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CLEAR III MONTHLY BROADCAST “CONSENT MONTH” June 2012 Agenda Enrollments and Announcements Consent Best Practice Amanda Bistran-Hall Mark A. Macek DSMB Preparation Schedule 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 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: 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 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 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 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 #08: An unhurried consent process 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 #06: Communicate 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’ 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 #1: Stick to the plan 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 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 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 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 Q: “Can I decline the study to receive the drug off-label?” A: The short-answer is “no ” Tough Questions: #2 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 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 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 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 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!