Summer 2010 Newsletter

FAST-MAG Times
Volume 7, Issue 2
Summer 2010
“But we had the perfect patient!”
FAST-MAG Clinical
Coordinating Center Staff
I
Jeffrey Saver, MD
Principal Investigator
Sidney Starkman, MD
Co–Principal Investigator
Latisha Ali, MD
Investigator
David Liebeskind, MD
Investigator
Lucas Restrepo, MD
Investigator
Nerses Sanossian, MD
Investigator
Fiona Chatfield, RN
Chief Nurse Coordinator
Sharon Craig, RN, BSN
Study Monitor
T. Keta Hodgson, RN
Gillian Devereux, RN
Annel Hernandez, RA
Editorial Staff
Inside this issue:
“But we had the perfect
patient!”
1
Fire Department Profiles
Santa Monica FD
2
Monrovia FD
Meet Your FAST-MAG Nurse
Coordinator: Barbara Tone
Paramedic Hall of Fame
2
3-6
Modified Los Angeles PreHospital Stroke Screen
7
1,000th Patient Enrolled
8
On-Scene to Door Time
Research 101:
Elements of Clinical Research
The enrolling MD must determine if the
n the FAST-MAG clinical trial, the
patient fully meets study inclusion and
enrolling MDs and paramedics work
exclusion criteria. Are there factors that
together as a team to ensure that all
might confuse our understanding of the
patients who are eligible for the study are
effect of magnesium on functional outcome?
enrolled. Paramedic screening for potential
Do they have a condition that would make it
FAST-MAG study subjects is the first step
unsafe to participate in the study? Paramedics
in the enrollment process. Sometimes an
already determine several key criteria, such
mLAPSS-positive patient who meets field
as patient age and blood pressure; they only
inclusion criteria cannot be enrolled in the
call the enrollment line for patients who pass
study.
the initial screen. However, there are
There are several reasons that a patient
additional factors involving medical
who initially seems to be an excellent study
judgments that only the enrolling MD
candidate may end up not enrolled in FASTcan make. Researchers must comply with
MAG. This is because study doctors have
federal guidelines regarding the informed
duties that they cannot delegate to others.
consent process and eligibility assessment.
First, they must determine if the patient
In the FAST-MAG clinical trial, the
can give informed consent. Does the
enrolling MDs are the individuals who
patient understand what is being said;
have the final responsibility for making
is the response appropriate? This can be a
these determinations.
challenge if the person’s ability to speak has
Data is collected on paramedic screened
been affected by the stroke. The enrolling
cases that will help researchers understand
MD must establish whether the problem is
the general application of the study results.
with slurred speech (dysarthria) or if there is
Thus even non-enrolled patients contribute
a problem with understanding language
to study results.
(aphasia). The stroke experts who enroll
Speaking of non-enrollments, Dr. Jeffrey
patients in FAST-MAG are qualified by
Saver, FASTtheir training and
MAG principal
experience to make
1,000th patient
investigator, says:
this judgment.
enrolled in
“We wish that every
By the rules
call to the enrollment
governing research,
FAST-MAG
line would result in
if patients are
an enrollment. We
competent
See photo page 8
try to put every
(understand what is
patient who meets
going on), they
trial criteria in the study. We are very aware
MUST provide consent for themselves. If
of the extra steps paramedics go through
a competent patient does not speak English
before they call the enrollment line and we
or Spanish, a family member cannot give
share their disappointment whenever a call
consent and the paramedic cannot
results in a non-enrollment.”
“translate.” If the enrolling MD is unable to
The enrolling MDs are extremely
communicate with the patient on the phone
grateful to their partners in the field
and they are competent, they cannot be
for identifying potential study patients.
enrolled in the study. Patients who are not
Remember: no matter the outcome of the
competent MUST have someone to provide
call, EVERY CALL COUNTS!
consent for them. It is the enrolling MD’s
responsibility to determine competence.
PAGE 2
F A ST - MAG T I MES
Fire Department Profiles
Santa Monica Fire Department
T
he City of Santa Monica has a
colorful history that ranges from
its naming by Spanish Conquistadors to
it being part of the Mexican Republic
to its starring role in numerous films
and novels. Almost 90,000 people
reside in the city, which covers 16
square miles (only half of which is
land).
The modern fire department began
life as the Santa Monica Hose, Hook
& Ladder Company #1 in 1889.
Santa Monica Fire Department
(SMFD) now has four stations with
six paramedic engines. All but one
of the engines has a crew of four.
There are 50 licensed paramedics
and 48 EMTs. Over half of the Santa
Monica fire fighters are also paramedics.
EMS requests account for 78% of
the calls received by their dispatch
department.
From the outset, SMFD has
provided trend-setting emergency
medical services. Their paramedic
program began scant months after
passage of the Emergency Medical
Services System Act of 1973. They
were the first in the nation to deliver
paramedic services via fire engines.
SMFD was among the first to add
cardiac pacing and CPAP to their
standard protocols.
Participating in the FAST-MAG
trial “fits with our organization; it’s
right in-line with our history,” says
FF/PM John Macinni. He continues,
“We are happy to be a part of advancing
medical therapies.”
Monrovia Fire Department
M
onrovia Fire Department has
something momentous to
celebrate. On January 24th this year it
turned 100 years old!
The city that Monrovia FD serves
is nestled in the foothills of the San
Gabriel Mountains. Monrovia is the
fourth oldest city in LA County,
incorporated in 1887. It is named
after William Monroe, whose ranch
formed a substantial section of modernday Monrovia. However, the formerly
abundant orange groves have now
made way for an established residential
area with a population of almost 40,000
within 13.8 square miles.
Monrovia FD has two fire stations:
one station has an engine, a squad and a
truck, and the other has a paramedic
engine. They respond to around 3,500
emergency calls annually. Paramedic
services started Thanksgiving Day
1972, making it one of the earliest
single city departments to adopt the
program. Currently there are 25 paramedics
and 14 EMTs. The recent centenary
activities reflect Monrovia FD’s solid
integration with the family-oriented,
community-spirited population it
serves. Speaking for the department,
Engineer Jeremy Sanchez thinks it is
great that the EMS in LA County is
“involved in something important like
the FAST-MAG research.” They hope
for a positive outcome from the study
so that they can help stroke patients in
the field. The FAST-MAG liaison for
Monrovia FD is Miranda Gordon, RN.
V OLUME 7 , I SSUE 2
Meet Your
FAST-MAG
Nurse Coordinator
B
arbara Tone, RN, has been with
FAST-MAG from the outset. She
came to the study with a background in
emergency nursing and a long history of
working with paramedics. Though she
may not give her age, she will tell you
that she was an emergency nurse in Los
Angeles County before there were
paramedics. “Not long before,” Barbara
says, “but definitely before.”
Having had a front seat to the development
of pre-hospital care in LA County,
Barbara says she continues to be
impressed by the contribution paramedics
have made to patient outcomes: “It’s a far
cry from the days of scoop-and-run. I’m
constantly amazed by the responsibilities
taken on by paramedics and the incredible
job they do. The height of pre-hospital
care used to be c-collars and backboards!”
After some years in consulting, medical
practice management, and freelance writing,
Barbara is happy to be back working with
paramedics in the pre-hospital arena of
FAST-MAG. “The medics have really
stepped up for this study and once again
have amazed me,” she says.
Barbara is site coordinator for Glendale
Adventist Medical Center, Henry Mayo
Newhall Memorial Hospital, Mission
Community Hospital, Providence Holy
Cross Medical Center, and White Memorial
Medical Center. She is liaison to LAFD
Battalions 7 and 12, and LA County Fire
Department Battalions 4 and 6.
PARAMEDIC HALL OF FAME November 28, 2009 - July 21, 2010
11/28/09
11/30/09
11/30/09
12/01/09
12/02/09
12/03/09
12/03/09
12/03/09
12/04/09
12/04/09
12/04/09
12/05/09
12/05/09
12/06/09
12/08/09
12/11/09
12/13/09
12/16/09
12/16/09
12/16/09
12/17/09
12/24/09
12/25/09
12/25/09
12/25/09
Jason Foster
David Fernandez
David Ellis
Brian Meyer
Tony Wren
Arturo Tarango
Stephen Ziemer
Bryce Lahiff
Tony Wu
Mike Cotter
Ryan Hickman
Paul Sawai
Danny Lopez
Tyler Ence
John Knox
Sean Anderson
Jack Moore
Mattias Wikstrom
Eric Nelson
Daniel Oropeza
Mark Moyer
Ruben Ruvalcaba
Brian Keeney
Kevin Ruger
Jeff Robson
Mike Cash
Chris Sebourn
Steve Kehoe
Scott Crosby
Albert Periquet
Matt Nichols
Scott Arnold
Daniel Stark
Anthony Trejo
Man Sivaborvorn
Brian Santagata
Mark Lees
Tom Hardy
Ron Hughes
Christian Fernandez
Nicholas Morantz
Jerome Woodcock
Tom Wells
Richard Ramirez
Andre Zimbeck
John Roe
Chris Justus
Brian Dudley
Dreon Brown
Alexis Echeverria
Jeff Williams
Greg Kindred
Gavin Kaufman
Joe Gandera
Kyle Anderson
LAFD RA 13
12/26/09
LA CO FD RS 106
12/31/09
01/02/10
LAFD RA 29
01/04/10
LA CO FD RS 36
Torrance FD 95
01/04/10
01/05/10
LAFD RA 33
LAFD RA 17
01/06/10
LAFD RA 66
01/07/10
LAFD RA 47
01/07/10
LA CO FD RS 28
01/09/10
LA CO FD RS 84
01/09/10
01/10/10
LAFD RA 21
01/11/10
LA CO FD RS 31
01/11/10
Torrance FD R 91
LAFD RA 91
01/12/10
01/13/10
El Segundo FD RS 32
LA CO FD RS 68
01/19/10
Long Beach FD RS 1
01/19/10
LAFD RA 38
01/19/10
LAFD RA 41
01/20/10
LAFD RA 56
01/21/10
LAFD RA 56
01/21/10
Torrance FD RA 93
01/24/10
LAFD RA 93
01/28/10
LA CO FD RS 3
02/01/10
Ted Saraf
Ruben Ruvalcaba
Kevin Poole
Adrian Reyes
James Guess
Sean Kinsner
Oscar Sepulveda
Mario Gomez
Danny Nausha
Matthew Lawrence
Siddharth Ramani
Keith Carlson
Steve Bernau
Mike Amador
Steve Ford
Matt Strittmatter
Randy Wright
Chris Schenk
Humberto Agurcia
Tom Stanfill
Eric Himler
Jack Francis
Mark Horan
Armando Ramirez
Wayen Habell
Robert Reyes
Dana Crutchfield
Arthur Rodriguez
Greg Davis
Roger Peterson
Octavio Corona
Clarissa Leos
Clark Wilmoth
Jason Murphy
Kent Hess
Frank Vogel
Kevin Ruger
Randall Wright
Joe Carvahlo
Jason Sutliff
Russell Wilcox
Nicholas Marantz
Christian Fernandez
Pedro Medina
William Sierra
Mattias Wikstrom
Andrew Schmaud
Eric Gardner
Nate Wilmarth
PI Norton
Ty D'Amico
Lisa Tathum
Kyle Anderson
Mike Dmytrowicz
Brian Barton
Bill Rankin
Mark Ashely
LA CO FD RS 45
LA CO FD RS 134
LA CO FD RS 68
Pasadena FD RS 34
Long Beach FD RS 9
LA CO FD RS 89
LA CO FD RS 84
LA CO FD RS 54
Santa Monica FD RS 5
Santa Fe Springs FD RS
84
LA CO FD RS 107
LAFD RA 61
LAFD RA 68
LA CO FD RS 19
Burbank FD RS 15
LA CO FD RS 84
LA CO FD RS 134
San Marino FD RS 91
Long Beach FD RS 10
Compton FD RS 441
LAFD RA 66
LAFD RA 73
Long Beach FD RS 17
LA CO FD RS 158
LA CO FD RS 135
PARAMEDIC HALL OF FAME November 28, 2009 - July 21, 2010
02/01/10
02/05/10
02/07/10
02/07/10
02/09/10
02/09/10
02/10/10
02/11/10
02/12/10
02/13/10
02/14/10
02/16/10
02/17/10
02/18/10
02/18/10
02/20/10
02/22/10
02/24/10
03/07/10
03/08/10
03/10/10
03/11/10
03/11/10
03/13/10
Ralph Pfeiffer
Rick Pfeiffer
Arturo Dominguez
Oscar Sepulveda
Dave Morales
Ray Schiller
Ted Saraf
Chris Barth
Joe Aki
Kevin Carey
Angel Meza
Sean Hossainzedah
Mike Leon
Daniel Sandoval
Ruben Rodriguez
Kyle Boyd
Nick Mandell
George Morgan
Greg Whitmore
James Woods
David Chavers
Bennett Rogers
Fernando Vasquez
Russell Wilcox
Bob O'Neill
Mark Dondanville
James Guess
Kevin Harmon
Mario Rodriguez
Dave Hernandez
James Oh
Daniel Kaminsky
Todd Tucker
Wayne Runcie
Joon Hang
Art Yepez
John Roberts
Antonio Soto
Rochard Canales
Jason Cervantes
Nicole Olsen
Dave Francis
Cameron Bothwell
Nate Deluca
Danny Nausha
Todd Witt
Brent Nunez
Rick Ortega
Alex Echeverria
Bradley Yocum
Wayne Habell
David Michael
Pat Morse
Louie Contreras
John Boyd
David Lake
Kenneth Coneval
Thomas Raymond
LA CO FD RS 16
03/15/10
Pasadena FD RS 34
03/16/10
LAFD RA 105
LA CO FD RS 45
03/17/10
Torrance FD R 96
03/19/10
LAFD RA 257
03/20/10
03/27/10
LA CO FD RS 135
03/27/10
LAFD RA 63
03/28/10
LA CO FD RS 191
LAFD RA 5
03/30/10
San Marino FD RS 91
04/04/10
04/05/10
LA CO FD RS 68
LAFD RA 13
04/06/10
LAFD RA 6
04/07/10
Glendale FD RS 25
LAFD RA 7
04/08/10
04/10/10
LA CO FD RS 28
04/11/10
Pasadena FD RS 31
04/12/10
LA CO FD RS 161
Pasadena FD RS 34
04/13/10
Torrance FD R 93
04/15/10
LA CO FD RS 107
04/15/10
LAFD RA 101
04/18/10
LAFD RA 87
04/20/10
Chad Richardson
Dan Kaminsky
Jason Hansen
Victor Lazaryan
Steve Hall
Paul Hampton
David Lee
Ryan Watson
Tony Rogers
Paul Porraz
Josh Massie
Rick Ornelas
Landon Rupright
Tyler Ence
Jose Perez
Jefferson Pytell
Mark Miller
Ryan Waddell
Emmanuel Lessis
Mike Fera
Chad Cornelius
Omid Kianersi
Erick Johnson
Brian Stevens
Jason Linder
Cory Barnett
Seybert
Morantz
Derek Ward
Chris Schenk
George Gillen
Christian Gassler
Nick Gonzalez
Ben Rossel
Octavio Corona
Simon Jaime
Ricardo Ruelas
Brian Keeney
Jose Tovar
Greg Davis
Adam Brown
Steven Keys
Ryan Lopez
Brian Murphy
Brian Knutson
Scott Miller
Rich Sutherlin
Jose Tovar
Rich Ruelas
Patrick Hanrahan
John Cantanero
Kevin O''Hara
Dave Saltmarsh
Sean Kinsner
Scott Larue
Ashley Haas
Alex Pacheco
LAFD RA 6
Pasadena FD RS 33
LA CO FD RS 147
Pasadena FD RS 32
LAFD RA 33
LAFD RA 33
Long Beach FD RS 11
Pasadena FD RS 36
Burbank FD RS 11
LA CO FD RS 29
Long Beach FD RS 2
LA CO FD RS 54
LAFD RA 7
LA CO FD RS 19
LA CO FD RS 28
LAFD RA 68
Glendale FD RS 25
LA CO FD RS 173
LA CO FD RS 28
LA CO FD RS 41
LA CO FD RS 71
LA CO FD RS 36
PARAMEDIC HALL OF FAME November 28, 2009 - July 21, 2010
04/23/10
04/23/10
04/26/10
04/26/10
04/28/10
04/28/10
05/01/10
05/06/10
05/07/10
05/09/10
05/09/10
05/10/10
05/10/10
05/10/10
05/12/10
05/12/10
05/13/10
05/14/10
05/16/10
05/17/10
05/18/10
05/21/10
05/21/10
05/21/10
05/21/10
05/22/10
Robert Miller
Mike Ross
Shawn O'Hara
Roland Meza
Jorge Guidos
Matt Heard
Rob Ortiz
Mark Sullivan
Ruben Torres
Jay Walker
Mark Hein
Brad McHenry
Dave Perusse
Alexander Reyes
Edbert Pasimojo
Ted Ecklund
Brian Rankin
Leon Dunn
Art Garcia
Rick Canales
Steven Pennington
Chris Stellern
Russell Arentzoff
Grover Lumas
Mike Harrison
Danny Sanchez
Brian Stevens
Jason Linder
Julian Singelakis
Matt Peterson
Michael Seers
Steven Smith
Jason Keener
Robert Fogelman
Ken McCoy
Ryan Hasert
Bruce Alpern
Armando Ramirez
W. Elliott
David Ellis
Rick Parker
Michael Brown
Al Maldonado
Ricky Herrera
Sonny Farrell
Jeff Castillejo
Danny Garcia
Patrick Hanrahan
Chris Hassler
Charlie Magdaleno
Nick Dabuet
Kevin Laidlaw
Todd Caldwell
Daniel Apodaca
Dustin Carson
Mark Wheeler
Joel Entreken
LAFD RS 99
05/23/10
LA CO FD RS 20
05/29/10
LA CO FD RS 32
05/30/10
LA CO FD RS 58
06/01/10
Bev Hills FD RS 2
06/01/10
Pasadena FD RS 31
06/02/10
LAFD RA 65
06/03/10
LA CO FD RS 40
06/04/10
LAFD RA 47
06/04/10
LAFD RA 19
06/05/10
Long Beach FD RS 9
06/05/10
LA CO FD RS 29
06/06/10
LA FD RA 74
LAFD RA 81
06/08/10
LAFD RA 70
06/11/10
LA CO FD RS 98
06/13/10
LA CO FD RS 111
LA CO FD RS 106
06/14/10
Alhambra FD RS 71
LAFD RA 36
06/15/10
LA CO FD RS 54
06/16/10
LA CO FD RS 41
06/17/10
06/18/10
LAFD RA 69
06/18/10
LA CO FD RS 50
06/19/10
LAFD RA 20
06/20/10
LA CO FD RS 20
06/20/10
Jeff Williams
Paul Vuoso
Corey Rodriguez
Jan Erik Swartz
J. Goldstein
B. Lanning
O. Kianersi
J. Williams
Leigh-Anne Orr
Brenda Akins
Steve Lund
Anthony Hildebrand
Joe Boehm
Eric Instad
Ashlin Wilbun
Ian Cooper
Bennett Rogers
Fernando Vasquez
Victor Duran
Samuel Hernandez
Steve Ziemer
Kyle Quiuntana
Mario Quintana
Robert Reinhold
Mike Reyes
John Rivas
Nick Board
Peter Mills
Jim Callison
Terry Black
Chris Stellen
Stephen Dennison
Steve Pennaleen
Scott Anderson
Robert Ponce
Otto Monzon
Adam Malouf
Andrew Respicio
Paul Hampton
Jason Hansen
Steve Hall
William Basulto
Brian Hammond
Robert Aceves
Steven Marczinko
Jason Jamal
Mike McElvaney
Gary Marshall
David Rindels
Paul Voorhees
Tim Corliss
Fred Gonzalez
Jose Perez
Matthew Carter
Roger Sackaroff
Keith Johnson
Mike Gonzales
Scott Wilcox
Torrance FD R 93
LAFD RA 72
Burbank RA 15
LA CO FD RS 171
Downey FD RS 642
LAFD RA 57
LAFD RA 5
LA CO FD RS 29
LAFD RA 11
LA CO FD RS 90
Monrovia FD RS 101
LAFD RA 100
LAFD RA 47
LAFD RA 104
Monterey Park RS 61
Pasadena FD RS 33
LAFD RA 46
LAFD RA 265
Santa Monica FD Eng 4
Culver City FD RS 3
LA CO FD RS 71
LAFD RA 33
LAFD RA 78
Downey FD RS 641
PARAMEDIC HALL OF FAME November 28, 2009 - July 21, 2010
06/22/10
06/22/10
06/22/10
06/25/10
06/26/10
06/27/10
06/27/10
06/28/10
07/04/10
07/06/10
07/06/10
07/06/10
07/07/10
07/08/10
07/09/10
Matthew Carter
Jesus Orozco
Paul Sawai
Paul Vuoso
Rico Mendez
Tim Behen
Michael Drury
Jason Koghin
James Drury
Shawn O'Hara
Roland Meza
Steve Phillips
Guadalupe Flores
Christian Brown
Kenneth Cordaro
Randy Plue
Peter Garcia
Paul Finger
Josh Pickard
Mike Hetrick
Rick Canales
P.T. Erin Regan
Ray Schiller
Mike Woll
P.T. Matthew Schafer
Michael Dula
Jorge Miranda
P.T/ Casey Gomez
Milo Garcia
Sara Stradtner
Sam Dominick, Jr.
Dave Bonanno
Steve Paige
Robert Russell
Chad Sourbeer
Moses Vargas
Chong Kim
Joe Jackson
LAFD RA 33
07/10/10
Torrance FD R 93
07/10/10
07/11/10
LA CO FD RS 158
07/11/10
LA CO FD RS 20
LAFD RA 19
07/12/10
LAFD RA 14
07/14/10
LAFD RA 96
07/14/10
LAFD RA 89
07/17/10
LA CO FD RS 28
LAFD RA 105
07/18/10
07/19/10
LAFD RA 77
07/20/10
Santa Monica FD RS 3
07/20/10
La Verned FD RS 61
07/20/10
07/21/10
LA CO FD RS 88
Long Beach FD RS 9
07/21/10
Mario Gonzalez
Jeff Bader
Corey Bower
Al Carter
Fred Barbosa
Norman Queen
Chad Boozer
Lenko Spaleta
Adam Belardi
David Pardo
Fred Carter
Erik Williams
Fernando Vasquez
Scott Miller
Scott Piche
Frank Garst
Greg Hoon
Darren Burkhart
Jim Michael
Tyler Richardson
Joe Coory
Wayne Runcie
Garrett Potter
Aaron Mann
John Thomas
Brian Hinsley
Michael Banda
Michael Gillissie
Jeff Rich
Mark Wheeler
Chris Manzanares
Anthony Trejo
Andrew Shade
Marshall Ott
Eddie Lee
Chiyoshi Hasegawa
Matthew Edgington
Matthew Davis
LAFD RA 87
LA CO FD RS 1
LA CO FD RS 32
LA CO FD RS 92
LAFD RA 5
LA CO FD RS 173
LAFD RA 98
Glendale FD RS 25
LAFD RA 257
LA CO FD RS 111
LAFD RA 35
LA CO FD RS 49
LAFD RA 98
LA CO FD RS 147
LAFD RA 1
Paramedic Bragging Rights!
Paramedics have enrolled more patients in FAST-MAG in under 2 hours from symptom onset
than in all previous stroke research trials combined.
VOLUME 7, ISSUE 2
PAGE 7
F A ST - MAG T I MES
Modified Los Angeles Pre-Hospital Stroke
Screen (mLAPSS)
S
troke researchers at UCLA developed the Los Angeles Pre-Hospital Stroke Screen
(LAPSS) because they realized that paramedic identification of stroke symptoms
could expedite delivery of acute stroke therapy. Los Angeles County paramedics
validated the LAPSS, which can identify a stroke with 97% accuracy.
The LAPSS was modified for use in FAST-MAG, thus the designation mLAPSS.
The screening questions help paramedics determine if the patient’s symptoms are related
to stroke or are from other causes that
mimic stroke such as a diabetic crisis or
seizures. The first and most important
determination is the last time the patient
was known to be well. Not only is this
essential to determine eligibility for FASTMAG, it is also used by the ED to determine
eligibility for the clot-busting drug tPA.
The mLAPSS includes a threeitem motor exam. If the exam is positive it
should be performed twice to confirm findings.
Motor symptoms must be unilateral. Most
stroke deficits will be on the same side of
the body. (Bilateral symptoms are rare and
represent neurologic problems outside the
scope of FAST-MAG.) The motor exam is
positive if just one deficit is present: face,
arm strength or grip.
The mLAPSS features field exclusion
criteria. If all of these items are negative the
patient is eligible for FAST-MAG. Eligibility
as determined by paramedics is the first step
in the screening process. After determining
hospital destination, mLAPSS-positive
patients should be told about the study and
invited to speak with an enrolling MD.
Though some mLAPSS-positive patients
will not be enrolled in FAST-MAG (see page 1), the paramedic assessment is crucial in
helping the enrolling MD make this determination.
The back of the mLAPSS form asks for vital information. The “Paramedic Global
Impression of Change Score” asks the paramedic to rate the degree of change since the
start of the study drug. Study drug start and end times are documented here as well as on
the run sheet. The form is signed and dated by the paramedic who completes it. The first
and last name of all personnel helps ensure that proper credit is given to everyone involved
with the enrollment. Each item on the mLAPSS is part of the FAST-MAG study
database so accurate completion is essential.
Orange County paramedics will be using a slightly modified version of the
mLAPSS to ensure that FAST-MAG procedures are compatible with their stroke
identification process.
Paramedic feedback in the validation and utilization of the mLAPSS has resulted in
a useful stroke assessment instrument. The mLAPSS allows for more accurate stroke
diagnosis in the field and more timely interventions in the hospital.
UPDATES
Enrollments
1,068
(through July 31, 2010)
FAST-MAG Hospitals
The hospitals listed below are
participating in FAST-MAG
Antelope Valley Hospital
Beverly Hospital
Brotman Medical Center
California Hospital Medical Center
Cedars-Sinai Medical Center*
Citrus Valley – Intercommunity
Citrus Valley – Queen of the Valley
Encino Hospital Medical Center
Garfield Medical Center
Glendale Adventist Medical Center*
Glendale Memorial Medical Center
Good Samaritan Hospital
Henry Mayo Newhall Memorial Hospital*
Hollywood Presbyterian
Huntington Memorial Hospital*
Kaiser – Woodland Hills
Kaiser – Sunset
Kaiser – West LA (Cadillac)
Kaiser – South Bay (Harbor City)
LAC – Harbor-UCLA Medical Center
LAC – Olive View Medical Center
LAC – USC Medical Center
Lakewood Regional Medical Center
Lancaster Community Hospital
Little Company of Mary – San Pedro*
Little Company of Mary – Torrance*
Long Beach Memorial Medical Center*
Marina Del Rey Hospital
Methodist Hospital of So. California*
Mission Community Hospital
Northridge Hospital Medical Center*
Olympia Medical Center
Pomona Valley Hospital
Presbyterian Intercommunity Hospital*
Providence Holy Cross Medical Center*
Providence Saint Joseph Medical Center*
Providence Tarzana Hospital*
San Dimas Community Hospital
Santa Monica – UCLA Medical Center
Sherman Oaks Hospital
St. Francis Medical Center
St. John's Health Center
St. Mary Medical Center
Torrance Memorial Medical Center*
UCLA (Westwood) Medical Center*
Verdugo Hills Hospital
West Hills Hospital & Medical Center
White Memorial Medical Center*
Whittier Hospital Medical Center – AHMC
*Approved Stroke Center
1,000th Patient Enrolled in FAST-MAG
FAST-MAG
Clinical Coordinating Center
1072 Gayley Avenue
Los Angeles, CA 90024
Visit FAST-MAG On The Web!
www.fastmag.info
LAFD FF/PMs Al Maldonado and Ricky Herrera
“Because Time is Brain”
FAST-MAG patient #1,000 was
enrolled May 17, 2010 by Los
Angeles Fire Department Rescue 36.
This remarkable milestone was
only possible because of all the
paramedics in LA County who
have identified a potential stroke,
determined hospital destination,
pulled the correct consent form,
introduced the study, called the
FAST-MAG enrollment line, initiated
study drug and provided outstanding
pre-hospital stroke care.
Thank you one and all!
On-Scene to Door Time
As first responders know, in stroke, “time is brain.” To minimize delay,
FAST-MAG field activities were designed to take place in parallel with
standard pre-hospital stroke care.
The FAST-MAG Paramedic Operations Committee ensures that study
procedures are not causing substantial delays by monitoring on-scene to
door times. For stroke, the national average for medic arrival on-scene to
patient arrival at the ED is between 34 and 40 minutes. For the first 1,000
patients enrolled in FAST-MAG, the on-scene to door time is 35 minutes.
If the paramedic or the enrolling MD become concerned about delays in
the process, or if the patient becomes unstable, either can abort the
enrollment attempt.
RESEARCH 101: Elements of a Clinical Trial
FAST-MAG is a Phase 3 clinical trial. This is the
final step that determines if a drug improves patient
outcome and should be approved by the FDA. Phase 3
trials are done after a drug has shown promise in animal
studies and has been studied to determine how it acts
in humans (Phase 1) and how safe it is for patients
with the disease being studied (Phase 2). The gold
standard for Phase 3 research protocols is the doubleblind, placebo-controlled, randomized trial.
Double-blind means that everyone involved in
the study – the patients, the investigators, the nurses,
and, in the case of FAST-MAG, the paramedics – are
blinded to the “treatment assignment.” That is, no
one knows if the patient receives the study drug or a
placebo. Blinding reduces the possibility of bias by
those who assess the patients and analyze the data. In
some clinical trials, patients can have side effects or
blood values that might indicate which treatment they
received. In order to “maintain the blind” this information
is not shared among team members.
Placebo-controlled means that some participants
receive the active treatment and some receive a placebo
(an inactive substance). In FAST-MAG, the active
treatment is magnesium sulfate dissolved in normal
saline and the placebo is normal saline alone. For this
study, 50% of patients receive magnesium and 50%
receive saline.
Randomized means that the investigator does
not determine the treatment assignment. This reduces
bias and maintains impartiality. In FAST-MAG, a
computer at Stanford University randomizes each kit
to a specific rig. In order to maintain the integrity of
the randomization process kits are not switched between
rigs. The randomization process in a large study like
FAST-MAG ensures that the active and placebo
groups will be well-matched. At the end of the study,
when factors such as age, blood pressure, diabetes,
smoking habits and history of previous stroke or
heart disease are tabulated, the active treatment and
placebo groups will be almost identical!
Careful adherence to the protocol ensures that
FAST-MAG maintains the gold standard for clinical
research, thereby achieving an outcome accepted by
the FDA, the broader medical community and the
general public.
Next issue: Paramedic Role in Clinical Research