Decision Making in the PICU: An Examination of Factors Influencing Participation Decisions in Phase III Randomized Clinical Trials

Abstract

<jats:p><jats:italic>Background</jats:italic>. In stressful situations, decision making processes related to informed consent may be compromised. Given the profound levels of distress that surrogates of children in pediatric intensive care units (PICU) experience, it is important to understand what factors may be influencing the decision making process beyond the informed consent. The purpose of this study was to evaluate the role of clinician influence and other factors on decision making regarding participation in a randomized clinical trial (RCT).<jats:italic>Method</jats:italic>. Participants were 76 children under sedation in a PICU and their surrogate decision makers. Measures included the Post Decision Clinician Survey, observer checklist, and post-decision interview.<jats:italic>Results</jats:italic>. Age of the pediatric patient was related to participation decisions in the RCT such that older children were more likely to be enrolled. Mentioning the sponsoring institution was associated with declining to participate in the RCT. Type of health care provider and overt recommendations to participate were not related to enrollment.<jats:italic>Conclusion</jats:italic>. Decisions to participate in research by surrogates of children in the PICU appear to relate to child demographics and subtleties in communication; however, no modifiable characteristics were related to increased participation, indicating that the informed consent process may not be compromised in this population.</jats:p>