Video-Based AI-Generated Peri-operative Instructions for Mitral Valve Surgery (VIP-IMPACT)

February 23, 2026 updated by: Joanna Chikwe

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

  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center Smidt Heart Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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.
  2. Inconsistent access to a smart device with internet connection throughout the study period.
  3. Inability to speak, read, and understand English or Spanish
  4. Need for any concomitant procedure at the time of MV repair

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peri-Operative Standard of Care and Artificial Intelligence Video Education Arm
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
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.
No Intervention: Peri-Operative Standard of Care Education only Arm
In this arm, patients will receive the usual Standard of Care Peri-Operative Education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Unplanned Healthcare Utilization events
Time Frame: From randomization to 30 days post-surgery
includes the following events: unplanned (i.e. patient initiated) phone calls, emails, clinic visits, and ED visits.
From randomization to 30 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joanna Chikwe

Collaborators

Cedars Sinai Medical Center, Los Angeles, USA

Investigators

  • Principal Investigator: Joanna Chikwe, MD, Cedars-Sinai Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 17, 2025

First Submitted That Met QC Criteria

June 17, 2025

First Posted (Actual)

June 25, 2025

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STUDY00003876

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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