Research Subject Enroller Program, Cobaugh et al.

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Research Subject Enroller Program: A Key to Successful
23 1

Emergency Medicine Research

Daniel J. Cobaugh, PharmD, Linda L. Spillane, MD. Sandra M . Schneider; M D

I ABSTRACT
................................................................................................................................

Objective: To describe the successful use and impact of individuals paid to enroll clinical research subjects
in support of emergency medicine (EM) research.
Program Description: Paramedics and college students were hired to identifylenroll subjects in EM research
studies 14 hourslday, 7 days/week. Potential subjects were identified by monitoring emergency medical ser-
vices radios, routine rounding in the ED, and communication with the ED attending and charge nurse. Enrollers
were trained in phlebotomy, obtaining ECGs, obtaining consent in appropriate studies, and post-ED follow-
up. They supported ED prospective studies and multicenter clinical trials, as well as departmental surveys
and retrospective studies. Survey support included mailing list development, mailing completion, survey da-
tabase design, and data entry.
Program Outcomes: Over 18 months, 17 prospective studies and 8 surveys/retrospective studies were com-
pleted. 2,175 subjects were enrolled in prospective studies and 6,500 surveydretrospective reviews were
completed. In the year prior to enroller program initiation, el00 subjects were enrolled in 3 departmental

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studies.
Conclusion: Use of paid, clinical research subject enrollers supports successful recruitment of study subjects
and the completion of EM research studies.
Key words: emergency medicine; research; research subject; clinical trial; enrollment.
Acad. Emerg. Med. 1997; 4:231-233.

I Many barriers to successful com-
pletion of emergency medicine (EM)
research have been identified.’-3 One
such barrier is the recruitment of sub-
jects in the often chaotic environment
of the ED. Although the ED is often
identified as a laboratory for EM re-
search and collaborative research
with other specialties, logistically it is
often difficult to identify and enroll
subjects for research studies using
clinical personnel working in the ED
envir~nment.~.’ This paper describes
the use of a dedicated research sub-
......................................................
ject enroller program to increase the
identification and enrollment of sub-
jects for EM research studies in the
ED of an academic medical center.
PROGRAM DESCRIPTION
The ED where this program was in-
troduced is a Level-1 trauma center at
a university hospital and provides
care to >58,000 adults and children
annually. The Department of Emer-
gency Medicine is a full academic de-
partment and has 24 full-time faculty.
...
The department has a 3-year EM res-
idency that trains 8 residents per year.
Paid paramedics and college stu-
dents were hired and trained to iden-
tify and enroll subjects in ED-based
studies. These include studies by the
EM faculty as well as collaborative
studies with other specialties. Cover-
age is provided for 14 hourslday from
9 AM until 11 PM, Sunday through
Thursday, and until 3 AM on Friday
and Saturday mornings. A full-time
enroller works from 9 AM until 5 PM,
Monday through Friday. All other
coverage is provided by 5 part-time

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From the University of Rochester Medical Center, Rochester; NX Depamnent of Emergency

enrollers. Vacations, holidays, and ab-
sences are covered by this part-time
staff. The mean enroller salary is

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$8.23 per hour. Oversight of the en-
Medicine (DJC, LLS, SMS) and Finger Lakes Regional Poison Center (DJC).
roller program is provided by a full-
Received: September 26, 1996; revision received: November 7. 1996: accepted: November 9. time faculty member and requires 5

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1996. hourslweek.
Prior presentation: 6th International Conference on Emergency Medicine, Sydnqy, Australia, The enrollers provide direct re-
November 1996. search support through: 1) identifica-
Address for correspondence and reprints: Daniel J. Cobaugh, PharmD, University of Rochester tion of potential study subjects; 2) no-
Medical Center, Department of Emergency Medicine, Box 321, 601 Elmwood Avenue, Rochester, tification of the attending physician
NY 14642. Fax: 716-244-1677; e-mail: dcobaugh@ed.urmc.rochester.edu that a patient may be a potential study
232 zyxwvutsrqpo
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subject; 3) notification, in concert
with the attending physician, of other
services and investigational teams
that a potential research subject has
presented to the ED; 4) completion of
surveys: 5) obtaining laboratory spec-
imens; and 6) completing post-ED
follow-up when required by a re-
search protocol. Patients who may be
potential subjects are identified by the
enrollers through monitoring of emer-
gency medical services radios, round-
ing in the ED, and communication
with the ED attending, charge nurse,
and triage nurse. Retrospective study
support, including medical record re-
view and data entry, is also provided.
The enrollers have no other duties in
the ED while they are performing en-
roller functions.
Initial training includes familiari-
zation with the ED and the clinical
information system, thorough review
of all current protocols, observation/
shadowing experiences, completion
of mock enrollment scenarios, phle-
botomy training, and ECG training.
The initial training, which is provided
by the full-time enroller, is 60 hours
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in length.
Several sources of financial sup-
port for the enroller program have
been available. These include: 1) ex-
tramural awards and grants; 2) mul-
ticenter clinical trials; 3 ) intramural
funding: and 4) departmental research
funds.
PROGRAM OUTCOMES
Over 18 months, 25 EM studies were
supported by enrollers: 2,175 subjects
were enrolled in prospective studies
and 6,500 surveyshetrospective re-
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views were completed. This included
a National Highway Traffic Safety
Administration (NHTSA)-sponsored
collaborative study with the Depart-
ments of Preventive Medicine and
Orthopedics.
In the year prior to enroller pro-
gram initiation, el00 subjects were
enrolled in studies in the ED. In 1 an-
algesic study, no subject was enrolled
in the 12 months prior to initiation of
ACADEMIC EMERGENCY MEDICINE MAR 1997 VOL 4/NO 3
the enroller program. The use of en- present to the ED 24 hours/day, 365
rollers in this study resulted in re- dayslyear, the use of the research sub-
cruitment of 115 subjects in 6 ject enroller makes it possible to suc-
months. In a survey of patients with cessfully conduct studies even when
chest pain in which the data sheet was a lead investigator is not present in
to be completed during the patient’s the ED. The use of the enroller pro-
stay in the ED, only 25 surveys were gram during the highest volume
completed over 4 months prior to the times, along with increased ED staff
enroller program. Upon institution of participation when the enrollers are
the enroller program, 400 patients not present, makes it possible to iden-
were surveyed in 6 months. During tify consecutive subjects for enroll-
the first year of the program, 3 papers ment rather than relying on conven-
that required enroller support were ience samples. During downtime, the
presented at national meetings. Dur- enrollers can also provide survey and
ing the program’s second year, the database support.
number of enroller-supported papers Bradley and colleagues have dem-
that were presented at national meet- onstrated that college students can be
ings increased to 10. Manuscripts for successfully used as research associ-
all of these presentations are currently ates in the ED.6 In their experience,
in progress. 41 undergraduate students completed
Since the inception of the pro- a mean of 10.3 ED shifts with a du-
gram, 1 full-time enroller and 10 col- ration of 4 hourskhift. During 1 se-
lege students have been employed. mester, 2 clinical studies were com-
The part-time enrollers work an av- pleted and these research associates
erage of 11.2 hours per week. Five of were involved in the conduct of 3
the undergraduates have terminated other studies. A difference between
employment upon graduation. Mean the program of Bradley et al. and our
length of employment has been 12.7 program is the number of individuals
months (range 5-24 months). involved. By using only 5 enrollers,
The total annual cost of the pro- we anticipate having greater consis-
gram has been $52,833. Extramural tency in performance of the functions
funding provides 55% of the support of the position. Also, since our en-
for the program, and 24% is provided rollers are paid, it is expected that
through intramural funding. Depart- coverage will occur during the iden-
mental funds were used for the re- tified hours. If an enroller is absent
maining 21%. Extramural funds were from work, the shift is still covered
received through an NIH-sponsored using a backup employee. In the pro-
project, 3 foundation awards, and 4 gram of Bradley et al., the students
pharmaceutical company-sponsored completed a mean of 10.3 out of 13
clinical trials. possible shifts. It is unclear whether
the additional shifts were otherwise
DISCUSSION covered. Further, the variable pres-
ence of the research associates within
The EM research process is hampered the ED may not be as functional as a
by the difficulties associated with regular employee (i.e., research sub-
identifying and enrolling subjects in ject enroller).
clinical studies in the setting of mul-
tiple patient care responsibilities and LIMITATIONS AND FUTURE
associated high clinical priorities. QUESTIONS
Several factors, including patient vol-
ume, time of daylweek, staff aware- Since the enrollers are present for
ness, staff interest, and complexity of only 14 hourdday, enrollment of
the enrollment process, may have a subjects into ED-based studies may
negative impact on ED research. continue to represent a convenience
Given that potential research subjects sampling. Since it is probably not
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Research Subject Enroller Program, Cobaugh er al.

financially feasible to have the en- creased emphasis on academic devel- REFERENCES
233

rollers present in the ED at all times,
efforts must be made to enhance iden-
tification and enrollment during the
uncovered hours. This may be more
achievable since patient volume typ-
ically decreases during the uncovered
times. The increased awareness of re-
search by our departmental staff, be-
cause of the enrollers, may encourage
after-hour clinical research subject
opment. The research subject enroller
program was part of the departmental
academic development plan. Even
though these factors may have influ-
enced departmental research activi-
ties, the increased subject enrollment
observed after initiation of the en-
roller program has been dramatic.
1. Meislin HW, Spaite DW, Valenzuela TD.
Meeting the goals of academia: characteristics
of emergency medicine faculty academic work
styles. Ann Emerg Med. 1992; 21:298-302.
2. Sanders AB, Fulginiti JV, Witzke DB. et al.
Characteristics influencing career decisions of
academic and nonacademic emergency physi-
cians. Ann Emerg Med. 1994; 23:81-7.
3. Chemow SM, Enierman CL, Langdorf M,
et al. Academic emergency medicine: a na-
tional profile with and without emergency

enrollment.
The increase in our departmental
research activities may have been in-
fluenced by several other factors. The
academic department was established
in September 1992, with the chair
on-site in July 1993. This led to an
increase in full-time faculty, recruit-
ment of a research director (Septem-
ber 1993), development of an EM
residency (July 1994), and an in-
CONCLUSION
The initiation of a research subject
enroller program has resulted in an
increase in the number of study sub-
jects enrolled in the ED. These en-
rollers also have contributed signifi-
cantly to the completion of retro-
spective studies and surveys. Anec-
dotally, the use of EM enrollers has
contributed to increased research pro-
ductivity within the department.
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medicine residency programs. Ann Emerg
Med. 1992; 21:947-951.
4. Gold I, Podolsky S, Baraff LJ. A review of
research methodology in an emergency medi-
cine journal. Ann Emerg Med. 1983; 12:769-
73.
5. Rusnak RA, Hamilton GC, Allison EJ. Au-
tonomous departments of emergency medicine
in contemporary academic medical centers.
Ann Emerg Med. 1991; 20:680-7.
6. Bradley K, Osborn HH, Tang M. College
research associates: a program to increase
emergency medicine clinical research produc-
tivity. Ann Emerg Med. 1996; 28:328-33.

Clinical Pearls (continued from page 224) reported as a result of rectal and GU trauma following

Diagnosis:

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Fournier’s gangrene.

Discussion: Fournier’s gangrene (FG) is an uncommon,

rapidly progressive infection of the genital, perineal, and
perianal regions. It is Characterized by a synergistic nec-
rotizing fasciitis leading to thrombosis of small subcuta-
neous vessels and development of gangrene.’ Jean Alfred
Fournier, a French venereologist, described this syndrome
instrumentation and surgical procedure^.^ Superficial soft-
tissue injuries of the perineum account for the remainder
of the causes. In women, FG may occur from septic abor-
tions and vulvar and Bartholin’s gland abscesses. The dis-
ease also has been documented following procedures such
as hysterectomy, pudendal nerve block, and episiotomy.’
Causes in children include trauma, insect bites, circum-
cision, burns, perirectal diseases, and systemic infection.’
Most patients who develop FG have underlying co-
morbid disease, particularly diabetes mellitus. Other con-

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in 1883 as gangrene of the penis and scrotum in young
healthy males that progresses rapidly and without appar-
ent cause. Today, the disease is not limited either to young
individuals or to males, and the cause of the infection can
usually be identified.’ Although the incidence of this dis-
ease is unknown, -500 cases of FG.have been described
in the l i t e r a t ~ r e . ”Females
~ are less commonly affected
than males. Stephens et al. report that 14% of their cases
occurred in fern ale^.^ Children are even less commonly
affected, with only 56 pediatric cases reported in the lit-
erature. FG can occur from the neonatal period to adoles-
cence, with 66% of the cases in children 5 3 months old.’.’
The ultimate source of the invasive infection often can
be localized to the colorectal or genitourinary (GU) tracts
(Table 1). Common initiating causes include perianal, per-
irectal, and ischiorectal abscesses; fissures; urethral stric-
tures with urine extravasation; lower GU tract anomalies;
and chronic urinary tract infections.’ FG also has been
tributing factors include alcoholism, advanced age, malig-
nancy, corticosteroid therapy, and malnutrition.’.’
Interestingly, there have been only 4 reported cases of FG
in association with HIV infection and AIDS. The first case
was described in 1991 by Murphy et al. and occurred in
an HIV-positive male who injected IV drugs into his fem-
oral veins.6 Two of the other cases resulted postopera-
tively, the last in a patient receiving chemotherapy for
Kaposi’s HIV infection appeared to be the
major risk factor in each case.
Clinical Presentation: Most patients seek medical atten-
tion an average of 5 days after the onset of symptoms?
Patients usually complain of perineal pain and swelling.
Early in the disease, the pain may be out of proportion to
the physical findings. The skin overlying the infection
may range from normal to gangrenous and underrepre-
sents the severity of the underlying disease. A feculent