Recruiting Minorities Where They Receive Care: Institutional Barriers to Cancer Clinical Trials Recruitment in a Safety-Net Hospital

Article (PDF Available)inContemporary clinical trials 30(6):552-9 · August 2009with44 Reads
DOI: 10.1016/j.cct.2009.06.009 · Source: PubMed
Abstract
Most research on the barriers to recruitment of ethnic and racial minorities focuses on patient factors. The purpose of this exploratory case study was to examine how institutional factors impacted recruitment and enrollment in a public hospital clinic frequented by minority patients. We used ethnographic methods (observations of patient-provider interactions and semi-structured interviews) to document and explain how a number of institutional barriers hindered trials enrollment in a public hospital outpatient breast cancer clinic. We identified two categories of institutional barriers: (1) organizational climate, and (2) research specific resources. Organizational climate included qualities of the clinic and hospital such as the clinic structure (clinic hours, patient assignment method), the interdisciplinary care team, the lack of continuity of care, and competing provider priorities of clinical care, teaching, and research. Research specific resources included: staff, funds and institutional status to facilitate opening a range of trials; and linguistically and literacy-appropriate research resources. Although we cannot determine from our qualitative data the relative impact of different kinds of barriers (e.g. patient, provider, institutional barriers), our data highlights the need to address the role of institutional barriers in efforts to improve minority recruitment to clinical trials. Recruiting participants in safety-net settings may be a reasonable strategy for increasing accrual of ethnic and racial minority patients to cancer clinical trials. However, our qualitative data suggest that while opening protocols for accrual at minority-serving institutions may signal nominal access to trials, achieving substantive access may require further steps to overcome substantial institutional barriers.
Recruiting minorities where they receive care: Institutional barriers to
cancer clinical trials recruitment in a safety-net hospital
Galen Joseph
a,
, Daniel Dohan
b
a
Department of Anthropology, History & Social Medicine, University of California, San Francisco, Box 0981, San Francisco, CA, 94143, United States
b
Philip R. Lee Institute for Health Policy Studies, University of California, San Francisco, Box 0936, San Francisco, CA 94143, United States
article info abstract
Article history:
Received 20 March 2009
Accepted 29 June 2009
Available online xxxx
Introduction: Most research on the barriers to recruitment of ethnic and racial minorities
focuses on patient factors. The purpose of this exploratory case study was to examine how
institutional factors impacted recruitment and enrollment in a public hospital clinic frequented
by minority patients.
Methods: We used ethnographic methods (observations of patient provider interactions and
semi-structured interviews) to document and explain how a number of institutional barriers
hindered trials enrollment in a public hospital outpatient breast cancer clinic.
Results: We identied two categories of institutional barriers: (1) organizational climate, and
(2) research specic resources. Organizational climate included qualities of the clinic and
hospital such as the clinic structure (clinic hours, patient assignment method), the
interdisciplinary care team, the lack of continuity of care, and competing provider priorities
of clinical care, teaching, and research. Research specic resources included: staff, funds and
institutional status to facilitate opening a range of trials; and linguistically and literacy-
appropriate research resources.
Conclusion: Although we cannot determine from our qualitative data the relative impact of
different kinds of barriers (e.g. patient, provider, institutional barriers), our data highlights the
need to address the role of institutional barriers in efforts to improve minority recruitment to
clinical trials. Recruiting participants in safety-net settings may be a reasonable strategy for
increasing accrual of ethnic and racial minority patients to cancer clinical trials. However, our
qualitative data suggest that while opening protocols for accrual at minority-serving
institutions may signal nominal access to trials, achieving substantive access may require
further steps to overcome substantial institutional barriers.
© 2009 Published by Elsevier Inc.
Keywords:
Recruitment
Enrollment
Barriers
Cancer
Clinical trials
1. Introduction
The 1993 NIH Revitalization Act mandated the inclusion of
women and members of minority groups in clinical research
sponsored by the US National Institutes of Health (NIH) for
reasons of fairness and scientic validity. The Act thus aimed
to address health disparities by creating equal access to
experimental treatments and by assuring the scientic
validity of new treatments for all populations. Sociologist
Steven Epstein points out that the NIH mandate represents a
twofold change: including all groups in research rather than
protecting the vulnerable from exploitation by researchers
and examining differences across groups rather than extra-
polating from a standard (often white, male) research
subject [1]. Epstein also notes that the implementation of
the NIH mandate has been both uneven and controversial.
Numerous investigators have identied approaches to
diversifying trial participation [27] as well as barriers to
effective recruitment [817], but no established best practices
yet exist (See Table 1 .). Existing studies of minority recruitment
have focused on barriers to recruitment among minority
patients, especially issues such asmistrustor misunderstanding
Contemporary Clinical Trials xxx (2009) xxxxxx
Corresponding author. Tel.: +1 415 514 8227; fax: +1 415 4765891.
E-mail address: gjoseph@cc.ucsf.edu (G. Joseph).
CONCLI-00393; No of Pages 8
1551-7144/$ see front matter © 2009 Published by Elsevier Inc.
doi:10.1016/j.cct.2009.06.009
Contents lists available at ScienceDirect
Contemporary Clinical Trials
journal homepage: www.elsevier.com/locate/conclintrial
ARTICLE IN PRESS
Please cite this article as: Joseph G, Dohan D, Recruiting minorities where they receive care: Institutional barriers to cancer
clinical trials recruitment in a safety-net hospital, Contemp Clin Trials (2009), doi:10.1016/j.cct.2009.06.009
of clinical research or researchers as expressed, for example, in
fear of experimentation or distrust of the medical system.
However, literature reviews also concluded that institutional
barriers within the delivery systems and clinics where recruit-
ment occurs deserve more attention [18,19]. Such institutional
barriers may be particularly relevant to minority recruitment
because of where minorities tend to receive carei.e. in
resource constrained safety-net hospitals and clinics for the
uninsured and federally insured poor (Medicaid) and elderly
(Medicare) [2022].
The mandate to increase diversity has spurred innovations
in the area of cancer trials recruitment. Innovative prevention
trials have included community-focused outreach to educate
minorities about the role of research in medicine, [24] and
the National Cancer Institute (NCI) has developed new
networks to provide enhanced infrastructure for conducting
treatment research in minority-serving health care institu-
tions [5,6]. The Minority-Based Community Clinical Oncology
Program (MBCCOP), with signicant resources from the NCI,
has successfully recruited minorities through institutions
where they receive care [6]. However, to our knowledge, there
has been little examination of how institutional processes
have facilitated or impeded recruitment in MBCCOP settings
where minorities are more likely to receive care.
We undertook an exploratory study of how institutional
factors can impact recruitment and enrollment in safety-net
cli nics frequented by minority patients. In accord with
Epstein's observation that the NIH mandate has been un-
evenly embraced and controversial, we expected to nd that
even when clinicians and researchers supported efforts to
expand minority recruitment, institutional factors could im-
pede their efforts.
This exploratory study describes how institutional factors
shaped trials recruitment in an interdisciplinary breast
oncology clinic at a safety-net medical center. We dene
institutional barriers to trials recruitment as relatively xed
characteristics of the clinical environment that negatively
impact the ability of providers to recruit patients on to clinical
trials. Our goal in this case study is to document how these
barriers operate in order to suggest areas for future research
and interventions (including appropriate resource allocation)
that will facilitate equal access to clinical trials.
2. Methods
2.1. Approach
The data presented here were collected and analysed as part
of a series of case studies of how institutional factors shape the
recruitment and enrollment of diverse patient populations to
cancer therapeutic trials in different healthcare settings [36].To
develop the case studies we used ethnography, a qualitative
research method for discovering and investigating social and
cultural patterns and meaning in communities, institutions, and
other social settings [37] See also [38]. Data was collected by
directly observing providerpatient interactions during discus-
sions, recruitment, and enrollment of patients on to clinical
trials. In addition we conducted in-dep th interviews with
patients and providers. Direct observation allowed us to
document the actual behaviors, everyday language, and specic
meanings of clinical trials recruitment in the settings where it
took place while the interviews allowed us to explore providers,
and patients, own views of what happened in clinic [39
41].A
ll
research procedures for this study were approved by appro-
priate Institutional Review Boards. In accord with our IRB
approved protocol, in this paper, all proper names are
pseudonyms, and we have changed some potentially identify-
ing characteristics of locations and individuals.
2.2. Setting and population
The data for this paper were gathered at a specialty breast
oncology clinic at Safety-Net Hospital (SNH). Like many
hospitals that make up the healthcare safety-net in the United
States, SNH was publicly owned and served many patients
who had no medical insurance or were covered by Medicaid,
the publicly-funded medical insurance program for the poor
or Medicare, the federal insurance for the elderly. Located in
an urban area, SNH serves more than 80,000 patients in
300,000 visits annually. It is afliated with a nearby academic
medical center (AMC), whose faculty and staff provided clin-
ical and teaching services at SNH.
SNH established an interdisciplinary surgical and medical
oncology breast clinic in the early 1990s for patients with
non-metastatic breast cancer and other breast disease. The
staff included: two surgeons, two medical oncologists, three
nurse practition ers (NPs), four patient navigators (case
managers who help patients access medical care and social
services), and one part-time clinical trials coordinator (CRC).
Like all SNH clinics, breast clinic was a teaching clinic for
physicians and nurses in training (housestaff including
students, residents and fellows). Attending surgeons and
medical oncologists (fully trained physicians with teaching as
well as clinical responsibilities) were AMC faculty, and some
also practiced at AMC. NPs were employed by the county
department of public health and worked in multiple oncology
clinics at the SNH including mammography, infusion, general
oncology, and in-patient oncology. Patient navigators helped
patients obtain treatment, access insurance and disability
benets and community services, and facilitated provider
patient communication via language and cultural translation.
A charitable foundation supported the navigators, the CRC,
and other cancer services at SNH and explicitly sought to
improve access to cancer clinical trials.
Table 1
Literature on barriers to clinical trials recruitment.
Barrier Explanation/Example Studies
Mistrust of medical
system and research
Due to historical abuses [3]
Provider role In referring, offering and explaining
trials
[13,23]
Socio-economic status Access to trials [10,11,24]
Trial design Exclusion criteria; patient diagnosis [8,15,25]
Group speci c barriers Culture, health beliefs, or group specic
issues (e.g., African Americans; Asian
Americans)
[8,2628]
Institutional factors Institutional racism; protocol
availability; inter-organizational
cooperation; organization size; stafng
[5,25,29
31]
Insurance and health
system issues
State-mandated coverage for trials [15,32,33]
Reviews N/A [19,34,35]
2 G. Joseph, D. Dohan / Contemporary Clinical Trials xxx (2009) xxxxxx
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Breast clinic served approximately 600 patients in 1600
visits annually. The breast clinic patient population was highly
diverse with respect to race and ethnicity. Table 2 shows that
the breast clinic patient population was similar to SNH as a
whole in terms of ethnic/racial diversity and insurance status.
Nearly a third of breast clinic patients did not speak English.
At nearby AMC, shown for comparison in Table 2, patients are
much less diverse and better insured.
In California, a diagnosis of breast cancer confers Medicaid
eligibility so all breast clinic patients had insurance. Because
SNH has private foundation and public Medicaid support that
most US safety-net settings do not enjoy, we frame this case
study as representing a best case situation.
2.3. Data collection
We conducted over two years of ethnographic research at
breast clinic including clinic observations and interviews with
physicians, nurses, CRCs and patients. For the observations,
we shadowed providers as they treated and discussed trials
with patients and conducted other tasks. We used standard
ethnographic research methods, designed to minimally
disrupt participants' usual social routines [38]. Our proce-
dures for direct observation attempted to e nsure that,
ethically, our research project did not compromise the patient
care and that, scientically, our data reected usual treatment
routines. During the course of this project, which included
case studies at SNH, AMC and private community clinics, we
observed hundreds of providerpatient interactions at the
various sites. This article presents the SNH breast clinic case
study (77 interactions, including 66 discussions of clinical
research) because this site had an active trials program in an
institutional contexta safety-net health care settingthat is
particularly relevant for the issue of minority recruitment.
Providers primarily included medical oncologists, surgeons,
nurse practitioners; additionally, oncologists and surgeons in
training (residents and fellows) were also included and
patient navigators were often present during these interac-
tions. We obtained verbal informed consent prior to all
observations.
In addition to the observations, we conducted 9 interviews
with SNH breast clinic providers whom we had observed in at
least 5 interactions using a semi-structured, open-ended
protocol [42]. The interviews represented the range of
providers in the clinic, and included three attending physi-
cians (two medical oncologists and one surgeon), three nurse
practitioners, one medical oncology fellow and two patient
navigators. Topics included: discussion of shadowed obser-
vations; patient care responsibilities; activities related to
clinical trials; views of medical research; personal and
professional background. Interviews were tape-recorded
and transcribed verbatim for analysis. We obtained written
informed consent for interviews. All interview participants
were compensated for their time with $20. Providers were
not involved in the development of our research study. Nor
were they involved in the development of the clinical trials
offered in the clinic, as those were all trials taken from the
CTSU menu.
2.4. Data analysis
Our analysis procedures resembled those of grounded
theory, which focuses on developing theory rather than
hypothesis testing [43]. As is typical in ethnographic research,
we adopted a relatively open approach to data analysis
reading through our data multiple times to identify key
themes that recurred in eld notes and transcripts. We used
Atlas-ti to manage data including observation eldnotes and
intervie w transcripts, and we coded data according to
substantive content to identify the key themes presented here.
3. Results
Summary of results
1. Organizational climate
1.1. Lack of clinic resources makes clinical research a problematic additional
burden
1.1.1. Providers already stretched to see patients scheduled for weekly
half-day clinic
1.1.2. Recruitment ties up clinic exam rooms longer than treatment-only
appointments
1.2. Clinic structure hampers providers' ability to support recruitment
1.2.1. Interdisciplinary clinic hinders providers' development of
knowledge
base about relevant trials
1.2.2. Lack of continuity of care hampers providerpatient communication
and relationship
1.3. Clinic prioritizes clinical care and teaching above research
1.3.1. Limited provider investment in learning about trials
2. Research specic resources
2.1. Research Infrastructure means only phase III trials are available
2.1.1. Providers would prefer to be able to offer innovative treatments
available only in Phase I/II trials
2.1.2. Patients nd r andomization unappealing and/or difcult to understand
2.2. Effective communication in diverse languages is not supported
2.2.1. Resources are not available to translate trial materials, e.g. consent
forms
2.2.2. Skilled medical interpreters are scarce and providers are not
trained to use them
3.1. Organizational climate
3.1.1. Clinic structure and the burden of research
At breast clinic, clinical research proved time consuming,
and logistics created a climate in which trials remained a low
priority. Clinic took place only one afternoon (4 h) a week, an
historical legacy that failed to meet current demand. Pro-
viders saw 3545 patients during each clinic, with appoint-
ments booked months in advance, and patients with urgent
Table 2
Patient populations at study sites.
a
AMC SNH (outpatients) SNH Breast Clinic
White 76% 22% 22%
African American 6% 19% 14%
Latino 7% 33% 26%
Asian 11% 22% 35%
Medicaid 9% 33% 56%
Medicare 25% 11% 16%
No insurance (self pay) 6% 43% 5%
Private Insurance 50% 3% 1%
Other
b
10% 10% 22%
a
Internal AMC and SNH reports.
b
Other includes county universal coverage, jail, military, veteran, Indian
public health, worker's compensation, unknown.
3G. Joseph, D. Dohan / Contemporary Clinical Trials xxx (2009) xxxxxx
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needs double booked into a single slot. Nominally, each
clinic had more than a dozen providers, but frequently a core
of 34 NPs and senior housestaff provided much direct care.
Attending physicians often missed clinic or taught housestaff
rather than seeing patients, nursing staff had to maintain
clinic ow, and navigators provided social but not medical
services.
The clinic was held in a small suite of exam rooms borro w ed
from the SNH surgery service. After a nur se roomed a p atient
for an exam, the patient chart was piled on a small shelf in the
clinic hallway. The CRC placed a sticky-note on the chart if a
patient might be eligible for a trial. Providers took charts from the
pilein theory, selecting the bottom chart that had been waiting
longest. Providers gathered around a small desk in the hallway to
discuss cases, but housestaff and NPs often waited 1 530 min to
discuss a case with attending phy sicians. Pat ient visitstypically
scheduled for 15 minregularly stretched 45 min or longer . On
most afternoons, the waiting room overowed as patients waited
23htoberoomed.
These clinic logistics made it impossible for providers to
maintain a continuous patient panel. The chartpile system
and changing roster of providers meant patients saw which-
ever provider became available. Any disruption in owe.g.
waiting for a translatorcould throw the fragile system into
disarray. Providers often counted research patients as a
disruption because explaining studies and getting consent
required extra time and effort. Some prov iders quietly
avoided patients who might be trials-eligible simply by not
picking up the charts to which the CRC had attached a sticky-
note. As one provider put it,
Honestly, it's a pain...It slows everything downYou can
spend 45 minutes talking about a trial and you basically
have maybe discussed possible options for treatment
then you come out and there's 40 more patients left to
see.
Even providers who supported recruitment sometimes
avoided research patients. As one clinical fellow explained,
the CRC discussed symptoms and side effects with the patient
as part of the trial protocol, but then I'm required to go in and
ask the same thingit kind of makes the provider look like a
robot.
3.1.2. Interdisciplinary structure and continuity of care
Like many breast specialty clinics, the SNH clinic was
interdisciplinary so patients received care from a clinic team
that included all relevant specialists and that could easily
communicate, coordinate, and collaborate in providing care.
Ironically, however, we observed that the interdisciplinary
structure of breast clinicin the context of other institutional
constraintsactually could impede trials recruitment because
it prevented the assignment of patients to a speci c provider,
required providers to act outside their area of expertise and
limited providers' awareness of specic trials.
The clinic's interdisciplinary structure provided clinical
benets
and convenience for the patient, but it also disrupted
the providerpatient relationship-building that could facil-
itate trials participation. As one NP told us, the interdisciplin-
ary clinic structure requires that you don't assign a patient to
one person [because] if you did they'd be in onc[ology] service
or they'd be in surgery service. The interdisciplinary structure
may be convenient, she continued, but not attaching the
patient to anyone is the problem. The patient navigator
program was designed to address this gap in provider
continui ty. Navigators helped patients obtain prescribed
treatments, access insurance and disability benets, and
communicate with providers (e.g. by helping patients ask
questions and alerting providers to issues that hindered
treatment adherence). However, navigators had little medical
training and could only do so much. In practice, the senior
medical oncologist was the go to person for all patients in the
clinic. Of course, given the minimal clinic time, patients had
limited access to her.
In theory, provider coordination could help patients follow
complex research protocols. In the interdisciplinary environ-
ment of breast clinic, this coordination of ten proved difcult
to achieve. One afternoon, a surgical attendingwithout
realizing the patient had enrolled on a trial that might require
adjuvant che mothera py be fore radia tion referred this
patient for radiation therapy and thus violated the trial
protocol. The senior oncologist had missed clinic that day, and
the resident who saw the patient ignored a post-it note on her
chart from the CRC regarding the trial. (Post-it notes were the
primary way the CRC communicated with most providers in
clinic).
As this example illustrates, in the context of a short-staffed
interdisciplinary clinic, providers regularly had to act outside
their area of expertise. When medical oncologists were tied
up or absent, students, fellows, and nurses asked attending
surgeons about chemotherapy treatments, and on days when
surgeons arrived late to clinic (or missed it altogether),
medical oncologists put patients on the surgery schedule.
Trials, nearly all of which focused on medical oncology, could
create tension between providers of different disciplines. For
example, a medical oncologist described her frustration with
a surgeon who did not want to talk to a post-op patient about
a trial.
He [was] going to ip the chart over and have me talk to
the patient about the clinical trial. There were only two of
us there that day. We were both very, very busy. And I
looked at him and I said, So why can't you talk to this
patient about this clinical trial?”…I've got plenty of other
things to do.
Over time, that surgeon became more engaged in trials
recruitment. Such was not the case for the senior surgical
attending. She had a clear commitment to clinical care not
research. Following her example, providers from surgery
infrequently learned about trials or facilitated research. In
addition, the nurses who staffed the clinic were, like the clinic
itself, borrowed from the surgery service. Taking their cue
from the senior surgeon, they too focused on clinical care and
were unfriendly to trials. Their attitude shaped the culture of
the clinic. For example, one nurse removed an AMC
researcher and trials patient from an exam room in order to
give it to a different patient. The same nurse said she believed
it was unethical and coercive to recruit this population for
research because
they don't understand what they're getting
int
o. As one oncologist put it, the clinic nurses viewed
research as an extracurricular activity.
4 G. Joseph, D. Dohan / Contemporary Clinical Trials xxx (2009) xxxxxx
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Given its interdisciplinary structure and lack of resources,
few providers had the expertise or time to address even basic
questions about open protocols at breast clinic or even knew
which trials were accruing. The CRC and senior oncologist met
weekly to identify eligible patients and, thus, were the
exception to this rule. Even they, however, found clinic follow-
up difcult. Before each clinic, the CRC reviewed the scheduled
patients and attached sticky notes to those potentially eligible
for trials. During clinic, she waited in the hallway and tried to
speak to each provider who picked up a sticky-noted chart.
Thus, providers only learned about a patient's eligibility
immediately before entering the exam room and introducing
themselves to the patient. During one interaction we observed,
a physician discussed a trial with a patient just after learning
about it from the CRC. After presenting some information to the
patient, she had to leave the room to ask the CRC questions
about the trial's pros and cons. The CRC then went back into the
exam room with the provider and re-presented the trial to the
patient and her family. Following this extended and awkward
introduction, the patient declined to participate.
Providers knew little about trials because there was no
time during the overowing clinic to educate them about
open protocols, and the overburdened staff may not have
wanted to take on additional duties in any case. Clinic leaders
recognized the barrier and conducted an in-service training
on trials for navigators and NPs. But the in-service did not
include everyone in the multi-disciplinary setting, and it
could not convince providers to fully commit to the process.
While interdisciplinarity has the potential to enhance com-
munication, better coordinate care, and improve the quality of
interactions between providers and patients, realizing this
potential requires providers from different elds to set
common goals and commit the time and effort to bridge the
divides that can separate disciplines. At breast clinic, some of
this potential came to fruition in the area of clinical care, but
fragile and fractured interdisciplinary relationships, as well as
limited awareness and knowledge of trials often appeared to
hamper trials recruitment.
3.1.3. Priorities: Clinical care, teaching, and research
At times, differences in how providers prioritized clinical
care, teaching and research created tension in breast clinic.
The senior medical oncologist felt that, as a teaching
institution, we should be putting people on trials and
showing the residents and fellows how to do that. But
SNH's primary mission was to provide clinical care, and the
culture of the hospital and of breast clinic reected this
commitment. One NP described the tension between teaching
and patient care.
[Doctors will say] he's learning, it's a learning moment.
And I'm like no, it might be a learning moment but they
have a patient and the purpose is for them to care for the
patient.
This prioritization of clinical care could impede research
recruitment. One fellow, who tried to enroll oncology patients
on his own prospective trial at SNH, reected there are a lot
of other stresses and priorities on people that take care of
patients in the system for them to say ooh, this patient might
be eligible for a trial. His work at breast clinic reected his
unsuccessful prior research experience at SNH; he remained
unenthusiastic about recruiting patients to trials throughout
his six-month rotation.
Given the complexity of treating breast cancer, of trials
enrollment, and of patient monitoring post-enrollment, the
uneven commitment to the research enterprise at SNH
whose primary mission was patient care and whose second-
ary mission was teachingmade trials enrollment extremely
difcult.
3.2. Research specic resources
Trials recruitment at SNH, as everywhere, needed specia-
lized infrastructure and resources to accommodate enroll-
ment and engage patients. The modest research
infrastructure (small research staff, limited funds) at SNH,
and its inability to afliate with an NCI cooperative group
because of its relationship to AMC) limited the number and
range of open trials in breast clinic. In addition, limited
res
ources for translation services for research activities
hindered effective patientprovider communication.
3.2.1. Research infrastructure and trial availability
In the early 2000s, three factors combined to enable the
breast clinic to re-open a dormant research program: 1) the
AMC's desire to recruit more minorities; 2) NCI's development
of the Clinical Trials Support Unit (CTSU) program, which
made cooperative group trials available to resource-limited
institutions such as SNH that did not have the infrastructure to
open investigator initiated or industry trials; and 3) funds
from a private foundation to support the CRC and patient
navigators. Despite the commitment and passion of the
medical oncologist who co-led the clinic and these three
factors, the trials program had only modest success at SNH
breast clinic. An internal review (2007) showed that with 8
breast cancer trials open, among the 78 breast cancer patients,
42 were ineligible,13 were offered participation, and two were
enrolled. The problems outlined in the previous section,
regarding the clinic organization, interdisciplinary structure,
continuity of care and provider priorities explain the low rate
at which eligible patients were offered participation.
Furthermore, the reliance on the CTSU menu and the
modest research infrastucture to support trials management,
limited the number and range of open trials in breast clinic.
The trials menu mostly consisted of CTSU supported multi-
center phase III studies. For the most part, these studies tested
incremental improvements to established treatment regi-
mens (e.g. by comparing an experimental agent or regimen
against a standard, either to determine superiority or, less
commonly, non-inferiority, or as in one trial open at SNH, to
compare a standard treatment regimen to alternative regi-
mens using the same drugs in an attempt to reduce side
effects.). Compared to phase I or II trials which often involve
higher risks to patients because they test safety and
appropriate dosing (phase I), and clinical efcacy/dosing
(phase II) of new agentsthese phase III studies entailed
modest risk, but they did not offer fundamentally new
treatments and almost always required randomization.
Patients with advanced disease and short life expectancy
might choose a phase I/II trial, despite the risks, in order to
obtain otherwise-unavailable drugs or treatments. Indeed,
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one SNH provider stated she would be more inclined to
discuss a phase I or II trial with patients because the access to
a new type of drug is a big motivator for me for something
that's pretty widely known to be metastatic and incurable
with a short life expectancy. Providing a new investigational
treatment that was only accessible through a trial seemed
consistent with the emphasis on clinical care at SNH.
In contrast, reasons for participating in a phase III trial
were less obvious. Patients often asked providers why they
would want to participate in a trial when the standard
treatment was effective and the experimental treatment
offered little additional benet. Providers could not count on
patients joining a trial in hopes of a miraculous curethe kind
of therapeutic misconception that motivated patients to join a
phase I or II trialbut rather they had to appeal to patients'
sense of altruism or obligation to the provider, clinic, or
community. One SNH attending often suggested to patients
that participation might help women in their position in 5 or
10 years or their daughters. For some patients, this provided
sufcient motivation.
Providers also had to explain and justify randomization,
which was a new concept for many patients. Even when
patients understood the rationale for randomization, they did
not necessarily feel comfortable with it and often equated it
with merely giving up control. As one patient stated, I want
to choose which medication I take. In the exam room, the
provider reassured the patient that, she too liked to have
control. Outside the patient's earshot, she reected, rando-
mization is a tough sell.
3.2.2. Facilitating communication during trials enrollment
processes
When patients agreed, in principle, to trials participation,
obtaining formal consent could be laborious and difcult.
Providers tried to navigate through this process by taking
extra time to explain consent forms, by developing a special
relationship with patients considering trials, and by discussing
trials in plain language rather than medical jargon. But breast
clinic often could not provide the necessary infrastructure
the spare time, the continuity of care, and the language trans-
lation services.
At breast clinic, providers had access to appropriate ma-
terials to explain standard treatments to their diverse patient
population. For research, however, the clinic relied on
information and consent forms provided by CTSU. These
forms, typically many pages of dense technical information
and medical jargon, addressed legal liability not patient
education. Most forms only came in English and assumed a
higher literacy level than many patients at SNH had. As the
CRC noted, these forms were of ten more scary than
informative because they explicated the risks of the study
but did not explain that standard treatment often used similar
treatments and thus posed similar risks.
[They] list all the side effects [and] it sounds like you are only
having those risks because you're in a study and it's not
clearthat if you were out of study you [w]ould go on these
drugs as well and you would have the same risks.
SNH did not have resources to develop more appropriate
materials. Thus, providers often struggled to understand and
address patient concerns about enrollment. For example,
when working with non-English speakerseither doing her
own Spanish translation or working with an interpreterthe
CRC rarely had time to translate verbatim the entire consent
form. Typically, she translated some sections in-depth and
summarized other issues.
Providers obtained translation from many sources. SNH
provided professional interpreters, but there was often a long
wait. Breast clinic navigators often translated Spanish ,
Mandarin and Cantonese. Bilingual clinic staff and family
members also regularly served as interpreters although they
had no formal training, nor much knowledge of clinical
r
esearch. When a trials-e ligi ble patient spoke Russian,
Tagalog, or Koreanor when multiple Spanish or Canto-
nese-speaking patients were in clinic at the same time, as was
often the caseproviders often could not even discuss a trial
with a patient.
Trials rec ruitment often demanded highly-skilled inter-
pretation. One provider described the importance of pre cise
wording. If the interpret er used the word experiment
instead of study, she said, forget about it, just stop the
conversationit kills any participation ever. Another pro-
vider described choosing words that could be easily
translated linguistically and culturally when discussing a
trial with a Canton ese-speaking patient. She noted that she
sometimes wanted to give up sooner when of fering a trial
via a translator rather than speaking directly to the patient.
Yet, ma ny providers treated interpretation as an intuitive
process rather than a specic skill, and we observed a range
of interpreterprovider interactions. Some providers spoke
to th e interpreter rather than the patient; others completed
paperwork while the interpreter translated. Navigators
could draw on their clinical knowledge and , oftentimes,
their established relationship with the patient. This famil-
iarity could, h owever, lead to well-intentioned efforts to
engage patient questions directly rather than accurately
translating for the CRC or provider.
4. Discussion
Unlike many studies of trials recruitment and enrollment
in the US, our study focused on institutional structures and
organizational climate in a minority-serving institution,
rather than on patients or provider attitudes toward trials
participation and recruitment. As such, our ndings provide
insight on how structural and institutional conditions shape
the providerpatient communication that is the c entral
practice of trials recruitment. We explored how institutional
factors shaped provider knowledge of trials, how providers
prioritized research versus clinical care, how the clinic
resources affected linguistically and culturally appropriate
communication about trials, and how the trials menu affected
recruitment. In addition, our ndings provide insight into
why providers might resist participation in the recruitment
process, why enrollment is low and what resources might be
needed to facilitate effective recruitment practices. In sum-
mary, our ndings illustrate how the structures of the clinic
and of the healthcare system can impede recruitment.
The US health care system remains racially and ethnically
segregated; some institutions care for many racial and ethnic
minority patients while in other settings, minority patients are
6 G. Joseph, D. Dohan / Contemporary Clinical Trials xxx (2009) xxxxxx
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Please cite this article as: Joseph G, Dohan D, Recruiting minorities where they receive care: Institutional barriers to cancer
clinical trials recruitment in a safety-net hospital, Contemp Clin Trials (2009), doi:10.1016/j.cct.2009.06.009
rare. Bringing trials to the healthcare settings where minority
patients already receive care can be an effective method to
increase minority recruitment and enrollment, as the history
of the NCI Minority-Based Community Clinical Oncology
Program (MBCCOP) attests [6]. The trials program at SNH
breast clinic reected, in part, a desire to increase the number
of minorities on trial at AMC-afliated clinics by making trials
available where a majority of minority patients in the area are
treated. Nevertheless, our research shows that this strategy
which we characterize as bringing trials to the patients”—is
not fail-safe. In contrast to the MBCCOP programs, few
additional resources for research were provided. For example,
AMC did not provide any direct support (e.g., clinical
research coordinators or nurses for the SNH research
prog ram), and the support from CT SU, where SNH acces sed
trials, was limited. SNH, AMC, and trials' s ponsors (including
NIH via CTSU) continued to allocate resources for trials
recruitment based on a generic model of a well-educated,
English speaking, middle class patient. There was little
inves tment in the infrastructuresuc h as time for providers
to learn about and explain protocols, translated forms, and
professional interpretersnecessary to prov ide genuine
access to clinical research to diverse populations. The lack
of investment in the infrastructure to make a successful
research programa failure to invest t hat was quite
apparent to outside observersremained unacknowledged
by most of those working at SNH. Trials recruitment
remained a low priority for SNH nu rses and navigators,
who tended to experience it as a burden imposed by others.
Responsibility for recruiting patients largely fell to physi-
cians and the research coordinato r, but both needed more
support. Physici ans were too busy providing direct patient
care to have time to recrui t, and the coordinator did not have
patients' trust. Nurses, navigators, physicians, and the
coordinator have begun to ackn owledge the institutional
barriers, a nd our results sugge st it may be difcult to
improve recruitment in breast clinic without addressing
these institutional barriers.
Our study of SNH has limitations. As in any qualitative
case study, we have no information on if or how ou r results
and conclusions generalize to other settings. We have
concluded that institutional barriers need to be considered
as much as ot her kinds of barriers (e.g. patient and provider
barriers). However, we cannot determine from our qualita-
tive data which kind of barrierpatient, provider, or
institutionalmight be most salient an d, therefore, which
should be the highest priority as an intervention target. Also,
while we employed multiple investigators, our ability to
assess the reliability of our data and analyses is limited.
However, as stated earlier, SNH may represent a best case
scenario among safety-net hosp itals due to private sector
fun ding for patient navigators, a clinical trials coordinator
and other resources. Clinic leaders have supported the
resumption of research at SNH, and private fundin g has
enabled it at breast clinic. Examining what may reasonably
be seen as a best case situation provides us some leverage
to interpret our results. We conclude that even in this best
case scena rio, substantial institutional challenges remain. It
seems reasonable to hypothesize that safety-net settings
that lack the special resources availa ble at SNH may have an
even more difcult time carrying out clinical research.
Our research highlights the need to address institutional
factors in order to improve the success of minority recruit-
ment. One implication is that these institutional factors should
be considered before undertaking interventions to improve
recruitment. For example, involving patient navigators has
been suggested as a model for recruiting minority patients. At
SNH, such an approach might have reduced the burden on
physicians for recruiting patients in breast clinic and improved
the
recruitment process. As this study shows, however, the
context in which these interventions take place may be
important in the strategy's ultimate success or failure. In the
SNH breast clinic, for example, navigators were overburdened
with patient care and they resisted participating in research
recruitment because they valued their role as facilitators of
treatment and social services, not of research. Involving
navigators in trials recruitment at SNH was not a successful
approach, which explains why the burden to recruit rested
heavily on physicians and nurse practitioners.
Thus, our results can g uide efforts to prepare clinics in
ways that make interventions m ore successful. Factors to be
considered prio r to developing and elding an intervention
inc lude how institut ional context and barriers affect provi-
der preparedness for recruitment, resources to support
providers in the recruitment process, and improvements to
the institutional climate. Future studies could employ
quantitative methods and a larger sample to qua ntify these
factors. For example, in deciding how to allocate resources to
address institutional factors, it woul d be important to know
how o ften institutional factors inhibit recrui tment as
com pared to other factors identied in the literature.
Opening research protocols for accrual at minority-
serving institutions may signal nominal access to trials, but
achieving substantive acces s requires that in ad dition to
opening trials, sufcient and appropriate institutional
resources (e.g. train ing for providers, sufcient translation
and interpreter services, support for an adequate range of
trials) are made available to support the complex process of
trials recruitment and enrollmen t. Our case study, along
with our research in academ ic and private oncology clinics,
suggests that the institutional barriers found in the breast
clinic exist to different degrees in a variety of other
institutions where patients are recruited for participat ion
in clinical research. Thus, researche rs and advocates may
reasonably enquire, once trials have been opened, about the
types and phases of trials available; to which patient s these
trials are made available; and what population-specic
resources have been put in place to support recruitment
and enrollment. Addressing the specics of how the
organizational climate facilitates and/or hinders clinical
trials enrollment and how research specic resources are
allocated will further the goal of increasing access to clinical
research for all cancer patients.
Acknowledgements
We would like to thank the leadership, staff and patients
of the SNH breas t clinic for allowing us to observe their daily
activities and for taking the time to speak with us about their
experiences. This research was supported by the American
Cancer Society through a career development award to
Daniel Dohan (MRSGT-05-194-01-CPHPS; PI D. Dohan).
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    • "The successful completion of a trial is dependent on achieving a significant sample size of patients enrolled into the trial within a limited time period. However, the process of eligibility determination is extremely challenging and timeconsuming , often mandating manual chart review [25,26]. Such reviews can involve repeated readings of the patients' Electronic Health Record (EHR) for multiple trials, across every visit. "
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