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Case Study — Cardiac Cath Lab Post-Treatment Surveillance

A world-leading cardiac catheterization laboratory (cath lab) associated with a major teaching hospital participates regularly as a co-investigator in clinical trials. They use a number of advanced treatments to treat their patients and are interested in the long-term benefits of the care they provide. Traditionally, they stopped tracking the progress of their patients once they were discharged from the hospital. However, because of recent highly publicized treatment failures, they have become more active in gathering post-treatment data.

Business Driver

The cath lab needed to respond quickly after receiving a multi-year research grant from a pharmaceutical company to gather information from thousands of patients who receive percutaneous catheter intervention (PCI). Under the terms of the research contract, the lab would be required to conduct a quality of care survey for patients at thirty-day and one year intervals following their discharge from the hospital. The data collected in the surveillance survey would focus on specific symptoms along with general quality of life information.

Solution Description

To meet these requirements, a senior analyst from Coping Systems worked in close partnership with researchers to deploy an automated survey solution that implemented the study protocol. This automated survey was approved by the hospital's Internal Review Board (IRB), a group responsible for the ethical foundation of the study as well as patient privacy.

On a nightly basis, the system queries the cath lab database and extracts discharged PCI-patient records into active case files. The software also checks for patients that have been re-admitted to the hospital for a PCI, as these patients are only surveyed once. Research assistants conducting the follow-up surveys can access these active case files. Cases are randomly assigned and automatically load-balanced among the research assistants.

Thirty days following discharge (if the patient has not opted out of the study), the Scheduler notifies a research assistant to contact the patient by telephone. The researcher has three attempts to contact each patient. For each subsequent attempt, the Scheduler automatically recommends a different time of day to call.

When the patient is contacted, the research assistant launches a SOURCE patient survey chart. The form prompts the user to ask the patient a series of twelve questions. The questions are presented in a sequential fashion using a branched script that follows a path according to the way the patient answered previous questions. All possible answers are available through drop down lists so that the research assistant can complete the calls efficiently and courteously.

Benefit

Since the initial installation, this solution has processed more than 3,000 patient participants through multiple trial milestones. By automating the survey system, the hospital estimates that it has saved the equivalent of a full-time staff member who would have been needed to manually manage the study. By monitoring the treatment and follow-up information, the hospital and sponsor company can better evaluate the data to ensure that the treatment being provided is safe.

Project Deployment

This was a fast-track project moving from initial conception to deployment in approximately two months. Because Coping Systems had already supplied a CASCADE database for the cath lab, gathering the data for the surveillance system was relatively straightforward. In later phases, it is expected that DELTA will be used to analyze the data statistically. Challenges met during this implementation included ensuring that the study protocol was implemented properly as well as providing a fool-proof system for the constantly changing research assistants conducting the survey.

System Configuration

Key Components
Products	CASCADE DELTA
Services	Detailed System Analysis and Design Project Management System Training Integration with Existing Hospital Systems Clinical Level Test Clinic Deployment Continuous Remote Monitoring of System Health
Infrastructure	Microsoft SQL Server Secure VPN Microsoft Office
Summary	Thousands of patients have been surveyed in a post market post treatment study sponsored be a medical device company. The surveillance system is HIPAA compliant and easy to use. The system automates an otherwise tedious and error-prone process.