RAPID2 Patient Notification

1. What is the study about?

Each year in the UK, over 75,000 people fracture their hip. This is an exceedingly painful injury and patients are given pain relief by a paramedic and taken to hospital by ambulance. The pain relief given usually includes morphine. This may not always work very well and can lead to side effects, such as confusion. In the RAPID2 study, paramedics may give a local anaesthetic injection (known as fascia iliaca compartment block or FICB) to patients with an injured hip before they are transported to hospital. Giving this injection may provide better pain control and better long-term outcomes than the alternatives currently in use.

Our aim is to test the safety, and effectiveness of paramedics providing FICB pain relief to patients with suspected hip fracture prior to hospitalisation.

This research has received government funding through the National Institute of Health Research Health Technology Assessment Programme (NIHR HTA) (https://www.nihr.ac.uk/explore-nihr/funding-programmes/health-technology-assessment.htm). It is led by Swansea University in partnership with academic and NHS organisations, including the following NHS ambulance service and hospital sites:

2. What data will be collected and how will it be used?

Only data for eligible patients will be collected. Eligible patients are those with a suspected hip fracture who are attended by a study paramedic and taken to a participating hospital. The ambulance services and hospitals will collect personal data (name, address, postcode, NHS number, date of birth and gender) for eligible patients. NHS staff will then invite these patients - or a family member/carer if appropriate - to complete patient questionnaires. The NHS staff will also use this information to ensure accurate recording of data relating to the suspected hip fracture in the ambulance service and hospital records. The NHS staff will send information about the clinical care of the suspected hip fracture, and information to enable linkage with routinely collected hospital data held in national databases. To do this, the NHS staff will use a process known as split file - whereby identifying information (e.g. NHS number, date of birth, gender) is separated from clinical information (e.g. date of admission to hospital) - to send data to be linked with routinely collected data held in NHS Digital (https://digital.nhs.uk/) and the Secure Anonymised Information Linkage databank (https://saildatabank.com/).

Identifying data will not be shared with the research team at Swansea University - they will only receive pseudo-identifiers - a long sequence of letters and numbers that enables us to link the datasets in question - age (not date of birth), and gender. It will not be possible for the Swansea research team to identify any patient.

Data processing is carried out under Articles 6 (1) (e) and 9 (2) (j) of the General Data Protection Regulations (GDPR). Data will be stored in a secure environment within Swansea University and only accredited researchers will have access to this data. Individuals data will not be shared with any other person or organisation. Study outputs will only report grouped data, and we will ensure that individuals cannot be identified in them. Data security arrangements within Swansea University conform to standards specified by the Health Research Authority, NHS Digital, and UKSeRP. Data will be archived for 5 years following the study.

3. Who has reviewed the study?

Our research has been approved by:

• Wales Research Ethics Committee 4 (reference: 21/WA/0175/291853)
• NHS Health Research Authority Confidentiality Advisory Group (21/CAG/0151)

4. How we will report our findings?

At the end of the study we will publish our results in peer-reviewed, open access academic journals. This ensures that anyone who wishes to can access the results free of charge. We will also present the study at relevant emergency and urgent care conferences. In addition, we will produce an end of study report and a separate summary document for the public, for our funder, for participating sites and other stakeholders. It will not be possible to identify any patient from the published results.

5. Opting out

Most people who are eligible to participate in the RAPID2 study will be approached by an NHS professional to discuss their involvement. It may not be possible to reach everyone. Eligible patients may, if they choose, opt out of their data being used for the study. To opt out please contact the RAPID2 research paramedic - emma.duncan@eastamb.nhs.uk

Your care and treatment will be not be affected by choosing to opt out of your data being used in the study.

6. What if there is a problem/question?

If you have questions or concerns, please contact:

Site Representative -

Emma Duncan

East of England Ambulance Service, Waveney Depot, Excalibur Rd, Gorleston-on-Sea, Great Yarmouth, NR31 7RQ

Email: emma.duncan@eastamb.nhs.uk

Trial Manager -

Mark Kingston

ILS2, Swansea University Medical School, Swansea University, SA2 8PP

Email: rapid2@swansea.ac.uk

Telephone: 01792 606844

Chief Investigator -

Professor Helen Snooks

Swansea University Medical School, Swansea University, SA2 8PP

Email: h.a.snooks@swansea.ac.uk

Thank you for taking the time to read this patient notification and for taking an interest in this research study.

v0.5 (10/11/2021)