Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05835440 |
| Other study ID # |
321650 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2023 |
| Est. completion date |
May 2025 |
Study information
| Verified date |
October 2023 |
| Source |
University of Oxford |
| Contact |
Gail Lang |
| Phone |
01865741155 |
| Email |
gail.lang[@]ndorms.ox.ac.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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'. 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.
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.
