hospitals that we surveyed used MRI scans for these patients.

The gap between what the best evidence suggests and what happens in clinical practice is a complex issue that requires further investigation. To develop a complex intervention to address this problem,a better understanding of the reasons why hospital services are currently unable to adopt the NICE guidance is needed. Clinical interventions in surgery exist on a spectrum from simple, such as closing a wound with stitches, to the complicated (carrying out a joint replacement for a neck of femur fracture) to complex (improving trauma theatre efficiency). The latter, more complex variety, are characterised by the 1) number of components in the intervention, 2) the range of behaviours targeted 3) the range and different levels of target recipients, 4) the expertise and skills required by those delivering and receiving the intervention 5) and or by the level of flexibility permitted in the intervention delivery. In 2000, the UK Medical Research Council (MRC) established guidance for developing and evaluating complex interventions to improve the delivery of health care services. An important stage in developing complex interventions and improving care is to fully understand current pathways and the context of care. This qualitative study aims to develop a better understanding of wrist injury pathways, and their context, in the NHS. We aim to (1) understand the barriers to early MRI for painful wrists and (2) understand what is important to patients when being treated with a wrist injury.

Read the detailed description

Around 70,000 patients per year in the UK attend hospitals with serious wrist pain after an injury, which although painful on examination, look 'normal' on x-ray. The National Institute of Care and Health Excellence (NICE) advises that this large group of patients who have pain, but normal x-rays, should be given MRI (magnetic resonance imaging) scans early on. Early MRI gives patients the best care, by picking up the serious injuries requiring early treatment and by enabling those without serious injuries to get back to activities quickly after being reassured and potentially saves NHS resource by reducing unnecessary clinic attendances(1). Although these benefits from early use of MRI scans, and the NICE guidance, are clear, it is known from our recent national (UK) survey that MRI scans are underused around the country. Only 13% (11 of 87) of centres currently use MRI directly for patients(2).

There are multiple, often complicated reasons, for centres not being able to follow the NICE guidance, however when they do use MRI scans early on, it makes patients better faster, and saves the NHS money(3). This implementation gap between what best evidence recommends and what happens in clinical practice is a complex issue that requires further investigation. To develop an effective complex intervention to address this problem, a far better understanding of the reasons underlying this failure to implement NICE guidance is needed. In 2000, the UK Medical Research Council (MRC) established guidance for developing and evaluating complex interventions to improve the delivery of health care services(4).This guidance advises that six core elements are considered when developing a complex intervention:

  1. How does the intervention interact with its context?
  2. What is the underpinning programme theory?
  3. How can diverse stakeholder perspectives be included in the research?
  4. What are the key uncertainties?
  5. How can the intervention be refined?
  6. Do the effects of the intervention justify its cost?

A vital early task in ensuring evidence-based treatment of wrist injuries is to develop a theoretical understanding of the drivers (or root causes) of the problem. To do this, we need to draw on existing evidence and theory from similar contexts, and verify our initial assumptions through primary research, for example interviews with stakeholders and the detailed mapping of care pathways. In this case, the relevant stakeholders are a highly diverse group including commissioners, managers, ED staff (including doctors, paramedics, nurses and other allied health professionals), administrative staff, radiologists, radiographers and surgical staff (including surgeons, nurses, physiotherapists and other allied health professionals).

It will be important to consider the potential barriers and facilitators to complex interventions in orthopaedic surgery. The Donabedian model of quality assessment is useful here(5). This model proposes that any given outcome (in this case early MRI of the wrist) is the product of (a) process factors (the way care is organised or delivered) and (b) structural factors (the physical capacity of the service to deliver the target outcome). Our exploratory work has demonstrated deeply entrenched negative views regarding the value of early MRI which are likely to be a barrier to change in some centres. MRI capacity may be a significant barrier to implementation. Process barriers might include inefficient use of existing MRI capacity, which would be amenable to pathway implementation to streamline and improve efficiency. Conversely structural problems, such as insufficient capacity despite optimising MRI efficiency may require the purchase of more scanners and recruitment of more staff. Structural problems are harder to influence with behaviour change interventions and generally need a different approach e.g., business case or funding (6).

This qualitative study aims to develop a better understanding of wrist injury pathways in the NHS.

Although it is not expected for harm to come to participants from the interview, qualitative interviews encourage people to talk about a range of subjects that can be upsetting. Our experience has shown us that talking can be a positive experience for many people. The participants will be interviewed by a trained NHS clinician who will direct any patients who experience worrying distress to the appropriate healthcare professional or encourage the person to speak to their GP. The interviewer will also structure the interview with a 'cool off' time at the end.

Being tested
no intervention
Medical subject headings
Wrist Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • no interventionOther

    interviews

Study groups in NCT05835440
Study groupRoleWhat they receive
staff stakeholdersThe potential stakeholders are a diverse population and will include managers, emergency department clinicians and practitioners, radiologists, radiographers, administrative staff and surgeons. A maximum total of 4 staff stakeholder interviews shall be undertaken.
Receives: Other: no intervention
patient participantsThe patient population are adults who have sustained a traumatic wrist injury with normal X-rays and have been treated by NHS services.
Receives: Other: no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Thematic analysis of interview data

    thematic analysis

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2023
  2. Study start1 Aug 2023
  3. Primary completionMay 2025 (estimated)
  4. Study completionMay 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05835440
Sponsor's protocol ID
321650
Acronym
I-WIP
Status last verified
Oct 2023
First submitted
18 Apr 2023
Last updated
5 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Scaphoid Fracture and Wrist Injuries, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gail Lang (01865741155, gail.lang@ndorms.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Thematic analysis of interview data (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023; AzTrials last refreshed its copy on 30 Oct 2026.

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