NCT07036926

Brief Summary

  1. 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. 2.The main procedures are questionnaires and watching a video.
  3. 3.The subject population includes patients who are scheduled for isolated mitral valve repair surgery.
  4. 4.All study procedures will occur here at Cedars Sinai.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Aug 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Aug 2025Dec 2026

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

February 25, 2026

Status Verified

June 1, 2025

Enrollment Period

11 months

First QC Date

June 17, 2025

Last Update Submit

February 23, 2026

Conditions

Mitral Valve Repair Surgery

Keywords

Artificial IntelligenceVideo education

Outcome Measures

Primary Outcomes (1)

  • Number of Unplanned Healthcare Utilization events

    includes the following events: unplanned (i.e. patient initiated) phone calls, emails, clinic visits, and ED visits.

    From randomization to 30 days post-surgery

Study Arms (2)

Peri-Operative Standard of Care and Artificial Intelligence Video Education Arm

ACTIVE COMPARATOR

In this arm, patients will receive AI-generated, interactive, peri-operative video education program in addition to standard of care education

Other: Artificial Intelligence Video Education Arm

Peri-Operative Standard of Care Education only Arm

NO INTERVENTION

In this arm, patients will receive the usual Standard of Care Peri-Operative Education

Interventions

Artificial Intelligence Video Education ArmOTHER

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.

Peri-Operative Standard of Care and Artificial Intelligence Video Education Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center Smidt Heart Institute

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (11)

  • 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: 36018625BACKGROUND

  • 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: 15196195BACKGROUND

  • 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: 12724430BACKGROUND

  • 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

    BACKGROUND

  • 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: 36937915BACKGROUND

  • 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: 29287049BACKGROUND

  • 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: 36641521BACKGROUND

  • 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: 21768583BACKGROUND

  • Fernandez-Castro M, Jimenez JM, Martin-Gil B, Munoz-Moreno MF, Martin-Santos AB, Del Rio-Garcia I, Redondo-Perez N, Lopez M. The influence of preoperative anxiety on postoperative pain in patients undergoing cardiac surgery. Sci Rep. 2022 Oct 1;12(1):16464. doi: 10.1038/s41598-022-20870-9.

    PMID: 36183003BACKGROUND

  • Prado-Olivares J, Chover-Sierra E. Preoperatory Anxiety in Patients Undergoing Cardiac Surgery. Diseases. 2019 Jun 19;7(2):46. doi: 10.3390/diseases7020046.

    PMID: 31248177BACKGROUND

  • Ramesh C, Nayak BS, Pai VB, Patil NT, George A, George LS, Devi ES. Effect of Preoperative Education on Postoperative Outcomes Among Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis. J Perianesth Nurs. 2017 Dec;32(6):518-529.e2. doi: 10.1016/j.jopan.2016.11.011. Epub 2017 Apr 13.

    PMID: 29157759BACKGROUND

Study Officials

  • Joanna Chikwe, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aminah Sallam, MD

CONTACT

3104233277aminah.sallam@cshs.org

Allen Armin Razavi, MD

CONTACT

3104233277armin.razavi@cshs.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor & Chairman, Department of Cardiac Surgery

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 25, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)