Initiative for Multicenter Pragmatic Anesthesiology Clinical Trials (IMPACT)
This award was established by leaders of academic anesthesiology organizations that recognized there was a need to conduct large pragmatic trials in order to answer important questions in anesthesiology-related research. Although there are several successful anesthesiology clinical trial networks around the world, until now, one did not exist in the United States. In an initial attempt to address this important opportunity, a consortium of academic anesthesiology organizations launched an initiative in 2018 to stimulate pragmatic research in the U.S. in collaboration with our colleagues in Canada, the Canadian Perioperative Anesthesia Clinical Trials Group (PACT), and elsewhere. This effort was conceptualized and endorsed by a few key organizations, which have as a common goal the advancement of knowledge in anesthesiology and the enhancement of care in perioperative medicine, critical care, pain management, and peri- and post-partum care. These organizations included:
- Association of University Anesthesiologists (AUA)
- Early-Stage Anesthesiology Scholars (eSAS)
- Foundation for Anesthesia Education and Research (FAER)
- International Anesthesia Research Society (IARS)
- Society of Critical Care Anesthesiologists (SOCCA)
- Multicenter Perioperative Outcomes Group (MPOG)
- Canadian Perioperative Anesthesia Clinical Trials Group (PACT)
These organizations have joined together and established a program to support the development of proposals for pragmatic clinical trials by anesthesiology investigators for submission to external funding sources, such as the NIH. By working together, we believe that we can improve the quality of the proposals and increase the prospects of securing funding.
Over the course of its initial two years, IMPACT awarded seed funding ($15,000 USD each) to six promising projects to develop a formal proposal for large scale trials. These projects are in various stages of grant preparation, review, or pilot work.
For 2020, based upon learnings from the initial award cycles and the larger context of pragmatic trials in anesthesiology medicine, we are making three major changes to the IMPACT award criteria. We are increasing our focus on:
- early and mid-career principal investigators;
- enabling a pilot / feasibility study essential for the successful planning and funding of pragmatic trials;
- clear prioritization of pragmatic rather than explanatory trials.
First, applicant principal investigators must be clinically active anesthesiologists within ten years of their initial faculty appointment to a Department of Anesthesiology. Next, rather than distributing funds to three different projects to enable grant preparation, a single award in the amount of $50,000 USD will be made to enable a pilot or feasibility trial in preparation for the design of a multicenter pragmatic clinical trial. Finally, while the value of explanatory randomized controlled trials is clear, the focus for IMPACT is clearly on pragmatic trials, as assessed by the PRECIS-2 tool.
The new and improved IMPACT program now includes an opportunity for input and advice from knowledgeable sources, along with a $50,000 grant to enable a pilot or feasibility trial in preparation for the design of a multicenter pragmatic clinical trial.
The process: The grant cycle is now open, with Letters of Intent accepted through 12/16/19. The Letter of Intent should outline the personnel, institutions and specific aims of a pragmatic clinical trial in perioperative medicine, see guidelines. The LOI’s are reviewed by a panel of Anesthesiology experts. From the pool of LOI’s, six applicants are chosen to write a full proposal. The six full proposals undergo an additional expert review and one finalist is chosen to receive the $50,000 award. The award is meant to support the one finalist with the development costs of writing a larger grant, to help increase the likelihood of a major grant award.
Karim Ladha, MD
The Comparison of Analgesic Regimen Effectiveness for Surgery (CARES) Trial
Assistant Professor & Staff Anesthesiologist
Department of Anesthesia and Pain Medicine
University Health Network, Toronto General Hospital
David Mazer, MD
TRICS IV-Restrictive versus Liberal Transfusion in Younger Patients Undergoing Cardiac Surgery
Associate Scientist & Professor
St Michael’s Hospital, Toronto
Robert Schonberger, MD, MHS
Improving population health via the surgical encounter: Targeting underuse of statins
Yale University – School of Medicine
Michael Aziz, MD
Optimized Opioid Management or Usual Treatment to Reduce Persistent Opioid Use Following Surgery (OPT-OUT).
Anesthesiology & Preoperative Medicine
Oregon Health & Science University
Randall Blank, MD, PhD
Individualized Intraoperative Protective Ventilation using an Open Lung Approach with Driving Pressure Limitation.
Associate Professor of Anesthesiology
Chief, Thoracic Anesthesia
Department of Anesthesiology
University of Virginia Health System
Frederic T. (Josh) Billings IV, MD, MSc
Intraoperative Normoxia versus Hyperoxia during Maintenance Anesthesia to Reduce Postoperative Complications.
Associate Professor of Anesthesiology and Medicine
Co-director, BH Robbins Scholars Physician-Scientist Development Program