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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02864238
• Other study ID #: IRB #151566
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: August 10, 2016
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2401
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Underwent cardiac valve surgery at vanderbilt university medical center between 1/1/2013 and 12/31/2014

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Other:
• electronic milestone pathway
an electronic based, clinical milestone driven pathway developed to guide the care of cardiac valve surgery patients.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	mortality rate for patients during index hospitalization	Post operative day 0 to post operative day 7	No
Secondary	Re-intubation rate within 48 hours	re-intubation rate within 48 hours of index procedure for patients undergoing cardiac surgery	48 hours of index procedure	No
Secondary	Acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines	Incidence of acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines during index hospitalization	All time points occurring between post operative day 0 and Post operative day 7	No
Secondary	Delirium	Incidence of delirium as defined by Intensive Care Unit Confusion Assessment Method (ICU-CAM) scoring system during index hospitalization	All time points occurring between post operative day 0 and Post operative day 7	No
Secondary	major adverse cardiac events	Incidence of major adverse cardiac events defined as death, need for re-operation, myocardial infarction during index hospitalization	All time points occurring between post operative day 0 and Post operative day 7	No
Secondary	Infection rates	defined as Catheter Associated Urinary Tract Infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), sternal wound infection during index hospitalization	All time points occurring between post operative day 0 and Post operative day 7	No
Secondary	Direct cost	summation of costs directly attributable to patient care during index hospitalization	All time points occurring between post operative day 0 and Post operative day 7	No
Secondary	total cost	summation of costs directly attributable to patient care, as well as costs to the patient which are not directly attributable to patient care (unspecified charges to patient such as OR utilization fees, laboratory staff fees, etc.)	All time points occurring between post operative day 0 and Post operative day 7	No
Secondary	variance in cost	total and direct costs attributable to each patient undergoing cardiac valve surgery will be averaged for all patients undergoing cardiac valve surgery during the study period. Each individual patient's direct and total costs will then be compared to the averaged cost for all patients undergoing cardiac valve surgery hospitalization to obtain a variance in cost for each individual patient undergoing cardiac valve surgery. The investigators will then compare average variance between the two cohorts.	All time points occurring between post operative day 0 and Post operative day 7	No