Transcript TACT Newsletter-April 2004 Edition

TACT
LOGO
NIH
TACT Newsletter
April 2004
Message from the Principal
Investigator – Gervasio A. Lamas, MD
Since our last quarterly Newsletter, we held our
second Investigators and Coordinators Meeting
on March 25-28. It was a huge success, with
about 60 sites attending the meeting in Miami
Beach. Participants attended lectures and
received important hands-on training. There
was even time for sites to demonstrate their
talent at the TACT Talent show! Congratulations
to Dr. Alden and Ashley Steele for winning first
place for their Romeo, Juliet and TACT
performance!
We now have over 80 sites that can enroll
patients! The enthusiasm generated from the
meeting has pushed enrollment to 165. We
have now surpassed our targets for the month
of April! Thanks to all the site investigators and
coordinators who helped make this happen. A
special congratulations goes to Dr. Rajiv
Chandra’s site who has enrolled 15 patients
since the investigators meeting. Dr. Shah is still
our number 1 enroller, with 20 patients. We
have learned from the successful sites that you
must approach all potential patients in order to
increase enrollment. I challenge all of you to be
our number one site!
We should all be optimistic that this trial will be a
success. However, without the continued
dedication and efforts from Investigators and
Coordinators we will never reach our goals. To
be successful, sites must convey their belief in
the importance of this trial to patients. We still
have a long way to go before we reach our goal
of enrolling 2372 patients.
We all know this trial is difficult and
controversial. If you have any concerns about
any aspect of this trial, please contact us. We
are happy to address any issues you may have.
Our congratulations and kudos to Site 234!
Dr. Rajiv Chandra, Terry Murphy and
Susan Hewitt from Tru Med ED of
Melbourne, Florida enrolled 8 patients in 7
days !!! What an example to follow!!
TACT Enrollment
227 Sangeeta Shah/ Tracey Wilks
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406 Patrick Golden/ Kathy Sasser
220 Ted Rosema/ Dolly Corbin
113 Russell Silverman/ Sherri Loucks
234 Rajiv Chandra/ Terry Murphy
115 Robert Weiss/ Diane Cass
312 Tammy Born/ Judy Schneider
302 Greg Flaker/ Jamie Easley
223 Roy Heilbron/ Celia Heilbron
212 Joseph O’Bryan/ Mary Barr
326 Kenneth Ganapini/ Venus Barney
232 John Griffin/ Terry Mellinger
216 Ricky Schneider/ Amy Abreu
112 Reed Snider/ Jean Provencher
407 Nampalli Vijay/ Melinda Washam
107 Allan Magaziner/ Betty Ann Persico
120 Majid Ail/ Boobullah Baig
217 James Carter/ David Maddox
110 Pamela Ouyang/ Melanie Herr
221 Denis Weinberg/ Raquel Rojas
307 Robert Waters/ Karen Fernholz
215 Shalendra Varma/ Sharon Collins
228 James Carter/ Jodie Ledbetter
408 Herman Casdorph/ Kathy Hutsinger
128 Stuart Freedenfeld/ Nella Hamtil
224 Angelique Hart/ Angelique Hart
108 Raymond Magorien/ JoAnn Homan
238 Lawrence Miller/ Deanna Overbeck
122 Harmony Reynolds/ Karen Hager
242 Miguel Trevino/ Tracy Osborn
226 Donald Tice/ Celeste Altman
416 William Voss/ Lorna Gordon
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TACT Newsletter Continued
TACT Enrollment, Actual and Projected, as of 15 Apr 2004
2,500
Randomized Patients
QUEST Laboratories
2,000
1,500
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Note: April "Actual" data is for a partial month
As a reminder, only laboratory tests required by the
TACT study protocol are to be sent to the Quest
laboratories.
Any ancillary tests are to be
performed at your local laboratory, using their
requisitions. The routine laboratory examinations
for this study are identified on page 45 of the
protocol or behind the Laboratory Tab in the TACT
Study Manual. If patients are unable to proceed
with their infusions due to laboratory delays, the
repeat safety bloods should continue to be sent to
Quest.
Pharmacy Reminder
A way to communicate with the pharmacy is right
at your figure tips. Use the ‘Message’ tab in
TrialMaster® and compose a note. Simply select
‘compose’ and open the address book. The
pharmacy is listed second, click this and set the
priority to HIGH. In the subject line, specify
‘infusion date change’. In this way the pharmacy is
alerted to your immediate need. This is especially
useful if you need to change a patient’s infusion
date and are concerned whether or not you will
receive your infusion in time for the next
scheduled visit.
Visit Projector
We hope that you have all taken advantage of the
“Visit Projector’ that has been produced especially
for the TACT study. This program allows you to
‘see into the future,’ the subsequent dates each
patient will be infused. This will help determine
potential scheduling conflicts for the site and the
patient. This information is on the TACT website.
Extra Forms
To help C of extra study forms. These
forms can be found in the TACTNIH.COM
website, the Document Tab in TrialMaster®
or your study manual.
Website Reminder
Please remember to check the tact website
for updates frequently. As we receive letters
from the DSMB or other important
information, it will be placed in the TACT
update section of the website
www.tactnih.com
username: infusion
Password: tactnih
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TACT Newsletter Continued
All things being EQOL…
Hypocalcemia
Question: If a patient is randomized to EQOL,
does he/she have to participate?
Yes, if someone is randomized to EQOL follow
up, it is required by the protocol that he/she
participate in EQOL. There will be 1,000 patients
participating in this important substudy. This is an
opportunity for them to provide information that
may determine how these treatments affect the
quality of life.
Patients randomized to EQOL will answer only
three questionnaires during the entire follow-up
period. These will be done at 6 months, 1 year
and 2 years. Please communicate this to your
patients so they will understand the importance of
participating in the survey. If there is a problem
with anyone’s participation, please contact the
EQOL group at the DCRI to assist with
problem solving,
Key points to ensure quality data and minimize
queries:
•
Each patient randomized to TACT must
have a Baseline QOL Questionnaire
administered.
•
The easiest time to complete is directly
following consent and before first infusion.
•
Enter the Baseline QOL Questionnaire into
TrialMaster and make sure that it reaches
a status of Signed (needed for site
payment)
•
Include detailed descriptions of a patient’s
work
duties
and
responsibilities.
Descriptions are used to code a job class.
•
Be sure to review the onscreen entries
before saving and signing the Questionnaire
form.
•
If patient is randomized to EQOL Follow-up,
remind him/her that someone from DCRI
will be calling.
If you have any questions, call:
Diane (919-668-8221) or
Jason (919-668-8640)
Thank you for all your efforts in administering the
TACT Baseline Quality of Life Questionnaires.
Keep up the good work!
When Ca+ is < 9 mg/dL take the following steps:
1. Increase infusion administration time from three
hours to 4 - 5 hrs (100 to 125 cc/ hr).
2. Re-draw calcium before the next infusion
3. The abnormal calcium value is considered an
adverse event and requires completion of an AE
form
If untreated, hypocalcemia may cause intestinal
cramps, arrhythmias, and muscle spasms. If
severe and chronic, hypocalcemia may cause
seizures and respiratory arrest.
Extra Items to Have on Hand
Calcium gluconate for treatment of severe
hypocalcemia, as ordered by MD
Heating pads for discomfort at IV site
Finger stick glucose monitors
Oral and IV glucose
IV lasix
O2 available
SPECIAL HINT
It is best to use the antecubital or proximal veins
for the infusions rather than hand veins.
Herbal Supplements
It has been noted on the iCRF that the section for
recording Herbal Supplements also includes the
listing of some nutritional supplements. To
accommodate this fact, a slight modification
to the wording will be made to this form. Thank
you for your understanding regarding this issue
TACT Communication
TACT (DCRI) Helpline 800-545-3853
Mt. Sinai 305-674-2794
DCRI 919-668-8253
TACT Newsletter Continued
Vitamin Accountability
The vitamin accountability form has it’s
home under the Infusion #1 visit, since this
is when vitamins are first dispensed. There
are currently five spaces available for both
tablets and blister packs. It will generally
take from 9 to 12 months to complete this
first record, depending on what has been
provided to each site/patient from the
pharmacy. When the form has been filled,
you will need to add another Vitamin
Accountability form. This new form will also
be housed under Infusion #1, so you will
always know where it is! This will continue
even through maintenance and follow-up.
To maintain accurate dispensing records,
make sure that the patients are instructed to
return all bottles/tablets and gel-caps/blister
packs.
Returned vitamins are to be
counted and the number remaining as well
those that are unaccounted for documented
in the appropriate space. You will need to
calculate how many tablets/gel-caps should
have been taken by counting the days from
the date the drugs were dispensed.
Unaccounted tablets/gel-caps are defined
as lost or discarded accidentally by the
patient.
When vitamins are re-supplied, you
should calculate your patients'
compliance to the protocol prescribed
directions. This compliance percentage
should be documented on your infusion
visit worksheet (source). If the
percentage is less than 85% talk with
your patient to find out why and provide
counsel as to the importance of taking
the vitamins as prescribed. The
compliance percentage is calculated by:
* count returned pills (separate high and
low dose)
* subtract the number of pills returned
from the number of pills distributed; this
will yield ACTUAL pills taken
* count the number of days between
distribution and resupply; this is the total
days for vitamins to be taken; for high
dose, multiply total count by 6; for low
dose multiply total count by 1; this will
yield EXPECTED pills to be taken
* divide the ACTUAL pills taken by the
EXPECTED pills taken and multiply by
100 to obtain your compliance
percentage.
If you have questions, please call your Regional Coordinator at DCRI.
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