Pittsburgh, August 2, 2022 – Alexis Steinberg, MD, department of neurology assistant professor, is the recipient of a $25,000 award for her project “Surrogates Reasoning to Decline Trial Consent” that she submitted to the University of Pittsburgh Clinical and Translational Science Institute’s Willingness 2 Participate (W2P) Pilot competition. The award period will last for twelve months from the date of award initiation.
The W2P Pilot Awards are meant to support studies on how people choose to participate in research. All projects that have received awards are helping understand how the people perceive research studies, the engagement rate of specific populations and test solutions to increase interest and engagement. Proposed research in this competition is meant to understand the prevalence of barriers and how to avoid them in potential participant populations.
Dr. Steinberg’s abstract for "Surrogates Reasoning to Decline Trial Consent" is stated below:
“Obtaining informed consent in trials of acute catastrophic illness is challenging. Barriers include limited time, emotional distress, and uncertainty of a patient’s wishes regarding research. We focus on the specific example of cardiac arrest. UPMC Presbyterian participates in the Influence of Cooling duration on Efficacy in Cardiac Arrest Patients (ICECAP) study. ICECAP randomizes comatose post-arrest patients to one of several durations of temperature control. Consent for ICECAP occurs within six hours of active cooling and may be obtained face-to-face or remotely. We will explore barriers and facilitators to consent for ICECAP. We will use purposive sampling of surrogates to recruit pilot participants who both consented to and declined ICECAP after in-person or remote discussion. We will perform semi-structured interviews of 40 surrogate-provider dyads and use inductive and deductive coding methods for thematic analysis. We will compare results between surrogates who consented and those who declined ICECAP participation (Aim 1) and between surrogates approached in-person or remotely (Aim 2). Our research team has clinical expertise in neurocritical care, experience obtaining emergency informed consent and in rigorous qualitative methods. Our pilot findings will support design and development of a competitive NIH award to expand our research across a multicenter cohort of Strategies to Innovate Emergency Care Clinical Trials Network (SIREN) trial sites including studies of adult and pediatric cardiac arrest and traumatic brain injury. Ultimately, our goal is to develop and refine strategies to improve volume and equity of recruitment for other future neurological emergency trials.”
