Abstract [from journal]
Rationale: Low and slow patient enrollment remains a barrier to critical care randomized controlled trials (RCTs). Behavioral economic insights suggest that nudges may address some enrollment challenges.
Objectives: To evaluate the efficacy of a novel pre-consent survey consisting of nudges on critical care RCT enrollment.
Methods: We conducted an RCT in 10 intensive care units (ICUs) among surrogate decision-makers (SDMs). The novel multi-component behavioral nudge survey was administered immediately prior to soliciting SDMs' informed consent for their patients' participation in a sham trial of two mechanical ventilation weaning approaches in acute respiratory failure (ARF). The primary outcome was the enrollment rate for the sham trial. Secondary outcomes included undue and unjust inducements. We also explored SDM and patient predictors of enrollment using multivariate regression.
Results: Among 182 SDMs, 93 were randomized to receive the intervention survey and 89 to receive standard informed consent. There was no statistically significant difference in enrollment rates between the intervention (29%) and standard consent (34%) groups (percentage difference 5%; 95% CI, -9% to 18%, p=0.50). There was no evidence of undue or unjust inducement. Caucasian SDMs were more likely to enroll the patient compared to non-Caucasian SDMs (OR 3.7, 95%CI 1.1-12.2, p=0.03). SDMs who perceived a higher risk of participation were less likely to enroll the patient (OR 0.57 95%CI 0.46-0.71, p<0.001).
Conclusions: A pre-consent behavioral nudge survey among SDMs of patients with ARF in the ICU did not increase enrollment rates for a sham RCT compared to standard informed consent procedures. Clinical trial registered with ClinicalTrials.gov (NCT03284359).