Cardiac SurgeryNCT02864238
The Utility of Clinical Milestones Pathway in a Cardiovascular ICU
An observational study of Cardiac Surgery, run by Vanderbilt University.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- electronic milestone pathway
- How many people
- 2,401 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who underwent cardiac valve surgery at vanderbilt university medical center between 1/1/2013 and 12/31/2014
Who may be able to join
- Underwent cardiac valve surgery at vanderbilt university medical center between 1/1/2013 and 12/31/2014
Who cannot join
- none
About this study
Official title: The Utility of an Electronic Based Milestone Pathway on the Care of Patients Undergoing Cardiac Valve Surgery
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.
Read more
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.
Read the 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.
- Conditions
- Cardiac Surgery
- Being tested
- electronic milestone pathway
- Keywords
- electronic milestone pathway, cardiac valve surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic milestone pathwayOther
an electronic based, clinical milestone driven pathway developed to guide the care of cardiac valve surgery patients.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: electronic milestone pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality rate for patients during index hospitalization
Measured: Post operative day 0 to post operative day 7
Secondary outcomes (8)
Re-intubation rate within 48 hours
re-intubation rate within 48 hours of index procedure for patients undergoing cardiac surgery
Measured: 48 hours of index procedure
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
Measured: All time points occurring between post operative day 0 and Post operative day 7
Delirium
Incidence of delirium as defined by Intensive Care Unit Confusion Assessment Method (ICU-CAM) scoring system during index hospitalization
Measured: All time points occurring between post operative day 0 and Post operative day 7
major adverse cardiac events
Incidence of major adverse cardiac events defined as death, need for re-operation, myocardial infarction during index hospitalization
Measured: All time points occurring between post operative day 0 and Post operative day 7
Infection rates
defined as Catheter Associated Urinary Tract Infection (CAUTI), Central Line Associated Blood Stream Infection (CLABSI), sternal wound infection during index hospitalization
Measured: All time points occurring between post operative day 0 and Post operative day 7
Direct cost
summation of costs directly attributable to patient care during index hospitalization
Measured: All time points occurring between post operative day 0 and Post operative day 7
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.)
Measured: All time points occurring between post operative day 0 and Post operative day 7
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.
Measured: All time points occurring between post operative day 0 and Post operative day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Kingeter, Vanderbilt University
- Investigators
- Lee Parmley, MD, JD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864238
- Sponsor's protocol ID
- IRB #151566
- Status last verified
- Aug 2016
- First submitted
- 13 Jul 2016
- Last updated
- 12 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Utility of an Electronic Based Milestone Pathway on the Care of Patients Undergoing Cardiac Valve Surgery
- ClinicalTrials.gov ID
- NCT02864238
- Acronym / sponsor ID
- IRB #151566
- Conditions
- Cardiac Surgery
- Keywords
- electronic milestone pathway, cardiac valve surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,401 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: electronic milestone pathwayThis cohort consists of patients who underwent cardiac valve surgery during calender year 2014 after the electronic milestone pathway had been instituted |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who underwent cardiac valve surgery at vanderbilt university medical center between 1/1/2013 and 12/31/2014
Key inclusion criteria (1 listed)
- Underwent cardiac valve surgery at vanderbilt university medical center between 1/1/2013 and 12/31/2014
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electronic milestone pathwayan electronic based, clinical milestone driven pathway developed to guide the care of cardiac valve surgery patients. | Other | post intervention |
Primary outcome
mortality
Time frame: Post operative day 0 to post operative day 7
mortality rate for patients during index hospitalization
8 secondary outcomes
Re-intubation rate within 48 hours
Time frame: 48 hours of index procedure
Acute Kidney Injury as defined by KDIGO (Kidney Disease Improving Global Outcomes) guidelines
Time frame: All time points occurring between post operative day 0 and Post operative day 7
Delirium
Time frame: All time points occurring between post operative day 0 and Post operative day 7
major adverse cardiac events
Time frame: All time points occurring between post operative day 0 and Post operative day 7
Infection rates
Time frame: All time points occurring between post operative day 0 and Post operative day 7
Direct cost
Time frame: All time points occurring between post operative day 0 and Post operative day 7
total cost
Time frame: All time points occurring between post operative day 0 and Post operative day 7
variance in cost
Time frame: All time points occurring between post operative day 0 and Post operative day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Parmley, MD, JD principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Surgery, run by Vanderbilt University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: Post operative day 0 to post operative day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2016.