Families Praise “Enhanced Pre-Consent Discussions” Before Entering Clinical Trials

Published July 2021 | Patient Education and Counseling

The good news is that families participating in a large clinical trial of a medication to treat Crohn’s disease generally liked it when clinicians used an “enhanced pre-consent discussion” technique during the enrollment process.

The challenging news is that the measures used to evaluate the technique were not sensitive enough to demonstrate much impact. And that has the study leaders, Ellen Lipstein, MD, MPH, and William Brinkman, MD, MEd, MSc, planning further research.

This project started from the idea that if people better understood that clinical trials are conducted when doctors do not know the best way to treat a condition, they may be more willing to participate. The team’s hypothesis: improved decision-support interventions could lead to higher enrollment rates.

To test this, the team developed a more conversational approach to describing the aims of a clinical trial, with the specific goal of engaging participants in shared decision-making.

Increasing understanding would, in theory, improve willingness to join. The technique was introduced to 241 participants in the multi-center COMBINE clinical trial, which evaluated low-dose methotrexate as a therapy for pediatric Crohn’s disease.

“Although the intervention was well-liked, we found no differences in knowledge, perceptions of decision support or study enrollment rates between arms of our study,” Lipstein says. The researchers say possible reasons for why the study showed no clear impact include wide variation in use of the technique among clinicians and a lack of sensitivity in the outcome measures.

However, there is value to a well-liked approach. The study demonstrates that incorporating an in-person shared decision-making intervention into the consent process is feasible, Lipstein says. Next, the team plans to work on more robust measurement strategies to better evaluate the technique in other trials.