SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent
ConditionPancreas Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 If a participant becomes pregnant during the study, they will be withdrawn and replaced with a new participant if resources allow.
Trial design
Design model
Parallel
Treatments tested in this trial
Standard Informed Consent
BehavioralParticipants 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
BehavioralParticipants 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Standard Informed ConsentActive comparator 1 intervention
Group B: Multimedia Video-Enhanced Informed ConsentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and up to 4 weeks after surgery2
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.
Time frame
Baseline and up to 4 weeks after surgerySecondary outcomes
1
Patient Preference for Consent Modality
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
Time frame
Baseline and up to 4 weeks after surgery2
Length of Stay, Readmission, and Complications
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.
Time frame
From surgery through 30 days post discharge3
Number of Patient Initiated MyChart Messages
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.
Time frame
From surgical consent through first postoperative outpatient follow up (≈3-4 weeks)Sponsors and contacts
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Source ClinicalTrials.gov
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