Transcript Document

Recruiting a representative patient population in a busy Emergency Department
Lea H. Becker, MT(ASCP); Elaine Dube, CCRP; Weitao Wang, Kaitlyn Brill, Robert O’Connor, MD
University for Virginia Health System, Department of Emergency Medicine
Introduction
A key requirement for completion of quality research is
the recruitment of a representative patient population.
Historically, minorities have been under represented in
clinical trials. Potential study participants must be
identified without bias and ideally would consent to
participate in a representative way. Factors that may
impact research participation choices are study
requirements, personal or social history, and current
environment. Our team felt that the first step would
be to work on the current environment , the clinical
care team. Any reservations from the care team could
negatively impact the attitude of the potential research
participant, especially if that patient distrusts the
medical system and researchers in general.
Solutions
Affirm
Inform
Include
Educate
Inform: Post very brief study descriptions in multiple
locations
Educate: Provide research focused continuing education at
resident conferences, quarterly nursing meetings,
shift change learning opportunities, and one on one.
Include: Communicate face to face with all care team before
inviting patient to become a research participant; ask
about clinical schedule to avoid duplicating
assessments and procedures for research purposes
Affirm: Thank all persons who contribute! Send notes, copy
supervisors, give small thank you gifts (if allowed by
local ethics). Update team on study progress with
Newsletters and e-mail announcements.
Conclusions
Even though the clinical staff now supports research
efforts, there are many in the general public who have
reservations. Consistent with historical findings,
minorities are less comfortable consenting to research.
Our results show greater minority participation than
reported by other academic institutions in the SE US.
This indicates that unreserved support of research
from the care team positively impacts patients
willingness to become research participants. However
additional attention is needed to promote
representative participation in clinical trials.
Results
Percent of those approached for
research who consented
100%
85
46
Declines
90%
80%
Consent
403
70%
93
Problems
• Clinical care team is task saturated in fast paced
environment
• Clinical care team not accustomed to research
activities
• Historic inequities cause some groups to be less
open to research participation
• Dedicated research team has limited time to earn
trust
60%
50%
40%
30%
20%
10%
0%
Whites
Minorities
Initially some staff were resistant to the research
activities, but they very quickly accepted research
as part of their culture and became supportive,
providing assistance and referrals.
We selected several studies involving minimal
risk and low time commitment to eliminate many
reasons for declination. The research team
tracked basic demographics and decisions to
consent or not.
Of the 627 patients approached for enrollment,
291 (42%) were women and 336 (58%) were men,
and 488 (78%) were self-described as white.
A total of 496 (79%) consented and 131 (21%)
declined. The consent rate was 80% for women
and 78% for men (p=0.49 ns).
The consent rate was 83% for whites and 67%
for non-whites (p<0.0001). The average age of
consenting vs. declining patients were 57.8 and
60.7, respectively (p=0.92 ns). Within each race
classification, there were no differences in rates of
consent by age or gender.
Next steps
Expand the inform, educate, include, affirm cycle to
reach out to the community with brochures, videos,
radio, and television spots. This may cause more
potential research participants to arrive with a positive
pre-disposition towards research. If we appropriately
target our efforts, we may be able to further reduce the
demographic gaps in clinical research.