Clinical Research Studies Continue in Duke Emergency Medicine

Photo above: Group picture of the Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (ICECAP) meeting

As the summer wore on, the Duke University School of Medicine cautiously started reopening clinical research studies following its shutdown due to the pandemic. After installing comprehensive plans for staff safety and training, detailed re-opening plans for individual studies were created and reviewed individually by the Vice-Dean of Research, Susanna Naggie, MD. Studies in which participants were at risk of worsened outcomes if the study did not continue were prioritized even during the initial shutdown. Next, studies with the potential for providing improved outcomes and treatments were prioritized for re-opening, balanced by the ability to do so in a safe manner. Accordingly, only studies that approached patients with ongoing clinical care were allowed to reopen.

One such study that Duke Emergency Medicine (Duke EM) is able to perform is a randomized trial of acupuncture versus usual care for musculoskeletal back pain. Patients are identified for the most part in our physician-in-triage areas and/or our SPEED Pod (similar to most emergency departments’ “fast-track” area). Patients with pain thought to be of musculoskeletal origin who enroll are randomized to not only receive acupuncture treatment in the Emergency Department by certified acupuncturists, but also have follow-up sessions at the Duke Center for Integrative Medicine.

Next, an ongoing study start-up that was able to be completed this summer was for the NIH SIREN Network’s study, “Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (ICECAP)." In this multicenter, pragmatic, adaptive trial, patients who have return of spontaneous circulation following out-of-hospital cardiac arrest and are treated with therapeutic hypothermia can be enrolled. The purpose of the study is to learn the ideal duration of therapeutic hypothermia, a longstanding modality of treatment in the standard of care for such patients.

One study with a relatively unique start-up activity is the BOOST3 study. This is the 2nd trial in Duke EM’s history to utilize the FDA’s mechanism for “Exception from Informed Consent” (EFIC) approval process. Due to the nature of the condition being studied (traumatic brain injury) and the emergent need to start the intervention being studied, patients or their loved ones would often not be able to provide informed consent themselves. Although the researchers would always seek to obtain the consent of the patient or their loved ones, experience demonstrates that this would often not be possible.  In the EFIC process, Duke EM and Neurology Intensive Care colleagues have conducted extensive community consultation and public disclosure procedures to alert the local community of the possibility of being enrolled in the trial and to learn whether the local community would approve of such a process. Duke is in the final stages of completing this process and submitting for approval to move this trial forward.

The COVID-19 pandemic has required several adaptations across healthcare and beyond. Emergency care research is no different and has required multiple adjustments to continue to find new ways to improve the care we provide.

Research Studies Mentioned in the Article:

ICECAP Study

BOOST3 Study