Background

There has been a growing focus on improving the informed consent process for research. However, some people with problems with their memory or understanding may lack capacity to provide consent for themselves. In these situations, a proxy decision-maker (usually a family member) is needed to help make a decision about whether they take part or not. Involving proxies can be challenging, which contributes to people with incapacity being under-represented in research.

Our previous study (DECISION Study) found that it was difficult for some family members to make a decision, and they experienced an emotional and decisional burden as a result. Families thought that greater support when making decisions about research would help. This led us to develop the first decision support tool for family members making decisions about research. This tool was found to be acceptable to families (DECISION 2 Study) and we now need to test whether it is an effective form of support. We have also conducted further work to explore how to measure its effectiveness through establishing which outcomes matter, to whom, and why (COnSiDER Study).

This NIHR Advanced Fellowship project, funded by Health and Care Research Wales, will explore whether the support tool is effective, what factors affect this, and how much it costs. This will be done using a Study Within a Trial (SWAT) which is a self contained research study that is embedded within a host trial/trials with the aim of evaluating a particular trial process.

Study aim

This project aims to support the inclusion of adults lacking capacity in research through improving decision-making by the family members involved. This will be achieved through understanding the barriers and facilitators to implementing the novel decision-support tool, exploring the feasibility of the tool and outcome measures being developed, and establishing whether the decision-support intervention is effective in improving the quality of decision-making by family members.

Study design

CONSULT-ENABLE will be conducted in three stages:

Stage one

In the CONSULT-ENABLE study, we will interview 20-25 professional stakeholders (e.g research nurses, trial managers) to explore their views about the barriers and facilitators to implementing a decision support intervention for families, and the acceptability of conducting a SWAT. We will also be developing a new questionnaire to measure the quality of proxy decisions made about research participation (CONCORD Scale - Combined scale for proxy informed consent decisions).

Stage two

We will conduct a feasibility study (embedded in host trials recruiting adults lacking capacity) to explore the feasibility of the intervention, conducting a SWAT, and the acceptability of outcome measures under development. This will be through piloting the intervention with 15 family members and up to 15 researchers/research nurses.

Stage three

We will conduct a randomised controlled trial as a SWAT to evaluate the effectiveness of the decision-support intervention. Embedded within this trial I will explore how and why the intervention is/isn't effective and evaluate the costs and resource use implications of the intervention.

In addition, we will develop an online toolkit for researchers and practitioners to provide resources on assessing capacity, legal frameworks, signposting to training and other resources, and a mechanism for implementation.

Stage four

In parallel, we will also be exploring how people can be enabled to express their wishes about research participation in advance of any loss of capacity to consent. In the CONSULT-ADVANCE study we will explore the views of people with personal experience of capacity-affecting conditions and researchers and other professionals about advance research planning. We will conduct online surveys followed by interviews with public and professional stakeholders.  We will use the findings to plan future research and to develop an advance research planning intervention.

Involving the public and patients

A Lay Advisory Group are supporting the project to help ensure that the findings are relevant to those involved in caring for people with problems with their memory or understanding who might be involved in making decisions about research.

Related publications

Shepherd V, et al. Development of a decision support intervention for family members of adults who lack capacity to consent to trials. 2021 BMC Medical Informatics and Decision Making