CONSULT SWAT
Background
Trials involving adults who lack capacity to consent can be challenging to design and conduct. Many of the challenges arise from the requirement for consultees or legal representatives to be involved in decisions about participation. Usually a family member is approached to act as a consultee or legal representative. Previous research has shown that family members acting as consultees and legal representatives express uncertainty about making what can be complex and challenging decisions, and some may experience decisional and emotional burden as a result. 'Proxy' decision-making for research has been demonstrated to be stressful in some settings, with some studies reporting that nearly all proxies experience some degree of burden when making decisions about research. This can lead to a higher proportion of families declining participation, compared to people providing their own consent. Despite numerous innovations to improve informed consent processes for research, there are no interventions for proxies who are making decisions on behalf of someone who lacks capacity.
Development of a decision aid for consultees and legal representatives
Decision support interventions, also known as decision aids (DAs), are increasingly being used to support patients making decisions about treatment or uptake of screening. More recently, DAs have been developed for people considering participating in clinical trials. DAs support the decision process by providing information about available options and their associated outcomes, alongside information that enables patients to consider what value they place on particular outcomes and provide structured guidance on steps of decision making.
A decision aid for family members making decisions about research ('Making decisions about research for others') has been developed in collaboration with lay involvement and stakeholder groups, and informed by theoretical frameworks and empirical research. The DA has undergone acceptability testing with both those who would deliver and receive the intervention. If effective, it would support families of adults who lack capacity to consent to make informed decisions about their participation, reduce the decisional burden they experience, and so support greater inclusiveness in research.
A decision aid for family members making decisions about research ('Making decisions about research for others') has been developed in collaboration with lay involvement and stakeholder groups, and informed by theoretical frameworks and empirical research. The DA has undergone acceptability testing with both those who would deliver and receive the intervention. If effective, it would support families of adults who lack capacity to consent to make informed decisions about their participation, reduce the decisional burden they experience, and so support greater inclusiveness in research.
Front cover of the decision aid being evaluated in the CONSULT SWAT
Evaluating the decision aid in the CONSULT SWAT (Study Within a Trial)
This study will evaluate decision-making by families of adults who lack capacity to consent when provided with the DA alongside standard study information, compared to standard study information alone. It will be evaluated as a ‘Study Within a Trial’ (SWAT) which is a is a self-contained research study that is embedded within a host trial with the aim of evaluating alternative ways of delivering or organising a particular trial process. SWATs can be evaluated across multiple host trials, either at the same time or sequentially and, whilst ideally they are built into the host trial from the start, a SWAT can be included in an ongoing trial and need not run for the whole duration of the host trial. This approach enables meta-analysis across multiple trials and can explore the effects of recruitment strategies varies across different trial contexts.
During the SWAT, an embedded process evaluation will address issues regarding reach, contamination, context, adaptation and fidelity, and an economic evaluation will explore the resources involved in delivering the DA intervention, including time. A mixed-methods feasibility stage will precede the main SWAT to test procedures such as recruitment and data collection.
CONSULT is led by the Centre for Trials Research (CTR) at Cardiff University. More information about the project can be found on the CONSULT page on CTR's website.
The CONSULT SWAT protocol paper has been published in Trials.
During the SWAT, an embedded process evaluation will address issues regarding reach, contamination, context, adaptation and fidelity, and an economic evaluation will explore the resources involved in delivering the DA intervention, including time. A mixed-methods feasibility stage will precede the main SWAT to test procedures such as recruitment and data collection.
CONSULT is led by the Centre for Trials Research (CTR) at Cardiff University. More information about the project can be found on the CONSULT page on CTR's website.
The CONSULT SWAT protocol paper has been published in Trials.
We are recruiting host trials now!
You can download a flyer about the SWAT here.
The SWAT will be conducted from early 2023 to late 2025. We are inviting approx. 5 host trials to participate in the SWAT.
Host trials are eligible if:
- Trial team anticipates that a reasonable proportion of potential participants will lack capacity to consent
- Utilises personal consultees or personal legal representatives
But not eligible if:
- Trial involves recruitment without prior consent (e.g ‘deferred’ consent) only
- Uses nominated consultees or professional legal representatives only
- Trial requires participation decision to made urgently or within a short timeframe
The SWAT has been designed to be flexible and to minimise the impact on host trials. For example, randomisation and recruitment processes will be aligned with those in host trials.
If you would like more information or to discuss acting as a host trial for the SWAT, please contact:
- CONSULT team via the contact page on this website
- Email us at [email protected]
- Email Dr Victoria Shepherd (PI for CONSULT Study) [email protected]
FAQ
What approvals are needed and in place?
The overarching SWAT has received a favourable opinion from Leeds West REC (22/YH/0121) and has HRA/HCRW approval in place (IRAS ID 308609). Each SWAT will then come under the approvals obtained for the respective host trials, either from the start of the trial or as a substantial amendment after the host trial has commenced. Example text that can be included in a host trial protocol is available. As host trial sites are classed as PICs for the SWAT (rather than sites for the purpose of the SWAT), local capacity and capability checks will be needed.
Has the SWAT been adopted onto the NIHR portfolio?
Yes, the study has been adopted onto the NIHR portfolio and assigned CPMS Study ID 53846. During recruitment accrual data will be submitted on a monthly basis.
What support is available for host trials/sites?
Host trial teams and their sites will be fully supported to integrate the SWAT into the host trial recruitment pathway. Full training will be provided, and SWAT materials (participant information, decision aid booklet, questionnaire etc) will be provided. Costs of up to £5000 are available for host trials/sites to support SWAT-related activities, for example to cover additional trial manager time for submitting a substantial amendment.
What are consent arrangements for the SWAT?
In order to minimise the burden on host trials and participants in the SWAT (family members acting as consultee/legal representative) a separate consent for is not required for the SWAT. We have approval to use a single combined brief information sheet and questionnaire, with return of the questionnaire indicating consent to participate in the SWAT.
What are the arrangements for transferring data between host trials/sites and the CONSULT team?
To minimise the data being transferred, the single questionnaire is anonymous with minimal demographic information such as the participant's relationship with the person they are representing (Part A). If SWAT participants are willing to be contacted by the CONSULT team about taking part in an optional interview, they can complete the 'consent to contact' section of the questionnaire (Part B). This will be the only identifiable data transferred. No data will be collected on participants in the host trial (the person who lacks capacity). Agreements will be in place to cover data sharing.
How do I express an interest?
If you would like more information, please get in contact with the CONSULT team via the contact page on this website or email us at [email protected]
The overarching SWAT has received a favourable opinion from Leeds West REC (22/YH/0121) and has HRA/HCRW approval in place (IRAS ID 308609). Each SWAT will then come under the approvals obtained for the respective host trials, either from the start of the trial or as a substantial amendment after the host trial has commenced. Example text that can be included in a host trial protocol is available. As host trial sites are classed as PICs for the SWAT (rather than sites for the purpose of the SWAT), local capacity and capability checks will be needed.
Has the SWAT been adopted onto the NIHR portfolio?
Yes, the study has been adopted onto the NIHR portfolio and assigned CPMS Study ID 53846. During recruitment accrual data will be submitted on a monthly basis.
What support is available for host trials/sites?
Host trial teams and their sites will be fully supported to integrate the SWAT into the host trial recruitment pathway. Full training will be provided, and SWAT materials (participant information, decision aid booklet, questionnaire etc) will be provided. Costs of up to £5000 are available for host trials/sites to support SWAT-related activities, for example to cover additional trial manager time for submitting a substantial amendment.
What are consent arrangements for the SWAT?
In order to minimise the burden on host trials and participants in the SWAT (family members acting as consultee/legal representative) a separate consent for is not required for the SWAT. We have approval to use a single combined brief information sheet and questionnaire, with return of the questionnaire indicating consent to participate in the SWAT.
What are the arrangements for transferring data between host trials/sites and the CONSULT team?
To minimise the data being transferred, the single questionnaire is anonymous with minimal demographic information such as the participant's relationship with the person they are representing (Part A). If SWAT participants are willing to be contacted by the CONSULT team about taking part in an optional interview, they can complete the 'consent to contact' section of the questionnaire (Part B). This will be the only identifiable data transferred. No data will be collected on participants in the host trial (the person who lacks capacity). Agreements will be in place to cover data sharing.
How do I express an interest?
If you would like more information, please get in contact with the CONSULT team via the contact page on this website or email us at [email protected]