SCHEMA: Lessons on inclusivity
Including underrepresented groups is central to how the Centre for Trials Research designs and conducts studies.
We have worked on our recruitment methods and study activities to broaden participation, but there has been less focus on how underrepresentation in certain research professionals or the complexity of the research environment can impact research inclusivity
The SCHEMA trial was a two-arm randomised trial exploring whether art therapy can reduce aggressive behaviours in adults with learning disability in NHS secure care. This group has been historically underrepresented in research, and secure care provides a unique research environment because of additional security and staffing requirements.
This trial also involved art therapists who are traditionally not involved in research delivery.
Our key question
How can a trial unit better support site research teams who may have limited experience of research or working in secure care settings?
Methods and findings
A survey was developed alongside collecting data regarding set-up timelines and reflections from the trial manager to understand key challenges and successes when setting up and managing the SCHEMA trial. The survey explored the site research teams' levels of research experience, avenues of support, and challenges experienced
For this trial, ward access challenges and population needs meant that the art therapists were involved in all aspects of the trial and not just in intervention delivery. They faced additional challenges, including balancing clinical workloads with trial requirements. Research support staff were also required to undergo additional training to access the wards for data collection. Concerns about making mistakes were also reported frequently. Trial set-up was identified as the most challenging period
Recommendations
Communication
The data showed structured guidance over and above the protocol, and regular contact, through email and fortnightly meetings with the central team, provided valuable support and reassurance to the site team. Trials requiring delivery in challenging environments or with staff who have limited research experience should look at developing trial activities summary sheets that are 1-2 pages long, listing key activities at each follow-up, as a prompt for trial staff.
Flexibility in Trial processes
Where possible, it is important to build in flexible trial processes to anticipate access or inclusion needs. This could include, for example, multiple ways to provide thank you vouchers or to assess fidelity. Engage with a range of sites, research delivery staff, and public & patient representatives to identify areas that could be flexible during the project development stage. This helps to avoid unnecessary modifications to trial protocols and delays in trial set-up activities.
Training
As balancing clinical and research workloads was identified as a significant challenge, review what study training is required, especially where staff may not have completed standard research courses such as Good Clinical Practice. Identifying key courses and engaging sites early, such as during the site assessment phase, can go a long way to ensuring staff have the knowledge and skills to be involved but not overburdened.
