Barriers and Facilitators of Surrogates Providing Consent for Critically Ill Patients in Clinical Trials: A Qualitative Study.

ABSTRACT

BACKGROUND: Enrollment into critical care clinical trials is often hampered by the need to rely on surrogate decision-makers. To identify potential interventions facilitating enrollment into critical care clinical trials, a better understanding of surrogate decision-making for critical care clinical trial enrollment is needed. RESEARCH QUESTION What are the barriers and facilitators of critical care trial enrollment? What are surrogate decision-makers' perspectives on proposed interventions to facilitate trial enrollment? STUDY DESIGN AND METHODS: We conducted semistructured interviews with 20 surrogate decision-makers of critically ill patients receiving mechanical ventilation. The interviews were recorded and transcribed verbatim, and analyzed for themes using an inductive approach. RESULTS: Thematic analysis confirmed previous research showing that trust in the system, assessing the risks and benefits of trial participation, the desire to help others, and building medical knowledge as important motivating factors for trial enrollment. Two previously undescribed concerns among surrogate decision-makers of critically ill patients were identified, including the potential to interfere with clinical treatment decisions and negative sentiment about placebos. Surrogates viewed public recognition and charitable donations for participation as favorable potential interventions to encourage trial enrollment. However, participants viewed direct financial incentives and prioritizing research participants during medical rounds negatively. INTERPRETATION: This study confirms and extends previous findings that health system trust, study risks and benefits, altruism, knowledge generation, interference with clinical care, and placebos are key concerns and barriers for surrogate decision-makers to enroll patients in critical care trials. Future studies are needed to evaluate if charitable giving on the patient's behalf and public recognition are effective strategies to promote enrollment into critical care trials.