Take-home naloxone in multicentre emergency settings: the TIME feasibility cluster RCT.

Background: Opioids kill more people than any other drug. Naloxone is an opioid antagonist which can be distributed in take-home 'kits' for peer administration (take-home naloxone). Aim: To determine the feasibility of carrying out a definitive randomised controlled trial of take-home naloxone in emergency settings. Design: We used Welsh routine data (2015-21) to test the feasibility of developing a discriminant function to identify people at high risk of fatal opioid overdose. We carried out a cluster randomised controlled trial and qualitative study to examine experiences of service users and providers. We assessed feasibility of intervention and trial methods against predetermined progression criteria related to: site sign-up, staff trained, identification of eligible patients, proportion given kits, identification of people who died of opioid poisoning, data linkage and retrieval of outcomes. Setting: This study was carried out in the emergency environment; sites comprised an emergency department and associated ambulance service catchment area. Participants: At intervention sites, we invited emergency department clinicians and paramedics to participate. We recruited adult patients who arrived at the emergency department or were attended to by ambulance paramedics for a problem related to opioid use with capacity to consent to receiving the take-home naloxone and related training. Interventions: Usual care comprised basic life support plus naloxone by paramedics or emergency department staff. The take-home naloxone intervention was offered in addition to usual care, with guidance for recipients on basic life support, the importance of calling the emergency services, duration of effect, safety and legality of naloxone administration. Discriminant function: With low numbers of opioid-related deaths (1105/3,227,396) and a high proportion having no contact with health services in the year before death, the predictive link between death and opioid-related healthcare events was weak. Logistic regression models indicated we would need to monitor one-third of the population to capture 75% of the decedents from opioid overdose in 1-year follow-up. Randomised controlled trial: Four sites participated in the trial and 299 of 687 (44%) eligible clinical staff were trained. Sixty take-home naloxone kits were supplied to patients during 1-year recruitment. Eligible patients were not offered take-home naloxone kits 164 times: 'forgot' (n = 136); 'too busy' (n = 15); suspected intentional overdose (n = 3). Qualitative interviews: Service users had high levels of knowledge about take-home naloxone. They were supportive of the intervention but noted concerns about opioid withdrawal and resistance to attending hospital for an overdose. Service providers were positive about the intervention but reported barriers including difficulty with consenting and training high-risk opioid users. Health economics: We were able to calculate costs to train staff at three sites (£40 per AS and £17 in Site 1 ED). No adverse events were reported. Progression criteria were not met - fewer than 50% of eligible staff were trained, fewer than 50% of eligible patients received the intervention and outcomes were not retrieved within reasonable timescales. Future work: The take-home naloxone intervention needs to be developed and evaluated in emergency care settings, with appropriate methods. Limitations: The Take-home naloxone Intervention Multicentre Emergency setting study was interrupted by coronavirus disease. Conclusions: This study did not meet progression criteria for intervention or trial methods feasibility, so outcomes were not followed up and a fully powered trial is not planned. Trial registration: This trial is registered as ISRCTN13232859. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/91/04) and is published in full in Health Technology Assessment; Vol. 28, No. 74. See the NIHR Funding and Awards website for further award information.

This study found that it was not feasible to deliver or evaluate this form of take-home naloxone, using this study design, in emergency care.

Routine outcomes to investigate differences between ethnic minorities and White British people presenting to emergency services for injury: the stakeholder consultation.

Introduction: Research has found differences in processes and outcomes of care between people in ethnic minorities and White British populations in some clinical conditions, although findings have been mixed. The Building an understanding of Ethnic minority people's Service Use Relating to Emergency care for injuries study is investigating differences in presentation, experience and health outcomes between people from ethnic minorities and White British people who seek emergency health care for injury. Objective: Our aim was to consult with stakeholders to define measurable outcomes available in routine ambulance and emergency department data; to assess the appropriateness of existing outcome measures for ethnic minorities and White British people; and to identify any gaps. Method: Clinicians, public contributors, researchers, people from the third sector, public health, healthcare inclusion were invited to join an online workshop to discuss routine outcomes. Results: Twenty participants attended the stakeholder consultation, with only one being a public contributor, a limitation. Eleven were from a minority ethnic background and seven were female. The integrated list of outcomes included 25 items, combining routine outcomes from the Building an understanding of Ethnic minority people's Service Use Relating to Emergency care for injuries protocol and literature (n = 17) with additional outcomes (n = 8). Notably, the initial list lacked provisions for safeguarding referrals and cases of treatment refusal, which were new additions. Safety concerns arose due to the lack of safeguarding referrals, treatment refusal and self-discharge. Factors such as pre-existing health conditions, injury location and experiences of discrimination were identified as possible influences on care quality and waiting times for ethnic minority patients. Conclusion: Although the number of stakeholders taking part in our consultation was low, their participation identified outcomes not found in routine data, supporting the adoption of a mixed-methods approach to answer our research questions. A future consultation could look to include more public members and wider range of clinicians including those who work in safeguarding and rehabilitation services. Funding: This article presents independent research funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme as award number NIHR132744.

Research has shown that people from ethnic minorities often have less favourable healthcare experiences and outcomes than white British people. Our BE SURE study aims to establish whether there are differences between these groups and whether this can be seen in routinely available health outcome data or through patients' own words through questionnaires and interviews. Before starting data collection, we wanted to consult with people who may deliver or receive emergency health care for injuries, about what routinely available healthcare measures and outcomes we should include in the study. Twenty stakeholders joined the meeting: clinicians, paramedics, researchers and representatives from healthcare organisations, the third sector and a public contributor. We firstly explained what the study was about, and what we hoped to achieve during the online consultation meeting. We presented examples of measurable outcomes that we had included in our original research proposal for injuries. We broke into small groups to discuss these outcome measures and identify gaps. We also asked for comments and suggestions to check the appropriateness of these measures. Participants agreed that the proposed measures were mostly appropriate; these included tests, treatments, waiting times, referrals to other doctors, leaving the hospital against medical advice and time spent in the emergency department. They identified two new outcomes, which were safeguarding referrals and refusal of treatment. The final agreed list of outcomes was 25. Participants also discussed disparities in medication and treatments provided to ethnic minorities compared to white British people, such as pain relief. Additionally, they explored various factors that could affect care differently across these groups. For instance, ethnic minorities may experience discrimination, have distinct health issues or experience variations in the location, nature and severity of injuries. These factors could influence waiting times, pain management and overall quality of care.

Transient Ischaemic attack Emergency Referral (TIER): randomised feasibility trial results.

BACKGROUND: Early assessment of patients with suspected transient ischaemic attack (TIA) is crucial to provision of effective care, including initiation of preventive therapies and identification of stroke mimics. Many patients with TIA present to emergency medical services (EMS) but may not require hospitalisation. Paramedics could identify and refer patients with low-risk TIA, without conveyance to the ED. Safety and effectiveness of this model is unknown. AIM: To assess the feasibility of undertaking a fully powered randomised controlled trial (RCT) to evaluate clinical and cost-effectiveness of paramedic referral of patients who call EMS with low-risk TIA to TIA clinic, avoiding transfer to ED. METHODS: The Transient Ischaemic attack Emergency Referral (TIER) intervention was developed through a survey of UK ambulance services, a scoping review of evidence of prehospital care of TIA and convening a specialist clinical panel to agree its final form. Paramedics in South Wales, UK, were randomly allocated to trial intervention (TIA clinic referral) or control (usual care) arms, with patients' allocation determined by that of attending paramedics.Predetermined progression criteria considered: proportion of patients referred to TIA clinic, data retrieval, patient satisfaction and potential cost-effectiveness. RESULTS: From December 2016 to September 2017, eighty-nine paramedics recruited 53 patients (36 intervention; 17 control); 48 patients (31 intervention; 17 control) consented to follow-up via routine data. Three intervention patients, of seven deemed eligible, were referred to TIA clinic by paramedics. Contraindications recorded for the other intervention arm patients were: Face/Arms/Speech/Time positive (n=13); ABCD2 score >3 (n=5); already anticoagulated (n=2); crescendo TIA (n=1); other (n=8). Routinely collected electronic health records, used to report further healthcare contacts, were obtained for all consenting patients. Patient-reported satisfaction with care was higher in the intervention arm (mean 4.8/5) than the control arm (mean 4.2/5). Health economic analysis suggests an intervention arm quality-adjusted life-year loss of 0.0094 (95% CI -0.0371, 0.0183), p=0.475. CONCLUSION: The TIER feasibility study did not meet its progression criteria, largely due to low patient identification and referral rates. A fully powered RCT in this setting is not recommended. TRIAL REGISTRATION NUMBER: ISRCTN85516498.

Evaluation of different models of general practitioners working in or alongside emergency departments: a mixed-methods realist evaluation.

Background: Emergency healthcare services are under intense pressure to meet increasing patient demands. Many patients presenting to emergency departments could be managed by general practitioners in general practitioner-emergency department service models. Objectives: To evaluate the effectiveness, safety, patient experience and system implications of the different general practitioner-emergency department models. Design: Mixed-methods realist evaluation. Methods: Phase 1 (2017-8), to understand current practice: rapid realist literature review, national survey and follow-up key informant interviews, national stakeholder event and safety data analysis. Phase 2 (2018-21), to collect and analyse qualitative (observations, interviews) and quantitative data (time series analysis); cost-consequences analysis of routine data; and case site data for 'marker condition' analysis from a purposive sample of 13 case sites in England and Wales. Phase 3 (2021-2), to conduct mixed-methods analysis for programme theory and toolkit development. Results: General practitioners commonly work in emergency departments, but delivery models vary widely in terms of the scope of the general practitioner role and the scale of the general practitioner service. We developed a taxonomy to describe general practitioner-emergency department service models (Integrated with the emergency department service, Parallel within the emergency department, Outside the emergency department on the hospital site) and present a programme theory as principal output of the study to describe how these service models were observed to operate. Routine data were of variable quality, limiting our analysis. Time series analysis demonstrated trends across intervention sites for: increased time spent in the emergency department; increased emergency department attendances and reattendances; and mixed results for hospital admissions. Evidence on patient experience was limited but broadly supportive; we identified department-level processes to optimise the safety of general practitioner-emergency department models. Limitations: The quality, heterogeneity and extent of routine emergency department data collection during the study period limited the conclusions. Recruitment was limited by criteria for case sites (time series requirements) and individual patients (with 'marker conditions'). Pandemic and other pressures limited data collection for marker condition analysis. Data collected and analysed were pre pandemic; new approaches such as 'telephone first' and their relevance to our findings remains unexplored. Conclusion: Findings suggest that general practitioner-emergency department service models do not meet the aim of reducing the overall emergency department waiting times and improving patient flow with limited evidence of cost savings. Qualitative data indicated that general practitioners were often valued as members of the wider emergency department team. We have developed a toolkit, based on our findings, to provide guidance for implementing and delivering general practitioner-emergency department services. Future work: The emergency care data set has since been introduced across England to help standardise data collection to facilitate further research. We would advocate the systematic capture of patient experience measures and patient-reported outcome measures as part of routine care. More could be done to support the development of the general practitioner in emergency department role, including a core set of competencies and governance structure, to reflect the different general practitioner-emergency department models and to evaluate the effectiveness and cost effectiveness to guide future policy. Study registration: This study is registered as PROSPERO CRD42017069741. Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: 15/145/04) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 10. See the NIHR Funding and Awards website for further award information.

Hospital emergency departments are under huge pressure. Patients are waiting many hours to be seen, some with problems that general practitioners could deal with. To reduce waiting times and improve patient care, arrangements have been put in place for general practitioners to work in or alongside emergency departments (general practitioner­emergency department models). We studied the different ways of working to find out what works well, how and for whom. We brought together a lot of information. We reviewed existing evidence, sent out surveys to 184 emergency departments, spent time in the emergency departments observing how they operated and interviewing 106 staff in 13 hospitals and 24 patients who visited those emergency departments. We also looked at statistical information recorded by hospitals. Two public contributors were involved from the beginning, and we held two stakeholder events to ensure the relevance of our research to professionals and patients. Getting reliable figures to compare the various general practitioner­emergency department set-ups (inside, parallel to or outside the emergency department) was difficult. Our findings suggest that over time more people are coming to emergency departments and overall waiting times did not generally improve due to general practitioner­emergency department models. Evidence that general practitioners might admit fewer patients to hospital was mixed, with limited findings of cost savings. Patients were generally supportive of the care they received, although we could not speak to as many patients as we planned. The skills and experience of general practitioners were often valued as members of the wider emergency department team. We identified how the care provided was kept safe with: strong leaders, good communication between different types of staff, highly trained and experienced nurses responsible for streaming and specific training for general practitioners on how they were expected to work. We have produced a guide to help professionals develop and improve general practitioner­emergency department services and we have written easy-to-read summaries of all the articles we published.

Programme theories to describe how different general practitioner service models work in different contexts in or alongside emergency departments (GP-ED): realist evaluation.

BACKGROUND: Addressing increasing patient demand and improving ED patient flow is a key ambition for NHS England. Delivering general practitioner (GP) services in or alongside EDs (GP-ED) was advocated in 2017 for this reason, supported by £100 million (US$130 million) of capital funding. Current evidence shows no overall improvement in addressing demand and reducing waiting times, but considerable variation in how different service models operate, subject to local context. METHODS: We conducted mixed-methods analysis using inductive and deductive approaches for qualitative (observations, interviews) and quantitative data (time series analyses of attendances, reattendances, hospital admissions, length of stay) based on previous research using a purposive sample of 13 GP-ED service models (3 inside-integrated, 4 inside-parallel service, 3 outside-onsite and 3 with no GPs) in England and Wales. We used realist methodology to understand the relationship between contexts, mechanisms and outcomes to develop programme theories about how and why different GP-ED service models work. RESULTS: GP-ED service models are complex, with variation in scope and scale of the service, influenced by individual, departmental and external factors. Quantitative data were of variable quality: overall, no reduction in attendances and waiting times, a mixed picture for hospital admissions and length of hospital stay. Our programme theories describe how the GP-ED service models operate: inside the ED, integrated with patient flow and general ED demand, with a wider GP role than usual primary care; outside the ED, addressing primary care demand with an experienced streaming nurse facilitating the 'right patients' are streamed to the GP; or within the ED as a parallel service with most variability in the level of integration and GP role. CONCLUSION: GP-ED services are complex . Our programme theories inform recommendations on how services could be modified in particular contexts to address local demand, or whether alternative healthcare services should be considered.

The cost of implementing the COVID-19 shielding policy in Wales.

BACKGROUND: The EVITE Immunity study investigated the effects of shielding Clinically Extremely Vulnerable (CEV) people during the COVID-19 pandemic on health outcomes and healthcare costs in Wales, United Kingdom, to help prepare for future pandemics. Shielding was intended to protect those at highest risk of serious harm from COVID-19. We report the cost of implementing shielding in Wales. METHODS: The number of people shielding was extracted from the Secure Anonymised Information Linkage Databank. Resources supporting shielding between March and June 2020 were mapped using published reports, web pages, freedom of information requests to Welsh Government and personal communications (e.g. with the office of the Chief Medical Officer for Wales). RESULTS: At the beginning of shielding, 117,415 people were on the shielding list. The total additional cost to support those advised to stay home during the initial 14 weeks of the pandemic was £13,307,654 (£113 per person shielded). This included the new resources required to compile the shielding list, inform CEV people of the shielding intervention and provide medicine and food deliveries. The list was adjusted weekly over the 3-month period (130,000 people identified by June 2020). Therefore the cost per person shielded lies between £102 and £113 per person. CONCLUSION: This is the first evaluation of the cost of the measures put in place to support those identified to shield in Wales. However, no data on opportunity cost was available. The true costs of shielding including its budget impact and opportunity costs need to be investigated to decide whether shielding is a worthwhile policy for future health emergencies.

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.

Implementing public involvement throughout the research process-Experience and learning from the GPs in EDs study.

BACKGROUND: Public involvement in health services research is encouraged. Descriptions of public involvement across the whole research cycle of a major study are uncommon and its effects on research conduct are poorly understood. AIM: This study aimed to describe how we implemented public involvement, reflect on process and effects in a large-scale multi-site research study and present learning for future involvement practice. METHOD: We recorded public involvement roles and activities throughout the study and compared these to our original public involvement plan included in our project proposal. We held a group interview with study co-applicants to explore their experiences, transcribed the recorded discussion and conducted thematic analysis. We synthesized the findings to develop recommendations for future practice. RESULTS: Public contributors' activities went beyond strategic study planning and management to include active involvement in data collection, analysis and dissemination. They attended management, scrutiny, planning and task meetings. They also facilitated public involvement through annual planning and review sessions, conducted a Public Involvement audit and coordinated public and patient input to stakeholder discussions at key study stages. Group interview respondents said that involvement exceeded their expectations. They identified effects such as changes to patient recruitment, terminology clarification and extra dissemination activities. They identified factors enabling effective involvement including team and leader commitment, named support contact, building relationships and demonstrating equality and public contributors being confident to challenge and flexible to meet researchers' timescales and work patterns. There were challenges matching resources to roles and questions about the risk of over-professionalizing public contributors. CONCLUSION: We extended our planned approach to public involvement and identified benefits to the research process that were both specific and general. We identified good practice to support effective public involvement in health services research that study teams should consider in planning and undertaking research. PUBLIC CONTRIBUTION: This paper was co-conceived, co-planned and co-authored by public contributors to contribute research evidence, based on their experiences of active involvement in the design, implementation and dissemination of a major health services research study.

STRategies to manage Emergency ambulance Telephone Callers with sustained High needs: an Evaluation using linked Data (STRETCHED) - a study protocol.

INTRODUCTION: UK ambulance services have identified a concern with high users of the 999 service and have set up 'frequent callers' services, ranging from within-service management to cross-sectoral multidisciplinary case management approaches. There is little evidence about how to address the needs of this patient group. AIM: To evaluate effectiveness, safety and efficiency of case management approaches to the care of people who frequently call the emergency ambulance service, and gain an understanding of barriers and facilitators to implementation. OBJECTIVES: (1) Develop an understanding of predicted mechanisms of change to underpin evaluation. (2) Describe epidemiology of sustained high users of 999 services. (3) Evaluate case management approaches to the care of people who call the 999 ambulance service frequently in terms of: (i) Further emergency contacts (999, emergency department, emergency admissions to hospital) (ii) Effects on other services (iii) Adverse events (deaths, injuries, serious medical emergencies and police arrests) (iv) Costs of intervention and care (v) Patient experience of care. (4) Identify challenges and opportunities associated with using case management models, including features associated with success, and develop theories about how case management works in this population. METHODS AND ANALYSIS: We will conduct a multisite mixed-methods evaluation of case management for people who use ambulance services frequently by using anonymised linked routine data outcomes in a 'natural experiment' cohort design, in four regional ambulance services. We will conduct interviews and focus groups with service users, commissioners and emergency and non-acute care providers. The planned start and end dates of the study are 1 April 2019 and 1 September 2022, respectively ETHICS AND DISSEMINATION: The study received approval from the UK Health Research Authority (Confidentiality Advisory Group reference number: 19/CAG/0195; research ethics committee reference number: 19/WA/0216).We will collate feedback from our Lived Experience Advisory Panel, the Frequent Caller National Network and Research Management Group for targeted dissemination activities.

Patients' experiences of attending emergency departments where primary care services are located: qualitative findings from patient and clinician interviews from a realist evaluation.

BACKGROUND: Patient experience is an important outcome and indicator of healthcare quality, and patient reported experiences are key to improving quality of care. While patient experience in emergency departments (EDs) has been reported in research, there is limited evidence about patients' specific experiences with primary care services located in or alongside EDs. We aim to identify theories about patient experience and acceptability of being streamed to a primary care clinician in an ED. METHODS: Using theories from a rapid realist review as a basis, we interviewed 24 patients and 106 staff members to generate updated theories about patient experience and acceptability of streaming to primary care services in EDs. Feedback from 56 stakeholders, including clinicians, policymakers and patient and public members, as well as observations at 13 EDs, also contributed to the development of these theories, which we present as a programme theory. RESULTS: We found that patients had no expectations or preferences for which type of clinician they were seen by, and generally found being streamed to a primary care clinician in the ED acceptable. Clinicians and patients reported that patients generally found primary care streaming acceptable if they felt their complaint was dealt with suitably, in a timely manner, and when clinicians clearly communicated the need for investigations, and how these contributed to decision-making and treatment plans. CONCLUSIONS: From our findings, we have developed a programme theory to demonstrate that service providers can expect that patients will be generally satisfied with their experience of being streamed to, and seen by, primary care clinicians working in these services. Service providers should consider the potential advantages and disadvantages of implementing primary care services at their ED. If primary care services are implemented, clear communication is needed between staff and patients, and patient feedback should be sought.

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

BACKGROUND: 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. AIM: To explore GPs' and practice managers' experiences of incorporating PRISM into routine practice. DESIGN AND SETTING: Semi-structured interviews were carried out with GPs and practice managers in 18 practices in rural, urban, and suburban areas of south Wales. METHOD: 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. RESULTS: Responders (n = 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. CONCLUSION: 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.

Evaluation of the shielding initiative in Wales (EVITE Immunity): protocol for a quasiexperimental study.

INTRODUCTION: Shielding aimed to protect those predicted to be at highest risk from COVID-19 and was uniquely implemented in the UK during the COVID-19 pandemic. Clinically extremely vulnerable people identified through algorithms and screening of routine National Health Service (NHS) data were individually and strongly advised to stay at home and strictly self-isolate even from others in their household. This study will generate a logic model of the intervention and evaluate the effects and costs of shielding to inform policy development and delivery during future pandemics. METHODS AND ANALYSIS: This is a quasiexperimental study undertaken in Wales where records for people who were identified for shielding were already anonymously linked into integrated data systems for public health decision-making. We will: interview policy-makers to understand rationale for shielding advice to inform analysis and interpretation of results; use anonymised individual-level data to select people identified for shielding advice in March 2020 and a matched cohort, from routine electronic health data sources, to compare outcomes; survey a stratified random sample of each group about activities and quality of life at 12 months; use routine and newly collected blood data to assess immunity; interview people who were identified for shielding and their carers and NHS staff who delivered healthcare during shielding, to explore compliance and experiences; collect healthcare resource use data to calculate implementation costs and cost-consequences. Our team includes people who were shielding, who used their experience to help design and deliver this study. ETHICS AND DISSEMINATION: The study has received approval from the Newcastle North Tyneside 2 Research Ethics Committee (IRAS 295050). We will disseminate results directly to UK government policy-makers, publish in peer-reviewed journals, present at scientific and policy conferences and share accessible summaries of results online and through public and patient networks.

Asylum seekers' and refugees' experiences of accessing health care: a qualitative study.

BACKGROUND: Asylum seekers and refugees (ASRs) often experience poor health in host countries. The United Nations High Commissioner for Refugees (UNHCR) requires hosts to ensure these sanctuary seekers have access to basic health care. AIM: To identify barriers and facilitators that affect access to health care by ASRs in Wales. DESIGN & SETTING: Participatory research approach using qualitative focus groups across Wales, which hosts 10 000 refugees. METHOD: Eight focus groups were undertaken with ASRs, support workers, and volunteers (n = 57). RESULTS: Specialist NHS-funded services and grant-aided non-governmental organisations (NGOs) facilitated access to health care, including primary care. Most ASRs understood the role of general practice in providing and coordinating care, but were unaware of out-of-hours services. Reported barriers included: language difficulties, health literacy, unrecognised needs, and the cost of travel to appointments. Participants recognised the importance of mental health, but were disappointed by the state of mental health care. Some feared seeking support for mental health from their GP, and few were aware they had the right to move practice if they were unhappy. Written information about health care was not as accessible to refugees as to asylum seekers (ASs). While some participants read such material before consulting, others struggled to access information when in need. Few participants were aware of health prevention services. Even when they knew about services, such as smoking cessation, these services' difficulty in accommodating ASRs was a barrier. CONCLUSION: The main barriers identified were: availability of interpreters; knowledge about entitlements; and access to specialist services.

Call volume, triage outcomes, and protocols during the first wave of the COVID-19 pandemic in the United Kingdom: Results of a national survey.

OBJECTIVES: During the first wave of the COVID-19 pandemic in the United Kingdom (UK), to describe volume and pattern of calls to emergency ambulance services, proportion of calls where an ambulance was dispatched, proportion conveyed to hospital, and features of triage used. METHODS: Semistructured electronic survey of all UK ambulance services (n = 13) and a request for routine service data on weekly call volumes for 22 weeks (February 1-July 3, 2020). Questionnaires and data request were emailed to chief executives and research leads followed by email and telephone reminders. The routine data were analyzed using descriptive statistics, and questionnaire data using thematic analysis. RESULTS: Completed questionnaires were received from 12 services. Call volume varied widely between services, with a UK peak at week 7 at 13.1% above baseline (service range -0.5% to +31.4%). All services ended the study period with a lower call volume than at baseline (service range -3.7% to -25.5%). Suspected COVID-19 calls across the UK totaled 604,146 (13.5% of all calls), with wide variation between services (service range 3.7% to 25.7%), and in service peaks of 11.4% to 44.5%. Ambulances were dispatched to 478,638 (79.2%) of these calls (service range 59.0% to 100.0%), with 262,547 (43.5%) resulting in conveyance to hospital (service range 32.0% to 53.9%). Triage models varied between services and over time. Two primary call triage systems were in use across the UK. There were a large number of products and arrangements used for secondary triage, with services using paramedics, nurses, and doctors to support decision making in the call center and on scene. Frequent changes to triage processes took place. CONCLUSIONS: Call volumes were highly variable. Case mix and workload changed significantly as COVID-19 calls displaced other calls. Triage models and prehospital outcomes varied between services. We urgently need to understand safety and effectiveness of triage models to inform care during further waves and pandemics.

Identifying safe care processes when GPs work in or alongside emergency departments: a realist evaluation.

BACKGROUND: Increasing pressure on emergency services has led to the development of different models of care delivery including GPs working in or alongside emergency departments (EDs), but with a lack of evidence for patient safety outcomes. AIM: This study aimed to explore how care processes work and how patient safety incidents associated with GPs working in ED settings may be mitigated. DESIGN AND SETTING: Realist methodology with a purposive sample of 13 EDs in England and Wales with different GP service models. The study sought to understand the relationship between contexts, mechanisms, and outcomes to develop theories about how and why patient safety incidents may occur, and how safe care was perceived to be delivered. METHOD: Qualitative data were collected (observations, semi-structured audio-recorded staff interviews, and local patient safety incident reports). Data were coded using 'if, then, because' statements to refine initial theories developed from an earlier rapid realist literature review and analysis of a sample of national patient safety incident reports. RESULTS: The authors developed a programme theory to describe how safe patient care was perceived to be delivered in these service models, including: an experienced streaming nurse using local guidance and early warning scores; support for GPs' clinical decision making, with clear governance processes relevant to the intended role (traditional GP approach or emergency medicine approach); and strong clinical leadership to promote teamwork and improve communication between services. CONCLUSION: The findings of this study can be used as a focus for more in-depth human factors investigations to optimise work conditions in this complex care delivery setting.

Parent recommendations to support physical activity for families with young children: Results of interviews in deprived and affluent communities in South Wales (United Kingdom).

BACKGROUND: Physical inactivity is the fourth leading cause of mortality worldwide. Early childhood is a critical period when healthy behaviours can be instilled for a future active lifestyle. We explored community, societal and environmental factors affecting child and family physical activity and sought parent recommendations to support physical activity in families with young children. METHODS: We interviewed 61 parents expecting a child or with a baby ≤12 months (35 mother and father paired interviews and 26 interviews with mothers only). We purposively sampled families for neighbourhood deprivation status (Townsend Index; 26 affluent; 35 deprived). We conducted thematic analysis of interview transcripts using Bronfenbrenner's socio-ecological framework to guide interpretation. RESULTS: We identified four themes: work family-life balance; spaces for activity; beliefs and attitudes; and physical activity facilitators. We found that parents from deprived neighbourhoods were more likely to be underactive because of a complex web of community, social and personal factors which reduced motivation and hindered opportunity for physical activity. To increase knowledge and opportunity, respondents suggested 'help not tell' messages covering 'why', 'how' and 'where' information about physical activity, and using physical activity to support community engagement and social interaction. CONCLUSIONS: Recommendations from parents highlight effective communication about the importance of early child and family physical activity and improved community access to safe facilities and opportunities. Both parents need to be engaged in designing interventions to support greater physical activity and healthy behaviours which are relevant and achievable in individuals' lives.

Public involvement and engagement in primary and emergency care research: the story from PRIME Centre Wales.

BACKGROUND: Policy throughout the United Kingdom promotes involvement of patients and public members in research to benefit patient care and health outcomes. PRIME Centre Wales is a national research centre, developing and coordinating research about primary and emergency care which forms 90% of health service encounters. In this paper, we describe our approach to public involvement and engagement in PRIME Centre Wales (hereafter called PRIME), in particular: how this approach has developed; ways in which public members contribute to PRIME activity; the strengths and limitations of our approach, challenges and future opportunities. PRIME ensures work is relevant to service users, carers, the public and policy makers by incorporating comprehensive patient and public involvement in every phase of our work. APPROACH: PRIME has policies and processes to enable and promote successful public involvement and engagement across research activities. This ensures public perspectives and patient experiences are integrated throughout research development, implementation and dissemination and in managing and delivering PRIME strategy over a 10 year timescale. A public/patient group called SUPER is a key resource providing wide-ranging perspectives via email and face-to-face discussion. We collect information on processes and experiences to assess value and impact, to guide ongoing involvement and engagement. A funded post provides leadership and support to staff and to public/patient contributors to facilitate collaborations. DISCUSSION: A stable, well-resourced structure has provided the timescales to build strong relationships and embed diverse approaches to public involvement and engagement within PRIME. Researchers and public contributors have committed to collaborations, developed knowledge and skills and sustained relationships. Effective approaches incorporate values and actions which, when operating together, strengthen processes and outcomes of public involvement and engagement. CONCLUSION: Supportive context, motivation and time are necessary to foster values and practices that enable effective public involvement and engagement. PRIME has embedded public involvement and engagement across research activities and structures. Central is the public/patient group SUPER offering experience-based expertise to add value to the research cycle. This innovative model, aligned with best practice, enhances relevance and quality of primary and emergency care research to benefit patients and the general population.

Is fascia iliaca compartment block administered by paramedics for suspected hip fracture acceptable to patients? A qualitative study.

OBJECTIVE: To explore patients' experience of receiving pain relief injection for suspected hip fracture from paramedics at the location of the injury. DESIGN: Qualitative interviews within a feasibility trial about an alternative to routine prehospital pain management for patients with suspected hip fracture. SETTING: Patients treated by paramedics in the catchment area of one emergency department in South Wales. PARTICIPANTS: Six patients and one carer of a patient who received fascia iliaca compartment block (FICB). INTERVENTION: FICB administered to patients with suspected hip fracture by trained paramedics. 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: Acceptability and experience of receiving FICB, assessed through interview data. We audio-recorded, with participants' consent, and conducted thematic analysis of interview transcripts. The analysis team comprised two researchers, one paramedic and one lay member. RESULTS: Patients had little or no memory of being offered, consenting to or receiving FICB. They recalled the reassuring manner and high quality of care received. They accepted FICB without question. Partial or confused memory characterised experience of subsequent hospital care until surgery. They said their priorities when calling for emergency help were to receive effective care. After hospital treatment, they wanted to regain their health and mobility and resume the quality of life they experienced before their injury. CONCLUSIONS: This study did not raise any concerns about the acceptability of FICB administered at the scene of injury by paramedics to people with suspected hip fracture. It adds to existing evidence about patient and carer experience of on-scene care for people with suspected hip fracture. Further research is needed to assess safety, effectiveness and cost effectiveness of this health technology in a new setting. TRIAL REGISTRATION NUMBER: ISRCTN60065373.

The impact of general practitioners working in or alongside emergency departments: a rapid realist review.

OBJECTIVES: Worldwide, emergency healthcare systems are under intense pressure from ever-increasing demand and evidence is urgently needed to understand how this can be safely managed. An estimated 10%-43% of emergency department patients could be treated by primary care services. In England, this has led to a policy proposal and £100 million of funding (US$130 million), for emergency departments to stream appropriate patients to a co-located primary care facility so they are 'free to care for the sickest patients'. However, the research evidence to support this initiative is weak. DESIGN: Rapid realist literature review. SETTING: Emergency departments. INCLUSION CRITERIA: Articles describing general practitioners working in or alongside emergency departments. AIM: To develop context-specific theories that explain how and why general practitioners working in or alongside emergency departments affect: patient flow; patient experience; patient safety and the wider healthcare system. RESULTS: Ninety-six articles contributed data to theory development sourced from earlier systematic reviews, updated database searches (Medline, Embase, CINAHL, Cochrane DSR & CRCT, DARE, HTA Database, BSC, PsycINFO and SCOPUS) and citation tracking. We developed theories to explain: how staff interpret the streaming system; different roles general practitioners adopt in the emergency department setting (traditional, extended, gatekeeper or emergency clinician) and how these factors influence patient (experience and safety) and organisational (demand and cost-effectiveness) outcomes. CONCLUSIONS: Multiple factors influence the effectiveness of emergency department streaming to general practitioners; caution is needed in embedding the policy until further research and evaluation are available. Service models that encourage the traditional general practitioner approach may have shorter process times for non-urgent patients; however, there is little evidence that this frees up emergency department staff to care for the sickest patients. Distinct primary care services offering increased patient choice may result in provider-induced demand. Economic evaluation and safety requires further research. PROSPERO REGISTRATION NUMBER: CRD42017069741.

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

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.