OPTIMISE-ing consent in care home research: recommendations for designing more inclusive consent processes

ByVictoria Shepherd

Introduction

Care home residents are often living with conditions such as dementia or stroke that may affect their ability to communicate or to make decisions. When it comes to research, this can mean they find it difficult to understand information about a study and provide consent if they wish to take part. This can lead to them being excluded or not taking part in a study, or being assessed as lacking capacity to consent, even though with the right support they may be able to make a decision about participation.

We know that there are evidence-based strategies which can support communication and decision-making. However, these are often not incorporated into consent processes for research studies. Researchers who want to improve inclusion of people with communication and/or decision-making needs in research asked for clear, practical guidance on how to incorporate these strategies when designing a study.

We conducted the OPTIMISE project to help researchers to design more accessible consent processes, including in clinical trials. Given that around 70% of care home residents have impaired capacity to consent to research, the recommendations may be particularly helpful in care home research. They could also help others who review research, such as members of research ethics committees (RECs), and public involvement contributors.

What did the OPTIMISE project involve?

OPTIMISE forms part of a larger programme of work (CONSULT) at Cardiff University exploring issues around involving adults with impaired capacity to consent in research.

The OPTIMISE project had four stages:

  1. Review of the literature on enhanced consent processes
  2. Hold an expert stakeholder workshop to develop the OPTIMISE recommendations
  3. Map CONSULT resources to the recommendations to provide practical examples and further information
  4. Create a toolkit to help researchers and others to use the OPTIMISE recommendations

When should the OPTIMISE recommendations be used?

Accessibility should be considered right throughout the lifecycle of a study, starting when initially developing a research idea and then developing participant information materials.

The time and resources needed to support inclusive consent should be included into a funding application where possible.

The key message is that even small achievable adaptations could meaningfully improve accessibility.

What are the OPTIMISE recommendations?

First, consider the three guiding principles that underpin inclusive consent:

Collaboration: work together with multi-disciplinary teams, participants, families, and carers who all have a role in facilitating inclusive consent

Ethics: ethical principles, such as trust, respect, and promoting autonomy are important throughout research and should be carefully considered during the ethical review process

Reflection: review whether consent processes are effectively meeting peoples’ needs or if additional support is needed and whether collaborations are working (for everyone involved)

Second, you can ‘OPTIMISE’ accessibility by considering these seven domains:

  • Content: the information you give to potential participants should explain key concepts (e.g randomisation, data protection) in an order which ensures the information is understandable
  • Language: use plain and accessible language, and consider whether some participants may require translation and interpretation
  • Format: use written, audio, video or pictorial formats (or a combination), and ensure they can be tailored to meet individuals’ communication and decision-making needs
  • Design: use accessible design principles when developing information materials, and keep the layout simple with careful use of supporting images where appropriate
  • Support: consider supportive strategies such as layering participant information (providing brief information first and then building on that to provide more detailed information) and using memory aids. Ensure those involved have the appropriate skills and training to communicate effectively and assess capacity if needed. Where required, support consultees/legal representatives to advise researchers about the person’s wishes
  • Timing: identify the best time to approach potential participants to maximise their ability to make an informed decision. Take time to deliver information, and revisit consent as required
  • Environment: choose quiet, familiar surroundings when discussing a study and ensure there are appropriate levels of sound, lighting and other sensory stimuli

What might inclusive consent look like in a care home study?

As an example, the CONNECT Study is looking at whether a new activity programme reduces loneliness, anxiety, and depression among care home residents. The research team could work with care home residents and staff to co-design the content of their participant information sheet and consent form using plain language and accessible design principles. They could also create versions in an easy read format to help layer information. The research team could provide additional training for researchers involved in recruiting care home residents to ensure they have the right skills, including assessing capacity where required. The researchers could be encouraged to work with care home staff to identify individual residents’ communication needs, and an appropriate environment in which to approach them. They could also facilitate the use of supportive communication aids (such as use of key words or Talking Mats) where appropriate, and ensure residents are given sufficient time to process information about the study. If, even with this support in place, a resident lacks capacity to consent then this support can enable them to express their wishes and a consultee or legal representative is involved.

How can OPTIMISE benefit care home research?

We hope these recommendations will reduce the exclusion of residents with communication and/or decision-making needs from research and create more equitable opportunities to take part. This will lead to better quality evidence to inform residents’ care in the future.

For researchers, OPTIMISE provides a framework to design consent processes that work in care-home contexts where residents often have communication and/or decision-making needs, thus enabling greater inclusion. It also helps them to enact principles of the Mental Capacity Act such as maximising peoples’ ability to make their own decisions where possible. This may help when seeking ethical approval for a study.

For care home managers and staff, being aware of inclusive research practices can help them to support resident participation and liaise with research teams about residents’ needs.

For residents and families, more accessible consent processes can help ensure that residents have a voice in research that affects care-home settings.

Resources to help use OPTIMISE

We have developed a toolkit of resources to help researchers to use the OPTIMISE recommendations, including case studies with practical examples, and a recording of the launch webinar. We have also co-produced easy read versions of the recommendations to support public involvement contributors to work with research teams.

We encourage care homes and care home researchers to help raise awareness about OPTIMISE. We welcome any feedback on the recommendations and toolkit. We also hope to hear their experiences of inclusive consent processes, how effective they were, and any lessons learned.

For more information, visit the OPTIMISE project webpage https://www.capacityconsentresearch.com/optimise or contact the project lead Dr Victoria Shepherd at [email protected]

Related resources: 

About the Author

Dr Victoria Shepherd leads the OPTIMISE project and the CONSULT research programme. She is a nurse by background and has extensive experience in care home research, including PRINCESS and COS-COVID-PCARE studies, and previously chaired the advisory board for ENRICH Cymru.

OPTIMISE was conducted together with Martina Svobodova, Research Associate at Cardiff University, and with invaluable contributions from the Expert Advisory Group and Lay Advisory Group who supported the OPTIMISE project.

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