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

Abstract

Background. 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). Method. 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. Results. 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. Conclusion. 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.

The Process and Impact of Stakeholder Engagement in Developing a Pediatric Intensive Care Unit Communication and Decision-Making Intervention

“…Clinicians and families make complicated medical decisions for pediatric intensive care unit (PICU) patients ( 1 , 2 ). In some cases, decisions have life-altering implications, such as whether to place a tracheostomy tube, participate in research, or withdraw life-sustaining therapies ( 3 - 5 ). Research demonstrates that high-quality communication positively impacts decision-making for families ( 6 , 7 ).…”

Decision-Making Styles and Managerial Creativity of Nursing Managers in Saudi Arabia: A Multi-Center Cross-Sectional Study

“…According to Al Shra'ah [23], the decision-making style of any manager or in any institution depends on competence and learning processes, in which academic achievement was thought to be a significant component in comprehending the decision-making process [24]. On the other hand, this conclusion conflicts with a report from Slosky et al [25], who noted that engagement in decision making was unrelated to academic qualifications.…”

“…illustrates that the rational style had the highest mean score (20.95 ± 2.03, 83.8%) and the widest range(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25), followed by the dependent style (17.01 ± 2.8, 68.04%) with a range of 11-23 and the avoidant style (12.8 ± 2.88, 51.2%) with the lowest mean score and a range of 7-21.Regarding the managerial creativity subdomains, synthesis and analysis had the highest mean score (22.55 ± 2.19, 90.2%) and the widest range (17-25), followed by maintaining focus and direction (21.76 2.04, 87.04%) with a range of 16-25 and originality (20.95 ± 1.8, 83.8%) with the lowest mean score and a range of16-25. …”

Patient and caregiver engagement in research: factors that influence co-enrollment in research

“…This project assists in better understanding patients’ and caregivers’ preferences regarding co-enrollment in research. While the majority of previous research on this subject has focused on co-enrollment from the perspective of the research team, some studies have been conducted to understand caregiver preferences [1, 6]. Specifically, Morley et al conducted a study to understand parents’ perspectives on enrolling their premature babies in multiple studies [1].…”

“…Co-enrollment into multiple studies is a strategy being used to overcome recruitment challenges for pediatric medical conditions with low prevalence rates [1–3]. Research in the area of co-enrollment has traditionally been based in critical care or intensive care unit (ICU) settings [2, 4–6]. Several studies have investigated the effect of co-enrollment on study design, including its ethical and scientific ramifications [3, 5, 7, 8].…”