TY - JOUR
T1 - A Qualitative Analysis of Factors Influencing Critical Care Trial Enrollment Among Surrogates
AU - Krutsinger, Dustin C.
AU - Hetland, Breanna D.
AU - O’Leary, Kelly L.
AU - Halpern, Scott D.
AU - Courtright, Katherine R.
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Dr. Krutsinger was supported by the National Institute of Health (T32 5T32HL098054-09). This project was supported in part by the Institute for Translational Medicine and Therapeutics (ITMAT) at the University of Pennsylvania (KRC) and the National Center for Advancing Translational Science (UL1TR001878). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center for Advancing Translational Science or the National Institutes of Health.
Publisher Copyright:
© The Author(s) 2021.
PY - 2022/3
Y1 - 2022/3
N2 - 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.
AB - 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.
KW - enrollment
KW - medical decision making
KW - randomized controlled trials
KW - surrogate decision makers
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U2 - 10.1177/0885066621998978
DO - 10.1177/0885066621998978
M3 - Article
C2 - 33655801
AN - SCOPUS:85102116739
VL - 37
SP - 430
EP - 434
JO - Journal of Intensive Care Medicine
JF - Journal of Intensive Care Medicine
SN - 0885-0666
IS - 3
ER -