Use of scratchcards for allocation concealment in a prehospital randomised controlled trial

BackgroundRapid Analgesia for Prehospital Hip Disruption was a small study designed to determine the feasibility of undertaking a randomised controlled trial (RCT) to test the clinical and cost-effectiveness of paramedics administering Fascia Iliaca Compartment Block as early prehospital pain relief to patients with a fractured hip. The objective was to devise a simple and effective method of random allocation concealment suitable for use by paramedics while in the emergency prehospital setting.MethodsScratchcards were produced using scratch-off silver stickers which concealed the trial arm allocation. Paramedics were each allocated a unique range of consecutive numbers, used as both the scratchcard number and the patient’s study ID. The cards were designed to allow the paramedic to write on the incident number, date and signature. A small envelope holding the cards was prepared for each paramedic. The study took place between 28 June 2016 and 31 July 2017 in the Swansea area.ResultsNineteen trial paramedics used 71 scratchcards throughout the study and reported no problems randomly allocating patients using the scratchcards. Five protocol deviations were reported in relation to scratchcard use. On auditing the scratchcards, all unused cards were located, and no evidence of tampering with the silver panel was found.ConclusionParamedics can use scratchcards as a method of randomly allocating patients in trials in prehospital care. In the future, a method that allows only the top card to be selected and a more protective method of storing the cards should be used. Scratchcards can be considered for wider use in RCTs in the emergency prehospital setting

Clinical and cost-effectiveness of paramedic administered fascia iliaca compartment block for emergency hip fracture (RAPID 2)—protocol for an individually randomised parallel-group trial

Approximately 75,000 people fracture a hip each year in the UK. This painful injury can be devastating-with a high associated mortality rate-and survivors likely to be more dependent and less mobile. Pain relief at the scene of injury is known to be inadequate. Intravenous morphine is usually given by paramedics, but opioids are less effective for dynamic pain and can cause serious side effects, including nausea, constipation, delirium and respiratory depression. These may delay surgery, require further treatment and worsen patient outcomes. We completed a feasibility study of paramedic-provided fascia iliaca compartment block (FICB), testing the intervention, trial methods and data collection. The study (RAPID) demonstrated that a full trial was feasible. In this subsequent study, we aim to test safety, clinical and cost-effectiveness of paramedic-provided FICB as pain relief to patients with suspected hip fracture in the prehospital environment. We will conduct a pragmatic multi-centre individually randomised parallel-group trial, with a 1:1 allocation between usual care (control) and FICB (intervention). Hospital clinicians in five sites (paired ambulance services and receiving hospitals) in England and Wales will train 220 paramedics to administer FICB. The primary outcome is change in pain score from pre-randomisation to arrival at the emergency department. One thousand four hundred patients are required to find a clinically important difference between trial arms in the primary outcome (standardised statistical effect ~ 0.2; 90% power, 5% significance). We will use NHS Digital (England) and the SAIL (Secure Anonymised Information Linkage) databank (Wales) to follow up patient outcomes using routine anonymised linked data in an efficient study design, and questionnaires to capture patient-reported outcomes at 1 and 4 months. Secondary outcomes include mortality, length of hospital stay, job cycle time, prehospital medications including morphine, presence of hip fracture, satisfaction, mobility, and NHS costs. We will assess safety by monitoring serious adverse events (SAEs). The trial will help to determine whether paramedic administered FICB is a safe, clinically and cost-effective treatment for suspected hip fracture in the pre-hospital setting. Impact will be shown if and when clinical guidelines either recommend or reject the use of FICB in routine practice in this context. ISRCTN15831813 . Registered on 22 September 2021. [Abstract copyright: © 2022. The Author(s).

Implementing emergency admission risk prediction in general practice: a qualitative study

Using computer software in general practice to predict patient risk of emergency hospital admission has been widely advocated, despite limited evidence about effects. In a trial evaluating the introduction of a Predictive Risk Stratification Model (PRISM), statistically significant increases in emergency hospital admissions and use of other NHS services were reported without evidence of benefits to patients or the NHS. To explore GPs' and practice managers' experiences of incorporating PRISM into routine practice. Semi-structured interviews were carried out with GPs and practice managers in 18 practices in rural, urban, and suburban areas of south Wales. Interviews (30-90 min) were conducted at 3-6 months after gaining PRISM access, and ∼18 months later. Data were analysed thematically using Normalisation Process Theory. Responders ( = 22) reported that the decision to use PRISM was based mainly on fulfilling Quality and Outcomes Framework incentives. Most applied it to <0.5% practice patients over a few weeks. Using PRISM entailed undertaking technical tasks, sharing information in practice meetings, and making small-scale changes to patient care. Use was inhibited by the model not being integrated with practice systems. Most participants doubted any large-scale impact, but did cite examples of the impact on individual patient care and reported increased awareness of patients at high risk of emergency admission to hospital. Qualitative results suggest mixed views of predictive risk stratification in general practice and raised awareness of highest-risk patients potentially affecting rates of unplanned hospital attendance and admissions. To inform future policy, decision makers need more information about implementation and effects of emergency admission risk stratification tools in primary and community settings. [Abstract copyright: © The Authors.

A co-produced method to involve service users in research: the SUCCESS model

Abstract Background Public and patient involvement is a routine element of health services research methods to produce better designed and reported studies. Although co-production is recommended when involving people in research, methods for involving people are usually designed and managed by researchers and there is little evidence about methods to co-produce models for effective public and patient involvement. We report the method used by a group of patient and carer service users to develop and implement a model for involving public members in research. Method We recruited people with experience of chronic conditions, as patients and carers, and supported them to develop and implement the involvement model. We collected written records to describe the processes of co-production. Results Sixteen service users were involved through a series of workshop, meeting and email discussions. They specified principles and operating characteristics of the model which concerned an inclusive culture, adequate resources, accessibility, good communication and clarity of purpose and roles. Components of the model included an on-line Panel of members (n = 20), Steering Group meetings, representation and communication system, facilitator, supportive research environment and access to research activities. Over 8 years, members were active in 218 research activities and held 22 Steering Group meetings. The model was named SUCCESS standing for Service Users with Chronic Conditions Encouraging Sensible Solutions. Conclusion We supported patients and carers to co-produce the SUCCESS model of involvement in research. The model’s components, addressing their needs and priorities, led to sustained involvement in research over 8 years. Further work is needed to apply the model in different settings and assess impact of this method of involving people in research

Building an understanding of Ethnic minority people’s Service Use Relating to Emergency care for injuries: the BE SURE study protocol

Introduction: Injuries are a major public health problem which can lead to disability or death. However, little is known about the incidence, presentation, management and outcomes of emergency care for patients with injuries among people from ethnic minorities in the UK. The aim of this study is to investigate what may differ for people from ethnic minorities compared with white British people when presenting with injury to ambulance and Emergency Departments (EDs).Methods and analysis: This mixed methods study covers eight services, four ambulance services (three in England and one in Scotland) and four hospital EDs, located within each ambulance service. The study has five Work Packages (WP): (WP1) scoping review comparing mortality by ethnicity of people presenting with injury to emergency services; (WP2) retrospective analysis of linked NHS routine data from patients who present to ambulances or EDs with injury over 5 years (2016–2021); (WP3) postal questionnaire survey of 2000 patients (1000 patients from ethnic minorities and 1000 white British patients) who present with injury to ambulances or EDs including self-reported outcomes (measured by Quality of Care Monitor and Health Related Quality of Life measured by SF-12); (WP4) qualitative interviews with patients from ethnic minorities (n=40) and focus groups—four with asylum seekers and refugees and four with care providers and (WP5) a synthesis of quantitative and qualitative findings.Ethics and dissemination: This study received a favourable opinion by the Wales Research Ethics Committee (305391). The Health Research Authority has approved the study and, on advice from the Confidentiality Advisory Group, has supported the use of confidential patient information without consent for anonymised data. Results will be shared with ambulance and ED services, government bodies and third-sector organisations through direct communications summarising scientific conference proceedings and publications

Paramedics’ experiences of administering fascia iliaca compartment block to patients in South Wales with suspected hip fracture at the scene of injury: results of focus groups

Objectives To explore paramedics’ experience of delivering fascia iliaca compartment block (FICB) to patients with suspected hip fracture at the scene of injury.Design Focus groups within a randomised controlled trial.Setting Paramedics based at ambulance stations in the catchment area of one Emergency Department in South Wales, recruited and trained in a feasibility study about an alternative to routine prehospital pain management for patients with suspected hip fracture.Participants 11 paramedics.Intervention Paramedic-administered FICB to patients with suspected hip fracture. We randomly allocated eligible patients to FICB, a local anaesthetic injection directly into the hip region—or usual care, most commonly morphine - using audited scratch cards.Outcomes Paramedics’ experiences of administering FICB gathered through thematic analysis of interview transcripts by two researchers, one paramedic and one lay member.Results Respondents believed that FICB was a suitable intervention for paramedics to deliver. It aligned with routine practice and was within people’s capabilities. They said it took up to 10 minutes longer than usual care to prepare and deliver, in part due to nervousness and unfamiliarity with a new procedure. They praised the training provided but said they were anxious about causing harm by injecting into the wrong location. Confidence increased after one paramedic team successfully treated a patient for local anaesthetic toxicity. Reported challenges related to the emergency context: patients often waited many hours for ambulance arrival; moving patients exacerbated their pain; family and neighbours were present as paramedics administered treatment.Conclusions Paramedics are willing and able to administer FICB to patients with suspected hip fracture before ambulance transport to hospital. Feasibility study findings will inform further research