Pediatric SurgeryNCT07875712
Risk Sharing vs Risk Dumping: Parental Attitudes About Risks
An observational study of Pediatric Surgery and Informed Consent, run by University of Chicago.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pediatric Surgery, Informed Consent, Shared Decision-making
- What is being tested?
- Research data collection only
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 1 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk Sharing vs. Risk Dumping: Parental Attitudes About Risks After Undergoing Informed Consent for Surgical Intervention in Their Child
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.
Read the detailed description
This hospital-based mixed-methods study examines parental attitudes after informed consent for pediatric surgery, specifically whether parents perceive the consent process as one in which risks are shared with the surgeon and the institution or shifted primarily onto the parent. The study addresses an important gap in pediatric surgical decision-making, where existing literature suggests that parents may have difficulty understanding probabilistic risk information and that trust, stress, communication quality, and shared decision-making influence their experiences.
Eligible participants are parents or legal guardians of children younger than 18 years who are scheduled for a surgical procedure requiring formal informed consent and who were present for that discussion. After completion of the clinical consent process, research staff will approach eligible parents/guardians for voluntary research participation. Participants will complete a survey before the child's surgery. Survey domains include demographics and clinical context, perceived risk sharing versus risk dumping, shared decision-making, quality of the consent process, trust in physician/institution, satisfaction, decisional conflict, anxiety, and open-ended feedback. A subset of participants will undergo semi-structured interviews exploring perceptions of responsibility, blame, support, and abandonment during the consent process.
Quantitative data will be analyzed descriptively and with bivariate and multivariable methods to identify predictors of perceived risk dumping. Qualitative interview transcripts will undergo thematic analysis. Integrated findings will be used to develop a conceptual mode of "risk sharing versus risk dumping" in pediatric surgical informed consent and to inform future improvements in communication and shared decision-making.
- Conditions
- Pediatric Surgery, Informed Consent, Shared Decision-making, Parental Decision Making for Seriously Ill Children, Surgical Risk Prediction
- Being tested
- Research data collection only
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research data collection onlyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Research data collection only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Parent/legal guardian self-reported understanding of the risks, benefits, and alternatives discussed during the surgical informed consent process, assessed by post-consent survey items.
Measured: Assessed once, after completion of the surgical informed consent discussion and before the child's surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion1 May 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pediatric SurgeryStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875712
- Sponsor's protocol ID
- IRB26-1290
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may contain sensitive survey and interview information from parents/legal guardians about their child's surgical consent experience. Because this is a single-site minimal-risk study involving potentially identifiable qualitative narratives, the study team has not yet made a final decision regarding whether de-identified IPD can be shared in a manner consistent with participant confidentiality and institutional requirements. Any future sharing would be considered only for fully de-identified data and only with appropriate approvals and data use protections in place.
Publications
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.
PubMed 25983006Loeff 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.
PubMed 34635277Opel 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.
PubMed 30385621Serhan 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.
PubMed 36797110Lashley 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.
PubMed 10699114Atsaidis 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.
PubMed 36031429
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Sharing vs. Risk Dumping: Parental Attitudes About Risks After Undergoing Informed Consent for Surgical Intervention in Their Child
- ClinicalTrials.gov ID
- NCT07875712
- Acronym / sponsor ID
- IRB26-1290
- 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
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This hospital-based mixed-methods study examines parental attitudes after informed consent for pediatric surgery, specifically whether parents perceive the consent process as one in which risks are shared with the surgeon and the institution or shifted primarily onto the parent. The study addresses an important gap in pediatric surgical decision-making, where existing literature suggests that parents may have difficulty understanding probabilistic risk information and that trust, stress, communication quality, and shared decision-making influence their experiences.
Eligible participants are parents or legal guardians of children younger than 18 years who are scheduled for a surgical procedure requiring formal informed consent and who were present for that discussion. After completion of the clinical consent process, research staff will approach eligible parents/guardians for voluntary research participation. Participants will complete a survey before the child's surgery. Survey domains include demographics and clinical context, perceived risk sharing versus risk dumping, shared decision-making, quality of the consent process, trust in physician/institution, satisfaction, decisional conflict, anxiety, and open-ended feedback. A subset of participants will undergo semi-structured interviews exploring perceptions of responsibility, blame, support, and abandonment during the consent process.
Quantitative data will be analyzed descriptively and with bivariate and multivariable methods to identify predictors of perceived risk dumping. Qualitative interview transcripts will undergo thematic analysis. Integrated findings will be used to develop a conceptual mode of "risk sharing versus risk dumping" in pediatric surgical informed consent and to inform future improvements in communication and shared decision-making.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parents/Legal Guardians after Pediatric Surgical Consent | – | Other: Research data collection onlyParents 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Research data collection onlyNo 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. | Other | Parents/Legal Guardians after Pediatric Surgical Consent |
Primary outcome
Parental perception of risk sharing versus risk dumping after pediatric surgical informed consent
Time frame: Assessed once, after completion of the surgical informed consent discussion and before the child's surgery
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.
1 secondary outcome
Parental understanding of risks and benefits
Time frame: Assessed once, after completion of the surgical informed consent discussion and before the child's surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Background: PubMed 25983006Wyatt 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.
- Background: PubMed 34635277Loeff 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.
- Background: PubMed 30385621Opel 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.
- Background: PubMed 36797110Serhan 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.
- Background: PubMed 10699114Lashley 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.
- Background: PubMed 36031429Atsaidis 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.
- Individual participant dataSharing planned: Undecided. Data may contain sensitive survey and interview information from parents/legal guardians about their child's surgical consent experience. Because this is a single-site minimal-risk study involving potentially identifiable qualitative narratives, the study team has not yet made a final decision regarding whether de-identified IPD can be shared in a manner consistent with participant confidentiality and institutional requirements. Any future sharing would be considered only for fully de-identified data and only with appropriate approvals and data use protections in place.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Surgery and Informed Consent, run by University of Chicago.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joan E Lee, MD (2132915053, joan.lee@uchicagomedicine.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental perception of risk sharing versus risk dumping after pediatric surgical informed consent (time frame: Assessed once, after completion of the surgical informed consent discussion and before the child's surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07875712, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.