Intraoperative Anesthesia Care Transition Checklist
Primary Purpose
Postoperative Complications
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-cardiac surgery
Sponsored by
About this trial
This is an interventional supportive care trial for Postoperative Complications
Eligibility Criteria
Inclusion Criteria:
- non-cardiac surgery
Exclusion Criteria:
- under 18 years of age
Sites / Locations
- Cleveland Clinic Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Checklist
Standard of Care
Arm Description
after non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care with an additional, electronically pre-populated checklist displayed on the anesthesia record keeping system
after non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care
Outcomes
Primary Outcome Measures
a composite of in-hospital mortality and 6 major morbidities including serious cardiac, respiratory, gastrointestinal, urinary, bleeding, and infectious complications
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02453828
Brief Title
Intraoperative Anesthesia Care Transition Checklist
Official Title
The Effects of Implementing an Anesthesia Information Management System Guided Intraoperative Anesthesia Care Transition Checklist on Postoperative Complications: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
PI has requested for this study be closed due to technical issues
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Perioperative management decisions must often be made quickly and rely on practitioners having relevant facts at hand. During transitions of patient care between anesthesia providers, known as "handovers," information may not be completely or faithfully communicated, consequently impairing the provider's ability to intervene correctly in response to subsequent events. Checklists have consistently proven to be effective at enhancing communications during handovers, but whether anesthesia checklists improve patient outcomes has yet to be proven. The investigators propose to randomize intraoperative anesthesia provider handovers to standard practice (no specific format) or to a handover checklist presented by a decision-support system in conjunction with the investigators electronic record. Specifically, the investigators will test the hypothesis that incorporating a largely pre-populated handover checklist into transitions of intraoperative anesthesia care decreases a composite of mortality and serious cardiovascular, respiratory, gastrointestinal, urinary, and infectious complications.
Detailed Description
The modern team-based approached to patient care often involves transitioning care between providers. Critical details may be lost during transition, or handovers, resulting in delays, inefficiencies, suboptimal care, or even patient harm. The Joint Commission on Hospital Accreditation declared that communication failures are the root cause of almost two-thirds of all sentinel events. The World Health Organization similarly listed "communication during patient care handover" as one of the highest patient safety initiatives. The consequence of ineffectual communication may be especially detrimental during surgery when patients are often unstable and post-handover decisions must be made quickly and accurately. In a preliminary study the investigators observed an 8% increase in odds of experiencing major in-hospital morbidity or mortality per for each intraoperative handover.
Checklists have been used for transitions of care in a variety of areas; orthopedic trauma, urological robotic surgeries, and emergency departments. The field of anesthesia has also embraced the use of checklists, especially in the handover to intensive care units. Post-anesthesia checklists have been the particular focus of anesthesia providers in recent years. Post-operative checklists clearly enhance information transfer, but have only been evaluated using historical controls which do not account for bias. The anesthesia area most lacking valid studies is intraoperative handovers.
Anesthesia-specific intraoperative handovers differ because the interaction is primarily between anesthesia providers while surgery continues without disruption. To date, there has only been one proposed checklist for intraoperative handovers between anesthesia providers and it has not been prospectively evaluated. A randomized study with contemporaneous controls, utilizing an anesthesia specific, electronically pre-populated checklist measuring objective "hard" outcomes will address the limitations of previous studies.
The investigators propose to test the hypothesis that incorporating an electronic handover checklist during transitions of intraoperative anesthesia care reduces serious complications. Specifically, the investigators will quantify the effect of a handover checklist on adverse outcomes as defined by a composite of mortality and serious cardiovascular, respiratory, gastrointestinal, urinary, and infectious complications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
7348 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Checklist
Arm Type
Experimental
Arm Description
after non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care with an additional, electronically pre-populated checklist displayed on the anesthesia record keeping system
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
after non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care
Intervention Type
Procedure
Intervention Name(s)
Non-cardiac surgery
Intervention Description
patients having non-cardiac surgery
Primary Outcome Measure Information:
Title
a composite of in-hospital mortality and 6 major morbidities including serious cardiac, respiratory, gastrointestinal, urinary, bleeding, and infectious complications
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-cardiac surgery
Exclusion Criteria:
under 18 years of age
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leif Saager, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
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Intraoperative Anesthesia Care Transition Checklist
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