Download 5-18-2012 - Brain Injury Outcomes

CLEAR III MONTHLY
BROADCAST
“CONSENT MONTH”
June 2012
Agenda
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Enrollments and Announcements
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Consent Best Practice
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Amanda Bistran-Hall
Mark A. Macek
DSMB Preparation Schedule
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Amanda Bistran-Hall
Congratulations to
May-June 2012 Enrollments
Dr Jody Leonardo (PI)
Mary Hartney & Jenna McAdoo (coordinators)
University of Buffalo
3rd enrollment on
5-18-2012
(the trial's 230th enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Francois Aldrich(PI)
Charlene Aldrich(coordinator)
University of Maryland
7th enrollment on
5-18-2012
(the trial's 231st enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Sagi HarNof (PI)
Shiri Fischler & Tali Kimchi (coordinators)
Chaim Sheba Medical Center , Israel
13th enrollment on
5-24-2012
(the trial's 232nd enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Sagi HarNof (PI)
Shiri Fischler & Tali Kimchi (coordinators)
Chaim Sheba Medical Center , Israel
13th enrollment on
5-24-2012
(the trial's 232nd enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Wendy Ziai(PI)
Mirinda White (coordinator)
Special Help from Natalie Ullman
Johns Hopkins Hospital
8th enrollment on
5-25-2012
(the trial's 233rd enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Diederik Bulters (PI)
Martina Brown (coordinator)
University of Southampton Hospital, UK
2nd enrollment on
5-30-2012
(the trial's 234th enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Sayona John (PI)
Terry Cole (coordinator)
Rush University
16th enrollment on
5-30-2012
(the trial's 235th enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Laszlo Csiba (PI)
Katalin Szabó (coordinator)
University of Debrecen, Hungary
1st enrollment on
6-15-2012
(the trial's 236th enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Kevin Cockroft (PI)
Deborah Hoffman (coordinator)
Penn State Hershey Medical Center
3rd enrollment on
6-17-2012
(the trial's 237th enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Alan Hoffer(PI)
Valerie Cwiklinski (coordinator)
Case Western
3rd enrollment on
6-20-2012
(the trial's 238th enrollment)
Congratulations to
May-June 2012 Enrollments
Dr Ashis H Tayal (PI)
Melissa Tian (coordinator)
Allegheny General Hospital
6th enrollment on
6-20-2012
(the trial's 239th enrollment)
BEST CONSENT PRACTICES
Mark A Macek
In collaboration with
Dr William David Freeman
Principal Investigator, Mayo Jacksonville
Tell us your experiences …
Based on your experiences, what are
some reasons why patients have
refused consent?
* Please raise your hand or type your response in the chat box
Top 10 CLEAR III consent failure reasons
2)
Family not interested in being videotaped
Drug not FDA approved for treatment via EVD
> 72 hours not long enough for family to make
a decision
High level of follow-up burden
Low level of family interest in research
Patient is already doing well, with a good
prognosis for recovery
Mortality concerns associated with the study
Deficits and disability associated with outcome
Bleeding risk on rt-PA
1)
50% chance of not receiving study drug!
10)
9)
8)
7)
6)
5)
4)
3)
#10: Not interested in being videotaped
Action:
Proxy video can be taken by care
team based only on information
gathered through interview
 Cross it out on the consent form if
necessary

#09: Drug not FDA approved
Action:
The process of becoming FDA
approved involves exactly this type
of intervention for this type of bleed
 The drug is FDA approved for blood
clotting in other areas of the body

#08: > 72 hours not long enough for family
to make a decision
Action:
Waiver possible if reasonable
 Investigate family concerns. “More
time” is usually a superficial reason to
a deeper concern

#07: Level of follow-up burden high
Action:
Follow-up is value added
 Study participation offers added
opportunity for medical oversight and
follow-up care throughout recovery

#06: Low level of interest in research
Action:
Teach the benefits of participating in a clinical trial from the NIH website
Clinical trials are well-designed and well-executed and are the best approach for
eligible participants to:

Play an active role in their own health care

Gain access to new research treatments before they are widely available
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Gain access to experts in intraventricular hemorrhage at leading international
health care facilities during the trial
Help others by contributing to medical research
Ask open ended questions to gauge which of these benefits might strike potential
interest
Tailor presentation to the unique dynamic of each family
#05: Patient is already doing well; with good prognosis
Action:
This is a watch and wait situation
 Confirm “Good prognosis” with the
care team
 Stay in touch with the care team

#04: Mortality concerns of the study
Action:
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
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The 19%-23% 30-day mortality in the CLEAR
program compares favorably to the 50%-80%
historic data
Low-dose rt-PA is judged to be safe to use in brain
hemorrhage
Emphasized that CLEAR trial patients do better than
historical IVH patients in reduced mortality
(Naff et al, Stroke, Nov 2011)

(Naff et al, Stroke, Nov 2011)
#03: Deficits and disability associated with outcome
Action:
The hope is that this therapy can
improve quality of life
 In CLEAR IVH-B, 50% of the subjects
achieved an mRS 0-3 at 180 days

#02: Bleeding risk on rt-PA
Action:
Very low bleeding risk when citing CLEAR phase II study:
“Frequency of events was substantially lower than expected
for death and ventriculitis and remained below the
prespecified threshold for bleeding ”
Stroke published online August 25, 2011
Low-Dose Recombinant Tissue-Type Plasminogen Activator
Enhances Clot Resolution in Brain Hemorrhage : The Intraventricular Hemorrhage Thrombolysis Trial

(Naff et al, Stroke, Nov 2011)
#01: 50% chance of not receiving study drug
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Action:
Anecdotal evidence suggests that both rt-PA AND saline
flush improve drainage with a good safety profile
Standard of care includes flushes for clogged drains so the
flushing is not experimental
Irrigation with saline flush improves clot resolution better
than EVD drainage alone
The placebo saline also has been approved by the NIH
Saline is used as the flush in the rt-PA group, so all patients
are flushed with saline
All patients enrolled in the trial receive equal care
Failed Consent Video
Failed Consent Elements
1)
2)
3)
4)
Being in a hurry and unprepared to discuss the specific
details of the study and questions from the family (risks,
benefits, follow-up, outcomes, etc )
Lack of study team unity and communication Not
discussing each case with the team can lead to a
disorganized and disjointed presentation to the family
Assuming that the family knows anything about the study
Failing to speak clearly and simply about the study details,
presenting in a highly technical manner, and not making
yourself available for follow-up questions
Not being mindful of the family dynamic Stress, emotions,
anxiety, sleep deprivation, inconsistent proxy perspectives,
any many other situations can lead to consent difficulties
Best Consent Video
Best Consent Elements on the Video
1.
“Impressions are everything!” Discuss the study as a team with both the PI
and coordinator
2.
Know the protocol
3.
Be prepared with forms, iPhone/Android app, consent, etc
4.
5.
6.
7.
Make time: sit down to explain what is going on to the patient/family to
build trust
Explain the study in simple terms and why is it best option for IVH patients
and NINDS funded
Cutting edge of research and they are getting our best care and this
study only available to them
Offer more time if they need to think about it, come back; but, let them
know the treatment window closure period gently
Top 10 Successful Consent Elements
10)
9)
8)
7)
6)
5)
4)
3)
2)
1)
Be prepared
Sit down
An unhurried consent process
Coordinator & PI together
Communicate
Educate the family about the natural history of IVH
The CLEAR III IVH study offers more than ‘standard of care ’
The needs of the patient come first
Consider reviewing the CT scan personally with the
patient/family
Stick to the plan
#10: Be prepared

One of the most common errors in the CLEAR III trial
is not having complete understanding of the
regulations or speaking points, especially when
speaking to astute patients or medically savvy
families who are asking questions about the study
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Take time to review the protocol summary before the
meeting
Have the consent form and other materials for the patient or
family to review
iPhone/iPad apps if on the go
Strasser FJ, Palmer L, Willey J, Shen L, et al
Impact of Physician Sitting Versus Standing
During Inpatient Oncology Consultations:
Patients’ Preference and Perception of
Compassion and Duration A Randomized
Controlled Trial
Journal of Pain and Symptom Management
489 Vol 29 No 5 May 2005
Strasser FJ, Palmer L, Willey J, Shen L, et al
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Strasser FJ, Palmer L, Willey J, Shen L, et al
Purpose: “What is the impact of physician
sitting versus standing on the patient’s preference
of physician communication style, and perception
of compassion and consult duration?”
Strasser FJ, Palmer L, Willey J, Shen L, et al
N = 60
 Consent presented standing vs sitting
 9 5 minute video presented in both groups
 Patients preferred:

 Standing
16 (23%)
 Sitting
35 (51%)
 No preference 18 (26%)
#09: Sit down
Families perceive physicians as more
compassionate when they sit down with them
 Be willing to spend the time with the family
and address their specific concerns
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#08: An unhurried consent process
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We realize everyone is busy; but, the time spent in
the consent process about a randomized trial leaves
the family with a positive impact regardless of the
outcome
“We’ll give you more time and be back ”
Gently mention there is a finite study enrollment
window
#07: Coordinator & PI together
Introduce yourself and what your role is if
you are not taking care of the patient
primarily
 Have your study coordinator with you to
address more specifics real-time and
have consent form ready
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#06: Communicate
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Communicate & update the patient
frequently (or their family) about the
patient’s condition
#05: Educate the family about the natural history of IVH

Educate the family about the serious
nature of the disease Explanations,
such as the use of an EVD and other
relevant practices, may help families
make an informed decision Use the
CT scan
#04: The CLEAR III IVH study offers more than
‘standard of care’
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Research ‘adds on’ in a positive way to their care and can
advance science
Gain access to new research treatments before they are
widely available
Gain access to experts in intraventricular hemorrhage at
leading international health care facilities during the trial
Saline injections and rt-PA usually drain IVH blood faster than
EVD alone
#03: The needs of the patient come first
The patient’s rights and health come
first
 Assure that best care will be given
and the needs of the patient met
whether they are in this study or not

#02: Consider reviewing the CT scan personally with the
patient/family
The goal is to make sure the family understands
clearly the patient’s current condition and the
intraventricular interventions
 “A picture can say a thousand words ”
 Reviewing the images might actually take less
time to explain what the study will be doing with
TPA and saline to dissolve the clot than simple
verbal attempts at this process
 A sample CT is on the iPhone/Android
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#1: Stick to the plan
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rt-PA is not offered outside the trial; the only way
to get the drug is in the trial If something occurs,
the patient and family member will always get
our best care
rt-PA outside the study is not FDA approved and
also may miss the opportunity to answer the
question scientifically
Giving the drug outside the study also has the
same complications and without a scientific IRB
safety review committee oversight
Tough Questions: #1
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Q: “Why Can’t I have the rt-PA outside the
trial?”
A: The correct answer and speaking point is the
patient cannot receive the drug outside the CLEAR
IVH trial
Standard of care does not include rt-PA
Tough Questions: #1
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Q: “Why Can’t I have the rt-PA outside the
trial?”
A: Dr Thomas Brott, who was involved with the
original intravenous IV rt-PA trial for ischemic stroke
vs. placebo, patients were told --who asked a
similar question-- “The only way to get the study
drug is within the trial There is no way to give the
drug outside of the trial ”
Lancet 2004; 363:768-74; Arch Neurol 2004; 61:1066-1070
Tough Questions: #1
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Q: “Why Can’t I have the rt-PA
outside the trial?”
It should be emphasized that CLEAR trial patients do better
than historical IVH patients in reduced mortality
The trial offers controlled management
Patients will be on a strict ICP management protocol
The entire protocol is monitored externally
By entering the study there will be more oversight
The study teams care for patients out to1year
Tough Questions: #2
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Q: “Can I decline the study to receive the drug
off-label?”
A: The short-answer is “no ”
Tough Questions: #2
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Q: “Can I decline the study to
receive the drug off-label?”
At this hospital we made a commitment to test the use
of rt-PA only under the controlled condition of an NIH
trial. We cannot offer it off-label at this hospital.
Giving off-label rt-PA to an eligible study patient
would be a violation of the investigator’s responsibility
to the trial
Tough Questions: #3
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Q: Can I withdraw from the study?
A: Communication is critical to finding out ‘why’ the
patient or the family wants out of the study
Tough Questions: #3
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Q: Can I withdraw from the study?
Are they upset with care for the patient unrelated to the study?
Are they are unhappy with the explanations about what is occurring
in the study?
Keeping the patient and family in the loop about the patient’s
condition is key
Focusing on the patient’s health and that you are trying to help them
as best as possible is reassuring
Try to find the answers that may comfort them enough to stay in the
study
However, patients have the right to leave the study if they wish
Cast of Characters
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William David “Dave” Freeman… PI
Amy Lannen……………………… Daughter
Eugene Richie…………………… The Husband
Lesia Mooney…………………… Coordinator
3G SIM man………………….. Patient with EVD
“SPECIAL THANKS”
Korin Albert, University of Scranton, editorial
assistance.
Upcoming DSMB Meeting
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Meeting date : August 15, 2012
Data Deadline: July 31, 2012
Data needed:
1)
2)
3)
•
All Day-30 data thru Patient 4216 (enrolled thru Mar
2012)
All Day-180 data thru Patient 4176 (enrolled thru Oct
2011)
All Day-365 data thru Patient 4142 (enrolled thru Jun
2011)
Including
the most important AE / SAE Data
Join us next month at our Webinar
on July 19th for our
CLEAR III Awards Ceremony!
Top Coordinator Prize:
Attendance to the
2013 International Stroke Conference
in Honolulu, Hawaii!