SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent (SURGIMEDIA)

April 6, 2026 updated by: UNC Lineberger Comprehensive Cancer Center
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • UNC Lineberger Comprehensive Cancer Center
        • Contact:
          • M
        • Contact:
        • Principal Investigator:
          • Jen J Yeh, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Standard Informed Consent
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.
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.
Behavioral: Multimedia Video - Based Informed Consent
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient comprehension of the intervention
Time Frame: Baseline and up to 4 weeks after surgery

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
Time Frame: Baseline and up to 4 weeks after surgery

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Preference for Consent Modality
Time Frame: Baseline and up to 4 weeks after surgery

Assesses pancreatoduodenectomy patients' preferred informed consent method (multimedia video vs. standard verbal consent) and how these preferences change over the perioperative period. Questionnaire items will capture preferred modality and factors influencing preference.

Patient preferences will be assessed using Satisfaction questions 10-11 systems survey (2 point Likert scale questionnaire) Minimum score 0 and maximum score 10
Baseline and up to 4 weeks after surgery
Length of Stay, Readmission, and Complications
Time Frame: From surgery through 30 days post discharge

Evaluates whether use of a multimedia video for informed consent affects postoperative clinical outcomes among pancreatoduodenectomy patients.

Measurement: Data collected will include: Length of hospital stay (LOS) in days, 30 day readmission (yes/no and reason) and postoperative complications, including type and severity (as recorded in clinical documentation). Outcomes will be compared between the multimedia video group and the standard informed consent group. Readmission and complications will be obtained by electronic medical record abstraction.
From surgery through 30 days post discharge
Number of Patient Initiated MyChart Messages
Time Frame: From surgical consent through first postoperative outpatient follow up (≈3-4 weeks)

Determines whether the multimedia informed consent video impacts postoperative communication needs by measuring patient initiated electronic messages sent to providers.

Measurement: Total number of MyChart messages sent by each participant (question based or concern based) will be extracted from the electronic health record and compared between study arms.
From surgical consent through first postoperative outpatient follow up (≈3-4 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNC Lineberger Comprehensive Cancer Center

Investigators

  • Principal Investigator: Jen J Yeh, MD, UNC Lineberger Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 20, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LCCC2535

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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