NCT02864238

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,401

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

1.9 years

First QC Date

July 13, 2016

Last Update Submit

August 10, 2016

Conditions

Keywords

electronic milestone pathwaycardiac valve surgery

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality rate for patients during index hospitalization

    Post operative day 0 to post operative day 7

Secondary Outcomes (8)

  • Re-intubation rate within 48 hours

    48 hours of index procedure

  • Acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines

    All time points occurring between post operative day 0 and Post operative day 7

  • Delirium

    All time points occurring between post operative day 0 and Post operative day 7

  • major adverse cardiac events

    All time points occurring between post operative day 0 and Post operative day 7

  • Infection rates

    All time points occurring between post operative day 0 and Post operative day 7

  • +3 more secondary outcomes

Study Arms (2)

Pre intervention

This cohort consists of patients who underwent cardiac valve surgery during calender year 2013 prior to the institution of the electronic milestone pathway

post intervention

This cohort consists of patients who underwent cardiac valve surgery during calender year 2014 after the electronic milestone pathway had been instituted

Other: electronic milestone pathway

Interventions

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

post intervention

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who underwent cardiac valve surgery at vanderbilt university medical center between 1/1/2013 and 12/31/2014

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Lee Parmley, MD, JD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 13, 2016

First Posted

August 11, 2016

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 12, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share