Principal Investigator

Funder

NIH/CTSA

A Randomized Trial of Nudges To Enhance Enrollment in Critical Care Research

Difficulties enrolling patients in randomized clinical trials (RCTs) have long been recognized as a major barrier to successfully evaluating medical interventions. This is particularly problematic among intensive care unit (ICU) trials, of which more than one-third do not reach target enrollment. Under-enrollment and selective enrollment reduce RCTs’ abilities to answer the research questions, thereby degrading the trials’ scientific value and ethics. Current evidence suggests that financial incentives can ethically increase study enrollment, but this approach can pose large up-front costs to researchers. However, several nonmonetary behavioral interventions, or nudges, may offer novel and easily scalable approaches to increase enrollment in RCTs.

Our project is a 3-arm RCT in 5 ICUs at Penn to test the relative effectiveness of 2 different nudges on enrollment rates. We hypothesize that a bundle of nudges during recruitment will increase enrollment rates compared to usual recruitment procedures, and that requiring participants to make a choice to participate or not with enhanced information about each option will increase enrollment. We will enroll 273 critically patients or their surrogate decision makers to engage in recruitment procedures for a simulated RCT comparing infection rates between two standard central venous catheters. We will also measure participants’ assessment of risk of the simulated trial after the informed consent process. This work will provide the first empirical evidence regarding the efficacy of two inexpensive, scalable nudges to potentially augment enrollment and reduce costs of future clinical trials.