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Postoperative ComplicationsNCT02453828

Intraoperative Anesthesia Care Transition Checklist

A study testing Non-cardiac surgery in people with Postoperative Complications, run by The Cleveland Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Complications
What is being tested?
Non-cardiac surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,348 participants
Where
1 siteUnited States
Study dates
Jun 2015to Dec 2018
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • non-cardiac surgery

Who cannot join

  • under 18 years of age

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: The Effects of Implementing an Anesthesia Information Management System Guided Intraoperative Anesthesia Care Transition Checklist on Postoperative Complications: A Randomized Trial

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.

Read the 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.

Being tested
Non-cardiac surgery
Medical subject headings
Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-cardiac surgeryProcedure or surgery

    patients having non-cardiac surgery

Study groups in NCT02453828
Study groupRoleWhat they receive
ChecklistExperimentalafter 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
Receives: Procedure: Non-cardiac surgery
Standard of CareActive comparatorafter non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care
Receives: Procedure: Non-cardiac surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionDec 2018
  4. Study completionDec 2018

Why it stopped: PI has requested for this study be closed due to technical issues

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
7,348 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02453828
Sponsor's protocol ID
15-192
Status last verified
Apr 2019
First submitted
9 Mar 2015
Last updated
10 Apr 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Non-cardiac surgery in people with Postoperative Complications, run by The Cleveland Clinic at 1 site in United States.

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: stopped early, as of the sponsor's last update on 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 was stopped early (reason given: PI has requested for this study be closed due to technical issues). Results are not available in the source record.

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?

a composite of in-hospital mortality and 6 major morbidities including serious cardiac, respiratory, gastrointestinal, urinary, bleeding, and infectious complications (time frame: 5 days). 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 10 Apr 2019.

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