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

Joanna Chikwe

Status: Not yet enrolling

Conditions: Mitral Valve Repair Surgery

Treatments: Other: Artificial Intelligence Video Education Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT07036926

STUDY00003876

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Other: Artificial Intelligence Video Education Arm

Peri-Operative Standard of Care Education only Arm

No Intervention group

Description:

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