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A Randomized Trial of Nudges to Enhance Enrollment...

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

Overview

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 research questions, thereby degrading trials' scientific value and ethics. Current evidence suggests that financial incentives can increase study enrollment, but this approach can pose large up-front costs to researchers. However, several non-monetary behavioral interventions, or nudges, may offer novel and easily scalable approaches to increase enrollment in RCTs. We will test the relative effectiveness of two different nudges on enrollment rates among 273 surrogate decision-makers of mechanically ventilated patients in a three-arm RCT across two ICUs within the University of Pennsylvania Health System. Participants will engage in recruitment procedures for a simulated RCT comparing infection rates between two methods of sample collection via bronchoscopy. We will also measure participants' assessment of risk of the simulated trial. 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.

Sponsors

  • Institute for Translational Medicine and Therapeutics of the Perelman School of Medicine at the University of Pennsylvania, Roybal Center on Behavioral Economics and Health, National Institute on Aging

NCT#

03284359

Study Status

Dissemination

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