Clinical trials are often criticised for not reflecting real-world populations. In a typical clinical trial, participants volunteer with the understanding that they have a 50% chance of receiving an intervention, regardless of whether they ultimately fall into the control group. As such, clinical trials tend to attract certain types of patients; those who, more often than not, have high-trust relationships with physicians and the healthcare system.
People from marginalised groups are less likely to participate in clinical trials. This means that often, research participants do not represent the diversity we would find in a typical hospital waiting room. This discrepancy introduces bias into the research and makes it more difficult to extrapolate to real-life situations. ESCAPE’s clinical trial, designed by Dr Tim Friede and Dr Christoph Herrmann-Lingen, utilises a comprehensive cohort study design with an embedded randomised control trial (RCT) in the hope of overcoming such bias.
ESCAPE aims to improve the physical and mental health of multimorbid elderly patients through the implementation of a blended-collaborative care (BCC) approach. ESCAPE’s innovative clinical trial design will evaluate the BCC approach. The RCT is embedded within a larger cohort study with patient recruitment occurring in two phases: once for the cohort study and then for the RCT, only those patients who volunteer for the cohort study are invited to partake in the RCT.
Because the cohort study is non-interventional, patients can volunteer comfortably knowing they will simply be asked questions about their regular care and quality of life. The ESCAPE team is hopeful that being consciously able to opt-out of the intervention means more patients, including those who are less comfortable with hospitals and healthcare procedures, will be willing to engage in the cohort study. Thus, providing a secondary and more robust control population for the intervention group to be compared against.
ESCAPE's clinical trial began in the spring of 2022 and recruitment is actively ongoing. If you are interested in yourself or a loved one participating in the clinical trial, please do not hesitate to get in contact and we can provide more information - info@escape-project.org.