Routinely collected hospital admissions data for care home residents

This Data Sharing Agreement (v.2) permits the retention of the data provided under previous iterations of this Agreement for an interim period. This is a pragmatic approach to provide an active Agreement whilst enabling the Univrsity of Leeds to complete the necessary actions to enable a subsequent application to extend the Agreement meeting all applicable data sharing standards as published in NHS Digital’s website (see: https://digital.nhs.uk/services/data-access-request-service-dars/dars-guidance).

The following provides background information on the purpose of the original study:

The University of Leeds primary aim is to assess the feasibility and reliability of routinely collected data on health resource use.

Residents of care homes are amongst the frailest in our population with significant health and social care needs. The health requirements of residents place considerable burden on the NHS, in primary and secondary care. Greater demands are placed on the workload of GPs providing care for care home residents than caring for people in their own homes, in face to face contacts and out of hours visits. Care home residents are significantly more likely to attend emergency departments by ambulance and be admitted to hospital compared to the older population generally.

Hospital admission exposes residents to risk of hospital acquired infections and falls and is disruptive for this frail population as they struggle to return to their previous health state once discharged. If not appropriately addressed, the burden on NHS primary and secondary care services will continue to rise for this expanding client group.

Promotion of health of frail older people in care homes is poorly and inconsistently developed. Despite the potential for reduced NHS expenditure from improved health, provision of programmes to support activity within UK nursing homes (which could promote health and well-being) is only patchily realised. Only 10% of care home residents receive physiotherapy, and just 3% occupational therapy.

The feasibility trial proposed by The University of Leeds is the final stage of a programme grant funded by the National Institute of Health Research (NIHR). The programme grant has been divided into 5 work streams, with earlier work involving observation of care home environments; interviews with care home staff, residents and relatives to explore how to best implement change in activity; assessing which questionnaires to use and how to best measure activity levels; and developing an appropriate intervention with the aim of increasing activity (or reducing sedentary behaviour) in care homes.

This trial is now testing the intervention in 6 of 12 homes from selected locations within Yorkshire, randomised on a 1:1 basis to receive the REACH intervention plus usual care, or to continue with usual care only. It is anticipated that 8 - 12 residents will be recruited from each of these care homes. Staff working in care homes randomised to receive the REACH intervention will implement the intervention in their care home. Staff working in care homes randomised to the control arm will continue with their usual routine care to residents.

All 12 homes will provide data for the trial, either directly in person, from care home records, or via routine data sources such as NHS Digital. Part of the trial aim is to look at the best method of obtaining both safety (i.e. hospital attendance) and health resource use data. If the University of Leeds are able to do this by collecting HES and other data sets this will inform how data is obtained ultimately to run a large scale trial in many homes. This would happen if The University of Leeds feasibility trial was successful.

The University of Leeds will seek to establish the number of admissions overall from the 12 participating care homes and assess the completeness of this data. This aggregate data will allow assessment of the effect of the intervention at a whole home level, rather than only being reported for consenting residents (a sub-set of the care home population). This will allow us to assess whether the consenting cohort is representative of the whole home or whether there are differences in the number of hospital attendances and admissions for those who are and are not taking part in the research.

Under this Agreement (v.2), the data may be securely stored but not otherwise processed. No new data will be provided by NHS Digital under this Agreement.

The following provides background on the processing activities undertaken prior to this Agreement:

1) Consented Record Level Cohort (153)

The University of Leeds CTRU will supply the following identifiers of the consented cohort to the HSCIC: - trial ID, NHS no, DoB uploaded by named CTRU statistician to NHS Digital secure data depot.

NHS Digital will provide a bespoke extract of HES using APC and A&E datasets for the consented cohort of 153 care home residents.

Data is uploaded to the data depot by NHS Digital, and downloaded by a named CTRU statistician.

2) Aggregate Level Cohort

The University of Leeds CTRU will provide NHS Digital with Participating Care Homes’ (N=12) postcodes.

NHS Digital will provide aggregate data for all residents 65 years old and over at these care homes collated. Tabulations will include the number of A&E visits, the length of these visits between certain data parameters; and for the APC dataset they will include the number of hospital admissions (planned and unplanned) and average length of stay.

Aggregate data sets (by care home) uploaded to the data depot by NHS Digital, and downloaded by a named CTRU statistician.

Data Storage

Data will be stored at The University of Leeds in a secure, limited access folder on CTRU network.

Data required for use by health economics will be transferred by the named CTRU trial statistician to the named health economist via the CTRU's secure file transfer system. This data will be stored at The University of Leeds in the Secure Electronic Environment for Data (SEED) system.

Data Processing

1) CTRU enter and store data securely on restricted access UoL server (IGT ref ECC0010) - Data required for use by health economics will be transferred from CTRU and stored in the SEED system (IGT ref 8E218).

2) Data collected for the trial + NHS Digital data used for REACH trial analysis (analysis undertaken by CTRU statistician and health economist as per trial protocol)

Data will be processed by a named statistician and named health economist who are substantively employed by The University of Leeds.

The data will not be used for commercial purposes, and will not be provided to any third party or used for direct marketing.

This Agreement permits the secure retention of the data only and no other processing.

The University of Leeds will begin the staged process of developing a complex intervention embedded in the routine of care homes to promote physical activity tailored to the context and environment of individual care homes and thereby enhance quality of life for this neglected group.

Ultimately, and if successful, the intervention strategies will be disseminated through the local Care Home Forum, local and national contacts with Adult Social Care and links with national care home providers through co-applicants and the Steering Group.

Successful completion of the feasibility trial (the last stage of the programme grant) will inform the application for funding to undertake a definitive Randomised Controlled Trial (as described in 'objective for processing'), to investigate the effectiveness of a physical activity intervention in care homes across England. The outputs will be used to establish a protocol for this trial (or otherwise, as appropriate).

The University of Leeds will report the results of the REACH trial to the NIHR (the funder) and, if the feasibility study results indicate that it is reasonable to proceed to a main trial, will apply for further NIHR funding to conduct a definitive main trial.

The feasibility assessment will be completed and published at the end of the programme grant (14 Feb 2018). Results for the trial will be presented in a report for the funding body NIHR. Academics will have access to the outputs via anonymised publication in journals. Indicators will not be produced that show the performance of organisations.

The outputs of this would inform best practice in care homes, and would be published in relevant academic journals (for example Age and Aging), non-academic platforms accessible to the general public (e.g. a study website), and would be disseminated to the care home community via relevant national and local forums or events.

Specifically the results of the feasibility study would be published in academic journals (e.g. Age and Aging, BMC Pilot and Feasibility Studies) and disseminated to the participating care home staff, residents and their relatives.

This Agreement permits the secure retention of the data only and no other processing.

No new outputs will be produced under this Data Sharing Agreement.

Outputs are expected in January 2018, when the study will complete analysis. Outputs will be disseminated as detailed above, regardless of the findings (and 'success') of the research.

Publications:

The study results were published in the "Age and Aging" peer review journal in July 2021 (access here on 21/09/2021 - https://doi.org/10.1093/ageing/afab130), and in the NIHR Monograph series in August 2021 (access here on 21/09/2021 - https://www.journalslibrary.nihr.ac.uk/pgfar/pgfar09090/#/abstract).

A) For the identifiable, consenting cohort benefits include:

• Obtaining reliable ‘safety’ information – i.e. data which will show the reasons for and number of hospital attendances or admissions. This is important to be sure there are no adverse impacts of the intervention. It could also give us an indicator that the new intervention might have some benefits if people from intervention homes attend hospital less.

• Obtaining health resource use information – e.g. the number, type and length of hospital admissions - is a key element of NIHR-funded research. It is important to have this ‘health economic’ data which details the full cost of an intervention – for example, an intervention may appear to be effective, but incur many additional NHS costs such as multiple hospital visits or GP call outs. Without collecting data on health service use we cannot undertake this analysis. Collecting hospital attendance data from HSCIC for the feasibility study will inform how to best undertake this for the main trial, as well as giving an early indicator of resource use.

B) For the aggregate, non-identifiable cohort benefits include:

• An overview of safety at the whole home level. This will help us see the overall safety of the intervention – so we would be able to observe any differences in hospital attendances between ‘intervention’ homes and usual care homes. This would contribute to our decision to proceed with a main trial – i.e. if there are no safety concerns we would be happy to proceed.

• Having hospital attendance data for all (or at least ‘most’) residents gives a more representative picture of health resource use, rather than just that used by recruited (consenting) residents. For example it might be that those who consented are less ill than those who didn’t, so we wouldn’t get a true picture of ‘whole home’ hospital admissions from consenting residents alone. It is an important benefit to be able to report the generalisability of research findings – this data would help us to do that.

Decreasing mobility and increasing dependency have many adverse effects. For residents in care homes, it may lead to increased incidence of pressure sores, contractures, cardio-vascular deconditioning, urinary infections, and loss of independence. Mobility problems and reduced physical activity compound health difficulties by directly affecting physical and psychological health and reducing opportunities to participate in social activities; social isolation negatively impacts on mood and self-esteem, which can then further adversely affect physical health. Residents identify mobility as of central importance to quality of life and well-being and residents with dementia wish for more day-time activities. Physical ill-health and disability are the most consistent risk factors for depression in later life with reports suggesting that, rather than illness per se, it is the resulting functional limitations (handicap) including social participation and meaningful relationships that increase risk of depression. Physical activity provides positive benefits for older people > 65 years for a range of outcomes: decreased disease risk, mood and overall health. For frail institutionalised older people, systematic reviews indicate that physical training can positively affect fitness for some participants; the level of effect may be related to level of frailty. A recent review of the effects of physical activity for older people with dementia (not all of whom were in institutions) reports some benefits for physical function.

Additional benefits may be accrued through enhancing social engagement directly by, for example, participation in communal activities such as exercise sessions, and indirectly by maintaining physical abilities sufficient for the resident to be mobile enough to move around the home and interact with other residents. Such social engagement has been shown to be linked with more successful ageing.

The University of Leeds proposed research to enhance routine physical activity supports the aims of the DH report, NICE guidance and BGS6 reports to promote the well-being of older people in long-term care. It is in keeping with the National Care Home Review, which promotes the concept of care homes as community places with emphasis on creating opportunities for meaningful activity, for shared decision making and for building an environment that supports community.

The outputs will inform feasibility assessment in relation to a larger definitive clinical trial which would assess incremental cost effectiveness of an intervention to increase physical activity in care homes, compared to usual care. This feasibility assessment will be complete by the end of the current NIHR programme grant (14 February 2018).

Not stated in the register.