SURGIMEDIA: Utilization of Multimedia for Enhanced Surgical Consent

Обзор

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

• Patient comprehension of the intervention [Срок оценки: Baseline and up to 4 weeks after surgery]
• Patient Satisfaction of the Intervention [Срок оценки: Baseline and up to 4 weeks after surgery]

Вторичные конечные точки (3)

• Patient Preference for Consent Modality [Срок оценки: Baseline and up to 4 weeks after surgery]
• Length of Stay, Readmission, and Complications [Срок оценки: From surgery through 30 days post discharge]
• Number of Patient Initiated MyChart Messages [Срок оценки: From surgical consent through first postoperative outpatient follow up (≈3-4 weeks)]

Критерии участия

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

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• UNC Lineberger Comprehensive Cancer Center — Chapel Hill

Идентификаторы

NCT: NCT07494994 · LCCC2535

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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