This activity has been approved for AMA Category 1 Credits™. THESE COURSES ARE NO LONGER AVAILABLE FOR CME CREDIT AS OF JULY 1 2017. To participate in the non-accredited activity please click here.
MISTIE (Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation) III Training Module – CME Version
Course Code: 80034366
DESCRIPTION
MISTIE-III is a 500-patient, international multicenter clinical trial launched in 2013 to confirm the safety and long-term efficacy of thrombolysis in the treatment of intracerebral hemorrhage (ICH). The 5-year trial is funded by NINDS and launched in 2013. Up to 100 of the top stroke centers across the world are expected to participate.
TARGET AUDIENCE
This online course has been prepared for neurosurgeons, neurologists, neurocritical care providers, emergency physicians, nurses, nurse practitioners, physician assistants, research associates, clinical research coordinators and pharmacists.
OBJECTIVES
After participating in the activity, the participant will demonstrate the ability to:
- Identify ICH patients appropriate for surgical treatment.
- Perform correct treatments and ensure patient safety when caring for ICH patients in the MISTIE trial.
- Monitor and assess clinical outcomes in ICH patients using standardized measures and appropriate clinical tests.
- Adhere to data collection standards and regulatory reporting requirements when caring for ICH patients in the MISTIE trial.
ACCREDITATION STATEMENT
The Johns Hopkins University School of Medicine is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
CREDIT DESIGNATION STATEMENT
The Johns Hopkins University School of Medicine designates this enduring material for a maximum of 9.0 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
OTHER CREDITS
The Johns Hopkins University has approved this activity for 9.0 contact hours for non-physicians.
American Nurses Credentialing Center
American Nurses Credentialing Center (ANCC) accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME.
American Academy of Nurse Practitioners National Certification Program
American Academy of Nurse Practitioners National Certification Program accepts AMA PRA Category 1 Credit™ from organizations accredited by the ACCME.
American Academy of Physician Assistants
American Academy of Physician Assistants (AAPA) accepts certificates of participation for educational activities certified for AMA PRA Category 1 Credit™ from organizations accredited by ACCME. Physician assistants may receive a maximum of 9.0 AAPA Category 1 CME credit(s) for completing this program.
POLICY ON SPEAKER AND PROVIDER DISCLOSURE
It is the policy of the Johns Hopkins University School of Medicine that the speaker and provider disclose real or apparent conflicts of interest relating to the topics of this educational activity, and also disclose discussions of unlabeled/unapproved uses of drugs or devices during their presentation(s). Johns Hopkins University School of Medicine OCME has established policies in place that will identify and resolve all conflicts of interest prior to this educational activity. Detailed disclosure will be made in the activity handout materials.
NOTICE ABOUT OFF-LABEL USE PRESENTATIONS
The Johns Hopkins University School of Medicine/MISTIE (Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation) III Training Modules (EM) may include presentations on drugs or devices, or use of drugs or devices, that have not been approved by the Food and Drug Administration (FDA) or have been approved by the FDA for specific uses only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice.
The Johns Hopkins University School of Medicine is committed to the free exchange of medical education. Inclusion of any presentation in this program, including presentations on off-label uses, does not imply an endorsement by Johns Hopkins of the uses, products, or techniques presented.
JOHNS HOPKINS STATEMENT OF RESPONSIBILITY
The Johns Hopkins University School of Medicine takes responsibility for the content, quality, and scientific integrity of this CME activity.
INTERNET CME POLICY
The Office of Continuing Medical Education (OCME) at the Johns Hopkins University School of Medicine is committed to protecting the privacy of its members and customers. Johns Hopkins University School of Medicine OCME maintains its Internet site as an information resource and service for physicians, other health professionals and the public. OCME at the Johns Hopkins University School of Medicine will keep your personal and credit information confidential when you participate in a CME Internet based program. Your information will never be given to anyone outside of the Johns Hopkins University School of Medicine CME program. CME collects only the information necessary to provide you with the services that you request.
COPYRIGHT
All rights reserved – The Johns Hopkins University School of Medicine. No part of this program may be used or reproduced in any manner whatsoever without written permission except in the case of brief quotations embodied in articles or reviews.
FULL DISCLOSURE POLICY AFFECTING CME ACTIVITIES
As a provider approved by the Accreditation Council for Continuing Medical Education (ACCME), it is the policy of the Johns Hopkins University School of Medicine OCME to require signed disclosure of the existence of financial relationships with industry from any individual in a position to control the content of a CME activity sponsored by OCME. Members of the Planning Committee are required to disclose all relationships regardless of their relevance to the content of the activity. Instructors are required to disclose only those relationships that are relevant to their specific presentation. The following relationships have been reported for this activity:
No instructor has indicated that they have any financial interests or relationships with a commercial entity whose products or services are relevant to the content of their presentation(s).
No planner has indicated that they have any financial interests or relationships with a commercial entity.
Note: Grants to investigators at the Johns Hopkins University are negotiated and administered by the institution which receives the grants, typically through the Office of Research Administration. Individual investigators who participate in the sponsored project(s) are not directly compensated by the sponsor, but may receive salary or other support from the institution to support their effort on the project(s).
OFF-LABEL PRODUCT DISCUSSION
| Issam Awad, MD, MSc, FACS, MA (hon) Mario Zuccarello, MD |
Minimally invasive surgery for hemorrhagic stroke is not standard of care |
| Karen Lane, CMA, CCRP | Use of recombinant tissue plasminogen activator for hemorrhagic stroke is not standard of care |
| Jihyun Esther Jeon, PharmD, MBA, BCPS | Use of recombinant tissue plasminogen activator for hemorrhagic stroke is not standard of care |
DISCLAIMER STATEMENT
The opinions and recommendations expressed by faculty and other experts whose input is included in this program are their own. This enduring material is produced for educational purposes only. Use of Johns Hopkins University School of Medicine name implies review of educational format design and approach. Please review the complete prescribing information of specific drugs or combination of drugs, including indications, contraindications, warnings and adverse effects before administering pharmacologic therapy to patients.
CONFIDENTIALITY DISCLAIMER FOR CME CONFERENCE ATTENDEES
I certify that I am attending a JHUSOM CME activity for accredited training and/or educational purposes.
I understand that while I am attending in this capacity, I may be exposed to “protected health information,” as that term is defined and used in Hopkins policies and in the federal HIPAA privacy regulations (the “Privacy Regulations”). Protected health information is information about a person’s health or treatment that identifies the person.
I pledge and agree to use and disclose any of this protected health information only for the training and/or educational purposes of my visit and to keep the information confidential.
I understand that I may direct to the Johns Hopkins Privacy Officer any questions I have about my obligations under this Confidentiality Pledge or under any of the Hopkins policies and procedures and applicable laws and regulations related to confidentiality. The contact information is: Johns Hopkins Privacy Officer, telephone: 410-735-6509, e-mail: HIPAA@jhmi.edu.
“The Office of Continuing Medical Education at the Johns Hopkins University School of Medicine, as provider of this activity, has relayed information with the CME attendees/participants and certifies that the visitor is attending for training, education and/or observation purposes only.”
For CME Questions, please contact the CME Office at (410) 955-2959 or e-mail cmenet@jhmi.edu.
For CME Certificates, please call (410) 502-9634.
Johns Hopkins University School of Medicine
Office of Continuing Medical Education
Turner 20/720 Rutland Avenue
Baltimore, Maryland 21205-2195
Reviewed & Approved by:
General Counsel, Johns Hopkins Medicine (4/1/03)
Updated 4/09
ACTIVITY DIRECTORS
Daniel Hanley, MD
Professor of Neurology
Professor of Neurological Surgery
David Newman-Toker, MD
Associate Professor of Neurology
Associate Professor of Otolaryngology-Head and Neck Surgery
GUEST SPEAKERS
Issam Awad, MD, MSc, FACS, MA (hon)
Director of Neurovascular Surgery
Section of Neurosurgery
University of Chicago Hospitals
Chicago, Illinois
Steven W. Mayo, PD, CCRA, PMP
President and CEO
Senior Clinical Research Consultant
Emissary International, LLC
Austin, Texas
Mario Zuccarello, MD
Associate Professor
Department of Neurosurgery
Director, Division of Clinical Trials
University of Cincinnati
Cincinnati, Ohio
JOHNS HOPKINS SPEAKERS
Jihyun Esther Jeon, PharmD, MBA, BCPS
Clinical Research Pharmacist
Investigational Drug Service
Karen Lane, CMA, CCRP
Administrator, Division of Brain Injury Outcomes
Department of Neurology
Ryan Majkowski
Research Program Assistant
Department of Neurology
Nichol McBee, MPH, CCRP
Safety and Protocol Compliance Manager
Research Assistant
Department of Neurology
Natalie Ullman
Sr. Research Program Supervisor
Department of Neurology
TALKS, INSTRUCTORS AND LEARNING OBJECTIVES
MISTIE III Protocol Course
Nichol McBee, MPH, CCRP
Objectives: To explain the study protocol; To describe the data being collected during the study.
MISTIE III Case Form Course
Steven W. Mayo, PD, CCRA, PMP
Objectives: To register a new patient in the EDC for enrollment or tracking of screen failures; To utilize the screening and baseline case form used to qualify a patient for the study; To assess the case forms used in surgical review, randomization and catheter placement; To use the daily in-hospital case forms; To use the post-discharge outcome assessments; To input medical history, concurrent procedures, adverse events, SAEs and MEOIs, utilization, final status and other summary forms; To upload source documents and understand the monitoring process.
MISTIE III Imaging Course
Natalie Ullman
Objectives: To determine if a patient is eligible for MISTIE III, using ABC/2 to measure ICH and determine stability, and the importance of ruling out underlying pathology; To determine the optimal trajectory for the MISTIE catheter is an essential part of the trial; To determine good catheter placement within the intracerebral hemorrhage; To discuss the importance of comparing each daily CT to the most recent previous CT to check for hemorrhage stability and treatment success; To discuss the imaging required upon reaching a study endpoint, either by treatment success or administering 9 doses; To analyze imaging studies that are acquired at follow-up visits.
MISTIE III Surgical Training Course
Issam Awad, MD, MSc, FACS, MA (hon)
Mario Zuccarello, MD
Objectives: To recognize the important role of the Surgical Center; To practice the eight essential elements of the MISTIE surgical process; To describe how to provide near real-time data for use by the Surgical Center to review catheter trajectory planning and placement; To recognize the steps required to obtain catheter consultation prior to dosing; To identify the surgical procedures required in this study.
MISTIE III Dosing Course
Karen Lane, CMA, CCRP
Objectives: To review the overall drug supply and materials needed for drug administration; To discuss the dosing precautions, advisories, and endpoints; To describe the catheter preparation for administering study drug and flush; To describe the study drug administration procedure; To discuss the requirements for documentation; To review the key pharmacology and toxicology of intracerebral rt-PA.
MISTIE III Safety Reporting Course
Nichol McBee, MPH, CCRP
Objectives: To review the definitions of AEs, SAEs, and MEOIs; To discuss the difference between expected and unexpected events; To review intensity grading and causality assessment; To review reporting requirements when AEs, SAEs, and MEOIs occur; To review how to record AEs, SAEs, and MEOIs in the case forms.
MISTIE III Regulatory Compliance Training Course
Ryan Majkowski
Objectives: To identify what documents are needed on the site level; To describe what documents are needed for various personnel; To state how to better manage the eTMF; To recognize nuances behind more complicated documents.
MISTIE III Outcomes Course
Karen Lane, CMA, CCRP
Objectives: To perform the eight major neurological exams used in MISTIE III; To administer examinations on the MISTIE III timeline; To analyze results of examinations; To assess patient interviews using the Modified Ranking Scale; To input results of outcomes assessments into the EDC database; To plan and conduct follow-up visits.
MISTIE III Pharmacist Training Course
Jihyun Esther Jeon, PharmD, MBA, BCPS
Objectives: To review the overall study design and randomization for the study; To describe the study drug preparation procedure; To discuss the pharmacist’s role in study drug inventory management and requirements for documentation.
COURSE FORMAT – METHOD OF PARTICIPATION
This enduring material is expected to take approximately 1 hour per training module to complete. There are no prerequisites.
RELEASE DATE: July 1, 2014
EXPIRATION DATE: July 1, 2017
Certificates of credit will not be issued after July 1, 2017.
POST-TEST AND EVALUATION
A participant post-test will be conducted at the conclusion of each module. A grade of at least 80% within three attempts is needed to receive a CME certificate. Your certificate will be emailed upon validation of your credits. Physicians must document the total number of credits they obtain by July 1, 2017.
FOR FURTHER INFORMATION
Confirmation/Certificates: (410) 502-9634
General Information: (410) 955-2959
E-mail the Office of CME: cmenet@jhmi.edu
For general information, the direct link for this CME activity web page is:
http://www.hopkinscme.edu/CourseDetail.aspx/80034366
To participate in additional CME activities presented by the Johns Hopkins University School of Medicine Continuing Medical Education Office, please visit www.hopkinscme.edu.
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