Eligibility
Study participants
Patients aged 16 years and older with an acute fracture of the distal radius who, in the opinion of the treating clinician, do not require a manipulation of the fracture.
Local study conflicts
- None specific. Participants can be co-enrolled into other studies that do not involve the wrist injury that will be part of the DRAFT3-CASP study, do not conflict with the follow-up of the study and with consideration to participant burden.
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study.
- Aged 16 years or above.
- Presenting with a fracture of the distal radius which, in the opinion of the treating clinician, does not require a manipulation of the fracture.
Exclusion Criteria:
- The patient presents to research team more than 2 weeks post-injury
- The fracture is open (Gustilo and Anderson >1) They are unable to adhere to trial procedures, e.g. patients with permanent cognitive impairment, or other concomitant severe injuries e.g. head injury.
- N.B. If a patient presents with a distal radius fracture to both wrists i.e. both wrists are eligible, the patient will be included but only one wrist will be randomised – whichever, in the clinician’s opinion, is the worse injury. It is expected that the other eligible injured wrist will be treated in the same way
If the patient is eligible:
Inform the patient that they may be eligible for the DRAFT study and that research team will come and speak to them.
Gain verbal agreement in principle before proceeding. Explain:
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition;
- If they change their mind they can withdraw their participation at any point
- Ask the patient to watch the DRAFT3 study video using this link: DRAFT3 animated patient information video
Step by Step Guide to Recruitment:
In the working hours of the research team:
- Monday-Friday 07:30 – 18:30
- Contact the EMROx research team on:
Mobile 0776818242
Tel 01865 222003
Bleep 6680
Out of hours and weekends:
Estimated time required to enrol:
- 20- 30 minutes
Eligibility confirmation: electronic
- Study delegated doctors and nurses will confirm eligibility. Log in via Login - Draft3 Study
- Note: Copy of delegation log can be accessed via this link: DRAFT 3 Recruitment pack
- The Password is a Generic password. Ask the EMROx team via the ED Research WhatsApp group
- Complete the Inclusion & Exclusion Criteria, then click submit tab. It will take you to the e-Consenting page
Gaining formal consent: Electronic
- Only clinicians on the delegation log can consent a patient.
- If they haven't already, ask the patient to watch the DRAFT3 study video using this link: DRAFT3 animated patient information video
- Or view it on their own device via this link:
- Answer all questions the patient may have
- Using an ipad or smartphone access the following website: The DRAFT3-CASP Study (digitrial.com)
- Click on ‘Patient Information Site’ link to open the patient information page in a new tab. Allow the patient to read through it or view the video
- Go back to the homepage on the previous tab (or use the same link above again to re-open) and click ‘Enrol a new patient’
- Complete the questionnaires with the patient
- Ask the patient to read through the consent information and, if they agree, choose I agree on the webpage. Patient signs the e-Consent on the following screen, Then delegated staffs signs their name on the person taking consent. Then Click submit tab. It will open the Randomisation Tab.
Randomisation procedure
- Completed the randomisation questions then select Randomise.
- Inform the patient and clinician looking after the patient the result of randomisation: Splint vs Cast
- Whilst waiting for ENP or Doctor to apply the allocated intervention. Ask the patient to answer the questions online
Carrying out the intervention:
- The Doctor or ENP will apply the study intervention; Splint or Cast
Disposition and follow-up:
Patients allocated to the Splint arm:
- Patient will be discharged with splint
- Provide patient with DRAFT3CASP_ John Radcliffe_ Rehab Booklet. Note, there is a different DRAFT3CASP Rehab book for Horton. Booklets are available in ENP Room. This contains contact information for patient to call if they have issues.
- Pain management as per hospital standard of care.
- No need for follow-up
- Wear the Splint 4-6 weeks and remove it after.
Patients allocated to the Cast arm:
- Patient will be discharged with CAST.
- Provide patient with DRAFT3CASP_ John Radcliffe_ Rehab Booklet. Note. There is a different DRAFT3CASP Rehab book for Horton. Booklets are available in ENP Room. This contains contact information for patient to call if they have issues.
- Pain management as per hospital standard of care.
- Doctor/ENP will arrange trauma clinic follow-up
- Cast will be worn for 4-6 weeks. Pt will need to come back to hospital to remove the cast
Documentation
- Document in the EPR that patient was confirmed to be eligible to DRAFT3 CASP. Study was discussed with the patient and patient has signed the e-Consent. Patient was allocated to : (Splint or Cast)
Links for further information:
Click here for trial websiteClick here for a 2 minute video animation to explain the study