Administrative information
Title {1} | Randomised trial of clinical and cost effectiveness of Administration of Prehospital fascia Iliaca compartment block for emergency hip fracture care Delivery (RAPID 2) |
Trial registration {2a and 2b}. | Registered: 22/09/21 ISRCTN15831813 https://doi.org/10.1186/ISRCTN15831813. |
Protocol version {3} | Version 1.2 25/03/2022 |
Funding {4} | Funded by the National Institute for Health Research Health Technology Assessment programme, project number 129972 |
Author details {5a} | 1 Swansea University Medical School, 2 South West Ambulance Services NHS Foundation Trust 3 Swansea Bay University Health Board 4 East of England Ambulance Service NHS Trust 5 The University of Sheffield 6 Public and Patient Contributor 7 Welsh Ambulance Services NHS Trust 8 Cardiff University 9 University of Lincoln 10 South East Coast Ambulance Services NHS Foundation Trust 11 Royal Surrey County Hospital NHS Foundation Trust |
Name and contact information for the trial sponsor {5b} | Research Engagement and Innovation Services, Swansea University, SA2 8PP—researchgovernance@swansea.ac.uk |
Role of sponsor {5c} | This is an investigator-initiated trial. The Chief Investigator, within the sponsor organisation, is responsible for the trial design, collection, management, analysis and interpretation of data, writing of the report and publication decisions. |
Introduction
Background and rationale {6a}
Aim and objectives {7}
Trial design {8}
Methods: participants, interventions and outcomes
Study setting {9}
Eligibility criteria {10}
Inclusion for randomisation
-
Assessed as having an isolated hip fracture—hip fracture assessment checklists will be provided to aid recognition, as in the feasibility study
-
Conscious (Glasgow Coma Scale Score of ≥ 13)
-
Haemodynamically stable
-
To be conveyed to a participating receiving hospital
Exclusion prior to randomisation
-
Are taking anticoagulants
-
Have a hip prosthesis on the affected side
-
Refuse analgesia
-
Are thought to be having a stroke
-
Are combative
-
Are attended by a paramedic working alone
Paramedic training
-
1) Online e-learning, covering administration of FICB and Good Clinical Practice training.
-
2) Group ‘classroom’ sessions, led by a consultant anaesthetist and covering hip fracture recognition, anatomy, pharmacology, FICB procedure and equipment, toxicity recognition and treatment, pre-hospital scenarios and trial processes. Life-sized groin models, custom made for training paramedics in the study, will be used to simulate administering FICB. A study site researcher will cover trial methods, including trial eligibility criteria, the importance of recording pain scores and the use of scratchcards and randomisation log. In the context of COVID, these training sessions may take place online.
-
3) In-hospital training. Pairs of paramedics will attend sessions at the receiving hospital where they will administer FICB to real patients, supervised by an anaesthetist or emergency medicine doctor. They will alternate between administering and critiquing the FICB to ensure their learning is active [33]. The paramedics must administer three FICBs competently and critique three FICBs performed by their peers, before being allowed to recruit patients to the study. The FICB and Intralipid (antidote for local anaesthetic toxicity) packs will be available for paramedics to familiarise themselves with. The anaesthetists providing training will run through prehospital scenarios with the paramedics, including assessing eligibility and taking consent. We will provide written material and assessments to optimise learning in between block performances. These will include research and clinical questions, e.g. patient trial eligibility, contraindications to FICB, information to give when taking consent for FICB including risks and how long the FICB will take to work.
Who will take informed consent? {26a}
Additional consent provisions for collection and use of participant data and biological specimens {26b}
Interventions
Explanation for the choice of comparators {6b}
Intervention description {11a}
-
Assess for any contraindication to FICB
-
○ Body mass apparently less than 50 kg
-
○ Pregnancy
-
○ Allergy to local anaesthetic
-
○ Neurovascular damage to the affected leg
-
○ Infection at the site of injection
-
○ Previous femoral bypass surgery
-
○ Inability to palpate the femoral artery on the affected leg
-
-
Explain the risks and benefits of FICB
-
Take verbal consent for the procedure
-
Move the patient into a suitable position to administer the FICB
-
Follow the treatment protocol for delivery of FICB (Fig. 2)×
Criteria for discontinuing or modifying allocated interventions {11b}
Strategies to improve adherence to interventions {11c}
Relevant concomitant care permitted or prohibited during the trial {11d}
Provisions for post-trial care {30}
Outcomes {12}
-
Ambulance service job cycle time (from 999 call to ‘ambulance free’)
-
Analgesia and anti-emetics administered prehospitally, including morphine and ‘rescue morphine’
-
Length of stay in hospital, ITU and residential rehabilitation care following injury
-
Subsequent ED attendances and emergency admissions
-
Mortality
-
Diagnosis (for patients who did not have a hip fracture)
-
Where patient was admitted from and discharged to
-
Satisfaction with care (Quality of Care Monitor at 1 month)
-
Health-related quality of life (HRQoL) (EQ-5D-5L at 1 and 4 months)
-
Mobility (Rivermead Mobility Index at 1 and 4 months. One question will be removed to enable the patient to complete the questionnaire by themselves)
Participant timeline {13}
Sample size {14}
Recruitment {15}
Assignment of interventions: allocation
Sequence generation {16a}
Concealment mechanism {16b}
Implementation {16c}
Assignment of interventions: blinding
Who will be blinded {17a}
-
The paramedics will be instructed to record the patient’s baseline pain score before randomisation
-
The triage nurse in the ED will be instructed to take the second pain score at handover, before the paramedic reveals which arm of the trial the patient was allocated to.
Procedure for unblinding if needed {17b}
Periodic review of unblinded data
Data collection and management
Plans for assessment and collection of outcomes {18a}
Monitoring for false positives
Health economics
Intervention costs
NHS resource use
Outcome measures for cost-effectiveness analysis (CEA) and cost utility analysis (CUA)
Plans to promote participant retention and complete follow-up {18b}
Data management {19}
Confidentiality {27}
Statistical methods
Statistical methods for primary and secondary outcomes {20a}
Data analysis
Health economic data analysis
Interim analyses {21b}
Methods for additional analyses (e.g. subgroup analyses) {20b}
SPIRIT guidance: methods for any additional analyses (e.g. subgroup and adjusted analyses)
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}
SPIRIT guidance: definition of analysis population relating to protocol non-adherence (e.g. as randomised analysis), and any statistical methods to handle missing data (e.g. multiple imputation)
Plans to give access to the full protocol, participant-level data and statistical code {31c}
Oversight and monitoring
Composition of the coordinating centre and trial steering committee {5d}
-
An independent Chair (and statistician)
-
Four independent clinician(s) or Scientist(s) with relevant experience (paramedic, Consultant of Emergency Medicine, Anaesthetist, Health Economist)
-
Two Public Contributors.
Composition of the data monitoring committee, its role and reporting structure {21a}
-
Health Economist (Chair), Statistician, Anaesthetist, Paramedic, Nurse.