Falls in Care Homes (FinCH) study: Data Access Request

BACKGROUND TO THE RESEARCH TRIAL

The Falls in Care Homes (FinCH) study; A multi-centre cluster randomised controlled trial to evaluate the Guide to Action Care Home (GtACH) fall prevention programme in old age UK care homes was funded by a grant from the NIHR Health Technology Assessment Programme (HTA 13/115/29) for £1.8 million in 2014.

The FinCH trial is sponsored by University of Nottingham and the Principle Investigator is based at the University of Nottingham, with analysis completed at University of East Anglia. It is the largest randomised controlled trial (RCT) conducted in UK care homes to date, and having access to detailed health service use for 1,661 residents will be a valuable resource to better understand this population. It covers England only. Unit costs will be allocated for each participant, for inclusion in a cost-effectiveness analysis of the falls prevention intervention compared to usual care. Cost per participant will be presented in aggregated form (comparing the two treatment arms) as opposed to at individual or record level.

The study recruited adult care homes and their residents from a broad geographical area in the UK, to capture a range of health and social contexts. The sample size of the study was 1308 residents (654 to intervention group and 654 to control group). Updated calculations were made to allow for a variation in cluster size and a smaller number of participants per care home. The updated calculation gives a recruitment target of 78 care homes and 1482 individuals. In total 87 homes and 1698 residents were consented.

To have been eligible for inclusion in the trial long term care home residents must have provided informed consent or those without capacity to have informed consent from a relative/consultee who will provide advice on their behalf. Residents were excluded if they were in receipt of end of life care or in the home for short term care, respite care or for rehabilitation.

Randomisation to intervention or control (usual care) was at the care home level. The intervention arm received the GtACH Intervention. The intervention involved care home staff completing the GtACH Tool with residents in a private area of the care home. The results were discussed with family, friends and other care home staff. Completed GtACH documentation was placed in the resident’s care records. The actions might have required changes within the care home, changes to residents’ personal care, referral to other services, or purchase of equipment. The actions were written in the GtACH documentation. The GtACH was completed ideally within four weeks of randomisation (and within two weeks of staff training being completed in the care home) for all trial participants in the care home. Actions were started immediately after the identification of risk. As part of GtACH training, re-assessment was undertaken if the participant developed a new medical or cognitive condition, if they fell, or every three- six months if there are no other changes.

Those in the control group received the comparator of usual care, i.e. the care that was in place prior to the trial.

More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf

The aim of the FinCH trial is to determine the clinical and cost effectiveness of the GtACH for fall prevention in care homes compared to usual care. This is important as 415,000 people live in UK care homes. These facilities provide care either with or without registered nursing input and are referred to as care homes with or without nursing respectively. The majority of residents are aged over 80, have cognitive impairment, mobility problems and multiple medical conditions. Health and social care interventions may require modifications in order to work in the care home setting, either because of the configuration of disability and dependency amongst residents, or to work within the organisational setting of care homes. One area where interventions might require to be designed with care homes specifically in mind is in the field of falls prevention. Community falls prevention interventions reduce falls and risk of falls by 30%, but literature to date has found no conclusive reduction in falls in care homes. Care home specific research is scarce and the existing research is inconclusive. Current fall interventions rely on patient engagement and adherence to advice. These present difficulties in care homes, where 75% of residents are cognitively impaired and non-targeted interventions with cognitively impaired older adults have not been successful.

At a rate of 2.5 falls per person, per year there are 160,000 falls per year in care home residents. In care homes, nearly one in ten people who fall sustain a fracture, one in five are admitted to hospital and one in five will die within a year due to a fall related injury. One third of the UK’s hip fractures occur in care home residents, which is devastating to residents and their carers, and costly to the NHS. Even when falls do not result in fractures, they frequently result in other forms of injury. They cause fear of falling which contributes to a cycle of functional decline and increasing dependency with associated care costs. The Guide to Action for Falls Prevention - Care Homes (GtACH) intervention aims to reduce fall rates by supporting care home staff to identify risk factors for falling pertinent for an individual and take action to reduce those risks. It was co-produced by a group of care home staff, clinicians, researchers, public, voluntary and social care organisations and includes care home staff training, support and documentation. With training, the GtACH takes on average 20 minutes to complete for each resident. Initial proof of concept work and a subsequent feasibility randomised controlled trial (RCT) have shown that GtACH is implementable and changes staff behaviour in line with gold standard practice. This study will determine whether the use of GtACH has an impact on clinical outcomes for care home residents that are at risk of falling.

More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf

PURPOSE OF THE DATA REQUESTED

The specific purpose of the data requested is to monitor number of hospital admissions, A&E visits, outpatient visits, and ambulance call outs for participants recruited to the Falls in Care Homes (FinCH) randomised controlled trial. The data requested is to be used in the economic evaluation which is nested within the FinCH clinical trial and will be reported alongside aggregated results in the NHIR journal monograph series and presented in peer-reviewed publications.

The data requested will enable the research team to estimate the secondary care costs over the trial period for all participants in the study such that we can report a mean cost per participant that includes all types of NHS care not just those based in the community. This will enable a more accurate estimate of the cost effectiveness of the falls prevention intervention compared to usual care. This information will in turn help inform the evidence base used to decide which fall prevention interventions should be funded in the care home setting.

Where possible, the study has collected resource use data from care home records, however information care homes document about secondary care lacks sufficient detail to allow accurate costing. The data requested here will build a more precise picture of the participants resource use during the trial follow-up period of 12 months.

DATA REQUIREMENTS:

[NO DATA IS REQUESTED UNDER V1.2 OF THIS DSA. THESE DATA REQUIREMENTS REFER TO VERSION 0.19 OF THIS DSA. DATA PROCESSING CONTINUES UNDER VERSION 0.19]

The data required is individual level data on the resource use of participants in the FinCH trial from the Hospital Episode Statistics (HES) Outpatients (OP), the Hospital Episode Statistics Admitted Patient Care (APC) and the Hospital Episode Statistics Accident and Emergency (A&E) in order to be able to cost their secondary care use over the trial period in order to see if mean cost in the intervention arm was different to that in the control arm. Identifiers will be provided to NHS Digital for linkage, but the data to be disseminated by NHS Digital will be pseudonymised. Data is requested for three periods (2016/17, 2017/18, and latest available(18/19)). The date range required is 1st August 2016 – 28th February 2019 to reflect the date’s recruitment into the trial and when 12 month follow-up completed. The geographical spread of the data requested reflects the locations of the care homes in the trial.

There are no alternative ways of collecting this data which is less intrusive. The study team have collected resource use data pertaining to primary and community care from care home maintained records but secondary care is not adequately recorded in care home records to enable recourse use to be costed.

The data is minimised in that it relates to the trial cohort only. In addition, the study team have taken on board the advice of data managers from NHS digital with respect to fields requested, and this is reflected in this agreement.

DATA CONTROLLERS AND PROCESSORS

There are two joint data controllers, reflecting the fact that the grant for the research was awarded to and managed by the University of Nottingham and that the University of East Anglia manage the day to day running of the trial via their Norwich Clinical Trials Unit and lead the health economic aspect of the grant. The University of East Anglia is the sole Data Processor.

Some other organisations are involved in an advisory capacity only - Nottingham City Care NHS and participating care homes. University Hospitals of Leicester and University of Leicester no longer have any involvement in the trial. The NIHR HTA programme funded the research but play no further role.

The data will not be used for commercial purposes or direct marketing. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

LEGAL BASIS

Processing shall be lawful as both Article 6 1(e) and 9 2(j) of the General Data Protection Regulation apply. Article 6 1(e) applies - 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 NIHR HTA FinCH trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The results of the research may inform public guidance and decisions about funding for care home fall prevention programmes and as such may help improve the health and well-being of care home residents in future. Processing shall be lawful as article 9(2)(j) applies - ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes…’ of Regulations (EU) 2016/679, April 27th 2016. The trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The data will not be used for commercial purposes, will not be provided in record level to any third party, and will not be not used for direct marketing. All analysis will be conducted at University of East Anglia.

The FinCH trial also has the consent of participants and consultees in order to meet the common law duty of confidentiality. Each individual participant has given clear consent for the research team to process their personal data for a specific purpose. This is evidenced in the patient consent form where individual participants or their consultee initial to show agreement to “I agree to hospital and social care information about me being requested from National Data providers such as the Health and Social Care Information Centre.” The individual or their consultee will have had chance to read about this in more detail in the patient information sheet prior to the consent process taking place. Participants are informed of their right to withdraw at any time from the study without this affecting their legal or medical rights. This is again detailed in both the consent form and participant information sheet. The PIS and consent forms were designed to meet the requirements for this vulnerable population. Feedback from PPI was to ensure that the documents were simple to read and understand, and contained the essential information to enable them to decide whether to participate or not. Although a proportion of care home residents have capacity, PPI, including family member of a care home resident and a Care Home Manager, as well as clinicians, recommended that the information provided to the resident was kept as simple as possible to cover the relevant areas of consent while avoiding confusion.

Where the consultee has consented on behalf of the participant, the research is being undertaken under the Mental Capacity Act 2005. This Act provides a framework for decision making on behalf of adults aged over 16 who lack capacity to make decisions themselves, including decisions to take part in research, such as health research. Sections 30-33 of the Act provide lawful authority for research to be carried out involving people without capacity provided that the research has been approved by an appropriate body. An appropriate body is a Research Ethics Committee (RECs) recognised by the Secretary of State or Welsh Ministers, and some RECs have particular expertise and training in considering such applications. This research is approved by the Yorkshire & The Humber – Bradford Leeds Research Ethics Committee which, as noted on the Health Research Authority (HRA) website, has this expertise – committee flag “Research Involving Adults Lacking Capacity” (https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/yorkshire-and-humber-bradford-leeds/).

Institutional consent was also sought to permit the study to be conducted within the care home, and as such the care home managers who are responsible for the use of their residents records were made aware of the purpose of the study including how their residents’ data would be used and consented to the study.

The results of the economic evaluation conducted alongside FinCH will be presented in the HTA monograph published on NIHR journals, submitted for publication to peer reviewed journals and presented at academic conferences. The HTA monograph needs to be submitted by the end of August 2019 alongside the submission of peer reviewed publications. Though publications may be submitted after this date where they explore specific aspects of the work in more detail.

The results of the trial will be reported first to all trial collaborators (i.e. University of East Anglia, University of Nottingham, Nottingham City Care NHS and patient/nursing home representatives). The main report will be drafted by members of the Trial Management Group, and the final version will be agreed by the Trial Steering Committee before submission for publication, on behalf of the collaboration. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All publications will be subject to the forthcoming FinCH publications protocol, which will explicitly stipulate the requirements for authorship of publications. Findings will be disseminated to academic audiences through publication in open access academic journals and presentations at academic conferences. Dissemination of findings will be prioritised to study participants (residents/care home staff) who will receive quarterly newsletter updates. At the end of active involvement participants will receive thank you letters. Oral/poster presentations and workshops at sponsor hosted events, community meetings and professional/stake holder/user conferences will be targeted. The study will be submitted by the end of August 2019 for publication in the NIHR Journals in due course.

The study team will seek to disseminate in a way to support best practice. They will liaise with ProFouND (The Prevention of Falls Network for Dissemination) and EnRICH to identify potential research users, other researchers, policy makers, commissioners, clinicians, care home managers and staff, care home residents and relatives. One member of the research team is the lead for the programmes related to older people in Collaboration for Leadership in Applied Health Research and Care East Midlands and the East Midlands Academic Health Sciences Network which will enable dissemination through these regional and national networks and to prepare for subsequent adoption at pace and scale. Dissemination outputs will be tailored towards each group including peer reviewed journal articles, evidence summaries, briefing papers, video clips and a DVD. Media coverage will be sought in the form of local newspapers, television and radio outlets. This will be enabled further via connecting with the university’s specialist experts in information technology and communication departments. Requests will be sent to relevant agencies to feature the research project in their newsletters and websites. A study web page will feature on the University of Nottingham Rehabilitation and Ageing divisional website.

The data will not be used for commercial or direct marketing purposes. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Data requested under version 0.19 of this agreement was not disseminated to the Data Processor until 26th September 2019 and as such the University of East Anglia have had less than 12 months to analyse / process the data received. Therefore, this 6 month extension is requested to allow access longer than originally planned in the application v0.19.

The University of East Anglia are in the process of analysing and writing up the HTA monograph and several peer-reviewed publications.

This version of the data sharing agreement (v1.2) is a 4 month extension to allow University of East Anglia to process the data they received under v0.19 of this DSA. The data disseminated by NHS Digital was delayed by 4 months, and thus this extension covers the additional processing needed by University of East Anglia to complete their analysis. No further data is required under this version of the application.

BACKGROUND TO THE RESEARCH TRIAL

The Falls in Care Homes (FinCH) study; A multi-centre cluster randomised controlled trial to evaluate the Guide to Action Care Home (GtACH) fall prevention programme in old age UK care homes was funded by a grant from the NIHR Health Technology Assessment Programme (HTA 13/115/29) for £1.8 million in 2014.

The FinCH trial is sponsored by University of Nottingham and the Principle Investigator is based at the University of Nottingham, with analysis completed at University of East Anglia. It is the largest randomised controlled trial (RCT) conducted in UK care homes to date, and having access to detailed health service use for 1,661 residents will be a valuable resource to better understand this population. It covers England only. Unit costs will be allocated for each participant, for inclusion in a cost-effectiveness analysis of the falls prevention intervention compared to usual care. Cost per participant will be presented in aggregated form (comparing the two treatment arms) as opposed to at individual or record level.

The study recruited adult care homes and their residents from a broad geographical area in the UK, to capture a range of health and social contexts. The sample size of the study was 1308 residents (654 to intervention group and 654 to control group). Updated calculations were made to allow for a variation in cluster size and a smaller number of participants per care home. The updated calculation gives a recruitment target of 78 care homes and 1482 individuals. In total 87 homes and 1698 residents were consented.

To have been eligible for inclusion in the trial long term care home residents must have provided informed consent or those without capacity to have informed consent from a relative/consultee who will provide advice on their behalf. Residents were excluded if they were in receipt of end of life care or in the home for short term care, respite care or for rehabilitation.

Randomisation to intervention or control (usual care) was at the care home level. The intervention arm received the GtACH Intervention. The intervention involved care home staff completing the GtACH Tool with residents in a private area of the care home. The results were discussed with family, friends and other care home staff. Completed GtACH documentation was placed in the resident’s care records. The actions might have required changes within the care home, changes to residents’ personal care, referral to other services, or purchase of equipment. The actions were written in the GtACH documentation. The GtACH was completed ideally within four weeks of randomisation (and within two weeks of staff training being completed in the care home) for all trial participants in the care home. Actions were started immediately after the identification of risk. As part of GtACH training, re-assessment was undertaken if the participant developed a new medical or cognitive condition, if they fell, or every three- six months if there are no other changes.

Those in the control group received the comparator of usual care, i.e. the care that was in place prior to the trial.

More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf

The aim of the FinCH trial is to determine the clinical and cost effectiveness of the GtACH for fall prevention in care homes compared to usual care. This is important as 415,000 people live in UK care homes. These facilities provide care either with or without registered nursing input and are referred to as care homes with or without nursing respectively. The majority of residents are aged over 80, have cognitive impairment, mobility problems and multiple medical conditions. Health and social care interventions may require modifications in order to work in the care home setting, either because of the configuration of disability and dependency amongst residents, or to work within the organisational setting of care homes. One area where interventions might require to be designed with care homes specifically in mind is in the field of falls prevention. Community falls prevention interventions reduce falls and risk of falls by 30%, but literature to date has found no conclusive reduction in falls in care homes. Care home specific research is scarce and the existing research is inconclusive. Current fall interventions rely on patient engagement and adherence to advice. These present difficulties in care homes, where 75% of residents are cognitively impaired and non-targeted interventions with cognitively impaired older adults have not been successful.

At a rate of 2.5 falls per person, per year there are 160,000 falls per year in care home residents. In care homes, nearly one in ten people who fall sustain a fracture, one in five are admitted to hospital and one in five will die within a year due to a fall related injury. One third of the UK’s hip fractures occur in care home residents, which is devastating to residents and their carers, and costly to the NHS. Even when falls do not result in fractures, they frequently result in other forms of injury. They cause fear of falling which contributes to a cycle of functional decline and increasing dependency with associated care costs. The Guide to Action for Falls Prevention - Care Homes (GtACH) intervention aims to reduce fall rates by supporting care home staff to identify risk factors for falling pertinent for an individual and take action to reduce those risks. It was co-produced by a group of care home staff, clinicians, researchers, public, voluntary and social care organisations and includes care home staff training, support and documentation. With training, the GtACH takes on average 20 minutes to complete for each resident. Initial proof of concept work and a subsequent feasibility randomised controlled trial (RCT) have shown that GtACH is implementable and changes staff behaviour in line with gold standard practice. This study will determine whether the use of GtACH has an impact on clinical outcomes for care home residents that are at risk of falling.

More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf

PURPOSE OF THE DATA REQUESTED

The specific purpose of the data requested is to monitor number of hospital admissions, A&E visits, outpatient visits, and ambulance call outs for participants recruited to the Falls in Care Homes (FinCH) randomised controlled trial. The data requested is to be used in the economic evaluation which is nested within the FinCH clinical trial and will be reported alongside aggregated results in the NHIR journal monograph series and presented in peer-reviewed publications.

The data requested will enable the research team to estimate the secondary care costs over the trial period for all participants in the study such that we can report a mean cost per participant that includes all types of NHS care not just those based in the community. This will enable a more accurate estimate of the cost effectiveness of the falls prevention intervention compared to usual care. This information will in turn help inform the evidence base used to decide which fall prevention interventions should be funded in the care home setting.

Where possible, the study has collected resource use data from care home records, however information care homes document about secondary care lacks sufficient detail to allow accurate costing. The data requested here will build a more precise picture of the participants resource use during the trial follow-up period of 12 months.

DATA REQUIREMENTS:

[NO DATA IS REQUESTED UNDER V1.2 OF THIS DSA. THESE DATA REQUIREMENTS REFER TO VERSION 0.19 OF THIS DSA. DATA PROCESSING CONTINUES UNDER VERSION 0.19]

The data required is individual level data on the resource use of participants in the FinCH trial from the Hospital Episode Statistics (HES) Outpatients (OP), the Hospital Episode Statistics Admitted Patient Care (APC) and the Hospital Episode Statistics Accident and Emergency (A&E) in order to be able to cost their secondary care use over the trial period in order to see if mean cost in the intervention arm was different to that in the control arm. Identifiers will be provided to NHS Digital for linkage, but the data to be disseminated by NHS Digital will be pseudonymised. Data is requested for three periods (2016/17, 2017/18, and latest available(18/19)). The date range required is 1st August 2016 – 28th February 2019 to reflect the date’s recruitment into the trial and when 12 month follow-up completed. The geographical spread of the data requested reflects the locations of the care homes in the trial.

There are no alternative ways of collecting this data which is less intrusive. The study team have collected resource use data pertaining to primary and community care from care home maintained records but secondary care is not adequately recorded in care home records to enable recourse use to be costed.

The data is minimised in that it relates to the trial cohort only. In addition, the study team have taken on board the advice of data managers from NHS digital with respect to fields requested, and this is reflected in this agreement.

DATA CONTROLLERS AND PROCESSORS

There are two joint data controllers, reflecting the fact that the grant for the research was awarded to and managed by the University of Nottingham and that the University of East Anglia manage the day to day running of the trial via their Norwich Clinical Trials Unit and lead the health economic aspect of the grant. The University of East Anglia is the sole Data Processor.

Some other organisations are involved in an advisory capacity only - Nottingham City Care NHS and participating care homes. University Hospitals of Leicester and University of Leicester no longer have any involvement in the trial. The NIHR HTA programme funded the research but play no further role.

The data will not be used for commercial purposes or direct marketing. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

LEGAL BASIS

Processing shall be lawful as both Article 6 1(e) and 9 2(j) of the General Data Protection Regulation apply. Article 6 1(e) applies - 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 NIHR HTA FinCH trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The results of the research may inform public guidance and decisions about funding for care home fall prevention programmes and as such may help improve the health and well-being of care home residents in future. Processing shall be lawful as article 9(2)(j) applies - ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes…’ of Regulations (EU) 2016/679, April 27th 2016. The trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The data will not be used for commercial purposes, will not be provided in record level to any third party, and will not be not used for direct marketing. All analysis will be conducted at University of East Anglia.

The FinCH trial also has the consent of participants and consultees in order to meet the common law duty of confidentiality. Each individual participant has given clear consent for the research team to process their personal data for a specific purpose. This is evidenced in the patient consent form where individual participants or their consultee initial to show agreement to “I agree to hospital and social care information about me being requested from National Data providers such as the Health and Social Care Information Centre.” The individual or their consultee will have had chance to read about this in more detail in the patient information sheet prior to the consent process taking place. Participants are informed of their right to withdraw at any time from the study without this affecting their legal or medical rights. This is again detailed in both the consent form and participant information sheet. The PIS and consent forms were designed to meet the requirements for this vulnerable population. Feedback from PPI was to ensure that the documents were simple to read and understand, and contained the essential information to enable them to decide whether to participate or not. Although a proportion of care home residents have capacity, PPI, including family member of a care home resident and a Care Home Manager, as well as clinicians, recommended that the information provided to the resident was kept as simple as possible to cover the relevant areas of consent while avoiding confusion.

Where the consultee has consented on behalf of the participant, the research is being undertaken under the Mental Capacity Act 2005. This Act provides a framework for decision making on behalf of adults aged over 16 who lack capacity to make decisions themselves, including decisions to take part in research, such as health research. Sections 30-33 of the Act provide lawful authority for research to be carried out involving people without capacity provided that the research has been approved by an appropriate body. An appropriate body is a Research Ethics Committee (RECs) recognised by the Secretary of State or Welsh Ministers, and some RECs have particular expertise and training in considering such applications. This research is approved by the Yorkshire & The Humber – Bradford Leeds Research Ethics Committee which, as noted on the Health Research Authority (HRA) website, has this expertise – committee flag “Research Involving Adults Lacking Capacity” (https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/yorkshire-and-humber-bradford-leeds/).

Institutional consent was also sought to permit the study to be conducted within the care home, and as such the care home managers who are responsible for the use of their residents records were made aware of the purpose of the study including how their residents’ data would be used and consented to the study.

The results of the economic evaluation conducted alongside FinCH will be presented in the HTA monograph published on NIHR journals, submitted for publication to peer reviewed journals and presented at academic conferences. The HTA monograph needs to be submitted by the end of August 2019 alongside the submission of peer reviewed publications. Though publications may be submitted after this date where they explore specific aspects of the work in more detail.

The results of the trial will be reported first to all trial collaborators (i.e. University of East Anglia, University of Nottingham, Nottingham City Care NHS and patient/nursing home representatives). The main report will be drafted by members of the Trial Management Group, and the final version will be agreed by the Trial Steering Committee before submission for publication, on behalf of the collaboration. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All publications will be subject to the forthcoming FinCH publications protocol, which will explicitly stipulate the requirements for authorship of publications. Findings will be disseminated to academic audiences through publication in open access academic journals and presentations at academic conferences. Dissemination of findings will be prioritised to study participants (residents/care home staff) who will receive quarterly newsletter updates. At the end of active involvement participants will receive thank you letters. Oral/poster presentations and workshops at sponsor hosted events, community meetings and professional/stake holder/user conferences will be targeted. The study will be submitted by the end of August 2019 for publication in the NIHR Journals in due course.

The study team will seek to disseminate in a way to support best practice. They will liaise with ProFouND (The Prevention of Falls Network for Dissemination) and EnRICH to identify potential research users, other researchers, policy makers, commissioners, clinicians, care home managers and staff, care home residents and relatives. One member of the research team is the lead for the programmes related to older people in Collaboration for Leadership in Applied Health Research and Care East Midlands and the East Midlands Academic Health Sciences Network which will enable dissemination through these regional and national networks and to prepare for subsequent adoption at pace and scale. Dissemination outputs will be tailored towards each group including peer reviewed journal articles, evidence summaries, briefing papers, video clips and a DVD. Media coverage will be sought in the form of local newspapers, television and radio outlets. This will be enabled further via connecting with the university’s specialist experts in information technology and communication departments. Requests will be sent to relevant agencies to feature the research project in their newsletters and websites. A study web page will feature on the University of Nottingham Rehabilitation and Ageing divisional website.

The data will not be used for commercial or direct marketing purposes. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Data requested under version 0.19 of this agreement was not disseminated to the Data Processor until 26th September 2019 and as such the University of East Anglia have had less than 12 months to analyse / process the data received. Therefore, this 4 month extension is requested to allow access longer than originally planned in the application v0.19.

The University of East Anglia are in the process of analysing and writing up the HTA monograph and several peer-reviewed publications.

1) Purpose of the data request:

The specific purpose of this data request is to monitor number of hospital admissions, A&E visits, outpatient visits, and ambulance call outs for participants recruited to the Falls in Care Homes (FinCH) randomised controlled trial. The FinCH trial is sponsored by University of Nottingham and the Principle Investigator is based at the University of Nottingham, with analysis completed at University of East Anglia. It is the largest randomised controlled trial (RCT) conducted in UK care homes to date, and having access to detailed health service use for 1,661 residents will be a valuable resource to better understand this population. It covers England only. Unit costs will be allocated for each participant, for inclusion in a cost-effectiveness analysis of the falls prevention intervention compared to usual care. Cost per participant will be presented in aggregated form (comparing the two treatment arms) as opposed to at individual or record level.

Where possible, the study has collected resource use data from care home records, however information care homes document about secondary care lacks sufficient detail to allow accurate costing. The data requested here will build a more precise picture of the participants resource use during the trial follow-up period of 12 months.

2) Legal basis:

Processing shall be lawful as both Article 6 1(e) and 9 2(j) of the General Data Protection Legislation apply. Article 6 1(e) applies, 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 NIHR HTA FinCH trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The results of the research may inform public guidance and decisions about funding for care home fall prevention programmes and as such may help improve the health and well-being of care home residents in future. Processing shall be lawful as article 9(2)(j) applies - ‘processing is necessary for archiving purposes in the public interest, scientific or historical research purposes…’ of Regulations (EU) 2016/679, April 27th 2016. The trial is publicly funded research being undertaken in the public interest to inform knowledge on how best to help prevent falls in a care home setting. The data will not be used for commercial purposes, will not be provided in record level to any third party, and will not be not used for direct marketing. All analysis will be conducted at University of East Anglia, Norwich, UK.

The FinCH trial also has the consent of participants and consultees in order to meet common law, that is the individual has given clear consent for the research team to process their personal data for a specific purpose. This is evidenced in the patient consent form where individual participants or their consultee initial to show agreement to “I agree to hospital and social care information about me being requested from National Data providers such as the Health and Social Care Information Centre.” The individual or their consultee will have had chance to read about this in more detail in the patient information sheet prior to the consent process taking place. Participants are informed of their right to withdraw at any time from the study without this affecting their legal or medical rights. This is again detailed in both the consent form and participant information sheet. The PIS and consent forms were designed to meet the requirements for this vulnerable population. Feedback from PPI was to ensure that the documents were simple to read and understand, and contained the essential information to enable them to decide whether to participate or not. Although a proportion of care home residents have capacity, PPI, including family member of a care home resident and a Care Home Manager, as well as clinicians, recommended that the information provided to the resident was kept as simple as possible to cover the relevant areas of consent while avoiding confusion.

Where the consultee has consented on behalf of the participant, the research is being undertaken under the Mental Capacity Act 2005. This Act provides a framework for decision making on behalf of adults aged over 16 who lack capacity to make decisions themselves, including decisions to take part in research, such as health research. Sections 30-33 of the Act provide lawful authority for research to be carried out involving people without capacity provided that the research has been approved by an appropriate body. An appropriate body is a Research Ethics Committee (RECs) recognised by the Secretary of State or Welsh Ministers, and some RECs have particular expertise and training in considering such applications. This research is approved by the Yorkshire & The Humber – Bradford Leeds Research Ethics Committee which, as noted on the Health Research Authority (HRA) website, has this expertise – committee flag “Research Involving Adults Lacking Capacity” (https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/yorkshire-and-humber-bradford-leeds/).

Institutional consent was also sought to permit the study to be conducted within the care home, and as such the care home managers who are responsible for the use of their residents records were made aware of the purpose of the study including how their residents’ data would be used and consented to the study.

3) Background to the research/trial:

The data requested will enable the research team to estimate the secondary care costs over the trial period for all participants in the study such that we can report a mean cost per participant that includes all types of NHS care not just those based in the community. This will enable a more accurate estimate of the cost effectiveness of the falls prevention intervention compared to usual care. This information will in turn help inform the evidence base used to decide which fall prevention interventions should be funded in the care home setting.

The Falls in Care Homes (FinCH) study; A multi-centre cluster randomised controlled trial to evaluate the Guide to Action Care Home (GtACH) fall prevention programme in old age UK care homes was funded by a grant from the NIHR Health Technology Assessment Programme (HTA 13/115/29) for £1.8 million in 2014.

The data requested is to be used in the economic evaluation which is nested within the FinCH clinical trial and will be reported alongside aggregated results in the NHIR journal monograph series and presented in peer-reviewed publications.

The study recruited adult care homes and their residents from a broad geographical area in the UK, to capture a range of health and social contexts. The sample size of the study was 1308 residents (654 to intervention group and 654 to control group). Updated calculations were made to allow for a variation in cluster size and a smaller number of participants per care home. The updated calculation gives a recruitment target of 78 care homes and 1482 individuals. In total 87 homes and 1698 residents were consented.

To have been eligible for inclusion in the trial long term care home residents must have provided informed consent or those without capacity to have informed consent from a relative/consultee who will provide advice on their behalf. Residents were excluded if they were in receipt of end of life care or in the home for short term care, respite care or for rehabilitation.

Randomisation to intervention or control (usual care) was at the care home level. The intervention arm received the GtACH Intervention. The intervention involved care home staff completing the GtACH Tool with residents in a private area of the care home. The results were discussed with family, friends and other care home staff. Completed GtACH documentation was placed in the resident’s care records. The actions might have required changes within the care home, changes to residents’ personal care, referral to other services, or purchase of equipment. The actions were written in the GtACH documentation. The GtACH was completed ideally within four weeks of randomisation (and within two weeks of staff training being completed in the care home) for all trial participants in the care home. Actions were started immediately after the identification of risk. As part of GtACH training, re-assessment was undertaken if the participant developed a new medical or cognitive condition, if they fell, or every three- six months if there are no other changes.

Those in the control group received the comparator of usual care, i.e. the care that was in place prior to the trial.

More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf

The aim of the FinCH trial is to determine the clinical and cost effectiveness of the GtACH for fall prevention in care homes compared to usual care. This is important as 415,000 people live in UK care homes. These facilities provide care either with or without registered nursing input and are referred to as care homes with or without nursing respectively. The majority of residents are aged over 80, have cognitive impairment, mobility problems and multiple medical conditions. Health and social care interventions may require modifications in order to work in the care home setting, either because of the configuration of disability and dependency amongst residents, or to work within the organisational setting of care homes. One area where interventions might require to be designed with care homes specifically in mind is in the field of falls prevention. Community falls prevention interventions reduce falls and risk of falls by 30%, but literature to date has found no conclusive reduction in falls in care homes. Care home specific research is scarce and the existing research is inconclusive. Current fall interventions rely on patient engagement and adherence to advice. These present difficulties in care homes, where 75% of residents are cognitively impaired and non-targeted interventions with cognitively impaired older adults have not been successful.

At a rate of 2.5 falls per person, per year there are 160,000 falls per year in care home residents. In care homes, nearly one in ten people who fall sustain a fracture, one in five are admitted to hospital and one in five will die within a year due to a fall related injury. One third of the UK’s hip fractures occur in care home residents, which is devastating to residents and their carers, and costly to the NHS. Even when falls do not result in fractures, they frequently result in other forms of injury. They cause fear of falling which contributes to a cycle of functional decline and increasing dependency with associated care costs. The Guide to Action for Falls Prevention - Care Homes (GtACH) intervention aims to reduce fall rates by supporting care home staff to identify risk factors for falling pertinent for an individual and take action to reduce those risks. It was co-produced by a group of care home staff, clinicians, researchers, public, voluntary and social care organisations and includes care home staff training, support and documentation. With training, the GtACH takes on average 20 minutes to complete for each resident. Initial proof of concept work and a subsequent feasibility randomised controlled trial (RCT) have shown that GtACH is implementable and changes staff behaviour in line with gold standard practice. This study will determine whether the use of GtACH has an impact on clinical outcomes for care home residents that are at risk of falling.

More details can be found in the published protocol: https://www.nottingham.ac.uk/emran/documents/issue-25-emran-feb-2019.pdf

4) Data requirements:

The data required is individual level data on the resource use of participants in the FinCH trial from the Hospital Episode Statistics (HES) Outpatients (OP), the Hospital Episode Statistics Admitted Patient Care (APC) and the Hospital Episode Statistics Accident and Emergency (A&E) in order to be able to cost their secondary care use over the trial period in order to see if mean cost in the intervention arm was different to that in the control arm. Identifiers will be provided to NHS Digital for linkage, but the data to be disseminated by NHS Digital will be pseudonymised. Data is requested for three periods (2016/17, 2017/18, and latest available(18/19)). The date range required is 1st August 2016 – 28th February 2019 to reflect the date’s recruitment into the trial and when 12 month follow-up completed. The geographical spread of the data requested reflects the locations of the care homes in the trial.

There are no alternative ways of collecting this data which is less intrusive. The study team have collected resource use data pertaining to primary and community care from care home maintained records but secondary care is not adequately recorded in care home records to enable recourse use to be costed.

The data is minimised in that it relates to the trial cohort only. In addition, the study team have taken on board the advice of data managers from NHS digital with respect to fields requested, and this is reflected in this agreement.

5) Organisations:

There are two joint data controllers, reflecting the fact that the grant for the research was awarded to and managed by Nottingham University and that the University of East Anglia manage the day to day running of the trial via their Clinical trials unit and lead the health economic aspect of the grant. Some other organisations are involved in an advisory capacity only - Nottingham City Care NHS and participating care homes. University Hospitals of Leicester and University of Leicester no longer have any involvement in the trial. The NIHR HTA programme funded the research but play no further role.

The data will not be used for commercial purposes or direct marketing. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide. All analysis will be conducted at University of East Anglia, Norwich, UK.

The results of the economic evaluation conducted alongside FinCH will be presented in the HTA monograph published on NIHR journals, submitted for publication to peer reviewed journals and presented at academic conferences. The HTA monograph needs to be submitted by the end of August 2019 alongside the submission of peer reviewed publications. Though publications may be submitted after this date where they explore specific aspects of the work in more detail.

The results of the trial will be reported first to all trial collaborators (i.e. University of East Anglia, University of Nottingham, Nottingham City Care NHS and patient/nursing home representatives). The main report will be drafted by members of the Trial Management Group, and the final version will be agreed by the Trial Steering Committee before submission for publication, on behalf of the collaboration. The trial will be reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. All publications will be subject to the forthcoming FinCH publications protocol, which will explicitly stipulate the requirements for authorship of publications. Findings will be disseminated to academic audiences through publication in open access academic journals and presentations at academic conferences. Dissemination of findings will be prioritised to study participants (residents/care home staff) who will receive quarterly newsletter updates. At the end of active involvement participants will receive thank you letters. Oral/poster presentations and workshops at sponsor hosted events, community meetings and professional/stake holder/user conferences will be targeted. The study will be submitted by the end of August 2019 for publication in the NIHR Journals in due course.

The study team will seek to disseminate in a way to support best practice. They will liaise with ProFouND (The Prevention of Falls Network for Dissemination) and EnRICH to identify potential research users, other researchers, policy makers, commissioners, clinicians, care home managers and staff, care home residents and relatives. One member of the research team is the lead for the programmes related to older people in Collaboration for Leadership in Applied Health Research and Care East Midlands and the East Midlands Academic Health Sciences Network which will enable dissemination through these regional and national networks and to prepare for subsequent adoption at pace and scale. Dissemination outputs will be tailored towards each group including peer reviewed journal articles, evidence summaries, briefing papers, video clips and a DVD. Media coverage will be sought in the form of local newspapers, television and radio outlets. This will be enabled further via connecting with the university’s specialist experts in information technology and communication departments. Requests will be sent to relevant agencies to feature the research project in their newsletters and websites. A study web page will feature on the University of Nottingham Rehabilitation and Ageing divisional website.

The data will not be used for commercial or direct marketing purposes. All outputs will be aggregated with small numbers suppressed in line with the HES Analysis Guide.

Yielded Benefits is not a requirement for new applications.