Table 4 NPT analysis for implementing INCLUDE Impaired Capacity to Consent Framework

Coherence (i.e. meaning and sense making by participants)

Is the intervention easy to describe?

The intervention is easy to describe.

Is it clearly distinct from other interventions?

The intervention is distinguishable from other tools such as the INCLUDE Ethnicity Framework.

Does it have a clear purpose for all relevant participants?

It has a clear purpose, although the purpose may be unclear to some, for example it could be confused with a tool to help assess capacity to consent. To be strengthened through additional messaging such as via an explainer video and infographics.

Do participants have a shared sense of its purpose?

The development of the framework originated in the MRC-NIHR TMRP Trial Conduct Working Group which, together with engagement with specialty leads and researchers, has provided a shared sense of purpose. To be strengthened through stakeholder consultation.

What benefits will the intervention bring and to whom?

The framework is expected to improve the ability of researchers to design trials to include adults with impaired capacity. It will also benefit funders, research ethics committees (RECs) and other organisations through providing assurance about the quality/appropriateness of the trial design. Longer term, it will benefit people with impaired capacity through improving access to trials and generating evidence to underpin their care.

Are these benefits likely to be valued by potential participants?

During public involvement activities and stakeholder consultations, researchers and patients/carers have stated that they value the potential benefits of the framework. Funders, RECs and other organisations have valued similar tools such as the INCLUDE Ethnicity Framework.

Will it fit with the overall goals and activity of the organisation?

Developing research that is more inclusive of under-served populations is a high priority for both policy (e.g. Department of Health and Social Care) and organisations (e.g. National Institute of Health and Care Research, Health Research Authority). The framework supports these strategic priorities to improve equality, diversity and inclusivity in research.

Cognitive participation (i.e. commitment and engagement by participants)

Are target user groups likely to think the intervention is a good idea?

Based on previous experience with the INCLUDE Ethnicity Framework, researchers and other stakeholders are likely to think the framework is a good idea.

Will they see the point easily?

Researchers and other stakeholders will see the point of the framework, but this may depend on the level of their own knowledge, ability and confidence. To be strengthened through additional messaging such as via an explainer video and infographics.

Will they be prepared to invest time, energy and work in it?

Time-constraints and the framework length and format may impact on researchers’ willingness to invest time and energy in it. Additional messaging (e.g. via an explainer video and infographics), maximising the usability of the framework (e.g. refining the format and content) and facilitating its use (e.g. through the development of workshop materials) will be key.

Collective action (i.e. the work participants do to make the intervention function)

How will the intervention affect the work of user groups?

The framework will increase time and work at the initial trial design phase, but that may be recouped when the framework is revisited to inform the protocol design and REC submission stages.

Will it promote or impede their work?

The additional time required to fully consider issues during the trial design stage may be viewed as impeding the process of developing funding application, but it may enhance the quality (and therefore its competitiveness) of the application. If the trial is funded, it may facilitate later stages, e.g. protocol design and application for ethical approval.

What effect will it have on processes?

The framework will encourage conversation, consideration, and collaboration during trial design decisions. The actions and resources needed to improve inclusion may appear to make the trial more complex and time and resource-intensive (i.e. less ‘efficient’) as economic benefits are typically easier to measure than social/wider health benefits. However, these should be viewed as ‘missing’ costs and challenge ideas around current efficiencies as ‘doing the wrong things righter’ which needs to change. To be strengthened through additional messaging, e.g. via an explainer video and infographics.

Will staff require extensive training before they can use it?

Most researchers will not need extensive skills and knowledge to use the framework, but they will require support to maximise their use of the framework and signposting to information and resources in order to ensure appropriate actions and resources are planned.

How compatible is it with existing work practices?

Establishing an additional (optional) step into the process of developing a trial for a funding application is compatible with existing work practices. However, it may increase the burden on researchers at an already busy time. The impact of this will need to be monitored. This could be explored as part of a future evaluation.

What impact will it have on division of labour, resources, power, and responsibility between different professional groups?

The framework is intended to be used collaboratively across the co-applicants, wider research team, and public contributors. It is not intended to be the work of one person. However, it may disproportionately increase the burden on some team members. The impact of this will need to be monitored. This could be explored as part of a future evaluation.

Reflexive monitoring (i.e. participants reflect on or appraise the intervention)

How are users likely to perceive the intervention once it has been in use for a while?

Use of this framework (and other similar frameworks) may be perceived as an important and necessary step when developing a trial, or an additional burden/hurdle to overcome as a ‘tick-box’ exercise. This will need to be monitored and could be explored as part of a future evaluation.

Will it be clear what effects the intervention has had?

The aim is for adults with impaired capacity to have better access to trials. The effect will need to be monitored, such as assessing the number/proportion of trials appropriately designed to include this group. This could be explored as part of a future evaluation.

Can users/staff contribute feedback about the intervention once it is in use?

Individuals and organisations will be encouraged to have ‘ownership’ of the framework through stakeholder consultations and subsequent engagement. Feedback will be sought following the facilitated workshops and via informal contact with researchers and organisations.

Can the intervention be adapted/improved on the basis of experience?

Further work is needed to address issues around intersecting factors, and the relationship between the frameworks for different under-served groups.