Risk Sharing vs Risk Dumping: Parental Attitudes About Risks

NCT07875712 | Not Yet Recruiting

• 1 other identifier: IRB26-1290
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

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

Keywords

Pediatric surgery; Informed consent; Shared decision-making; Parental decision-making; Surgical risk perception; Surrogate decision-making; Trust in physician; Parent attitudes; Communication quality; Pediatric surgical consent

Outcome Measures

Primary Outcomes (1)

• Parental perception of risk sharing versus risk dumping after pediatric surgical informed consent

  Parent/legal guardian perception of whether responsibility for surgical risk was shared with the clinician and institution or shifted primarily onto the parent following the informed consent discussion for the child's surgical procedure. This outcome will be measured using a study survey composed of Likert-scale items assessing perceived shared responsibility, blame, partnership, and legalistic versus supportive framing of risk.

  Assessed once, after completion of the surgical informed consent discussion and before the child's surgery

Secondary Outcomes (1)

• Parental understanding of risks and benefits

  Assessed once, after completion of the surgical informed consent discussion and before the child's surgery.

Study Arms (1)

Parents/Legal Guardians after Pediatric Surgical Consent

Parents or legal guardians of children younger than 18 years who are scheduled for a pediatric surgical procedure requiring formal informed consent who were present for the clinical consent discussion. Participants complete a one-time post-consent survey before the child's surgery to assess perceptions of risk sharing versus risk dumping, share decision-making, trust, satisfaction, anxiety, and decisional conflict. A subset of participants will also complete semi-structured interviews exploring experiences of responsibility, blame, support, and the informed consent process. No study intervention is administered.

Other: Research data collection only

Interventions

Research data collection only OTHER

No intervention will be performed. Post-consent survey and optional semi-structured interview will be performed. No therapeutic, preventive, diagnostic, or behavioral intervention is administered for this study.

Parents/Legal Guardians after Pediatric Surgical Consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parents and legal guardians of pediatric patients younger than 18 years undergoing surgical procedures at Comer Children's Hospital for which formal surgical informed consent has been obtained. Participants are recruited after the clinical consent discussion and before the child's surgery. The study population is intended to represent parents or guardians serving as surrogate decision-makers in pediatric surgical care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Related Publications (6)

• Wyatt KD, List B, Brinkman WB, Prutsky Lopez G, Asi N, Erwin P, Wang Z, Domecq Garces JP, Montori VM, LeBlanc A. Shared Decision Making in Pediatrics: A Systematic Review and Meta-analysis. Acad Pediatr. 2015 Nov-Dec;15(6):573-83. doi: 10.1016/j.acap.2015.03.011. Epub 2015 May 14.

  PMID: 25983006 BACKGROUND

• Loeff DS, Shakhsheer BA. The ethics of informed consent and shared decision-making in pediatric surgery. Semin Pediatr Surg. 2021 Oct;30(5):151101. doi: 10.1016/j.sempedsurg.2021.151101. Epub 2021 Sep 5.

  PMID: 34635277 BACKGROUND

• Opel DJ. A 4-Step Framework for Shared Decision-making in Pediatrics. Pediatrics. 2018 Nov;142(Suppl 3):S149-S156. doi: 10.1542/peds.2018-0516E.

  PMID: 30385621 BACKGROUND

• Serhan O, Moise A, Guadagno E, Issa AM, Poenaru D. Exploring trust development in families of children towards surgical and emergency care providers: A scoping review of the literature. J Pediatr Surg. 2023 May;58(5):871-878. doi: 10.1016/j.jpedsurg.2023.01.022. Epub 2023 Jan 19.

  PMID: 36797110 BACKGROUND

• Lashley M, Talley W, Lands LC, Keyserlingk EW. Informed proxy consent: communication between pediatric surgeons and surrogates about surgery. Pediatrics. 2000 Mar;105(3 Pt 1):591-7. doi: 10.1542/peds.105.3.591.

  PMID: 10699114 BACKGROUND

• Atsaidis Z, Antel R, Guadagno E, Wiseman J, Poenaru D. Understanding the effectiveness of consent processes and conversations in pediatric surgery: A systematic-scoping review. J Pediatr Surg. 2022 Dec;57(12):834-844. doi: 10.1016/j.jpedsurg.2022.08.004. Epub 2022 Aug 11.

  PMID: 36031429 BACKGROUND

Central Study Contacts

Joan E Lee, MD

CONTACT

2132915053; joan.lee@uchicagomedicine.org

Baddr A Shakhsheer, MD

CONTACT

703-282-8826; baddr.shakhsheer@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 15, 2026
• Study Start: October 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10