NCT05835440

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

December 5, 2023

Status Verified

October 1, 2023

Enrollment Period

1.8 years

First QC Date

April 18, 2023

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Thematic analysis of interview data

    thematic analysis

    12 months

Study Arms (2)

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

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

Interventions

interviews

patient participantsstaff stakeholders

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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

You may not qualify if:

  • \- Learning difficulty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OUH NHS TRust

Oxford, Oxon, OX3 7LD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Wrist Injuries

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

August 1, 2023

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

December 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations