Introduction: Studies have shown race-ethnic disparities in clinical trial enrollment, including in acute stroke, preventing neurotherapeutics from being well tested in all relevant populations, including commonly underrepresented groups. An important source of disparities is variable clinical care and research recruitment processes at individual hospitals. A promising approach to mitigate this variability is for a central neurologist panel, via prehospital telemedicine, to perform enrollment of all qualifying patients being transported by all ambulances throughout a geographic region.
Methods: We analyzed all patients enrolled in the NIH FAST-MAG prehospital trial, which recruited in 315 ambulances traveling to 60 hospitals throughout Los Angeles and Orange Counties between Jan 2005 and Dec 2012. Over 98% of patients were enrolled using explicit informed consent, with the patient or on-scene legally authorized representative speaking to on-call central enrolling English and Spanish-speaking neurologists.
Results: Among the 1700 enrolled patients, race-ethnic distribution was: White, non-Hispanic 54.3%, Hispanic White 23.6%, Black 12.8%, Asian 8.2%, and Other 1.0%. The different race-ethnic groups showed substantial differences in stroke mechanisms, vascular risk factor, age, and additional characteristics that might affect treatment response. In the Los Angeles County region, compared with the race-ethnic population of the County (total 10.1 million persons), the trial population had greater proportion of Black patients (13.5% vs 9.2%, p < 0.0001); and substantial representations of Hispanic and Asian patients, though not equal to County levels (Hisp 24.2% vs 34.2%, Asian 8.1% vs 14.6%). Compared with concurrent, national NIH trials enrolling acute stroke patients after hospital arrival, the FAST-MAG population had substantially higher representation of Hispanic and Asian patients.
Conclusion: Trial enrollment by a central neurologist accessing acute stroke patients in all ambulances throughout a wide geographic region is associated with substantial reduction in race-ethnic disparities.