Intraoperative Anesthesia Care Transition Checklist

NCT02453828 | Terminated

• 1 other identifier: 15-192
• Study Type: interventional
• Target: 7,348
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• a composite of in-hospital mortality and 6 major morbidities including serious cardiac, respiratory, gastrointestinal, urinary, bleeding, and infectious complications

  5 days

Study Arms (2)

Checklist

EXPERIMENTAL

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

Procedure: Non-cardiac surgery

Standard of Care

ACTIVE COMPARATOR

after non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care

Procedure: Non-cardiac surgery

Interventions

Non-cardiac surgery PROCEDURE

patients having non-cardiac surgery

Checklist; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• non-cardiac surgery

You may not qualify if:

• under 18 years of age

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Leif Saager, M.D.

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: May 27, 2015
• Study Start: June 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: April 10, 2019

Record last verified: 2019-04

Locations

US (1)