Clinical trial NCT02864238: The Utility of Clinical Milestones Pathway in a Cardiovascular ICU
Official title: The Utility of an Electronic Based Milestone Pathway on the Care of Patients Undergoing Cardiac Valve Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Surgery
Keywords: electronic milestone pathway
cardiac valve surgery
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 2401
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who underwent cardiac valve surgery at vanderbilt university medical center between 1/1/2013 and 12/31/2014

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* none

Primary outcomes:
measure: mortality
timeFrame: Post operative day 0 to post operative day 7
Secondary outcomes:
measure: Re-intubation rate within 48 hours
timeFrame: 48 hours of index procedure
measure: Acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines
timeFrame: All time points occurring between post operative day 0 and Post operative day 7
measure: Delirium
timeFrame: All time points occurring between post operative day 0 and Post operative day 7
measure: major adverse cardiac events
timeFrame: All time points occurring between post operative day 0 and Post operative day 7
measure: Infection rates
timeFrame: All time points occurring between post operative day 0 and Post operative day 7
measure: Direct cost
timeFrame: All time points occurring between post operative day 0 and Post operative day 7
measure: total cost
timeFrame: All time points occurring between post operative day 0 and Post operative day 7
measure: variance in cost
timeFrame: All time points occurring between post operative day 0 and Post operative day 7
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lee Parmley, MD, JD
role: PRINCIPAL_INVESTIGATOR
References: