The Utility of Clinical Milestones Pathway in a Cardiovascular ICU

Cardiac Surgery Clinical Trial

Official title: The Utility of an Electronic Based Milestone Pathway on the Care of Patients Undergoing Cardiac Valve Surgery

Status Completed

Clinical Trial Summary

The economic burden of health care is becoming a greater burden from year to year. Medicare spending, which represented 20 percent of national health spending in 2013, grew 3.4 percent to $585.7 billion, a slowdown from growth of 4.0 percent in 2012. This slowdown was attributed largely to slower enrollment growth and impacts of the Affordable Care Act (ACA) and sequestration. Per-enrollee spending in 2013 grew at about the same rate as 2012.

The push to create Accountable Care Organizations (ACO) has taken these initiatives a step further. The goal would be to move away from a fee for service system and base reimbursement on quality of care. Clinical metrics, re-admissions, and patient satisfaction in categories of acute myocardial infarction, congestive heart failure, pneumonia, surgeries and healthcare associated infections will be the foci for 2013. Centers for Medicare and Medicaid Services (CMS) has also initiated a valve bundled payment system that encompasses total patient care for 90 days, including readmissions.

Leapfrog and the ACO movement along with the nonprofit group Institute for Health Care Improvement have placed quality and cost effectiveness into the spotlight for clinicians in the ICU and beyond. While clinicians have always been focused on evidence based therapies with little concern for cost, in the new era of healthcare understanding cost, value and effectiveness of therapies will be key for improved patient outcomes and institutional solvency in trying economic times.

Vanderbilt elected to enroll in the CMS valve bundle trial. The Leadership team in the heart and vascular institute identified the importance of an electronic medical record that includes display and utilization of key drivers of quality and success across the continuum of care (Preoperative assessment to discharge up to 90 days) in the bundled payment model of care. A multidisciplinary team was developed in conjunction with nurses, midlevel providers, multi-specialty physicians, case managers, informatics specialists, and performance improvement representatives to develop an electronic pathway of care using evidence based and best practices for cardiac surgery.

Clinical Trial Description

A multidisciplinary team consisting of physicians, pharmacists, nutritionists, social workers, bedside nurses, physical therapists, and mid-level providers developed the structure and key elements of the milestone pathway. The Vanderbilt University Informatics Team developed the electronic version of the consensus milestones. The pathway encompasses 17 phases beginning with the pre-procedure evaluation and continuing through the perioperative period until the three-month follow-up post procedure. The nursing staff performed documentation of pathway stages during the index hospitalization, and the milestone stage was displayed on the door of the patient's room. The milestone stage was discussed on multi-disciplinary bedside rounds in the ICU, and if a patient could not progress to the next stage the nurse would document the reason for failure to progress.

In this study, the investigators compared patients who underwent valve surgery with the milestone pathway in place, to patients who underwent valve surgery without the milestone pathway in place. Patients were adjusted according to baseline characteristics such as demographics, procedure, and proceduralist collected from the electronic medical record and Society of Thoracic Surgeons (STS) database.

The investigators primary clinical outcome is mortality, and secondary clinical outcomes include the incidence of re-intubation within 48 hours, acute kidney injury as defined by Kidney Disease Improving Global Outcome (KDIGO) criteria, delirium, major adverse cardiac events (MACE), and infection rates for catheter and central line associated infections as well as sternal wound infection. In addition the investigators examined financial outcomes including variance in direct and total cost, and direct and total cost per patient. ;

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiac Surgery

• NCT number: NCT02864238
• Study type: Observational
• Source: Vanderbilt University
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Completion date: December 2014