SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07494994
Status
Not Yet Recruiting

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Conditions

  • Pancreas Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
Jun 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Standard Informed Consent
    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.
  • Experimental: Multimedia Video-Enhanced Informed Consent
    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.

Primary Outcome Measure

Patient comprehension of the intervention [ Time Frame: Baseline and up to 4 weeks after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599
Mia A MacDonald, MD
[email protected]
919-984-0000
M
Jen J Yeh, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UNC Lineberger Comprehensive Cancer Center· Chapel Hill, NC

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