Mitral Regurgitation
Conditions
Brief summary
This is a prospective Quality Improvement (QI) study using the Model for Improvement framework. The objective of this study is to implement a structured, comprehensive, innovative, and sustainable approach to the management of patients with advanced mitral valve (MV) disease and heart failure (HF) in Southeastern Ontario and to improve healthcare delivery, patient care, and patient outcomes in the context of structural surgical and percutaneous MV interventions. This will be achieved through the strategic implementation, promotion, and evaluation of: i.The first local Southeastern Ontario Structural Mitral Valve Clinic using an Interdisciplinary heart team (IHT) at the Kingston Health Sciences Centre (KHSC) and its integration with the KHSC's existing Heart Failure Clinic; ii.The first provincial Structural Mitral Valve Clinic electronic referral service on the Ontario electronic services platform; and iii.The promotion of the above through targeted KT (Knowledge Transfer) outreach activities. Patients for this study will be recruited through medical referral within the south eastern Ontario, Canada region.
Interventions
PROCEDUREMitraClip procedure
MitraClip is surgical procedure to repair the mitral valve in your heart. During the procedure, the doctor will access the mitral valve using a thin tube (called a catheter) that is guided through a vein in your leg to reach your heart. A small implanted clip is attached to the mitral valve to reduce the leaking across the valve and to reduce symptoms and stress on the heart.
Sponsors
AFP Innovation Fund
Queen's University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
All adults (≥18 years of age) patients with primary and secondary moderate to severe MR with HF (preserved or reduced ejection fraction with New York Heart Association (NYHA) Class \>II), who have had at least one previous hospitalization for HR, require specialist advisement, and have provided signed informed consent.
Exclusion criteria
* Those who are not eligible for either an MV surgical intervention or a TMVI procedure. * Females of childbearing age who are not willing or unable to use a reliable method of birth control. * Inpatient referrals.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wait time 1 | At week three following study entry. | The time between date referral made and date acknowledged by cardiologist. |
| Wait time 3 | At week sixteen following study entry. | The time from acceptance for a procedure to time of procedure. |
| Wait time 2 | At week sixteen following study entry. | The time from acceptance for a procedure to time of pre-procedure imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity 1 | At 30 days post procedure. | Morbidity = all cause hospitalization and heart failure hospitalization post procedure. |
| Morbidity 2 | At one year post procedure. | Morbidity = all cause hospitalization and heart failure hospitalization post procedure. |
| Mortality 1 | At 30 days post procedure. | Mortality = all cause mortality |
| Mortality 2 | At one year post procedure. | Mortality = all cause mortality |
Other
| Measure | Time frame | Description |
|---|---|---|
| Electronic referral patient experience survey | At day one (study entry). | A survey of patient experience and satisfaction with the electronic referral method. Comments: The survey will be developed by the study investigator and each patient experience related question will be answered using the following scale: Strongly agree ☐ Agree ☐ Neither agree or disagree ☐ Disagree ☐ Strongly disagree. ☐ NA |
| Electronic referral usage - inappropriate eReferrals | At day one (study entry). | proportion (%) of inappropriate eReferrals. |
| Electronic referral usage - response time | At day one (study entry). | median specialist response interval time (days). |
| Electronic referral usage - eReferrals answered | At day one (study entry). | Proportion (%) of eReferral answered |
| Electronic referral usage - specialist time | At day one (study entry). | median time (hours) spent by specialist on eReferral. |
| Cost comparison 1 | At one day post procedure. | Cost comparison between eReferral and traditional referrals based on number of baseline (pre-procedural) lab tests and investigations. |
| Cost comparison 2 | On the day prior to procedure. | Cost comparison between eReferral and traditional referrals based on number of missed clinic visits. |
Countries
Canada
Contacts
Primary ContactBrigita Zile, RN, CCRP
Backup ContactWael Abuzeid, MD
Outcome results
None listed