The HOME Study

BACKGROUND – THE HOME STUDY:

NHS general hospitals have more than two million unplanned admissions of people aged 65 and older every year. These patients typically spend more time in hospital than those aged under 65. Prolonged hospital stays are known to be detrimental to older people and known to be caused in part by lack of attention to psychiatric problems such as delirium, dementia, and depression as well as psychological issues such as minor cognitive impairment or anxiety that may slow patients’ discharge from hospital. The University of Oxford Psychological Medicine Research group has developed a new approach to the identification and management of psychological problems (called Proactive Liaison Psychiatry or Proactive Psychological Medicine, PLP/PPM) which aims to reduce the time that older people spend in acute general hospital wards.

The HOME Study is a two-arm parallel-group randomised controlled trial. It aims to determine whether adding PLP/PPM to usual care reduces the time spent by older patients in acute hospital wards in the month (30 days) after randomisation (primary outcome), when compared with usual care alone. A number of secondary outcomes, including patients’ views of their length of time in hospital, their quality of life, their secondary healthcare use in the year post-randomisation and deaths will also be evaluated. The HOME Study will also determine the cost-effectiveness of adding PLP/PPM to usual care.

Participants in The HOME Study are adults aged 65 or over, who were admitted non-electively to a general hospital in Oxford, Exeter or Cambridge between May 2018 and March 2020. Recruitment to The HOME Study has now closed. Informed consent (or consultee agreement, in accordance with the Mental Capacity Act 2005, for patients who lacked capacity to consent) was obtained for trial participation.

AIM AND PURPOSE OF THIS AGREEMENT:

The aim of this agreement is to access the 'routine data' that participants have consented to the researchers using in order to complete The HOME Study.

The ‘routine data’ required are participants’ healthcare use in the year prior to recruitment, data on time spent in hospital in the month post-recruitment (trial primary outcome), healthcare use in the year post-recruitment (NHS secondary care resource use is a trial secondary outcome), and information on deaths (trial secondary outcome). These data are from the Hospital Episode Statistics (HES) Accident and Emergency, Admitted Patient Care, Critical Care and Outpatients datasets; the Emergency Care Dataset; the Mental Health Services dataset and the Civil Registration (Deaths) dataset.

These pseudonymised, record level data are the minimum required to analyse the secondary healthcare use and deaths of participants in The HOME Study, comparing the outcomes of participants allocated to PLP/PPM with those allocated to usual care. There are no alternative, less intrusive ways of achieving this purpose. It is important to receive the NHS Digital data described above as participants are likely to have received healthcare (and died) in different settings from those where they had their initial acute admission.

The data requested are limited to The HOME Study participants only and those variables required to address the study aims. As the aim is to collect data on specific individuals who are taking part in the study, the use of anonymised data is not feasible. The number of years requested and geographical spread of the data requested are defined by the HOME Study participants’ dates of randomisation and locations respectively.

ORGANISATIONS:

The University of Oxford (the study Sponsor) is the Data Controller responsible for determining the purpose and manner in which any personal data collected for clinical research are, or are to be, processed for this study.

The University of Oxford, the University of York and London School of Hygiene and Tropical Medicine are data processors for this study; researchers in these organisations will conduct statistical and health economic analyses.

The University of Oxford is a ‘public authority’, as defined in the Data Protection Act 2018, with a principal object of the organisation being research and its dissemination. The processing of identifiable personal data, including special category data, is necessary to carry out medical research that serves the public interest. The legal basis for processing personal data is: Article 6(1)e of the GDPR, ‘processing is necessary for the performance of a task carried out in the public interest’; and Article 9(2) j of the GDPR ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes’.

The processing of sensitive personal data by The HOME Study researchers is in the public interest as it will provide information to guide doctors’ decisions about the care of patients and to guide policy makers’ decisions about NHS service provision. The processing is of medical data about particular individuals and will be related to their involvement in the randomised trial.

A number of other organisations are involved in the study but not in the processing any data disseminated under this agreement nor do they carry out any data controllership activities. These are: Oxford University Hospitals NHS Foundation Trust, Devon Partnership NHS Trust, Royal Devon and Exeter NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Cambridgeshire and Peterborough NHS Foundation Trust (patient recruitment); University of Exeter, University College London, University of Nottingham, University of Manchester, University of Birmingham, Worcestershire Acute Hospitals NHS Trust (collaborators).

FUNDING:

The study is funded by the National Institute for Health Research Health Services and Delivery Research Programme. The funder has no role in the design or conduct of the study, and will not be processing or accessing any data.

The University of Oxford will provide identifiers (NHS number, date of birth, sex, name), a unique study ID and the participant’s date of recruitment to NHS Digital for consented participants in The HOME Study via a Secure Electronic File Transfer (SEFT).

The pseudonymised data requested from NHS Digital are from the Hospital Episode Statistics (HES) Accident and Emergency, Admitted Patient Care, Critical Care and Outpatients datasets; the Emergency Care Dataset; the Mental Health Services dataset (MHSDS) and the Civil Registration (Deaths) dataset, covering the period from May 2017 to March 2021. HES and MHSDS data will be minimised to the year prior to and the year post recruitment for each study participant.

The study manager at the University of Oxford holds the identifiable information for all members of the cohort, and will receive the NHS Digital data. The study manager has disseminated existing trial data (including participant study ID, date of birth and sex) for cohort members, obtained with consent/consultee declaration from their medical records and participant/proxy reports, to the relevant statisticians and health economists at the University of Oxford, University of York, and the London School of Hygiene and Tropical Medicine.

The study manager will disseminate subsets of NHS Digital data to the relevant statisticians and health economists at the University of Oxford, University of York and the London School of Hygiene and Tropical Medicine to complete the requisite analysis. There will be no requirement or attempt by data analysts at these organisations to re-identify individuals. Analysts will not be provided with participants’ names, NHS numbers or contact details. Existing trial data may be linked with NHS Digital data by analysts using the unique study ID where relevant to ensure participant information is complete and accurate for data analysis purposes.

The data requested will be used in the following ways:

Healthcare use (admissions, outpatient visits, Accident and Emergency attendances) in the year prior to randomisation and ethnicity – to describe trial participants at the time of their recruitment to the study.

Number of days spent as an inpatient in a general hospital in the month (30 days) post-randomisation – to compare the outcomes of participants allocated to PLP/PPM with those allocated to usual care. This is the trial’s primary outcome.

Healthcare use (admissions, outpatient visits, Accident and Emergency attendances) in the year after randomisation- to compare the outcomes of participants allocated to PLP/PPM with those allocated to usual care and to determine the cost-effectiveness of PLP/PPM compared with usual care.

Deaths - to compare the outcomes of participants allocated to PLP/PPM with those allocated to usual care.

Statisticians at the London School of Hygiene and Tropical Medicine will conduct the analyses that describe trial participants at the time of their recruitment to the study and compare the outcomes of participants allocated to PLP/PPM with those allocated to usual care. Health economists at the University of York will conduct the cost-effectiveness analysis.

The data will be stored as follows:

The University of Oxford will store the data on Oxford University’s Medical Science Division IT’s High Compliance system (HCS). This is a service for Clinical Trials Units (CTUs) and Medical Sciences Division Departments or Units which need to access applications securely, and manipulate and store very sensitive data. The HCS is a controlled environment within which sensitive data can be manipulated and de-classified for further processing.

The London School of Hygiene and Tropical Medicine will store the data on the Secure Data Server which can only be accessed at London School of Hygiene and Tropical Medicine. The data will be accessible only to named HOME Study researchers who have authorisation from the applicant.

The University of York will store and access the data on the Safe Haven. The data will be accessible only to named HOME Study researchers who have authorisation from the applicant.

Data will only be accessed and processed by substantive employees of the University of Oxford, The University of York and the London School of Hygiene and Tropical Medicine, and will not be accessed or processed by any other third parties not mentioned in this agreement. Data will only be accessed for the purposes of HOME Study analyses.

The data will be safely held in an encrypted form on the University of Oxford Medical Science Division’s High Availability Novell network for 5 years.

All organisations party to this agreement must comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).

Over the year following receipt of the data (by the end of 2022), the findings of The HOME Study are expected to be published and disseminated as papers, reports and conference presentations.

The research is anticipated to be published in high impact peer-reviewed journals and presented at national and international conferences including those held by the Royal College of Psychiatrists in the UK, by the Academy of Consultation-Liaison Psychiatry in the USA, and the European Association of Psychosomatic Medicine in Europe.

It is hoped that the trial results will shape the NHS investment in liaison psychiatry services and will also inform the Royal College of Psychiatrists Psychiatric Liaison Accreditation Network system, which promotes the development of high quality, evidence-based, liaison psychiatry services and is linked to the Care Quality Commission’s new inspection regimen.

The trial is expected to also have major international impact. It is anticipated that the findings will be used by healthcare policy makers worldwide, in particular in the USA, due to the current substantial interest in developing liaison psychiatry services, including proactive service models, to meet the needs of older medical inpatients with multimorbidity.

The PLP/PPM intervention manual is intended to be made freely available to the NHS. If the trial results favour PLP/PPM we anticipate that the manualised intervention will form a framework for liaison psychiatry provision nationally.

A process evaluation-based commissioning and implementation guide is expected to provide key recommendations to service providers and purchasers, and form the basis for commissioning and quality assurance of services.

It is planned that the results will be made available to participants and the public on the study website. The HOME Study has a dedicated Patient and Public Involvement (PPI) panel, made up of people who have personal experience of being an older general hospital inpatient or being a caregiver for an older general hospital inpatient. The PPI panel members were actively involved in the development of the PLP/PPM intervention and the trial procedures as well as in training HOME Study research staff. The panel will meet with the research team to discuss the study findings and assist in their interpretation. They will also advise the team on how to best disseminate the findings and ensure that the results are clearly described.

The researchers intend to actively work with the University of Oxford communications team and the Science Media Centre (London) for assistance with effective dissemination of results via the press and social media.

The study team will also, when reviewing the results of the analysis, consider whether any change in individual facility visiting policies could impact the study, during and post the Covid-19 pandemic.

All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

The dissemination of the data will allow the completion of The HOME Study, an NIHR-funded trial which is expected to have a large impact on the provision of psychiatric care for older people admitted to general hospitals in the UK and internationally.

Acute NHS hospitals have more than two million unplanned admissions of people aged 65 and older every year. The greater length of stay of older patients means that these admissions account for most of the available emergency bed days. The UK Department of Health set out a policy to shift care from hospitals to community settings. But despite this, the last decade has seen a large increase in emergency admissions, the majority of those being of people aged over 65, a trend likely to continue as the population ages.

Prolonged hospital stays are known to be detrimental to older people and known to be caused in part by lack of attention to psychiatric problems. The HOME Study aims to determine the effectiveness and cost-effectiveness of Proactive Liaison Psychiatry / Proactive Psychological Medicine (PLP/PPM) which is a new way of delivering psychiatric care for older general hospital inpatients that aims to address this problem of prolonged hospital stays.

The dissemination of the findings of The HOME Study is in the public interest due to the large benefits that this research could have for patient care. The trial results are expected to shape the decisions that are made about NHS investment in liaison psychiatry services. If the PLP/PPM intervention is effective and cost-effective, this model of care rolled out across the UK could improve the lives of the large number of older people admitted to NHS general hospitals every year, as well as saving NHS costs.

The use of NHS Digital data is fundamental to the achievement of the scientific aims of The HOME Study. The study protocol and analysis plan included the use of these data and all participants have agreed to their NHS healthcare data being used in this way.

The expected benefits include both a major contribution to our knowledge of how best to care for older patients in general hospitals, published in peer-reviewed journals, as well as information that could directly enable commissioners and policy makers to make decisions about NHS care. The knowledge that will be gained is expected to inform NICE guidance as well as the Royal College of Psychiatrists Psychiatric Liaison Accreditation Network system, which promotes the development of high quality, evidence-based, liaison psychiatry services and is linked to the Care Quality Commission’s new inspection regimen.

No benefits have yet been yielded as the study is on-going.