COUCH Health were commissioned by a top 20 pharmaceutical company headquartered in the US. The company commissioned COUCH Health to improve diverse representation in their Phase 3 systemic lupus erythematosus (SLE) clinical research study. The reason was two-fold: A need to accelerate enrolment, and to improve enrolment from underserved populations. Although the study was global, COUCH Health were commissioned to support with 23 US sites based in underserved areas.
People who are African American, Hispanic, and those of Indian descent have a higher incidence of developing SLE, and these underserved populations have historically not been represented in SLE research. The reasons for this are complex and varying. The study was not enrolling at rates expected and had already been delayed in meeting enrolment goals by approximately 9 months.
The challenges the sponsor was facing
There was no centralised patient recruitment strategy, the strategy was to act on site requests if received.
Community group outreach
Due to the population to be engaged and the lack of trust in clinical research and healthcare on the whole, it was recommended to target community groups around a 20 mile radius of 23 key sites in the US.
These groups consisted of:
Once community groups were engaged, IRB approved materials promoting the study were shared with the groups to include in newsletters, events, notice boards, and sermons.
Local healthcare professional referrals
Due to the population being engaged, COUCH Health worked with Federally Qualified Healthcare Centers (FQHCs) across the US to refer patients to the study. As people under FQHCs are on Medicare/Medicaid, referrals can be a quick-win.
Pre-screening prior to site-referrals
Using our nurse-led call centre, we were able to qualify patients before site referrals.
78% of patients screened were from a diverse background
63% of patients screened were randomised, substantially bringing down the screen failure rate
95% of sites agreed they would work with COUCH Health again
19 out of 23 of the sites agreed to receive cultural safety training from COUCH Health, which was delivered via weekly lunch and learns (held virtually)
The number of sites actively enrolling was higher for those receiving COUCH Health support compared to those that were not supported by COUCH Health
Sites that participated in cultural safety training with COUCH Health enrolled 26% more diverse patients compared to those that did not receive training
57 patients randomised
179 community hospitals engaged
13 FQHCs engaged
279 communities engaged
Screen failure rate improved by 21%
19 sites engaged