A Qualitative Analysis of Factors Influencing Critical Care Trial Enrollment Among Surrogates.

BACKGROUND: We sought to identify factors that influence surrogate decision makers' decisions to enroll patients into a critical care randomized controlled trial. METHODS: We conducted a qualitative study embedded within a randomized controlled trial testing the effect of a behavioral nudge intervention for surrogate decision makers on enrollment rate in a sham ventilatory weaning trial among patients with acute respiratory failure. Participants were adult surrogate decision makers of patients receiving mechanical ventilation for acute respiratory failure. The study was conducted in 10 ICUs across 2 urban hospitals within an academic medical center in Philadelphia, Pennsylvanaia, United States. Immediately following their trial enrollment decision, surrogate decision makers were asked to enter free-text responses about the factors that influenced their decision. Responses were analyzed using content analysis. RESULTS: Of the 90 (49%) participants who provided free-text responses, the mean age was 54.9 years (SD 14.3), 69 (79%) were Caucasian, and 48 (53%) were the spouse of the eligible patient. We identified 5 themes influencing enrollment decisions: (i) trial characteristics, (ii) patient clinical condition, (iii) decision making processes, (iv) altruism, and (v) enrollment attempt. Among surrogates who enrolled the patient in the trial (n = 40), the most commonly cited factors were helping future patients (n = 24, 60%) and following the patient's wishes (n = 11, 28%). In contrast, those who declined enrollment (n = 50) most commonly reported that the patient was too sick (n = 27, 54%) and that they feared complicating the patient's condition (n = 11, 22%). CONCLUSIONS: Surrogates who enroll patients into trials most often cite altruistic motivations, while those who decline enrollment are most often concerned with the severity of the patients' condition.

A Randomized Controlled Trial of Behavioral Nudges to Improve Enrollment in Critical Care Trials.

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 preconsent 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 multicomponent behavioral nudge survey was administered immediately before soliciting SDMs' informed consent for their patients' participation in a sham trial of two mechanical ventilation weaning approaches in acute respiratory failure. 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% confidence interval [CI], -9% to 18%; P = 0.50). There was no evidence of undue or unjust inducement. White SDMs were more likely to enroll the patient compared with non-white SDMs (odds ratio, 3.7; 95% CI, 1.1 to 12.2; P = 0.03). SDMs who perceived a higher risk of participation were less likely to enroll the patient (odds ratio, 0.57; 95% CI, 0.46 to 0.71; P < 0.001).Conclusions: A preconsent behavioral nudge survey among SDMs of patients with acute respiratory failure in the ICU did not increase enrollment rates for a sham RCT compared with standard informed consent procedures.Clinical trial registered with ClinicalTrials.gov (NCT03284359).