NIHR HS&DR 18/03/02 STRETCHED (Snooks)

Swansea University requires access to NHS England data for the purpose of the following research project:

STRETCHED - STRategies to manage Emergency ambulance Telephone Callers with sustained High needs – an Evaluation using linked Data

Background

STRETCHED (“STRategies to manage Emergency ambulance Telephone Callers with sustained High needs – an Evaluation using linked Data”; IRAS ID 262419) is a study looking at the impact of multi-disciplinary case management approaches to handling frequent callers to the ambulance service. Frequent callers are defined as people who phone 999 more than 5 times in a month, or more than 12 times in three months. Frequent callers often have complex medical needs, but often do not require immediate medical attention.

Multi-disciplinary case management brings together professionals such as members of the ambulance service, primary and secondary care providers, third sector health and social care providers, the patient's GP, and mental health service providers. These professionals attend joint meetings to develop shared care plans that address the patient's needs more completely than any service could individually. As such, the nature of the case management process itself varies considerably from area to area, and from patient to patient.

STRETCHED will compare outcomes for frequent callers that do and do not receive case management according to a pre-specified statistical analysis plan to determine the safety and efficacy of this intervention. These outcomes include:

- further emergency contacts (999 calls, emergency department attendances and emergency admissions to hospital)

- effects on other services (including outpatients appointments, elective admissions, and GP contacts);

- adverse events, including patient safety (particularly mortality, but also injuries and serious medical emergencies, arrests/convictions, and complaints made by the patient about their local ambulance service);

- any associated costs/savings to the NHS.

Data from NHS England provided information on dates, times, reasons for, and outcomes of non-ambulance service NHS contacts by frequent callers. These Data are essential to understand the wider impact of the case management process, including whether any reduction in the number of 999 calls is a consequence of shifting demand elsewhere in the NHS.

STRETCHED has a sister project, INFORM (“Improving care for people who Frequently call 999: co-production of guidance through an Observational study using Routine linked data and Mixed methods”; IRAS ID 250693). INFORM is a Health and Care Research Wales Fellowship project looking at the epidemiology of frequent callers in Wales. INFORM will use data from the Secure Anonymised Information Linkage (SAIL) databank and qualitative interviews with stakeholders. INFORM will not use Data provided NHS England.

GDPR/Legal Basis

There is a quantitative and qualitative element to this project.

Section 251 support is in place for the Quantitative element. This element is observational, with a focus on describing the epidemiology of "frequent callers" and related outcomes,as obtained from retrospective routine data. This is the NHS England related part of the project.

Consent will be in place for the qualitative element - patient interviewees and focus group participants (health and allied care professionals). This is separate to the data linkage project done by NHS England.

Section 251 support from the Confidentiality Advisory Group (CAG) (Reference 19/CAG/0195) is in place to cover data flow and linkage to NHS England Data. GDPR Articles 6 (1) (e) and 9 (2) (j) are the legal basis for processing of these data.

Data will be processed under Article 6 (i) (e) of the General Data Protection Regulation – “task in the public interest”. Special categories of data will be processed under Article 9 (2) (j) – “… scientific or historical research purposes or statistical purposes…”. Ambulance services struggle to manage the volume of callers, and this is likely to get more difficult in the future. STRETCHED may help ambulance services better meet the needs of frequent callers and release capacity for more urgent cases. Therefore, this project, led by an experienced team from Swansea University – a leading UK medical school and research institution - is clearly in the public interest.

Cohort members were identified by research paramedics from frequent caller lists held by the East of England Ambulance Service, the London Ambulance Service, the West Midlands Ambulance Service, and the Welsh Ambulance Service. Cohort identification files were uploaded directly into NHS England by research paramedics in the East of England Ambulance Service, London Ambulance Service and West Midlands Ambulance Service. Cohort identification files for the Welsh Ambulance Service were sent to the NHS Wales Informatics Service, where a linking field was generated. This linking field was sent to the SAIL Databank (part of Swansea University), where it was used to identify the anonymised health records of patients in Wales.

The study management team (defined below) do not have access to direct patient identifiable Data. This methodology was approved by Wales Research Ethics Committee on 14 August 2019. Section 251 approval was granted by the Confidentiality Advisory Group on 27th May 2020.

COHORT

Cohort members were identified by research paramedics at each site (East of England Ambulance Service, London Ambulance Service, West Midlands Ambulance Service) screening the frequent callers list for people living in specific CCG areas added to the frequent callers list during 2018. If a list of frequent callers is not available from the time, frequent callers were identified by a database search of 999 calls for individuals making 5 or more calls in a single month. Nursing/care/residential homes and similar institutions were excluded. All adults that met these criteria were included in the study cohort; there were no further screening processes. The study cohort is approximately 1,264 frequent callers, aged 18 years and above. Cohort members are a mixture of ages, sex, and ethnicities, split approximately evenly across these ambulance services. Cohort members were identified by their local ambulance service. The East of England Ambulance Service, London Ambulance Service, and West Midlands Ambulance Service, will upload data directly into NHS England. The Welsh Ambulance Service uploaded data to the NHS Wales Informatics Service as described above.

Data items provide by NHS England include the date, time, reason for, and outcome of all accident and emergency department contacts, unplanned hospital admissions, and mortality, during the lead-in and follow-up periods. Patients who phone 999 might do so for any number of reasons and might contact any number of other agencies for any number of reasons. This data will determine if the case management intervention had any impact on other NHS Services (including health economics).

In addition - the pseudonymised demographic Data fields provided by NHS England are:

- the study ID,

- sex of patient,

- month and year of birth

It is not possible to flag for the presence/absence of an event. Analysis includes exploratory analysis across several time periods and consider frequency of events.

All possible filtering (e.g. by time, geography, or clinical factors) etc. was applied during cohort identification. Data could not be obtained by less intrusive methods. Any other approach would require contacting patients out of the blue, which is intrusive and could cause distress. Data would also be less reliable due to recall bias, the aforementioned complex/sensitive needs, the potential for missing data, and the possibility the patient has died since the time period under study.

For each cohort member, Swansea University requires Data for 6 months each side of the date they were first added to their local ambulance service frequent callers list in 2018 (6 months to establish a baseline, and 6 months follow-up). Swansea do not require Data outside this 1-year period for any given person. However, the overall dataset spans the period July 2017 to June 2019. This is 6 months before the earliest possible cohort member became eligible on 1st January 2018, to 6 months after the last (on 31st December 2018). Because HES extracts are packaged in financial years, Swansea University requires Data from 2017/18, 2018/19, and 2019/20 (with 17/18 Data from July 2017 onwards only, and 19/20 Data (April 2019 - July 2019)

DATA CONTROLLER/PROCESSOR

Swansea University is the sole data controller, who also process Data provided by NHS England.

The participating ambulance services are East of England Ambulance Service, London Ambulance Service, West Midlands Ambulance Service, and the Welsh Ambulance Service. Research paramedics from each ambulance service identified the study cohort from data held by that ambulance service, and uploaded patient identifiers using NHS England's Secure Electronic File Transfer platform (or to the NHS Wales Informatics Service in the case of the Welsh Ambulance Service). Each ambulance service is the sole data controller for the underlying data from which the study cohort for that service is drawn. The ambulance services are neither data controllers nor data processors for NHS England Data.

The study sponsor is Swansea University: It's the sponsor who determines what data is collected for the research study through the protocol, case report form and/or structured data fields in a database. The sponsor therefore acts as the controller in relation to the research data.

A study management group consists of academics, researchers, methodologists and administrators from Swansea University, Cardiff University, Northumbria University, and Lincoln University; representatives of the four participating ambulance services; and two lay members. The study management group advised the sponsor (Swansea University) regarding the overall study design. The study management group will review aggregated data with small numbers suppressed from the analysis but not make decisions regarding data processing, and do not have access to record-level Data. The study management group, and their respective organisations (with the sole exception of Swansea University) are neither data controllers nor data processors."

There is also a study steering committee, which provides independent oversight of the study. The steering committee consists of experts in prehospital and emergency care, methodological experts, stakeholder representatives (including ambulance services, the UK Frequent Callers Network, the police, and charities), and lay representatives. The steering committee does not make any decisions regarding data processing and are neither data controllers nor data processors. They will not see record-level NHS England Data, only anonymous, aggregated data with small numbers suppressed from the statistical analysis.

FUNDER

The project is funded by the National Institute for Health Research (NIHR; Health Services and Delivery Research programme). The NIHR has no ongoing involvement in study management, data analysis, or interpretation of study findings. The NIHR is neither a data controller nor a data processor for the STRETCHED project.

DATA FLOW

Frequent callers were identified retrospectively by research paramedics at the East of England Ambulance Service, the London Ambulance Service, the West Midlands Ambulance Service, and the Welsh Ambulance Service). The cohort consists of 846 patients who were identified and traced for NHS England linkage.

Researcher paramedics at the East of England Ambulance Service, London Ambulance Service, and West Midlands Ambulance Service provided the following identifiable data to NHS England to enable cohort linkage:

• NHS Number,

• Postcode – District Level,

• Date of Birth,

• Sex.

Equivalent data for the Welsh Ambulance Service was uploaded to the NHS Wales Informatics Service, where a linking field was generated. This linking field was then sent to the SAIL Databank (Swansea University) where it was used to identify the anonymous health records for patients in Wales.

The statistical analysis team at Swansea University do not have access to patient identifiable information; the statistical analysis team at Swansea University accessed study ID, month and year of birth, sex, and ethnicity. Only NHS England or NHS Wales Informatics Service (as appropriate) and the ambulance service providing the data had access to any patient’s NHS number, postcode district, and full date of birth.

The East of England Ambulance Service, London Ambulance Service, and West Midlands Ambulance Service provided data to Swansea University. This was linked with the HES Data provided by NHS England (via the Study ID). Linkage to the following study data was performed by Swansea University:

- the date cohort members were added to, or removed from, the ambulance service frequent callers list

- the date, time, reason for, and outcome of 999 calls made by cohort members during the study period.

- the date, time, condition codes and outcome of any ambulance call-outs to cohort members during the study period

Equivalent data for the Welsh Ambulance Service was imported into SAIL Databank instead.

Record-level Data from NHS England and NHS Wales Informatics Service, including the ambulance service data on 999 calls and ambulance call-outs, was imported into the SAIL Databank for analysis. The SAIL Databank is a secure data haven hosted at Swansea University. Access to data in the SAIL Databank is restricted to specific, authorised users with appropriate training as described below.

There will be no subsequent flow of record-level Data. Data will not be matched to other publicly available data, and there will be no attempt to re-identify individuals. Record level Data will not be shared with the research management group, the study steering committee; or the participating ambulance services (East of England Ambulance Service, London Ambulance Service, West Midlands Ambulance Service and the Welsh Ambulance Service). All study outputs, and all statistical analysis findings, will report anonymous, aggregated data with small numbers suppressed only in line with the HES analysis guide.

DATA REQUESTED

STRETCHED is investigating the impact of multidisciplinary case management on frequent callers to the ambulance service. Outcomes include:

- any change to the number of 999 calls made,

- any impact on the wider health service (including emergency department attendances, emergency hospital admissions, outpatient appointments, elective admissions),

- signs of any adverse impact on the patient (including mortality, serious medical emergencies, other injuries, arrests, convictions, and patient complaints about their local ambulance service).

The following Data products from NHS England have been provided under the previous iteration of this agreement:

Hospital Episode Statistics Admitted Patient Care (2017/2018 – 2019/2020)

Hospital Episode Statistics Accident and Emergency (2017/2018 – 2019/2020)

Hospital Episode Statistics Outpatients (2017/2018 – 2019/2020)

Civil Registration (Deaths) - Secondary Care Cut – Linked to HES

HES: Civil Registration (Deaths) bridge

The research team requires date and cause of death to determine if there is any difference in mortality between frequent callers that are/are not in case management areas.

The research team require the date, time, reason for, and outcome of any emergency department attendances, emergency hospital admissions, outpatient appointments, and elective admissions to determine if there is any difference in hospital service use between frequent callers that are/are not in case management areas.

Healthcare resource group codes will allow the research team to determine the health economic impact of any differences thus observed.

The research team require lower super output area codes and index of multiple deprivation scores to determine if the impact of case management varies with social deprivation level.

The research team require month and year of birth, sex, and ethnicity to adjust for demographic factors when investigating any effect of case management, and to check that the case management process does not adversely discriminate on any of these grounds.

The research team will use data on the dates, times, reasons for, and outcomes of 999 calls and ambulance callouts provided by the East of England Ambulance Service, the London Ambulance Service, the West Midlands Ambulance Service, and the Welsh Ambulance Service to assess if there is any difference in the number of 999 calls and ambulance callouts between areas that do/do not use multi-disciplinary case management.

DATA MINIMISATION

The study cohort consists of patients added to the frequent callers list by the East of England Ambulance Service, the London Ambulance Service, the West Midlands Ambulance Service, and the Welsh ambulance Service during 2018. The cohort used for NHS England Data linkage consists of 846 patients.

Data was only provided about patients that form part of this cohort from the East of England Ambulance Service, the London Ambulance Service, and the West Midlands Ambulance Service. However, all Data items were required for these cohort members to conduct the planned analysis. All possible filtering was applied during cohort identification. Therefore, the Data could not be further minimised by geography, demographics, or any other factors. Data for cohort members identified by the Welsh Ambulance Service was obtained from the SAIL Databank.

Data are required for 6 months before the patient is added to the frequent callers list to establish baseline trends, and for 6 months afterwards to identify any change in resource use. Thus, the full dataset spans the period July 2017 to June 2019. Data outside this period were not required.

All patient episodes in the requested datasets during the requested period are needed. The number of NHS contacts within six months of classification as a frequent caller is a key study outcome. Details of each contact are required in order to check for signs of harm resulting from the intervention, or unintended effects on other NHS services.

Frequent callers are a group with complex and sensitive needs. There are no study-specific visits or activities and following up patients directly could cause unintended distress. Therefore, use of routine Data is the least intrusive and most reliable method for follow up. This methodology was approved by Wales Research Ethics Committee 4 on 14 August 2019. Section 251 approval was granted by the Confidentiality Advisory Group on 27th May 2020.

DATA PROCESSING

Data will only be processed by substantive employees of Swansea University (the sole Data Controller and Data Processor) who have appropriate training in data protection and confidentiality. Data will only processed via the SAIL Databank, a secure data haven hosted at Swansea University.

Access to the SAIL Databank is via a two-factor authentication procedure (a personal username and password, and individually issued Yubikey device). The remote desktop environment has built-in measures to protect data including logging all user activity; restricting internet access; and preventing data exports without prior approval.

Remote processing will be subject to the following being in place:

Multifactor authentication (MFA);

Access controls granting users the minimum level of access required;

Secure connections (e.g., VPNs or secure protocols) to protect data during remote access;

Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls.

All remote access is undertaken within the scope of the relevant organisations’ DSPT (or other security arrangements as per this Data Sharing Agreement (DSA)).

Data will not be matched to other publicly available data, and there will be no attempt to re-identify individuals. All findings of the statistical analysis, and all study outputs, will present as anonymous, aggregate data only.

The study team engaged in strong service user involvement throughout the planning stages for this study. PPI research team members participated in discussions on study design including primary outcome selection and judgement of meaningful difference between study arms. Swansea will seek to widen PPI links during the study to better reflect the diverse patient population

Dissemination will seek to maximise stakeholder interest and understanding of the study as well as its outputs and maximise the impact of the findings on ambulance service policy, processes, practice and patients. Dissemination will build on the research management group’s profile and reputation with previous studies focused on improving the quality of pre-hospital care. From the first stage, the research management group has and will continue to work with Patient and Public Involvement contributors and co-applicants to develop communications, publications and dissemination plan including the assessment of stakeholder needs and communications activities and milestones. The plan will include engagement with patient and professional groups, NHS managers, commissioners, and policy makers. Lay summaries will be produced where appropriate.

Key audience groups for dissemination will include policymakers on emergency care, care-commissioning bodies and ambulance service providers, emergency-care practitioners, and the general public. The primary focus of dissemination efforts will reflect the importance of communicating findings regarding the effectiveness or otherwise of case management approaches for people who make high use of the 999 ambulance service to relevant policy makers and to the bodies that implement policy. The research management group will exploit existing links with UK ambulance services; they have already engaged with FreCANN (the Frequent Caller National Network; two members are co-applicants), and will, at an early stage in the study, present initial findings to the wider FreCANN network, seeking their input on identifying key messages which can then inform policy and practice.

The research management group will use strong links with ambulance services directly and through national bodies (National Ambulance Research Steering Group, National Ambulance Services Clinical Quality Group, Association of Ambulance Chief Executives (AACE) and National Ambulance Services Medical Directors. The research management group will further strengthen these links by contributing to the annual Ambulance Leadership Forum (organised by AACE). The research management group will liaise with NHS England, clinical commissioning boards in England, and Health Boards in Wales, Scotland and Northern Ireland; local authorities; social services and care/nursing home representatives to ensure findings can inform practice at a local community level. This is particularly relevant, as community-level services often share with ambulance services patients who frequently call 999.

Swansea University will seek the advice of the study management group for further dissemination of key findings to front-line ambulance service staff, this can take the form of contributions to internal ambulance boards, service briefings and bulletins, and practitioner/professional publications.

The study team will disseminate their findings through the following outputs. Outputs will be produced on an ongoing basis; with primary analysis concluded in June 2023.

1) A final comprehensive research report was submitted to the study funder in June 2023, and is now under review. This report detailed all the work undertaken together with supporting technical appendices, abstract and executive summary. The plain English executive summary focused on results/findings and will be suitable for use separately from the report as a briefing for NHS managers, emergency care practitioners and the general public.

2) Interim reports at intervals agreed with the funders (now concluded with submission of the final report).

3) A set of PowerPoint slides presenting the main research findings for use by the research team or others in disseminating research findings to the NHS and other stakeholders.

4) Papers for academic peer-reviewed journals such as the Annals of Emergency Medicine, Emergency Medical Journal, BMC Emergency Medicine, Social Science and Medicine and Implementation Science. This will ensure the research forms part of the scientific literature and is available to other researchers. The study team support an open-access model of research dissemination.

5) Articles for professional journals which are read by the NHS management community and which will be helpful in raising wider awareness of the research findings e.g. Ambulance UK, Health Services Journal.

6) Seminars, workshops, conferences at regional, national and international level and other interactive events, where the research team will present and discuss the research and its findings with NHS managers.

7) Guidance to inform the future care of frequent callers in order to maximise the potential to support the shift of care out of hospitals and into the community.

8) User-friendly materials for service managers and commissioners/policymakers using infographics to maximise accessibility and reach.

The study communications, publications and dissemination plan will contain media engagement, to include written press coverage, online media, and social networking, with the support of the dedicated marketing team in Swansea University Medical School. Given the implications for practice, policy, and research, the research management group disseminated findings through the 2023 999 EMS Research Forum Emergency Care Conference, which is hosted each year by a UK Ambulance service and is administered by Swansea University PRIME Research Network for Unscheduled Care and brings together academics and practitioners. In addition to a full final study report, STRETCHED will produce a summary version to be disseminated through the PRIME network. The research management group will present findings at other appropriate national and international events, such as the Health Services Research Network annual conference, the International Forum for Quality in Healthcare, and the European Society for Emergency Medicine. The research management group will ensure that the wider learning from the study (i.e. lessons which are not specific to emergency care) is disseminated to appropriate audiences.

In addition to disseminating findings through publications and through conference presentations at regional, national and international level, the research management group will:

(a) hold a dissemination workshop in collaboration with the 999EMS Research Forum and/or College of Paramedics;

(b) offer to present findings directly to the three participating ambulance services at dedicated workshop events in their area. The research management group will ensure that dissemination goes beyond ambulance services to include other key health care providers and policy makers with an interest in the wider picture of urgent and emergency care. Dissemination will also target the academic community to ensure that future research in this area takes account of and builds further upon study findings.

Conference presentations, posters and similar will be conducted throughout and following the study as opportunities arise. Scientific papers will be prepared once the final report has been approved by the funder. Study outputs will present aggregate data only with small number suppression applied in line with the HES analysis guide. Record-level Data will not be shared outside the statistical team.

STRETCHED is a natural experiment looking at activities already carried out by ambulance services. No exploitable intellectual property is anticipated. Should any be developed, the research management group will seek professional advice from the Research, Engagement and Innovation Services department at Swansea University.

It is hoped that STRETCHED will benefit the provision of health care experienced by vulnerable patients. It is hoped it will improve the quality of decision making around alternative care pathways, improve information transfer between organisations to benefit patient safety and quality of care, and streamline patient flow.

There is increasing pressure on ambulance clinicians to make decisions regarding onward patient care, including when it is safe to refer the patient to community-based services instead of taking the patient to hospital. Appropriate models of care can support ambulance clinicians as their role shifts from that of pre-hospital care providers to autonomous clinical decision-makers.

If case management is shown to be effective and safe, then this will help to encourage its adoption. In turn, this will hopefully help ambulance services meet the needs of frequent callers, and release resources to help other callers. If the intervention is not safe and effective, ambulance services can focus their efforts on other approaches instead.

To demonstrate safety and effectiveness, STRETCHED needs to show a reduction in the number of 999 calls made by frequent callers and demonstrate that this does not cause the caller undue harm. Furthermore, case management may simply shift demand from one part of the NHS to another. This might affect the care provision of other patients, as well as the frequent caller, or have cost implications. Either of these could put greater strain on the NHS in the longer term. These elements can only be understood by following up frequent callers over time and comparing their NHS presentations with historical trends.

STRETCHED has a composite primary outcome including: 999 calls, ED attendances, emergency admissions to hospital, and death. These components are analysed individually and cumulatively, according to the hierarchy of severity using multilevel generalised mixed linear models. The primary analysis will be conducted by treatment allocated; patients in case management areas will be analysed as part of that cohort regardless of whether they were offered case management. Outcomes will be measured at six months from a patient’s first appearance on the frequent callers list during the study period. Historical Data on prior service use and demographic information will allow adjustment for differences between cohorts as required.

Secondary outcomes include declassification and reclassification as a frequent caller (using ambulance service 999 call information), costs of service delivery, effects on other services, and details of demographics, case mix and call patterns. Screening and eligibility data will be presented as a CONSORT diagram. Descriptive baseline data on demographics and call characteristics will be presented by ambulance service, and by site.

The STRETCHED team hope that, by demonstrating whether the intervention is effective, ambulance services will be steered towards a more effective way to manage their caseloads and improve the quality of decision making towards frequent callers. This, in turn, should benefit the health of frequent callers, other ambulance service users, and hopefully relieve some of the pressures on ambulance services themselves.

STRETCHED is not in support of a PhD or post-graduate research study. It has a sister project, INFORM (“INFORM: Improving care for people who Frequently call 999: co-production of guidance through an Observational study using Routine linked data and Mixed methods”), which forms the basis of a Health and Care Research Wales Fellowship. INFORM looks at the epidemiology of frequent callers in Wales and will not use Data from NHS England.

The final study report to the funder (National Institute for Health Research) was submitted in June 2023, and is currently undergoing peer review. The draft report includes a discussion on strengths and limitations of the research, and the extent to which it achieved its original objectives. The report also contains suggestions for further research and some implications for policy and practice in this area. Further outputs, summarising or focussing on specific aspects of the study, are in preparation for submission to high-impact peer-reviewed academic journals.

Preliminary findings were reported to stakeholders including ambulance service research leads, practitioners, and academics as an oral presentation at the EMS 999 Research Forum in Manchester (June 2023). An abstract of this presentation will appear in the Emergency Medicine Journal. Further presentations at academic conferences and to other stakeholder groups such as FreCANN, the Frequent Caller National Network, are planned.

The Study Team will be able to update this summary and provide further details via the funder’s chosen portal (researchfish) once the final study report has been approved and as outputs appear.