Transcript Recruiting Research Subjects in the Inner City

Recruitment of low-income and
minority subjects
for clinical research
George T. O’Connor, MD, MS
Pulmonary Center, BUSM
October 7, 2008
Why focus research on inner-city
communities?
• High-risk, vulnerable population
– Asthma, diabetes, HTN, HIV, etc.
– Violence, smoking, environment, addiction, etc.
– Socioeconomic and racial disparities, environmental
justice
• Pathogenetic clues from racial differences
• Research funding
– Targeted initiatives of NIH and foundations
– Major strength of BUMC. This is who we are!
Case studies at BUMC
• Framingham Omni Cohort (1994-1999)
• Inner-City Asthma Study (1998-99)
• Feasability of Retinoid Therapy for Emphysema
(2001-2002)
• Asthma Genetics Study (2001-2006 )
• Asthma Control Evaluation Study (2004-2006)
• Urban Environment and Childhood Asthma Study
(Jan 2005 )
• Inner-City Asthma Treatment with Anti-IgE
(ICATA) Study (October 2006 )
• Airway Response to Tobacco Smoke (ARTS)
Study (2008 )
Barriers to recruiting and retaining
research participants in
low-income urban communities
• Can’t be bothered (like everyone else!) – no
incentive to participate
• Suspicion of investigators
• Fear of adverse medical and social consequences
of participation
• Education
• Language and culture
• Transportation
• Scheduling (too busy vs. too disorganized)
• Overly broad exclusion criteria
General approach to
recruitment and retention
• Investigate best sources of subjects, and be
willing to revise plans as needed
• Create incentives to participate
• Overcome barriers (really…not sort of)
• Create relationships
– With subjects
– With staff who can offer help with recruitment
FHS Omni Cohort
• Rationale: We needed minority subjects to
qualify for NIH funding!
• Demographics: Framingham, MA had
changed but FHS had not.
• Challenge: Population-based recruitment of
minority population of Framingham.
FHS Omni Cohort
• Strategy:
– Previously recruited 100-member Framingham
Minority Cohort
– English and Spanish in local newspapers
– Church and social groups
– Flyers in public places
– Direct mailing to all 4914 households in two
Framingham Census tracts with large minority
populations
– Word of mouth
• Subject motivation: Health screening
FHS Omni Cohort
Men
Women
Black non-Hispanic
71
113
Hispanic
79
124
62
56
Asian / Pac Island
Native American
2
* White non-Hispanic
3
3
Total
215
298
FHS Omni Cohort
• Follow-up
– 299 of the 500 participated in Sleep Heart
Health Study, along with 699 Offspring
– Omni: 48 dropped out or lost by 9-10 years
• Majority Latino immigrants
– Offspring: 5 dropped out or lost by 9-10 years
• Limitations
– Not as “population-based” as original FHS
cohort
– Recent immigrants not as stable for long-term
follow-up
Inner-City Asthma Study
Seattle/Tacoma
J. Stout
Boston
G. O’Connor
Chicago
R. Evans
Tucson
W. Morgan
Dallas
R. Gruchalla
Bronx
E. Crain
New York
M. Kattan
DCC-Chapel Hill
H. Mitchell
ICAS: Study Design
• Multi-center, randomized, controlled trial of
physician feedback and environmental
remediation in seven inner-city environments
• 2 x 2 design powered for both interventions
• One year of intervention followed by one year
of observation
ICAS: Study Population
• Children aged 5 to 12 with moderate asthma enrolled
from inner-city census tracts (> 20% of families with
income below federal poverty level)
• Severity in last 6 months:
– One overnight hospitalization for asthma
- or – Two unscheduled clinic visits for asthma
• Positive skin test to > 1 indoor allergen
• Sleep at one address > 5 nights per week
ICAS recruitment issues in Boston
• Advantages
– BMC provided lists of patients with ER visits or
hospitalizations for asthma. IRB allowed us to write
parents then call them
• Challenges
– Patients of Co-PI Suzanne Steinbach, MD excluded
(lots of them!)
– Compared to other ICAS cities, Boston has welldeveloped NHC network, free-care system, and asthma
specialists available to inner-city children  not so
many really sick kids
– Boston’s inner city smaller than New York, Chicago,
etc.
ICAS recruitment history in Boston
• Boston always lagged other sites, vying with
Seattle for last
• Direct contact of patients identified from BMC
lists remained most productive source of
participants, but it wasn’t enough.
• We added:
– Census tracts in Lynn, MA, screening at LCHC
– Collaborator at Children’s Hospital to identify children
from that site
– Outreach to staff at HealthNet NHCs
– Ads in neighborhood newspapers
ICAS – Lessons learned
• Follow recruitment weekly  if it’s not working,
change it ASAP
• Remove transport barriers: we paid for round-trip
taxi for GCRC visits
• Financial compensation for participants  a (the?)
major motivating factor! Should reflect fair value
of their time and effort.
–
–
–
–
$50 for coming to GCRC
$10 for home visit
$10 for each two phone call
Intervention groups kept vacuum cleaner, HEPA filter,
etc.
Feasability of Retinoid Therapy for
Emphysema (2001-2002)
• Rat model: all-trans retinoic acid appears to
reverse elastase-induced emphysema
• NHLBI workshop: recommended studies to
examine feasability of human studies
• FORTE Study established after RFP and
competitive application process
• BU, U Pittsburgh, Columbia, UCLA, UCSD
FORTE recruitment
• Goal: 60 subjects with emphysema at each site
– Age > 44; not currently smoking; not currently on
prednisone; etc.
– Diffusing capacity < 80% predicted; etc.
– > 10% of lung with emphysema by quantitative CT
analysis (UCLA CT reading center)
• Recruitment proved difficult at all sites (144/300)
– Bronchoscopy was part of protocol
– Smoking and prednisone were common issues
– Medication exclusions included calcium channel
blockers
FORTE recruitment at BUMC
• The birth of HIPAA: No access to BMC
lists of patients with COPD, emphysema
– Alternative: BMC sends list of own patients
with diagnosis to PCP 
PCP sends to us list of those OK to contact 
We write letter from PI and PCP to patient 
We get PCP to sign letter, then we mail it 
Follow-up phone call to patient.
– IRB approved this, but we never pulled it off
FORTE recruitment at BUMC
• Minority recruitment goals:
– I initially proposed 30% in my application
– I later reduced this to 10% when NHLBI
pressed us for realistic numbers
– We recruited no minorities at BUMC
• WBZ ad  calls
• Boston radio station with African-American
audience  no calls
• My own patients  no interest
• Typical BUMC participants: White, internetconnected patients from Maine to Florida
– Study-wide: 1 minority subject of 144 total
FORTE – Lessons learned
• You may not be able to recruit minority
subjects for a given study in proportion to
the demographics seen at BMC.
• ? African-American patients especially
reluctant to consider experimental
medications and invasive procedures
Asthma Genetics Study
• Initial hypothesis focuses on IL-16 promoter
polymorphism
• 400 asthmatics and 200 non-asthmatic controls
with goal of about 2/3 African-American and
Latino
• Phone screen: Age < 44, smoking < 10 pack-years
• Single visit of about 1 hour: questionnaires,
spirometry, blood draw. $30 compensation.
Asthma Genetics Study
• Identification and recruitment of asthmatics
– Our own patients:
• High yield but numbers limited
• Letter then phone call from research team
– Referral from pulmonary and PCC colleagues
• They have to think of it!.. And they won’t
– Ads: Metro paper works well, although milder
asthma severity and fewer minorities
Asthma Genetics Study
• Identification and recruitment of controls
– Genetic association studies and population
stratification
– Initial plan: friend control of same gender and
similar age and racial-ethnic background
• Most cases not providing friend control
• When they do, racial-ethnic match is very good
– Revised plans:
• Added $10 “finder’s fee” compensation for referral
• Open up to non-referred control volunteers,
collecting detail info on race and ethnicity
• Hang out in Ortho Clinic to recruit health controls:
not efficient
Research recruitment in Boston’s lowincome communities: lessons learned
• Ethnic background and linguistic abilities of
research staff should match target population.
• Plan on recruitment being the most difficult
challenge of the study, and have the staff to devote
the needed time.
• Making a separate trip to BUMC is a big barrier.
• Use multiple recruitment modalities as needed.
• Compensate participants fairly.
• Be ready to revise plans as you go.
• Depending on the study, it might not work!
Hi Tom,
An issue that has bothered me for some time is the following. Our IRB
here at BUMC prohibits us from mentioning in flyers and advertisements
the dollar amount of compensation that participants in clinical research
will receive. I guess the rationale for this policy is that listing $ amounts
will somehow be coercive. This policy seems misguided to me for
several reasons:
1. Most other institutions permit advertising dollar amounts. Any day of
the week you will see ads from the Brigham offering specified dollar
amounts to research volunteers.
2. The IRB will, quite appropriately, not let an investigator pay a coercive
amount. Instead, we offer reasonable compensation for time and effort.
3. If we want the ad or flyer to provide adequate info on which a
prospective volunteer can base a decision whether it is worth his/her
time to call about the study, listing the dollar amount would be
beneficial to the volunteer.
4. It will greatly help us recruit subjects.
Can we change the BUMC policy on this?
Thanks for your consideration of this issue.
George
Two more recent studies of Inner-City
Asthma Consortium…
• Asthma Control Evaluation (ACE) Study
– 320 (52 Boston) asthmatics age 12-20
– RCT of eNO in asthma management
– 9 visits over 1 year; $815 compensation plus
transportation (we arranged and paid for taxis)
• Urban Environment and Childhood Asthma
(URECA) Study
– 500 (125 Boston) newborns with parental history of
asthma or allergy
– Birth-cohort study (recruit pregnant women) of
environmental risk factors for asthma
– 3 years follow-up in initial phase; home and clinic
visits; $495 compensation plus transportation
Two more recent studies of Inner-City
Asthma Consortium…
• Asthma Control Evaluation (ACE) Study
– Sources of subjects: Dr. Steinbach’s practice; some
referrals from NHCs or school nurses; newspaper ads
– Motivating factors: $815; both groups received frequent
specialist asthma care
• Urban Environment and Childhood Asthma
(URECA) Study
– Sources of subjects: Prenatal practice at BMC.
– Key to success: Aviva-Lee Parritz, MD as coinvestigator
– Motivating factors: $495; interest in whether child will
develop asthma and allergy
Airway Response to Tobacco Smoke
(ARTS) Study
• Never, former, current, and passive smokers
• Single visit with nasal and oral mucosa brushing
and blood  mRNA arrays, along with spirometry
and questionnaire.
• $50 compensation for one-hour visit
• BU “Quickie Jobs,” Craigslist, Metro ads  not
many heavy smokers; no passive smokers
• Soliciting smokers in front of Menino Pavilion
and at BUMC bus stops  whoa, baby!!
Community involvement in research
• A “holy grail” that I have yet to really figure out
how to apply.
• Focus of some NIEHS RFAs
• Who exactly is “the community” and how
“involved” should they be in our research?
• Models involving churches, etc.
• Colleagues at JHU in Baltimore: community
advisory board for their research on inner-city
asthma (Swartz LJ et al., Methods and issues in
conducting a community-based environmental
randomized trial. Environ Res. 2004; 95:156-65.)
• Project ACCESS in Boston – in progress
Acknowledgments
• The incredibly talented and hard-working
study coordinators and research assistants
who make it all possible
• Carolina Jordan, MPH; Lisa Gagalis, RN;
Martine Dumas, MPH
• IRB staff
…our study participants