Mitral Valve Repair SurgeryVIP-IMPACTNCT07036926
Video-Based AI-Generated Peri-operative Instructions for Mitral Valve Surgery
A study testing Artificial Intelligence Video Education Arm in people with Mitral Valve Repair Surgery, run by Joanna Chikwe at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Repair Surgery
- What is being tested?
- Artificial Intelligence Video Education Arm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients ≥ 18 years planned for elective, isolated MV repair.
- Provide Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cedars Sinai Medical Center Smidt Heart Institute
Los Angeles, California, 90048
Aminah Sallam, MD, 310-423-1874, aminah.sallam@cshs.org
About this study
Official title: Video-Based AI-Generated Peri-operative Instructions for Mitral Valve Surgery: A Randomized Controlled Trial on Health Outcomes and Patient Experience
- 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
- The main procedures are questionnaires and watching a video.
- The subject population includes patients who are scheduled for isolated mitral valve repair surgery.
- All study procedures will occur here at Cedars Sinai.
Read the 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.
- Conditions
- Mitral Valve Repair Surgery
- Being tested
- Artificial Intelligence Video Education Arm
- Keywords
- Artificial Intelligence, Video education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Unplanned Healthcare Utilization events
includes the following events: unplanned (i.e. patient initiated) phone calls, emails, clinic visits, and ED visits.
Measured: From randomization to 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start1 Aug 2025
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mitral Valve Repair SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joanna Chikwe
- Sponsor type
- University, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Responsible party
- Sponsor-investigator, Joanna Chikwe, Cedars-Sinai Medical Center
- Investigators
- Joanna Chikwe, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07036926
- Sponsor's protocol ID
- STUDY00003876
- Acronym
- VIP-IMPACT
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36018625Tromp 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.
PubMed 15196195Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
PubMed 12724430Ljungqvist 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.
PubMed 36937915Watson 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.
PubMed 29287049Brodersen 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.
PubMed 36641521Berkman 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.
PubMed 21768583Fernandez-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.
PubMed 36183003Prado-Olivares J, Chover-Sierra E. Preoperatory Anxiety in Patients Undergoing Cardiac Surgery. Diseases. 2019 Jun 19;7(2):46. doi: 10.3390/diseases7020046.
PubMed 31248177Ramesh 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.
PubMed 29157759
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video-Based AI-Generated Peri-operative Instructions for Mitral Valve Surgery: A Randomized Controlled Trial on Health Outcomes and Patient Experience
- ClinicalTrials.gov ID
- NCT07036926
- Acronym / sponsor ID
- VIP-IMPACT / STUDY00003876
- Conditions
- Mitral Valve Repair Surgery
- Keywords
- Artificial Intelligence, Video education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Joanna ChikweUniversity, hospital or other
- Collaborators
- Cedars-Sinai Medical Center
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- The main procedures are questionnaires and watching a video.
- The subject population includes patients who are scheduled for isolated mitral valve repair surgery.
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-Operative Standard of Care and Artificial Intelligence Video Education Arm | Active comparator | Other: Artificial Intelligence Video Education ArmIn this arm, patients will receive AI-generated, interactive, peri-operative video education program in addition to standard of care education |
| Peri-Operative Standard of Care Education only Arm | No intervention | –In this arm, patients will receive the usual Standard of Care Peri-Operative Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients ≥ 18 years planned for elective, isolated MV repair.
- Provide Informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence Video Education ArmA 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. | Other | Peri-Operative Standard of Care and Artificial Intelligence Video Education Arm |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 36018625van 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.
- Background: PubMed 15196195Tromp 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.
- Background: PubMed 12724430Kessels RP. Patients' memory for medical information. J R Soc Med. 2003 May;96(5):219-22. doi: 10.1177/014107680309600504. No abstract available.
- BackgroundLjungqvist 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: PubMed 36937915Grab 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.
- Background: PubMed 29287049Watson 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.
- Background: PubMed 36641521Brodersen 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.
- Background: PubMed 21768583Berkman 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.
- Background: PubMed 36183003Fernandez-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.
- Background: PubMed 31248177Prado-Olivares J, Chover-Sierra E. Preoperatory Anxiety in Patients Undergoing Cardiac Surgery. Diseases. 2019 Jun 19;7(2):46. doi: 10.3390/diseases7020046.
- Background: PubMed 29157759Ramesh 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.
- Individual participant dataSharing planned: No
Related trials for Mitral Valve Repair Surgery
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Recruiting
Use of Force Feedback Instruments With the da Vinci Surgical System, Model IS5000 for Mitral Valve Repair
Mitral Regurgitation (MR)
Active, not recruiting
PRIMARY Ancillary Substudy
Mitral Valve Prolapse, Left Ventricular Fibrosis
RecruitingObservational study
Management and Clinical Outcomes of Patients With Severe Mitral Valve Disease Not Suitable for Surgery
Mitral Valve Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanna Chikwe, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence Video Education Arm in people with Mitral Valve Repair Surgery, run by Joanna Chikwe at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aminah Sallam, MD (3104233277, aminah.sallam@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Unplanned Healthcare Utilization events (time frame: From randomization to 30 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07036926, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.