Pancreas Cancer
Conditions
Keywords
informed consent, pancreaticoduodenectomy, Whipple operation, educational video, complex surgical operation
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.
Interventions
BEHAVIORALStandard 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.
BEHAVIORALMultimedia 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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient comprehension of the intervention | 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. |
| Patient Satisfaction of the Intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference for Consent Modality | 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 |
| Length of Stay, Readmission, and Complications | 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. |
| Number of Patient Initiated MyChart Messages | 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. |
Countries
United States
Contacts
CONTACTMia A MacDonald
PRINCIPAL_INVESTIGATORJen J Yeh, MD
UNC Lineberger Comprehensive Cancer Center
Outcome results
None listed