SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent

NCT07494994 | Not Yet Recruiting DMC

• 1 other identifier: LCCC2535
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Informed consent is an ethical and legal component of the pre-procedural process. Informed consent involves the explanation of procedural steps and discussion regarding the risks, benefits, and alternatives of the proposed procedure. The current informed consent process lacks standardization, and patient experience can vary widely depending on the provider obtaining consent. This pilot study aims to ensure high quality informed consent for patients undergoing a complex oncologic operation known as a pancreaticoduodenectomy (Whipple operation), through the creation of an educational video as a method of obtaining informed consent. This study will explore whether the application of an educational video as part of the informed consent process increases patient understanding, comfort, and overall satisfaction throughout the Whipple operative course. The primary objective of this study is to determine whether implementation of a multimedia video as an enhancement to surgical informed consent improves patient satisfaction, promotes understanding, and informs operative expectations. The desired outcome is to standardize the informed consent process to eliminate variability in the quality of the consent process and to mitigate the impact of healthcare barriers such as health literacy and language proficiency in the informed consent process.

Conditions

Pancreas Cancer

Keywords

informed consent; pancreaticoduodenectomy; Whipple operation; educational video; complex surgical operation

Outcome Measures

Primary Outcomes (2)

• Patient comprehension of the intervention

  This outcome evaluates whether implementation of a multimedia video for informed consent improves patient comprehension of the pancreatoduodenectomy (Whipple) procedure, and clarity of operative expectations. These domains will be assessed using validated questionnaires administered at three time points: preoperative: Immediately after surgical consent, postoperative (inpatient): During postoperative hospitalization and postoperative (outpatient): At first follow-up visit (approximately 3-4 weeks after surgery). Patient responses across these time points will be compared between the multimedia video group and the standard informed consent group. Patient satisfaction will be measured using patient understanding and communication module of the PSQ-3 (Patient Satisfaction Questionnaire-III), a 5-item survey scored on a 5-point Likert scale (Strongly Agree → Strongly Disagree). Total scores range from 0 to 15, with higher scores indicating greater dissatisfaction.

  Baseline and up to 4 weeks after surgery

• Patient Satisfaction of the Intervention

  This outcome evaluates whether implementation of a multimedia video for informed consent improves patient satisfaction, comprehension of the pancreatoduodenectomy (Whipple) procedure, and clarity of operative expectations. These domains will be assessed using validated questionnaires administered at three time points: preoperative: Immediately after surgical consent, postoperative (inpatient): During postoperative hospitalization and postoperative (outpatient): At first follow-up visit (approximately 3-4 weeks after surgery). Patient responses across these time points will be compared between the multimedia video group and the standard informed consent group. Patient satisfaction will be measured using satisfaction module of PSQ-3 (Patient Satisfaction Questionnaire-III), a 8-item survey scored on a 5-point Likert scale (Strongly Agree → Strongly Disagree). Total scores range from 0 to 40, with higher scores indicating greater dissatisfaction.

  Baseline and up to 4 weeks after surgery

Secondary Outcomes (3)

• Patient Preference for Consent Modality

  Baseline and up to 4 weeks after surgery

• Length of Stay, Readmission, and Complications

  From surgery through 30 days post discharge

• Number of Patient Initiated MyChart Messages

  From surgical consent through first postoperative outpatient follow up (≈3-4 weeks)

Study Arms (2)

Standard Informed Consent

ACTIVE COMPARATOR

Participants receive the current standard-of-care informed consent process for Whipple surgery. A consenting provider presents the procedure, risks, benefits, and alternatives, and is available to answer questions. Participants complete pre- and post-intervention surveys and are audio recorded during the consent process.

Behavioral: Standard Informed Consent

Multimedia Video-Enhanced Informed Consent

EXPERIMENTAL

Participants view a multimedia, animated educational video that explains major steps of the Whipple procedure, benefits, alternatives, and peri-/post-operative concerns using simple, non-technical language. After viewing, a consenting provider is available to answer questions. Participants complete pre- and post-intervention surveys and are audio recorded during the consent process.

Behavioral: Multimedia Video - Based Informed Consent

Interventions

Standard Informed Consent BEHAVIORAL

Participants receive the institution's standard verbal informed consent discussion delivered by a qualified provider, covering the Whipple operation, expected outcomes, risks, benefits, and alternatives. The provider answers follow-up questions.

Standard Informed Consent

Multimedia Video - Based Informed Consent BEHAVIORAL

Participants view a narrated, animated video explaining the Whipple procedure; benefits, alternatives, and potential perioperative and postoperative complications; and resources for recovery. Afterward, a provider answers questions.

Multimedia Video-Enhanced Informed Consent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information
• Subjects is willing and able to comply with study procedures based on the judgement of the investigator.
• Age ≥ 18 years at the time of informed consent for study participation.
• Scheduled to undergo a standard of care pancreaticoduodenectomy procedure.
• English as the patient's self-reported preferred language.

You may not qualify if:

• Inability to speak English.
• Dementia altered mental status, or any psychiatric condition that would prohibit understanding or rendering of informed consent as determined by the study physician.
• Currently pregnant. If a participant becomes pregnant during the study, they will be withdrawn and replaced with a new participant if resources allow.

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Jen J Yeh, MD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mia A MacDonald

CONTACT

919-984-0000; Mia_MacDonald@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): January 1, 2030
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)