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.

National Heart, Lung, and Blood Institute ( NHLBI)
National Center for Advancing Translational Sciences ( NCATS)