The effect of alcohol care teams on hospital admissions in England: interrupted times series and health economic analysis using routine collected NHS hospital episode statistics

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

The effect of alcohol care teams on hospital admissions in England: interrupted times series and health economic analysis using routine collected NHS hospital episode statistics

The following is a summary of the aims of the research project provided by the University of Hull:

Alcohol-related hospital admissions exceeded 1.26m in 2018/19, an increase of 155% over 15 years. A disproportionate impact of alcohol on the NHS is exerted by those with chronic alcohol disorders with approximately 80% of costs related to emergency department (ED) attendances and admissions. Since 2008, the UK Government response has involved the expansion of hospital-based alcohol services. The National Institute for Health Research (NIHR) commissioned the ProACTIVE Team to evaluate the impact of Alcohol Care Teams (ACTs) in England using a mixed-methods approach. The ProACTIVE research programme is a multi-disciplinary, integrated, mixed-methods study designed to evaluate the impact of ACT at policy, health system and patient level. It will identify the 'optimal' models of ACTs, define the components which best support the identification, and cost-effective management of hospitalised adults with alcohol disorders, and will facilitate the rapid dissemination of the results. This study, which is a part of this programme of research, hopes to identity the impact, value and effectiveness of alcohol care teams in England. Synthesis of study outcomes should inform future commissioning of these services by NHS England.

This project is part of work package 2 (WP2), which makes up the overall NIHR funded programme of research that is being conducted to evaluate the impact, value and effectiveness of alcohol care teams (ACT) in England. Work packages 1, 3 and 4, which are also looking into ACTs, will not use the NHS England data requested under this Agreement. The overall outcomes from these work packages will be disseminated to policy makers and commissioners to inform future funding of hospital-based alcohol care.

The University of Hull will conduct an interrupted times series analysis (ITS) to explore the impact of ACTs on hospital activity outcomes at a national level. Hospital Episode Statistics Admitted Patient Care (HES APC) site data 24 months before and 24 months after the active implementation of well developed (i.e. ‘optimised’) Alcohol Care Teams (oACTs) will be used to measure hospital activity for those with specified alcohol codes. Following data receipt, the University of Hull will identify approximately 50-100 hospitals with oACTs for analysis. The primary outcome measure is 30-day readmission (any condition) rate after discharge from an alcohol-related admission, calculated for each hospital at each time point. each hospital acts as its own control in an ITS design to identify outcomes on hospital activity (clinical outcomes) and hospital cost data from HES-APC to compare costs between intervention and control groups. There are no other means by which the University of Hull can establish this information. Alcohol care teams do not routinely collect data. Additionally, ACTs are not resourced to intervene with every individual alcohol-related admission, however, they should provide hospital-wide training, support and liaison. Therefore, the use of ITS can measure the impact of these ACTs at a hospital level using changes in admissions before and after optimisation.

NHS resource use will be established using Hospital Resource Group (HRG) codes from the HES-APC extract. Item-level costs for each HRG code will be taken from the relevant NHS reference costs. Intervention costs will be estimated using data from the ProACTIVE national survey of hospital-based alcohol services, combined with published item-level resource costs where appropriate.

The primary outcome measure is 30-day readmission (any diagnosis or condition) rate after discharge from an alcohol-related admission, calculated for each hospital at each time point, and estimated NHS costs for all hospital admissions commencing within 30 days of discharge from an alcohol-related admission. An individual will be identified as experiencing an alcohol-related admission based on the contributing impact of alcohol on any of their recorded diagnosis/condition (e.g., alcohol dependence, alcohol withdrawal, alcohol liver disease) available within the HES-APC dataset.

Secondary outcomes for the short-term health economic analysis will be:

• NHS costs associated with alcohol-related readmissions within 30 days of discharge from an alcohol-related admission

• NHS costs associated with all readmissions commencing within 90 days of discharge from an alcohol-related admission

• Results from the primary analysis will be used to calculate the net NHS costs associated with the introduction of an oACT after accounting for the costs of the intervention itself.

A prospective study will be conducted simultaneously with the ITS to examine patient level outcomes, with qualitative methods being used to elucidate experiences of patients, clinician and key stakeholders.

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary to calculate costs on a per hospital spell basis utilising length of admission and procedural/health resource group codes present in the HES APC Data. Specifically, access to HES APC data has been requested to help identify the impact of ACTs as this will help to ascertain the effectiveness of services by those who need them and access them.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to all patients aged 18 and above. The cohort includes those individuals who were aged 18 or over at the time of admittance. No data will flow for individuals prior to that date.

> This will include patients admitted to a hospital with a wholly attributable alcohol condition (primary or secondary diagnosis) and controls without a wholly alcohol attributable condition for comparative purposes. The University of Hull require to retain controls (I.e., those without alcohol diagnoses) to observe any potential changes in overall hospital admissions amongst all patients. For example, reductions in alcohol-related admissions might be related to changes in hospital-level strategies rather than attributed to alcohol care team interventions. Following data receipt, the University of Hull will filter the data on diagnostic codes to identify the cohort of patients admitted to a hospital with a wholly attributable alcohol condition.

> Limited to data between 2009-2020. Data is required for the 24 months before and after the defined effective period of introduction (2012-2017);

> National data is required to understand the impact, value and effectiveness of service at a national level. The Data requested cannot be minimised by sites. The University of Hull need to observe if reductions in individual hospital admissions are not an artefact of displaced activity. It is possible that strategies aimed to avoid alcohol-related admissions employed by one hospital admission may have the unintended consequence of displacing clinical activity to neighbouring sites.

> Wholly alcohol-attributable admission diagnostic codes are used as the cohort involves clinical conditions (for example, alcohol dependence, alcohol withdrawal, alcohol related liver disease, alcohol related pancreatitis, screening for alcohol) targeted by optimised ACTs services.

> All diagnostic codes are requested to help identify the influence of co-morbid clinical conditions and help establish re-admissions that were anticipated or potentially avoidable.

The University of Hull is the controller as the organisation responsible for ensuring that the Data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

This processing is in the public interest because the study will help to ascertain the effectiveness of ACT services by those who need them and access them. These analyses will support health service planners and policy makers consider the effectiveness and cost effectiveness of alcohol care teams in commissioning of local services uses public funds.

The funding is provided by NIHR. The funding is for the programme of work and is not specifically limited to the study described.

The funder(s) will have no ability to suppress or otherwise limit the publication of findings.

The University of Sheffield is a processor acting under the instructions of the University of Hull. The University of Sheffield’s role is limited to health economic analysis.

Arrow Business Communications Ltd (ARROW) provides IT hosting services to the University of Hull and will store the Data as contracted by the University of Hull. Arrow Business Communications Limited role is solely limited to provisioning, securing and back-up of the Data Safe Haven.

Data will be accessed by:

> Substantive employees of the University of Hull and the University of Sheffield.

> Honorary contract holders (visiting academics) from the University of Kent who analyse the Data in the University of Hull TRE. The Honorary contract holders will be members of the Institute for Clinical and Applied Health Research at the University of Hull and accountable to the Chief Investigator and are employed under the visiting status of the University of Hull for the duration of the study. Each Honorary contract holder has agreed to maintain appropriate standards of conduct in line with the University of Hull policies and will be held to account for their practice in accordance with these policies.

Individuals holding an honorary contract under the supervision of a substantive employee of The University of Hull for the purposes described in this DSA only. The University of Hull must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

- Their substantive employer;

- Their role in respect of the purpose for the processing specified in the DSA;

- The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

- The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

- Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

The ProACTIVE consortium and proposal was developed with input and contribution from a member of the public with lived experience of alcohol use. Following receipt of the award, the ProACTIVE research team employed a full time Public, Patient Involvement and Engagement (PPIE) Co-ordinator with lived experience of alcohol use, who has co-ordinated patient advisory and stakeholder groups. This group is being maintained over the duration of the research programme. The development of this project and the study protocol were reviewed by the PPIE co-ordinator and patient advisory group. There is full support for this study in helping to identify the potential benefits of ACTs, however, given the technical nature of the planned analyses. The PPIE advisory groups facilitated by the PPIE Co-ordinator, who has declared lived experience of alcohol dependence and hospital admissions, identified unconditional support for this analyses. They will be actively engaged in the sharing and understanding of study findings. The preliminary summary results will be presented to our PPIE groups so that they can input into interpretation.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the HES APC dataset to the University of Hull’s Trusted Research Environment (TRE; Hull Data Safe Haven (DSH)). The Data will contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

The Data will be stored within the University of Hull Data Safe Haven (DSH). This is a Trusted Research Environment (TRE) hosted by Arrow Business Communications Limited.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England. The data will not leave England at any time.

Data will be accessed by individuals with a visiting contract with the University of Hull. The individuals will act as an agent of the University of Hull at all times under supervision from employees of the University of Hull. Aside from these individuals, access is restricted to employees of the University of Hull and the University of Sheffield who have authorisation from the Chief Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will not be linked with any other data.

Data for each project is logically separated meaning there is no ability to access or link to datasets from other projects within the DSH. When working within the environment users have no way to move data from within the DSH to any device outside of it. All data enters and leaves through a digital airlock which is linked to the above authorisation workflow, which includes review and authorisation by the Chief Investigator.

Analysts from the University of Hull, the University of Sheffield and visiting academics from the University of Kent will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> A report of findings to NIHR at the end of the study.

> Submissions to peer reviewed journals. Target peer-reviewed journals include, Addiction, Alcohol & Alcoholism, British Medical Journal (BMJ) or Emergency Medicine Journal (EMJ). Alternative specialist peer-reviewed journals applicable to specific methodologies (e.g., qualitative methods, etc) will also be targeted.

> Presentations at appropriate conferences, including, Research Society on Alcohol (USA); Lisbon Addiction Conference, Society for the Study of Addiction Annual Symposium, Medical Council on Alcohol, Annual Conference, and RCPsych Annual Conference for the Faculty of Addiction.

> Policy briefs and lay summaries for the Alcohol Care Team (ACT) Stakeholder Network and ProACTIVE Patient Advisory Group members for feedback. These briefs will subsequently be refined into interim policy briefs and plain English summaries following best practice guidelines in terms of structure, style, and content.

> Implementation toolkit specifying guiding principles for effective and sustainable ACT commissioning and delivery.

> Recommendations for future policy and practice including resource, training, and research needs.

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

Target dates for the outputs detailed above are dependent on the results of this research, however, the intention is to engage in publications and conference presentations within six months of study completion.

The findings of this study will add to the growing literature and research related to the reduction of alcohol-related hospital burden which highlights the need to tackle unmet needs of patients with alcohol disorders to reduce the overall burden on health service provision. This study will help identify the impact, effectiveness and cost-effectiveness of optimised hospital-based alcohol care team that are commissioned via NHS England.

These findings will also help inform key stakeholders who are responsible to the commissioning of alcohol treatment provision in England (i.e., NHS England, OHID, Integrated Care Boards (ICBs)) as to the value of these services within the hospital and wider alcohol treatment provision.

The findings ultimately will be used to inform the commissioning cycle. The results of these analyses, alongside findings from the other ProACTIVE work streams, are expected to identify the benefits of these services on the health care system through this ITS, and on a patient-level through the patient study. These outcomes will help sustain alcohol care teams or identify core elements that are most effective in demonstrating positive outcomes. There is the potential that services with minimal provision will receive increased investment. Alternatively, funding may conceivably be reduced dependent on the outcomes of the overall ProACTIVE programme. Ultimately, this project will contribute to a national perspective which will inform key policy makers.

The use of the data could:

> help the system to better understand the health and care needs of populations.

> lead to the identification or improvement of health and care system design to improve health and care outcomes or experience.

> advance understanding of regional and national trends in health care needs.

> advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations with alcohol dependence admitted to acute NHS hospitals.

> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

> inform decisions on how to effectively allocate and evaluate funding according to health needs.

> provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

> support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The Principal Investigator and co-investigators retains membership of multiple expert and strategic groups at a national level (NHS England Alcohol Care Team Working Group, UK Clinical Guideline Group for Alcohol Use Disorders, NICE Quality Standards for Alcohol Use Disorders, Royal College of Psychiatrists, NIHR Clinical Research Networks, NIHR Mental Health Implementation Network, etc.) to ensure the findings are disseminated within policy, clinical and research networks, ensuring that the public interest is ultimately best served by this research.

Not stated in the register.