Helping people to engage in clinical trials; the Bump2Baby and Me experience

Clinical trials are an important part of getting evidence into practice. Their purpose is to test if a treatment works and is safe to use. They can also be used to look at other aspects of care such as improving the quality of life for people with chronic illnesses or in the case of the Bump2Baby and Me trial, testing a new way of delivering care. People take part in clinical trials for a variety of reasons. Healthy volunteers tend to say that they participate to help other people and move the science forward.

Research shows that more than three quarters of the public are willing to take part in clinical trials¹ but many studies still struggle to recruit participants and keep them engaged in studies. Clearly more effective engagement with eligible people is needed and this should continue throughout the clinical trial to ensure that participants are supported to remain in the study.

Improving engagement in clinical trials

A lack of awareness is one of the biggest barriers to engagement globally. Most people are not aware of what clinical trials involve, why taking part might be important, or how their individual participation can make a big difference. Most people don’t know that they can take part in trials when they are healthy or where to find out about opportunities to enrol.

The main learnings for improved engagement with the Bump2Baby and Me trial and the wider pregnant population at our sites were:

• Using plain language in all communications including written materials. Ensuring everything speaks directly to the woman’s needs, addresses their concerns, clearly outlines the study goals and is transparent about the study risks and commitments.
• Sharing relevant trial information with healthcare practitioners in a way that is straightforward and ensuring the woman’s care pathway is aligned with the study to increase its relevance within health systems.
• Encouraging participants to form a sense of ‘study identity’ and enabling them to become part of a community through use of regular participant newsletters and other communications such as birthday cards.

Addressing the barriers

Raising awareness is only the first step to increasing engagement with clinical trials but the crucial step is addressing the barriers to accessibility. The biggest barriers to participation are normally where people must travel long distances to take part, where taking part costs them time or money. The ways Bump2Baby and Me has tried to address these barriers are:

• Changing the recruitment strategy to allow for telephone contact instead of face-to-face initially. This change was introduced mainly due to the COVID-19 pandemic, but it also had the benefit of reducing the need to travel for some sites in particular.
• The study tried to line up the first baseline visit with usual antenatal care to minimise inconvenience.
• The intervention was designed to be delivered remotely so this meant it removed any need to travel to engage with it.
• The study had an implementation focus from the outset and aimed to align as closely as possible within routine care. This meant that we screened a large number of women but those that met our eligibility criteria, were approached for a recruitment conversation.

Communication is key in clinical trials

One of the key learnings from delivering the recruitment across the different Bump2Baby and Me sites and in different languages, was that exceptional patient communication was critical. When engaging a participant the elements of communication that matter the most are:

1. Explaining the processes involved in the study upfront. This includes explicitly going through what the commitment of the intervention involves and running through the measures that will be taken at baseline and follow-up visits
2. Checking in with participants regularly. Giving them a chance to ask any questions and checking that they don’t have any issues is important.
3. Showing appreciation at the end of the trial and giving them an opportunity to voice what their experience was like. This step is important on two levels as it can give you valuable data on the participant experience but also helps you acknowledge their valuable contribution.
4. Sharing the study results. Too frequently this step is missed. Participants are partners in our research so we need to let them know what the outcomes are so they can see the difference they make and hopefully want to keep contributing to science!

References

¹ Center for Information and Study on Clinical Research Participation (CISCRP) 2019 Perceptions and Insights Study.