Improving Wrist Injury Pathways (I-WIP) Study (I-WIP)

• ClinicalTrials.gov Identifier: NCT05835440
• Recruitment Status: Recruiting
• First Posted: April 28, 2023
• Last Update Posted: December 5, 2023
• Sponsor: University of Oxford
• Collaborator: AO Research Fund
• Information provided by (Responsible Party): University of Oxford

Study Description

Brief 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'. 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.

Condition or disease	Intervention/treatment
Scaphoid Fracture; Wrist Injuries	Other: no intervention

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 70 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Improving Wrist Injury Pathways (I-WIP): a Qualitative Study
• Actual Study Start Date: August 1, 2023
• Estimated Primary Completion Date: May 2025
• Estimated Study Completion Date: May 2025

Groups and Cohorts

Group/Cohort	Intervention/treatment
staff stakeholders; The 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.	Other: no intervention; interviews
patient participants; The patient population are adults who have sustained a traumatic wrist injury with normal X-rays and have been treated by NHS services.	Other: no intervention; interviews

Outcome Measures

Primary Outcome Measures :

1. Thematic analysis of interview data [ Time Frame: 12 months ]
   thematic analysis

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

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.

Criteria

Inclusion Criteria

- 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

Exclusion Criteria

- Learning difficulty

Contacts and Locations

Contacts

Contact: Gail Lang; 01865741155; gail.lang@ndorms.ox.ac.uk

Locations

United Kingdom

OUH NHS TRust; Recruiting

Oxford, Oxon, United Kingdom, OX3 7LD

Contact: Gail Lang 01865741155 gail.lang@ndorms.ox.ac.uk

Sponsors and Collaborators

University of Oxford

AO Research Fund

More Information

• Responsible Party: University of Oxford
• ClinicalTrials.gov Identifier: NCT05835440
• Other Study ID Numbers: 321650
• First Posted: April 28, 2023
• Last Update Posted: December 5, 2023
• Last Verified: October 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Wounds and Injuries; Wrist Injuries; Arm Injuries