CONSULT SWAT
Research type
Research Study
Full title
Supporting consultees and legal representatives who are making decisions about research on behalf of adults lacking capacity to consent: a randomised Study Within a Trial
IRAS ID
308609
Contact name
Victoria Shepherd
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
2 years, 6 months, 30 days
Research summary
Some people with problems with their memory or understanding may lack capacity to consent to take part in a research study. In these situations, a family member is usually involved to help decide whether they should take part or not. Some family members find it difficult to make a decision, and they may experience an emotional burden as a result. A decision aid for family members making research decisions has been developed (a booklet called ‘Making decisions about research for others’). We now need to test it to see whether it is an effective form of support. This will be done using a Study Within a Trial (SWAT) which is a self-contained research study that is embedded within host trials with the aim of evaluating a particular trial process.
The first stage of the project is a feasibility stage. The decision aid will be piloted with 20 family members in one host trial. They will be randomised to receive the decision aid alongside the usual information about the study, or usual information alone. Participants will complete a questionnaire about their decision-making (CONCORD Scale). We will use the findings to refine the second stage of the project.
Stage two is a randomised SWAT to evaluate the effectiveness of the decision aid in up to four host trials. Host trials will be selected based on the population, setting and design of the study. As in stage one, family members will be randomised to receive the decision aid or not. We will compare questionnaire responses from those who received the decision aid and those who did not to see if it increased knowledge and helped decision-making. We will interview some family members and researchers to explore issues such as how the intervention was used. We will also look at resources and costs involved.
Lay Summary of Results:
Some people with problems with their memory or understanding may lack capacity to consent to take part in a research study. In these situations, a family member is usually involved to help decide whether they should take part or not. However, some family members find it difficult to make a decision, and they may experience an emotional burden as a result. Families said they wanted more support and guidance when making decisions about research which led us to develop a decision support tool to help them - a booklet called ‘Making decisions about research for others’. In this part of the CONSULT project, we wanted to test whether the decision support tool is an effective form of support.
We did this through conducting a Study Within a Trial (SWAT) which is a self-contained research study that is embedded within other host studies. Family members approached to act as a consultee or legal representative for the host studies were randomised to receive either the decision aid booklet or a plain notebook (as a control) in addition to the usual study information. They were asked to complete a questionnaire about their experience and invited to take part in a semi-structured interview. The first stage of the CONSULT SWAT explored the feasibility of the decision support tool and of conducting a SWAT in one host study that was recruiting adults lacking capacity, followed by embedding the SWAT in other host studies. A Lay Advisory Group were involved throughout the SWAT and the wider CONSULT project.
In total, 93 family members were randomised and 16 returned the questionnaire. Interviews were conducted with four family members and five host study staff. The findings showed that fewer questionnaires were returned than anticipated and there was little difference in the responses between participants and between the groups who received the decision support tool or the ‘control’ notebook. Key findings from the interviews showed that the decision support tool and the SWAT were feasible, although some changes were needed. Family members often found it hard to remember details about being approached and there was less interaction with the decision support tool than intended, which may have affected their responses. Members of the host study teams reported that the decision support tool had positively impacted their own research practice, which was one of its aims.
The decision support tool and CONSULT SWAT materials are now available to other research teams who wish to embed it in their studies. The findings can then be combined across these different host studies. As studies are increasingly using different methods for contacting and consulting with family members, such as through digital routes, we have also developed an information video for families approached to act as a consultee or legal representative. The video is publicly available via the CONSULT website, alongside the findings from the CONSULT SWAT and wider CONSULT project https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.capacityconsentresearch.com%2FNBTI%2FGMLEAQ%2FAQ%2Fba0aa030-6d96-4423-bfa6-cfc1584b4c0c%2F2%2FPiOAsHoES8&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C296c7157c08b41dda34d08de9c7e6ce5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639120264016170018%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=VPPQR74QsWmho3rx0Y1hYKY6rRrAcLb8pjAlFMiRGLA%3D&reserved=0
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: The study is a SWAT (Study Within a Trial) and as such is registered as a trials methodology project on the SWAT repository (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.qub.ac.uk%2Fsites%2FTheNorthernIrelandNetworkforTrialsMethodologyResearch%2FSWATSWARInformation%2FRepositories%2FSWATStore%2F&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C296c7157c08b41dda34d08de9c7e6ce5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639120264016189832%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=lphvkdFOzbc4bhu7TDG%2BmB7xCmHWQqYz0JadKjqq5YI%3D&reserved=0). There is currently no mechanism for the SWAT repository to update entries with study results.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Yes
If yes, describe or provide URLs to disseminated materials: The study results are publicly available on the study page of the project website (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.capacityconsentresearch.com%2Fdecision-support&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C296c7157c08b41dda34d08de9c7e6ce5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639120264016208286%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=dbuR4NSbtsYyG15be6vayGCKR2Kjd5b%2BRE5LjbwCj90%3D&reserved=0) and as part of the lay summary of the CONSULT project as a whole and an infographic version of the summary which are both available on the project website (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.capacityconsentresearch.com%2F&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C296c7157c08b41dda34d08de9c7e6ce5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639120264016226408%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=sVcdkUz4%2BOrG91VpNGGECNO8PkE%2BqC6JTftT%2BMaJczs%3D&reserved=0)
If pending, date when dissemination is expected:
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: Yes
If yes, describe and/or provide URLs to materials shared and how they were shared: Participants have been provided with the lay summary of the CONSULT project as a whole and an infographic version of the summary which are both available on the project website (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.capacityconsentresearch.com%2F&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C296c7157c08b41dda34d08de9c7e6ce5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639120264016246150%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=o7ZjXeMy5PetZENzhz9PUtt2mR1RGdOFDA%2BWKbu0u6c%3D&reserved=0)
If pending, date when feedback is expected:
If no, explain why they haven't:
Have you enabled sharing of study data with others?: Yes
If yes, describe or provide URLs to how it has been shared: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Ftrack.pstmrk.it%2F3ts%2Fwww.cardiff.ac.uk%252Fcentre-for-trials-research%252Fcollaborate-with-us%252Fdata-requests%2FNBTI%2FGMLEAQ%2FAQ%2Fba0aa030-6d96-4423-bfa6-cfc1584b4c0c%2F3%2Fws7YvKGowk&data=05%7C02%7Cleedswest.rec%40hra.nhs.uk%7C296c7157c08b41dda34d08de9c7e6ce5%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639120264016272612%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=fPUZiWYY7F78W9F%2FS8HCBdNgvuSdqDXlFO9%2Fu09b9KQ%3D&reserved=0
If no, explain why sharing hasn't been enabled:
Have you enabled sharing of tissue samples and associated data with others?: No
If yes, describe or provide a URL:
If no, explain why: Tissue samples were not collected for this study
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Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
22/YH/0121
Date of REC Opinion
28 Jun 2022
REC opinion
Further Information Favourable Opinion