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Not Yet Recruiting NCT07875712

Risk Sharing vs Risk Dumping: Parental Attitudes About Risks

Conditions: Pediatric Surgery, Informed Consent, Shared Decision-making, Parental Decision Making for Seriously Ill Children, Surgical Risk Prediction

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 150
Sponsor: University of Chicago

Summary

This study will evaluate how parents or legal guardians perceive responsibility for surgical risk after the informed consent discussion for their child's operation, focusing on whether the process feels like "risk sharing" with the clinical team or "risk dumping" onto the parent. In pediatric surgery, parents often serve as surrogate decision-makers, and little is known about how consent conversations shape feelings of support, blame, trust, and decisional burden. Using a mixed-methods, cross-sectional design, the study will recruit parents/legal guardians of children under 18 years of age undergoing pediatric surgical procedures at Comer Children's Hospital after the clinical consent discussion and before surgery. Participants will complete a post-consent survey assessing perceptions of risk sharing versus risk dumping, understanding of risks and benefits, satisfaction with the consent process, trust in the surgeon/institution, decisional conflict, anxiety, and relevant demographic and clinical factors. A subset of participants will also complete semi-structured interviews to further explore experiences of responsibility, blame, institutional support, and suggestions for improving the consent process. The goal is to characterize parental perceptions of responsibility in pediatric surgical consent and identify communication, demographic, and clinical factors associated with greater perceived risk dumping. Findings may help inform interventions to improve informed consent and shared decision-making practices in pediatric surgery.

Eligibility Criteria

Inclusion Criteria: * Parent or legal guardian of a child younger than 18 years who is scheduled for a surgical procedure requiring formal informed consent * Present for clinical informed consent discussion for the child's surgical procedure * Able to provide informed consent for research participation * Able to complete the survey and, if selected, participate in an interview Exclusion Criteria: * Family members of patients requiring emergent procedures without a standard, non-pressured informed consent process * Parent/legal guardian in acute emotional distress at the time of recruitment such that participation would not be appropriate * Parent/legal guardian with cognitive impairment precluding informed consent or meaningful participation * Cases involving emancipated minors who make their own medical decisions * Individuals who decline or are unable to provide informed consent for the research study

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07875712). StuddyBuddy aggregates publicly available trial information.