Digital Health – Coronary Stent Registry
BUSINESS CASE
Client intended to conduct a Post Market Surveillance (PMS) registry of Coronary Stent System for percutaneous coronary intervention in all-comers Indian population.
THE STUDY
- was a multi-center, non-randomized, single arm clinical trial to be conducted at up to 50 sites in India
- purpose to assess the clinical efficacy; document the safety and effectiveness of the stent system.
- aimed to enroll 1000 patients with symptomatic ischemic heart disease that is amenable to percutaneous coronary intervention (PCI) and stent deployment.
BUSINESS REQUIREMENT
A web based information system that can capture the CRF (Case Report Form) data comprising patient inclusion, angioplasty intervention, post-op follow up, adverse event records with easy to use interface for coordinators and site investigators (Cardiologists) to input patient follow-up data post percutaneous coronary intervention (PCI) and stent deployment for up to 1.5 years.
Real-Time Remote Patient Monitoring Solution
To meet Client’s business requirement as outlined above, Mutelcor architected and developed a multi-user, scalable, centralized Digital Health platform to drive, administer, compute registry statistics, and implement decision support to achieve the desired clinical performance outcomes to ensure the success of registry milestones. In order to achieve the same, Digital Health solution comprised of following components:
A dedicated Mobile App for Coordinators (Nurses)
A simple to use android based application for the coordinators (nurses) to pre-screen, register enroll and follow up patients, post percutaneous coronary intervention (PCI) and stent deployment across all 50 centers in India with following as key features of the mobile app:
Digital Form Filling: Patient Data form filling (Baseline Characteristics, Inclusion, Angioplasty Intervention, Follow up & Adverse Event Reporting); attach & upload patient reports.
Patient Manager: Patient Manager allowed the coordinator to view all patient enrolment listing and add new patients as part of the enrolment process
Patient Follow up Notifications: ‘Push Notification’ on the mobile application anytime there is an activity related to form submission, updation and patient follow up for the coordinators to keep the track of patient follow up as desired and defined in the pioneer registry process.
Responsive Web Portal for Site Investigators (Doctors) & Administrators
A multi user responsive web portal for the site investigators and project administrators to assess the registry performance, view progress on daily basis & structure the post market surveillance activities in line with the registry requirements; this was achieved through key functionalities of web based information system such as:
- Doctor Dashboard: View/track center wise registry KPI performance Analytics
- Administrator Dashboard: View/track zone wise registry KPI performance Analytics
- Task Management such as Auto Notifications/Reminders/Comments/Notes/Calendar/Follow up scheduling
Patient Database Management
A cost-effective cloud platform was deployed to support secure sharing and accessibility of patient health data by providing scalability, flexibility, protection and back-ups. Cloud based data management helped the client save significant operational costs, drive an error free and paperless operation in the registry process across 50 hospitals/centers in the country. Hence the custom cloud solution helped the client focus on registry milestones rather than diverting attention to manage physical data center warehousing in multi centers.
Overall benefit to the client
- Real-time Remote Patient Monitoring from anywhere globally
- Quick and easy Paperless Registry Operation
- Error-Free Secured patient data capturing
- Multi-dimensional Detailed Analytics of vast data within seconds
- Fast measurement of Registry Management KPIs