Video-Based AI-Generated Peri-operative Instructions for Mitral Valve Surgery

Официальное название

Video-Based AI-Generated Peri-operative Instructions for Mitral Valve Surgery: A Randomized Controlled Trial on Health Outcomes and Patient Experience

Обзор

1. The purpose of this study is to evaluate the impact of a novel, AI-generated, interactive peri-operative video education program on total unplanned healthcare utilization 2. The main procedures are questionnaires and watching a video. 3. The subject population includes patients who are scheduled for isolated mitral valve repair surgery. 4. All study procedures will occur here at Cedars Sinai.

Подробное описание

This study is a prospective, single center, randomized trial comparing an AI-generated peri-operative video education program to standard of care education (1:1 ratio) in patients undergoing MV repair. The trial will be conducted in Southern California. The primary aim of this study is to evaluate the impact of a novel, AI-generated, interactive peri-operative video education program on total unplanned healthcare utilization, defined as a composite of hospital readmissions, ED visits, and unplanned outpatient visits, among patients undergoing mitral valve (MV) repair compared with standard of care education. The secondary aim is to analyze the association between utilization of this educational program with hospital length of stay (LOS) and patient cardiovascular medication compliance compared to standard of care education. The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (levels of anxiety, satisfaction, and discharge location) following receipt of this educational program compared with standard of care.

Вмешательства

• Другое Artificial Intelligence Video Education Arm
  A novel, AI-generated, interactive peri-operative video education program. AI videos will be personalized using medical record chart data, specifically the patient's name, surgery date, and past medical history.

Первичные конечные точки

• Number of Unplanned Healthcare Utilization events [Срок оценки: From randomization to 30 days post-surgery]

Критерии участия

Критерии включения

• Adult patients ≥ 18 years planned for elective, isolated MV repair.
• Provide Informed consent

Критерии исключения

• Insufficient computer/smart device knowledge. Children or caregivers can assist, but patients should be able to access their own email or text messages and navigate to the internet to use the provided AI generated educational intervention.
• Inconsistent access to a smart device with internet connection throughout the study period.
• Inability to speak, read, and understand English or Spanish
• Need for any concomitant procedure at the time of MV repair

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

Организация здравоохранения

Центры проведения

США · 1 центр

• Cedars Sinai Medical Center Smidt Heart Institute — Los Angeles

Публикации

• van Steenbergen G, van Veghel D, van Lieshout D, Sperwer M, Ter Woorst J, Dekker L. Effects of Video-Based Patient Education and Consultation on Unplanned Health Care Utilization and Early Recovery After Coronary Artery Bypass Surgery (IMPROV-ED): Randomized Controlled Trial. J Med Internet Res. 2022 Aug 26;24(8):e37728. doi: 10.2196/37728. PMID 36018625
• Tromp F, Dulmen S, Weert J. Interdisciplinary preoperative patient education in cardiac surgery. J Adv Nurs. 2004 Jul;47(2):212-22. doi: 10.1111/j.1365-2648.2004.03081.x. PMID 15196195
• Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available. PMID 12724430
• Ljungqvist O, Francis NK, Urman RD, eds. Enhanced Recovery After Surgery: A Complete Guide to Optimizing Outcomes. Springer International Publishing; 2020. doi:10.1007/978-3-030-33443-7
• Grab M, Hundertmark F, Thierfelder N, Fairchild M, Mela P, Hagl C, Grefen L. New perspectives in patient education for cardiac surgery using 3D-printing and virtual reality. Front Cardiovasc Med. 2023 Mar 3;10:1092007. doi: 10.3389/fcvm.2023.1092007. eCollection 2023. PMID 36937915
• Watson DJ. Nurse coordinators and ERAS programs. Nurs Manage. 2018 Jan;49(1):42-49. doi: 10.1097/01.NUMA.0000527718.90264.89. No abstract available. PMID 29287049
• Brodersen F, Wagner J, Uzunoglu FG, Petersen-Ewert C. Impact of Preoperative Patient Education on Postoperative Recovery in Abdominal Surgery: A Systematic Review. World J Surg. 2023 Apr;47(4):937-947. doi: 10.1007/s00268-022-06884-4. Epub 2023 Jan 15. PMID 36641521
• Berkman ND, Sheridan SL, Donahue KE, Halpern DJ, Crotty K. Low health literacy and health outcomes: an updated systematic review. Ann Intern Med. 2011 Jul 19;155(2):97-107. doi: 10.7326/0003-4819-155-2-201107190-00005. PMID 21768583

Идентификаторы

NCT: NCT07036926 · STUDY00003876

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗