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The toolkit identifies the principles that should guide research in care homes and signposts researchers to other, more detailed sources of information.

We suggest that there are five key issues for those wanting to carry out research in care homes:

  1. An appreciation of the potential benefits of research for care home residents, staff, and families;
  2. An understanding of what is different about doing research in care homes; compared with other environments;
  3. Preparation and planning the study;
  4. Carrying out the research study;
  5. Feeding back the results.

Please use the left hand navigation bar to view relevant reports and guidance around designing and delivering your study. You will also find below a number of case studies to help describe how others have approached particular challenges, such as acquiring consent, involving care home managers and gaining staff buy-in.

The case studies illustrate the short-term and long-term benefits to care homes and help staff to understand what is involved. Written by care home staff and researchers, they provide real life examples of the challenges and lessons learned by those involved in research.

NIHR research funding opportunities

Links to organisations, resources and other useful information.

1. Understanding Care Homes

Researchers wanting to work with care homes, or planning a study involving care home residents, need to recognise the differences between patients and residents, and the particular challenges of conducting research outside NHS healthcare settings.

THE CARE HOME SECTOR: HOME NOT HOSPITAL

In the UK, the majority of long-term care for older people is provided by staff working in care homes. The overarching ethos in care homes is that they are places where people with complex health needs live; it is their home, and quality of life matters. Approximately 416,000 people live in care homes (Laing and Buisson survey 2016). This is 4% of the population aged 65 years and over, rising to 16% of those aged 85 or more.

There are different levels of care accommodation available depending on the level of care required. Care homes are a catch-all term used for nursing homes (care homes with nursing care) and residential care homes (care homes without nursing care). Care homes with nursing care provide help and assistance with personal care, which is also provided by those without nursing care (residential care homes), but they also have professional registered nurses and experienced care assistants who provide 24-hour nursing care services for people with more complex health needs. In addition to being registered to provide general nursing care, many homes also offer rehabilitation services which include different therapies, such as physical, speech and pain therapies and specialist health care including, dementia care, EMI nursing care and palliative care. These homes are for people who are very frail or for people who are unable to care for themselves and have complex health care requirements.

There are also a number of other care plus, and retirement communities where other types of care are provided.

CARE HOME RESIDENTS: HIGH LEVELS OF NEED

There is considerable overlap in health status and need for care and support among residents in all care homes, and in particular a high prevalence of cognitive impairment (conditions such as dementia), co-morbidity (people who have more than one illness) and polypharmacy (people who take several prescribed drugs).

Most care home residents are women and are over 85 years old, with an average life expectancy of less than two and a half years. This means that end-of-life care is a core component of care home activities, and this can have an impact on research studies, regardless of the research question.

While residents differ, many have complex health care needs including diseases, disabilities and conditions that affect older people and which reduce life expectancy. Some challenges are unique to the sector. To provide some context, here we present further information on four of the most common conditions residents of care homes may have/live with, which require careful consideration in a study:

Musculoskeletal problems

Musculoskeletal disorders are among the most common problems affecting older people. The resulting loss of mobility and physical independence can be particularly devastating in this population. Rheumatoid arthritis alone affects over 85,000 people over the age of 75 (Arthritis Research UK 2015), many of the people affected live in care homes.

Dementia

In England, approximately 283,000 people with dementia live in care homes (Alzheimer’s Society 2015). Over 42% of care homes are registered as providers of specialist dementia care. The Alzheimer’s Society also reports that around 80% of care home residents have dementia or severe memory problems, however, this varies by the type of home. Care homes are quickly adapting to the needs of increasing numbers and proportions of residents with dementia, and homes that specialise in the care of people with dementia are becoming more common.

Stroke

There are approximately 1.2 million stroke survivors living in the UK, over a third of stroke survivors in the UK are dependent on others but only 1 in 5 are cared for by family and / or friends (Stroke Association 2015). Many stroke survivors need a long period of rehabilitation, and approximately 11% of stroke patients move to a care home after their stroke (NAO 2010). By the age of 75, 1 in 5 women and 1 in 6 men will have a stroke (Stoke Association 2015). Stroke is reported to be the second most common cause of disability after dementia in a UK nursing home population (Martin 1998).

Parkinson’s Disease

It is estimated that around 1 in 500 people are affected by Parkinson’s Disease and there are currently 127,000 people in the UK with the condition. Around 5% of people living in care homes have Parkinson’s Disease (Parkinson’s UK, 2015). As with other conditions those residents with Parkinson’s Disease have very specific care needs, which may be met by specialist care homes or other more general care homes. These include swallowing problems, risk of falls, bladder and bowel problems and sleep difficulties. These are often the subject of research.

Palliative / end-of-life care

Approximately 60% of all deaths that occur each year in the UK are expected and predictable. The main causes are cancers, end stage organ failure, neurodegenerative diseases and dementia. Around 97,000 people (17.8% of all those who die in England each year) die in a care home (2008-2010 data from Office for National Statistics (ONS) for England and Wales). Approximately 3,000 care homes in England are registered as specialising in end-of-life and palliative care (CQC 2015), and at the time of producing this website (January 2019) over 600 had been re-accredited for the Gold Standards Framework for quality of care provided to people at the end-of-life.

The approaches that care homes bring to end-of-life care can help to illustrate the differences between homes. Goodman et al (2010) found the way care home managers offered personal care and support to residents at the end-of-life and their approach influenced their level of engagement with NHS health care staff. This study showed that even though these variations are not desirable, the approach could range between:

  • Care home for life: where the care home always aimed to keep the resident in the care home and support their end-of-life care wherever possible;
  • In and out of hospital: where the clinical needs of the resident are dealt with in secondary care settings (hospitals) and then the resident may be returned to the care home for end-of-life care;
  • Transfer to specialist  or nursing home care: if a resident is assessed as dying they are transferred to another care setting;
  • Care homes as end-of-life specialists: care home managers who accept people who are dying as new residents.

A study of strategies to optimise care homes’ use of hospital services that focuses on the clinical needs of residents but neglects the underlying assumptions and the culture of care may produce misleading or unhelpful results.

Researchers should ask themselves how their planned study fits both with the ethos of the care home, and the realities of residents’ lives there.

Ownership

Nearly three quarters of care homes are owned by the private or commercial sector (74%), 20% are voluntary sector run, 4.7% are local authority owned and the very small percentage remaining are supported by the NHS. There are 20,067 registered care homes for adults in the UK providing accommodation and care for up to 545,351 people (www.caredata.co.uk). Some homes are run by owner managers, like family businesses, others are part of national or international chains and have shareholders, and others are run as charities (Orellana 2014).

MATTERS TO CONSIDER
  • Care homes can vary in size from less than 10 places to over 100, however the trend is for care homes that have a higher number of beds due to the economies of scale.
  • Care homes may have changes in ownership or management while a study takes place (some managers may be temporary).
  • Staffing levels and skill mix vary between types of care home (residential and nursing) and between individual care homes.
  • Many staff working in care homes are female workers who work part-time or flexibly; they are often paid very close to the National Minimum Wage. Staff turnover can affect the stability of the working environment. Staff turnover may be highest among more junior care assistants who provide the majority of the day-to-day care.
  • Care homes can work with between one and over 20 separate GP practices.
  • Access to community health services and specialist services is variable across the country and is subject to local interpretation by commissioners and NHS practitioners. It is important to distinguish between care homes that offer personal care and support only and those that offer nursing care. In a care home that is registered to provide both nursing and personal care, a resident’s status can change to requiring nursing care. This does not necessarily mean they will move to a different care home, but there is a possibility that they need to move rooms, or to parts of the building with different access to common areas and a change of care home worker.
  • The dependency or disability of residents,  the proportion that have been admitted from hospital, and funding or payment mechanisms (i.e. self-funding, wholly public funding, NHS continuing care, intermediate/respite/re-ablement care, public funding with top-up from resident or family) can impact upon staffing levels, investment in staff training, and the relationship with local NHS and Local Authority services.
  • The regulator (In England: the Care Quality Commission – CQC / Care Inspectorate (CI) in Scotland and Care and Social Services Inspectorate in Wales (CSSIW)) is responsible for assessing the quality of care against National Minimum Standards. These standards influence how records and notes are organised, kept and maintained in care homes as well as a range of other organisational factors.
Additional Statistics
  • The care home resident population for those aged 65 and over has remained almost stable since 2001 with an increase of 0.3%, despite growth of 11.0% in the overall population at this age (Changes in the Older Resident Care Home Population between 2001 and 2011. Office for National Statistics 2014).
  • Only 16% of people aged 85+ in the UK live in care homes (Care of Elderly People Market Survey 2013/14. Laing and Buisson 2014)
  • The median period from admission to the care home to death is 462 days or 15 months (Length of stay in care homes. Julien Forder and Jose-Luis Fernandez, PSSRU Discussion Paper 2769, 2011)
  • Around 27% of people lived in care homes for more than three years (Length of stay in care homes. Julien Forder and Jose-Luis Fernandez, PSSRU Discussion Paper 2769, 2011)

Some studies estimate that depression affects 40% of older people in care homes (Depression and Older People: Towards securing well-being in later life, Help the Aged 2004).

INFORMATION FOR FUNDERS

Research funders reviewing proposals are advised to look for evidence that the applicant understands the environment in which they intend to work. This understanding may be evident in the proposed recruitment timetable, work schedules and costs of research assistants (allowing for out-of-normal-hours working) and plans for flexibility in on-site working. Funders should be aware that homes may have to withdraw from a study for a variety of reasons and arrangement for loss of participating homes should be outlined in the research application. Funders should also be aware that some staff will be low paid and that the offer of some form of compensation to the care home may be well received.

 

” We found that approaching organisations at the same time as individual care homes has worked very well and saved time as well as increasing recruitment. They have also helped support the study and access to care homes. ”

Claire Surr, Professor of Dementia Studies, March 2015

“We have much appreciated the support and advice that ENRICH has provided for our study PAAD. Providing potential members for our Trial Steering Committee through the Research Ready Care Home Network and advice on practical issues such as care home indemnity through the toolkit. This support has been very valuable to us.” Victoria goes on to say “Conducting research in this care setting feels like treading a lonely path and its reassuring to know that there are others out there!”

Victoria Shepherd, Research Lead for PAAD, South East Wales Trial Unit at Cardiff University, August 2013

2. Reasons for working with care homes

  1. Residents in care homes need good care

Residents in care homes are a vulnerable group, often lacking an effective voice due to dementia and other communication difficulties. There is therefore a risk that their health and social care rights are neglected.

  1. Research provides evidence of what works best for the vulnerable population who live in care homes.

We have relatively little research evidence from care homes, particularly in the UK. Significant differences in the organisation and provision of care in the UK, compared with other European and non-European countries, limits the applicability of findings from studies outside the UK.

Care home residents are under-represented in research studies. Funders and researchers have in the past made the incorrect assumption that they have nothing to say or that it is too difficult to include them.

This means that in a number of areas the evidence to support best practice is weak and we have limited evidence to guide ways of improving residents’ quality of life.

See the Cochrane Editorial Unit ‘Care homes for older people’ and Gordon et al (2012) Systematic mapping review of RCTs in care homes BMC Geriatrics.

  1. Research can help raise standards

Research evidence can be instrumental in helping raise the standards of care in care homes. Providing the evidence needed to encourage changes in practice, and develop new ways of working.

For example, one study providing training and support for care home staff resulted in reduced antipsychotic medication use in residents with dementia by 50% without worsening any behavioral symptoms. This reduction was sustained for 12 months (Fossey et al. 2006).

  1. Research can lead to improvements in quality of life or wellbeing of residents and care teams.

People in care homes and their families may want to be involved in research for a variety of reasons, which may include giving them a voice, sense of purpose, increased self-esteem and enjoyment.

It is important to ensure that there are opportunities for care home residents, their families and staff to participate in research studies. They may have different ideas about what quality of life or care mean to them.

  1. Research guides best practice

Research provides an opportunity to develop the evidence base to guide best practice in care homes.

Collaboration with care homes can improve researchers’ understanding of how care is delivered and offer opportunities to work with residents who are at a particular stage in their illness.

FOR INFORMATION

This toolkit initially focused on research in the field of dementia. It is being expanded to cover a wider range of topics in health and social care, and to be applicable to anyone working with care home residents. Working with residents in care homes can be incredibly rewarding, and thanks to researchers, information and the lessons learned about good practice in this field are being applied to other settings of care.

 

“We found that expectations and attitudes were still firmly of the view that people with dementia either have nothing to offer the research process or cannot be engaged in any meaningful way.”

Increasing the Voice, Choice and Control of Older People with High Support Needs, Gillian Granville et al, May 2011 www.cpa.org.uk

“I wanted to get involved in research as I believe it is good for personal and service development. The staff became engaged, and were enthusiastic to help test the new ways of working being tested and the training provided has made a difference to care.”

Miranda Morgan, Care Home Manager, Surrey, March 2015

3. Benefits of care home research

Research in care homes should always have some benefit for those taking part even if the findings will only be useful for future residents and care home staff. It is very important that when approaching the care homes and building relationships that you properly articulate what you would like to achieve through your research, and focus on how it may benefit residents currently or in the future.

Historically, many care homes have been isolated communities. Participation in research can help to build links with other local health and social care services. Studies that bring training and access to other areas of healthcare e.g. physiotherapy have proven extremely successful. It is important that researchers support the care home to achieve its own goals and ambitions through its involvement in research. Good research in care homes is mutually beneficial with both the research team and the participants gaining from their involvement. Education and training for staff are always valued, as is the opportunity to discover improved ways to care and engage with residents.

It is important that care home owners, managers, staff and residents are involved in the study, ideally through all stages of developing and delivery. Treating the care home staff as co-researchers, and not only research subjects, will help to gain support.

It would be very disappointing if a study had the effect of making managers decide that research is too difficult or disruptive, but anecdotally we know this can occur.

The NIHR School for Social Care Research (NIHR SSCR) Methods Review on care home research outlines more in this area. Benefits to care home residents and their families are likely to be study-specific, but it’s important to ensure that you communicate these benefits. For example:

  • Research could enhance quality of life for residents, if they are able to participate in an activity or have someone to talk to.

A recent study found that some residents were able to talk to researchers about their lives and matters that were important to them, and said that this was generally not possible to do with others working in the home. Other studies have found that the boredom often reported by care home residents is ameliorated when researchers are around and interested in talking with them.

  • Research addresses issues that can be of great interest to staff, residents and their loved ones like frailty and nutrition, symptom management and end-of-life care.

Research studies that have encouraged partnerships, refined research questions with staff, and discussed findings, report positive responses and a willingness from care homes to continue involvement with research. Studies may lead to greater contact between care homes and the other health and care networks locally which can enrich mutual understanding and negate the stereotyped view that research focuses only on deficits and limitations.

  • Care homes may learn about new developments that are of use to their business. For example, the EVIDEM Mental Capacity Act (MCA) study provided one page summaries of the MCA to homes.
  • Homes may wish to say that they provide such opportunities to potential residents and their families to convey that they are leading their field and actively involved in knowledge creation and evidence-based care (e.g. include it in their information leaflet or website).
  • Care teams may experience greater job satisfaction if they feel that they are participating in studies where their skills and expertise are being recognised, it can also be beneficial to those studying for Qualification Credit Frameworks (QCFs) or the Care Certificate.
  • Staff and the care home may be provided with a certificate of participation which they can use in their portfolio or display.
INFORMATION FOR FUNDERS

Funders may seek evidence from grant applicants that researchers when designing a study have anticipated and worked with care homes to optimise the gains to residents, staff and the residents’ families.

 

“Elm Tree Court and the whole HICA group are committed to ensuring high standards of support to individuals. We therefore embrace new research and good practice guidance.  It is wonderful to be involved in the MARQUE study and we are looking forward to seeing what outcomes and recommendations may come from the research to enhance care for people.”

Manager of the Elm Tree Court care home in Hull

4. Preparing research studies

It is important that researchers preparing research studies take time to properly understand the care home sector.

There is considerable variation between individual care homes in terms of organisational culture, management and delivery of care. Researchers are advised to spend time understanding the care home sector, how it works and the challenges it faces. This will ensure that appropriate consideration can be made when discussing support for studies.

Researchers should consider how these differences can be accommodated and how study delivery can be integrated into normal care and activities as well as how the setting and differences could influence research findings. The advice below will help researchers achieve this.

A major reason why research bids fail is the inability of applicants to show that their recruitment strategy is feasible. Ensure you identify the care homes you would like to work with as early as possible, and plan and test feasibility together.

Involvement of stakeholders at all stages of the design and implementation of a study is essential (Chapter 5, Hood et al (2014) Probiotics for Antibiotic-Associated Diarrhoea (PAAD): a prospective observational study of antibiotic-associated diarrhea in care homes)

In preparing studies, researchers should consider the following practical tips from those experienced in this field:

 Considerations
  • The research is being done in the residents’ home which is also other people’s workplace. As such there may not be staff rooms or many places where you can talk privately with residents or staff.
  • Consider the researcher’s experience and skills of working in a care setting.  Researchers need to be prepared for working in this environment as it can be mentally and emotionally draining and sometimes stressful when working with vulnerable people.
  • Involve care home staff in the study design and development. They will help you to identify any issues before carrying out the study.
  • Encourage the care home to identify a small number of key members of staff covering all shift patterns who can act as a point of contact between the staff and research team and can help disseminate information and updates about study procedures.
  • It is important that the researchers engage with care home staff at all levels, and not just with management. For studies to be successfully delivered it is important that all groups understand the aims and delivery mechanisms, and that all ‘buy-in’ to a study.
  • Care home residents may have the capacity to make their own decision regarding whether they wish to participate in a research study, or they may lack the capacity to decide. This may change over time with some individuals losing capacity as cognitive function declines, others may regain capacity and for some it may fluctuate. The decision whether to include both people with and without capacity will depend on the design of the study.
 Flexibility
  • Take time to understand the sector, and the statistics. Did you know the average number of residents per care home is less than 30, and that 30% of care homes are not part of any group.
  • Despite the large number of homes, it can take a significant amount of time finding care homes that are willing and right for your study. Researchers are advised to start identifying partners at the earliest opportunity, ideally during study development. This will allow any variance and costs to be properly accommodated. This should include looking across all of the UK for recruitment and not only in one area.
  • Take time and be flexible in your approach to carrying out the research.  Allow additional time for recruitment, consent, data collection, and where relevant, conducting the intervention.
  • Staged recruitment processes are preferable to allow sufficient time to establish relationships with care home managers and workers, health and other professionals, as well as residents and relatives. You need to understand their priorities, concerns, goals of care and everyday routines. This can help to avoid delay to study start up.
  • Allow extra time for outbreaks of influenza, periods of being understaffed, care home inspections or contract renewal, changes of ownership and other factors that are likely to cause delays.
  • During the study it is likely that the care staff working in the care home may change (as is likely in many care services). Consideration should be given to how training and study communications can continue to be delivered as staff change, including to those staff for whom English is not their first language or who may not read and write English well.
  • Some staff may only work weekends or at night and they need to be involved as well as staff who are more ‘visible’ to researchers. Timing of training sessions will need to be planned to include those staff who work outside conventional working hours. Development of training packs and materials, which can be used for cascade training within care homes, are recommended.
  • If Good Clinical Practice (GCP) training is required for care home staff taking part in the research this should be included in the training plan/schedule. Bespoke on-site training may be available, or options such as access to online training modules may be available.
  • It is not uncommon for care workers to hold a nursing qualification in their home country that has not been recognised yet in the UK and so care is needed about terminology when considering data, for example, reference to someone as a nurse or matron may need to be clarified.
 Complexity
  • The research process needs to fit the environment and work culture of the care home.
  • For example:
    • Care homes are extremely busy places and staff workloads need to be considered.
    • Researchers may need to visit the home at night, early morning, or over weekends to fit in with the work schedules.
    • Not all care homes have a computer or internet available for staff use. Studies will need to consider this in their application if they propose a web-based intervention or intend to collect data this way.
  • Engagement with care home staff should not replace the engagement you would expect to have with residents, relatives and family carers. This issue is addressed in the ‘ LINK: Carrying out Research’ section. A number of research projects have been conducted on methods development for engaging people with dementia in research, and in the care homes setting. The Dementia Services Development Centre in Stirling has also published a number of Case Studies for researchers working with care homes – http://dementia.stir.ac.uk
 Compensation
  • The level of disruption that participation in research will cause needs to be estimated, and compensation made for it.  Above all, staff need to know what this might be. Researchers should not expect to use care home staff time without providing compensation. Without this, that staff time is unlikely to be replaced, and could have a negative effect on the care provided.
  • It is good practice to offer to pay lay people (including residents and carers) for their participation as members of advisory groups and similar activities. This is a requirement of many funders. Researchers should follow the guidance produced by INVOLVE on Public Participation Involvement and should also be aware of the potential effect on people’s benefits if they are paid or are offered payment (this does not usually apply to older people in care homes but may apply to family members). Rules on reimbursements and payments for service user involvement can be found on the Social Care Institute for Excellence (SCIE) website.
RESEARCH NETWORKS

5. Approaches to care

The ownership, size and range of services provided affect the organisation of a care home. It would be unwise to think that all the care homes are the same in culture and ideology. For example, a faith based care home may engage in conversations about dying and end-of-life in a different way to care homes that have intermittent contact with faith groups.

From the outset researchers are advised to spend time understanding how the care home is managed, how care is delivered and the overall culture of the setting. Taking time out to understand the workings of the physical environment, schedules and day-to-day routines of the care home, and motivations of and pressures on staff can ensure that studies are conducted in a way that is achievable.

Understanding the history of a care home and who its residents are is important. Care homes that used to be owned by the local authority and cater mainly for people funded by the local authority will have different experiences and patterns of organisation to care homes that have a high proportion of self-funders and/or are part of a for-profit organisation.

There is a range of frameworks that can be used to inform a systematic assessment of the culture of a care home. The following are examples of different ways of assessing and categorising care that have been used in long-term settings

  • Sheltered Care Environment Scale (Moos and Lemke 1992);
  • Controlled, Cosmetic and Complete Community Categories: Davies (2002) classified care homes into three categories of how they approached the delivery of care;
  • The VIPS framework Brooker (2007) designed to help service providers for people with dementia to assess the relative strengths and weaknesses with regard to providing person-centred care;
  • Promoting Action on Research Implementation in Health Services Framework (PARIHS): Developed to support practice development, through observations and field notes the framework can be used to assess a care home’s environment and culture using an inventory form (informed by the PARIHS framework, Rycroft-Malone et al, 2002). This includes an assessment of the physical environment, staff/resident relationship and resident well-being;
  • Senses Framework:  Nolan (2004, 2006) and Faulkner et al (2006). Based on a model that advocates relationship-centred care, six dimensions are identified that, with supporting questions help to structure a review of how care is organised and experienced by residents and the staff that care for them. These dimensions are a sense of security, a sense of continuity, a sense of belonging, a sense of purpose, a sense of fulfillment and a sense of significance.
  • Dementia Care Mapping (University of Bradford, 2007) is an observational practice development framework which documents the culture of care from the perspective of people with dementia. It records: how the resident spends their time; their level of mood and engagement; and the number and type of personal detractors and personal enhancers. Staff teams are supported to use this evidence-base to reflect on their practice and to create, implement and monitor action plans designed to improve residents’ quality of life.

“Research and development work may challenge care homes, as it adds yet another pressure on an already heavily-burdened sector.”

Understanding Care Homes: A Research and Development Perspective, Jessica Kingsley Publishers, ISBN1843105535 (Froggatt et al 2009)

7. Costs of conducting research in care homes

When developing a study, it is important to consider which activities will be eligible for NHS Clinical Network Service Support, and which will require research funding from another source.

Research studies funded by the NIHR or one of its research partners may be eligible to be considered for inclusion on the NIHR Clinical Research Network (CRN) portfolio. Inclusion on the portfolio does not automatically lead to an entitlement to NHS Clinical Network Service Support. Studies funded by the NIHR are automatically eligible, to be considered, for inclusion on to the CRN portfolio, however they must still meet the eligibility criteria, and that includes a requirement to involve the NHS.

To be included on the CRN portfolio, and to receive network support from the NIHR CRN and full support from the ENRICH Research Ready Care Home Network, the study has to meet the criteria set out in the document Eligibility Criteria for NIHR Clinical Research Network Support.

Through the NIHR ENRICH Research Ready Care Home network some ‘pre-application’ support is available to help input to feasibility, and ensure future studies are well designed and able to work within the care home setting. This improves future ‘deliverability’. For further information contact your local network or email enrich@nihr.ac.uk. The study must also involve activities that are classified as ‘support’ activities as defined by the Department of Health (see AcoRD).

  • Recruitment of NHS patients in an NHS ward, clinic or GP surgery, by staff employed by the NHS, would qualify as a NHS support activity as would reviewing NHS patient records to identify appropriate people to approach for recruitment.
  • Seeking consent from NHS patients residing in a care home to take part in an NHS clinical research study is a NHS support activity; who performs this function will determine how it is resourced. ‘Consenting’ care home residents to take part in a research study that does not involve the NHS is not a NHS support activity. The prevailing view is that it is a research cost, which needs to be confirmed with the research funders. However, this is a complex issue – it is not always easy to work out who is funding a care home resident and this can often not be known until someone is recruited to the study and has given consent for information of this kind to be accessed.

It is important to remember that NHS Clinical Network Service Support activities are defined as additional patient care activities that end once the study ends.  If residents in care homes require additional NHS patient care as a result of taking part in an NHS clinical research study, the costs of that additional NHS care will need to be met by the NHS either through NHS Clinical Network funding or through normal commissioning arrangements, depending on how the cost is attributed.  If the additional care provided to care home residents as a result of participating in a study were to become standard and the cost of the care would not be met directly by the NHS, the cost of the activity during the study cannot be defined as a NHS cost.

Where researchers request care home staff to undertake some form of research related activity, it is important to agree in advance if and how this work will be compensated. Ideally this should take place in the study development phase to allow those costs to be accounted and planned for. If staff time is to be paid, researchers should enquire with the individual care homes what the likely charges / rates will be, as this may vary across the country.

Below are two examples to act as a guide to what is and is not eligible for service support:

 Study 1

Description:

  • A research team at a University has developed an online training tool aimed at improving the quality of care provided by care home staff for people living with dementia in care homes.
  • A study of the tool’s effectiveness compared with existing training has been funded by the NIHR Health Technology Assessment (HTA) programme. The hypothesis is that the new training tool will improve care in care homes, improve quality of life for people with dementia living in care homes, reduce use of antipsychotic medication and reduce admissions to acute hospitals and other NHS inpatient facilities.
  • The study will recruit both people living with dementia and the care home staff providing their care, and randomise them to two groups in which the staff either receive training with the new tool or continue with normal training.
  • Staff and residents will be identified by care home managers using care home records. Participants’ consent will be sought by the University research team, who will also provide the training and collect the research data.

Q. Is the study on the NIHR CRN Portfolio?

Yes. It meets the criteria set out.

Q. Which elements of this study are eligible for NHS support costs through the Clinical Research Network?

None. Although the study is on the portfolio, there are no elements that are classified as NHS Support as defined by the DH (see AcoRD).

Q. Why isn’t the identification of patients for NIHR Portfolio research a NHS support activity?

Recruitment of NHS patients in an NHS ward, clinic or GP surgery by staff employed by the NHS would qualify as a NHS Service Support activity as would reviewing NHS patient records to identify appropriate people to approach for recruitment. Reviewing care home data to identify staff or residents who could take part in a study would not be classified as an NHS Service Support cost as it does not involve the NHS.

 Study 2

Description:

  • Research published in Italy suggests that nutrition may play an important role in reducing the use of antipsychotic medication in people with dementia. The NIHR PGfAR programme has funded a programme to investigate this further in care home settings in the UK.
  • The last part of this programme is a large randomised control trial involving people with dementia living in care homes. Participants will be randomised in one of two groups: to receive a particular food supplement or a placebo. The hypothesis is that there will be a reduced use of antipsychotic medication and reduced hospital admissions in people receiving the supplement.
  • The inclusion criteria require that participants have a diagnosis of dementia and are receiving an acetylcholine inhibitor (ACI). During the study period participants will have their blood pressure monitored regularly by care home staff as a safety precaution as the extent of any interaction between the supplement and the ACI is not fully understood in this patient group.
  • Participants will be identified by screening the NHS records of people with dementia living in care homes. Participants will be ‘consented’ by the registered nurses in the care homes who will be trained to explain the study to the participants and their carers. Where the family/carer have POA it is possible that the consenting will be done by them. The intervention/placebo will be given as a powder added to a hot drink once a day. Blood pressure monitoring will be done by a member of the care home team.

Q. Who should pick up the cost of identifying patients?

As the identification is being done by reviewing NHS records this is an NHS service support activity that should be met by the NIHR Clinical Research Network, provided the activity is being performed by staff employed by the NHS

Q. What if the patients were being identified by care home managers screening care home records, for example if the inclusion criteria were patients with behavioural problems?

This would not be a NHS service support activity as it is being carried out by care home staff using care home records.

Q. The participants’ consent will be sought in the care home, so is this a cost that the care home needs to meet?

No. These NHS patients are being consented to participate in a NHS Clinical Research study that involves an intervention that would, if adopted as normal care, be funded by the NHS. Registered nursing care for some people living in care homes is directly funded by the NHS through the Registered Nurse Care Contribution (RNCC) therefore this is an eligible NHS Service Support activity if performed by staff employed by the NHS.

Q. What about the additional blood pressure monitoring? This is being done by care home staff but is required by the GP for patient safety. Is this an NHS cost?

Yes, as this is an activity funded by the NHS through the Registered Nursing Care Contribution (RNCC) although carried out by care home staff. This is an NHS support cost because the activity relates to patient care but would stop when the research stops even if the intervention continued. If the blood pressure measurement was required routinely, or if the intervention was to become normal practice, then it would be an NHS treatment cost and have to be met by the normal commissioning systems. However, it is not possible for service support costs to be transferred to the care home provider, funding could be sought in the grant application or NHS staff could deliver the service, but this may not be practicable depending on the frequency of the monitoring.

Q. Who should pay for the intervention – the food supplement?

This is an NHS treatment (or excess treatment) cost as dietary supplements for people living in care homes are typically funded through GPs.

Here you will find a simple matrix to advise on the application of AcoRD in relation to activities that might be delivered as part of a care home research study.

The rules governing support costs are complex. We encourage researchers planning studies in care homes to discuss their costs with their local Research Development Service, or with their local Clinical Research Network, at an early stage.

“From the pilot phase of the Newcastle 85+ study, it became very obvious that additional funding, in terms of researcher time, was needed to recruit people from care homes above that needed for community recruitment from other sources. Additional layers of stakeholder discussion and negotiation were needed and this has also been accounted for in our recent MRC application for a follow-on programme grant”.Louise Robinson, University of Newcastle

8. Carrying out research studies

Irrespective of where the research is conducted, almost all research must receive both ethics and governance approval but all must meet the legal requirements of the Mental Capacity Act 2005.

At this point, many researchers will also need to consider the practicalities of carrying out the study. To successfully carry out a study in care homes, it is important that researchers consider the ethical and governance aspects unique to this environment.

This section provides researchers with examples of delivering studies and practical advice for conducting a study within a care home, including recruitment, set up, sharing of information, seeking consent and maintaining relationships.

CASE STUDIES

The case studies below are real accounts, written by researchers and local network staff and provide information, ideas and lessons learned from carrying out research in care homes.

Getting care home staff involved in research

This dementia study found that involving care home staff in research activity improved their knowledge of dementia care and treatment, boosted their confidence and empowered them to influence other colleagues’ care practice.  This case study outlines the importance placed on clinical engagement, enthusiasm and working closely with staff, residents, and family members to conduct a study.

Successfully working with care homes

This case study outlines the experiences of nine care homes involved in an Antibiotic Associated Diarrhoea study. It describes the approach the researcher took to engaging the staff, bolstering  their enthusiasm, as well as  practical details about carrying out the study.

Utilising your Research Network to boost recruitment

NIHR CRN Thames Valley helped to deliver a UK wide, multicentre, randomised clinical trial involving care home residents within their local regions.  Through a designated team the Local Research Network developed creative and different ways of recruiting residents from care homes.

Staff become co- researchers

Researchers applied a unique approach to delivering research in care homes whereby care home staff were trained to become co-researchers. The results of the study indicate that involving staff in research potentially improves staff morale, confidence and general opinion of how the care home operates and delivers care.

Testing methods in the real world

Care home managers are often keen to engage with educational interventions that will benefit staff development and improve resident care. PiTStop! (Pilot trial of Stop Delirium! in older people) trial aimed to test the methods for a full trial of Stop Delirium!, an enhanced educational programme that seeks to reduce the poor outcomes associated with delirium through early detection, treatment and prevention. This case study details the experience of the PiTStop! research team and provides learning points for others wishing to conduct a research project in a care home.

Working in the field – lessons for care home researchers

We spoke to Julie Watson, a PhD student at the University of Edinburgh, about her research on the caring relationship between people with advanced dementia and care home staff. Julie reported on the lessons she’d learnt in setting up the project and carrying out the field work

SUPPORT

The NIHR Clinical Research Network has experience in supporting research in all fields and the relevant network can provide advice and guidance to support study delivery. Specialist areas include dementia, neurodegenerative diseases, cancer, primary care, stroke, diabetes etc. Details of Local Networks can be found at www.crn.nihr.ac.uk.

INFORMATION FOR FUNDERS

Funders need to take into account the reality of proposed recruitment strategies in research projects designed for care home residents, including engagement with care home staff and timescales for recruiting residents. A recruitment rate of 60% or more is usually only achievable when this has been addressed and time given to establishing good working relationships. Funders should also ensure that the researchers are planning to feedback their research findings to homes in accessible formats.

“People with dementia may be willing and able to discuss preferences even when they are no longer considered to have the capacity to make advance decisions in their legal form.”

Jo Moriarty, Fellow Kings College London, August 2013

9. Practical advice

Researchers who have undertaken research in care homes have given the following advice on recruitment, set up, sharing information, consent and maintaining relationships:

 Recruitment

When recruiting care homes to studies consider the following:

  1. Identifying care homes
  • It will take much longer than you might expect, so allow much longer than anticipated to identify initial participants.
  • The ENRICH Research Ready Care Home Network brings together researchers with enthusiastic research friendly care homes. Currently there are around 1,000 care homes participating, through local networks and corporate partnerships with large national providers. For information on how the network can support recruitment / identification of care home to support research at any stage of the development cycle email enrich@nihr.ac.uk or contact your local ENRICH Office.
  • Lists and contact details for local care homes can be found through the Care Quality Commission at cqc.org.uk (or Care Inspectorate in Scotland or CSSIW in Wales)
  • Local Community Mental Health Teams (CMHT) or General Practices often have a good relationship with care homes and can be an invaluable resource.
  • Care homes that have been identified as ‘at risk’ may not be suitable for recruitment, particularly if participating in research is likely to distract from other areas of care. Care homes can be identified and recommended by local health care professionals, carer organisations and local authority staff.
  1. Approaching care homes (NB care homes that are members of ENRICH network can be contacted via the network)
  • Send out invitation letters to the care home manager. You may find it helpful to ask an appropriate care home manager to read through a draft and give you feedback.
  • Follow up invitation letters with a phone call to the care home manager.
  • In your letter and telephone call:
  • Be explicit about the amount of time, resource and involvement required of staff.  Estimate the level of disruption that participation in the study will cause, and ensure you have costed compensation for it.
  • Highlight the benefits of being involved; ask yourself the question ‘what’s in it for them?’
  • Describe incentives for care homes to join the study (for the organisation and staff involved).
  • Discuss anonymity and confidentiality.
  • Discuss in advance what would happen in the event that a member of the research team had concerns about a resident’s care or concerns about abuse.
  • Provide the care home with assurances that the researchers have had Criminal Record Bureau/Disclosure and Barring Service checks if needed, are insured, and ask about any possible requirements for immunisations.
  • Provide care homes with examples of studies carried out in other care homes.
  • Check if there is anyone else in the organisation that needs to be contacted to agree to the care homes participation e.g. the owner. This is particularly important for the larger chains and often it is better to make the first approach to head office.
 Set up
  • Finding appropriate, interested and supportive care homes to partner with and support a study is a key element. Researchers consulted in production of this toolkit all advise that this stage will take much longer than anticipated, and should be started as soon as possible.
  • Be aware of ‘winter pressures’ on care homes, as this can influence which months to start your study.
  • Stage the recruitment of care homes into groups. This allows time to establish relationships with the managers and staff, and to understand how that care home runs, their priorities, concerns, goals of care and everyday routines.
  • The normal research “best practice” standards should be applied irrespective of where the research is conducted.
 Sharing information
  • Sharing information is essential to the smooth running of a study. Ensure you agree with the care home manager the best approach for researchers to communicate with staff, residents and resident’s family members.
  • Be prepared to answer questions that the care home staff are likely to ask. These can be found in Questions to Ask Researchers.
  • Give enough information to staff and residents and provide them with opportunities to ask questions about the proposed study.
  • Use various communication materials to inform care home staff, residents and family members about the study.  Try using a resident information leaflet, staff posters, staff handover meetings, workshops, study champions, letters to residents’ families and friends, and newsletters.
  • Find out where you can take residents and staff for private conversations if possible.
  • If appropriate, let all the GPs with residents in the home know of the study and seek their ‘buy-in’.
  • Family members (or the person who knows the resident best) should be treated as an expert partner in care in all settings and be involved in all care-planning and decisions.
  • Normal research “best practice” standards should be applied irrespective of where the research is conducted.
 Seeking Consent
  • Care home managers and/or senior care staff will know their residents well so involve them in identifying residents to take part in the study.
  • Plan how you intend to gain consent, and allow ample time for this.
  • For some residents you may need to seek the views of consultees or people who have been given Lasting Power of Attorney (See Mental Capacity Act 2005) or legal representatives (see Medicines for Human Use (Clinical Trials) Regulations 2004), this can sometimes take longer.  Ensure you work with the care home to identify the best method for achieving this.
  • The normal research “best practice” standards for gaining consent consistent with the Mental Capacity Act and other requirements should be applied, such as approaching consultees. More and more residents will have set up a Lasting Power of Attorney so be familiar with this.
 Maintaining Relationships

Maintaining relationships is vital to completing the study:

  • Develop strategies that encourage a sense of involvement and partnership with all staff. Researchers may want to identify ‘study champions’.
  • Be respectful of people’s time.
  • Build a good relationship with the manager, staff, residents and families / visitors; get to know the home and how it runs.
  • Experienced researchers should pass on to the research team their experiences of working in a care home environment and prepare them mentally and emotionally for working in this setting.
  • Researchers may need to visit the home outside of usual hours of work, at night or over weekends, to fit in with the work schedules or care home work shifts.
  • Research in care homes is different from hospitals, as the place you will be working is the resident’s home. There will likely be some research in public areas. However your research may involve spending time in the resident’s private spaces or bedroom. It is essential that you recognise and respect this and ensure you have permission to be there.
  • Researchers who are not familiar with the MCA could consult the general document What every Carer Needs to Know – a guide to mental capacity. It is in plain English and helpful to understanding what processes might be involved and that gaining consent has to be decision-specific.
  • If the researcher is dealing with people whose cognition is impaired, it is very helpful if the person who knows the resident best (and maybe has been their main carer prior to moving to the care home) can be involved as much as possible with the research.
  • The normal research “best practice” standards should be applied irrespective of where the research is conducted.
PRACTICAL ADVICE: INVITE STUDY CHAMPIONS

Overcoming the challenges of recruiting care homes

At the beginning of the study, researchers may want to identify particular care home staff to act as ‘study champions’. Identifying interested and enthusiastic people at the outset may help to spread news about the study, gain ‘buy in’, and encourage others to get involved.

Some researchers have worked with ‘study champions’ to:

  • Advocate for their study; to provide a simple and clear description of the study to other members of staff to help improve everyone’s understanding;
  • Act as good role models by piloting the study intervention within the care home (i.e. carrying out some aspect of occupational therapy, cannula checks, physical exercise, etc);
  • Improve communication channels between the research team and the care home;
  • Speak up when they become aware of concerns about the research or quality of care being provided to residents.

It is important when recruiting ‘study champions’ to communicate at the outset the benefits of them getting involved in the study, how much time will be taken from their shift to complete the role and to discuss it with their manager.  Studies should provide staff with incentives to get involved such as compensation, vouchers, training or educational seminars to help with professional development.

“Support and advice from other researchers and networks, such as ENRICH, is vital for conducting research in this setting. Many of the challenges encountered are unique to this setting and addressing them is essential in order to produce the high quality research required to provide the best evidence-based practice for this much under-represented population.”

Victoria Shepherd, Research Lead for PAAD, South East Wales Trials Unit at Cardiff University, March 2015

10. Concerns about quality of care

As with all care settings, researchers may on occasion observe and document poor care or have general concerns about the quality of care and residents’ safety. The majority of care homes provide good care often with limited resources and limited access to external support and training. However, it is important that researchers be prepared for this eventuality and have given some consideration to appropriate responses.

ADVICE

The following suggestions may help researchers establish good working relationships with care homes and ensure that the safety and well-being of residents and staff are maintained:

  • Identify care homes through the regulator. Care homes can be identified through the regulator, the Care Quality Commission, Care Inspectorate in Scotland, or Care and Social Services Inspectorate Wales, which registers and inspects all care homes. Details of individual care homes and recent inspection reports can be located online (Care Quality Commission or Care Inspectorate in Scotland or CSSIW).  Care homes that have been identified as ‘inadequate’ or even in need of improvement may not be suitable for recruitment, particularly if participating in research is likely to distract from other areas of care. Care homes can also be identified and recommended by local health professionals, carer organisations and local authority staff.
  • Create and maintain a climate of trust with care homes. When gaining access to the care home it is important to create and maintain a climate of trust and assure staff of the care home’s anonymity. See the School for Social Care Research (SSCR) methods review for further advice.
  • Agree protocols and ground rules. All research in care homes needs to anticipate how researchers will work with care home staff and have agreed protocols and ground rules if problems arise (e.g. if bad practice is observed, or study findings highlight problems or if staff or residents identify areas of concern). The Nursing and Midwifery Council website gives useful advice on safeguarding to nurses but the requirements for researchers should have been addressed when seeking ethical permissions.
  • Agree how to feedback information. For concerns where there is no question of a resident being at risk of harm, it is helpful to agree procedures with the care home manager and build in methods for researchers to agree how to feedback information from residents (with their permission) on aspects of care and for care home staff to express their concern or feedback.  Should a researcher observe bad practice or something that is more serious then they should follow the local policy and procedures on adult safeguarding. Further safeguarding guidance is also available from SCIE. Researchers have a duty of care themselves, for example, in that many are nurses, and might find the National Midwifery Council (NMC) site on safeguarding very helpful.

Overall, concerns about safeguarding need to be raised with the local safeguarding service or with CQC (CI in Scotland). More general information and advice are at the following places:

  • Action on Elder Abuse free advice for anyone concerned in any way about the abuse of older people.
  • The NHS and social care whistle-blowers helpline – 08000 724 725 – if you have concerns but are unsure how to raise them or simply want advice on best practice.
  • Panicoa: this resource includes studies of neglect and abuse that may help researchers understand the area of abuse and neglect.

“The underlying message is that there are many great care homes operating up and down the country but unfortunately it is the odd few that create the negative headlines.”David Leach, Managing Director, HWA, May 2013

11. Network support

The Clinical Research Network (CRN) is part of the National Institute for Health Research (NIHR) and provides the infrastructure that allows high-quality clinical research to take place within the NHS and across wider health and social care settings.

NIHR ENRICH RESEARCH READY CARE HOME NETWORK

The NIHR ENRICH Research Ready Care Home Network has been created to support researchers, to establish and deliver studies involving care homes and studies which involve (or could potentially involve) care home residents, family members or staff.

The NIHR ENRICH Research Ready Care Home Network operates through local offices across England, Scotland and Wales.

Through the local offices the network is able to support identification of sites, facilitate recruitment and feasibility activities and provide a forum for researchers to link with enthusiastic local care homes dedicated to improving the lives, care and treatments of residents.

To find out if the Network can provide support to you contact one of the local offices supporting delivery of the Network.

“With the knowledge we have gained about implementation of research in care homes and the connections that we have since established, we have successfully been awarded an NIHR Portfolio Development grant to support development of research funding proposals to tackle the unmet needs of stroke survivors in care homes. We would not have been able to progress in this important area without the help and support from the ENRICH team”Dr Daniel Lasserson from the Department of Primary Care Health Sciences at University of Oxford

“The interest in ENRICH has been very encouraging. Care homes are the main providers of long term care for older people in England. Older people living in care homes should have the same opportunities as everyone else to contribute to and participate in research that seeks to improve their health and wellbeing.”Claire Goodman, Professor of Health Care Research, University of Hertfordshire