Care home residents, capacity and consent

Providing older people living in care homes with the opportunity to participate in research is more important than ever given the devastating impact of COVID-19 on people living with dementia and older people living in care homes. Care home residents often have multiple long-term conditions and many have complex care needs, and account for over half of all excess deaths in England and Wales during the pandemic. Without research to underpin the evidence base for their care, we don’t know how best to manage conditions that affect residents’ health or to deliver care that improves their quality of life.

However, around 70% of care home residents will be unable to provide their own consent to take part in research due to dementia or other conditions that affect memory and understanding. People with impaired capacity to consent are often excluded from research due to ethical concerns about including ‘vulnerable’ groups, and the practical challenges of involving others to help make decisions about participation on their behalf. For example, the nationwide trial that is investigating different medicines for the treatment of COVID-19 in older people living at home and in care homes (PRINCIPLE) does not include people who are unable to consent for themselves.

Our pre-COVID-19 research identified the crucial role that care home staff have in supporting older people to participate in research and ensuring that research is inclusive of residents with impaired capacity to consent. I also interviewed family members of people who were unable to consent to a range of studies, including care home studies, to find out what their experiences were of deciding whether their relative took part in a study or not. The aim is to share this information with both research and care home communities to help support the inclusion of care home residents with impaired capacity in research.

Supporting care home residents to participate in research

Research active care homes (such as those who are part of the ENRICH network) can provide opportunities for residents to contribute to developing the evidence-base. Care home staff have a key role in helping to identify residents who might be eligible to take part in a particular study, can help share information about studies with care home residents, and introduce them to members of the research team if they are interested in finding out more. As they know the residents they care for well, they may also act as a ‘bridge’ to help facilitate communication between residents and researchers.

Maximising capacity and ability to consent

Staff also play an invaluable role in supporting residents to understand information about a study and to maximise their ability to provide consent should they wish to participate. This might include advising researchers about whether the residents use any communication aids or, where a resident might have fluctuating capacity, they might advise about the best times and environment to approach the resident. Where there are concerns about a resident’s capacity, care home staff work with the researchers to assess their capacity to consent.

Enabling consultation with family members

Where a resident lacks capacity to consent to take part in a study, there are legal arrangements for an alternative decision-maker to be involved. This is usually a family member or close friend who is consulted and asked to advise the researchers about what in their opinion the resident’s wishes and preferences would be about taking part if they had capacity to do so. If the study is a clinical trial of a medicine, they are asked to provide consent on the person’s behalf. Care home staff know who would be most suitable to approach as consultee (termed a legal representative if it is a clinical trial), and often help researchers to contact that person.

Advising about wishes and preferences

Some residents may not have any family members or close friends, or they may not wish to be involved in decisions about research. Some families and friends do not respond when contacted by researchers. This leaves the resident unrepresented and excludes them from being involved in the study when they might have wanted to do so. There are legal arrangements for someone else who knows the resident well in a professional capacity to act as nominated consultee (or professional legal representative). This can be a member of the care home team, provided they are not involved in the study. They can advise researchers about whether the resident should take part in the project, and what, in their opinion, the resident’s wishes and feelings about taking part in the project would be likely to be if they had capacity.

Talking about research with residents

While there is a growing emphasis on discussing future preferences about care and treatment, and on advance planning in the event of incapacity to make decisions, preferences about research participation are rarely included in these discussions. Our research found that family members found it difficult to make a decision about research on behalf of someone with a condition such as dementia, and many experienced a decisional and emotional burden as a result. Care home staff can play a role in encouraging discussions about research participation with residents and their families which may help families and staff who are approached to help make a decision about the resident taking part in a study in the future.

Conclusion

Improving the care provided to older people living in care homes requires an increase in the amount of research conducted with care homes, and greater awareness about the need to appropriately involve the frailest residents in research to ensure that the findings are applicable to all residents. We hope that sharing our research and the lessons we have learned can support care home staff to ensure that older people in their care have the opportunity to participate in, and benefit from research, both during COVID-19 and beyond.

This research has led to the development of a decision support tool for family members acting as consultees and legal representatives which we hope will support them to make informed decisions about research that reflect the wishes and preferences of the person they represent. The next stage is to test whether it is an effective form of support.

For access to the full paper in Nursing Older People click here

For more information from ENRICH Cymru about how residents lacking capacity can be included in research click here