Menu
Recruiting NCT07036926

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

No phase Interventional Mitral Valve Repair Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artificial Intelligence Video Education Arm.
Who it may be relevant to
Registry conditions: Mitral Valve Repair Surgery. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Cedars Sinai Medical Center Smidt Heart Institute — Los Angeles

Publications

  • 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

Identifiers

NCT: NCT07036926 · STUDY00003876

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗