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.
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.
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.
- Conditions
- Postoperative 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Non-cardiac surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted27 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: PI has requested for this study be closed due to technical issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leif Saager, M.D., Principal investigator, The Cleveland Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Implementing an Anesthesia Information Management System Guided Intraoperative Anesthesia Care Transition Checklist on Postoperative Complications: A Randomized Trial
- ClinicalTrials.gov ID
- NCT02453828
- Acronym / sponsor ID
- 15-192
- Conditions
- Postoperative Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has requested for this study be closed due to technical issues
- Enrolment
- 7,348 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 May 2015 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Checklist | Experimental | Procedure: Non-cardiac surgeryafter 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 |
| Standard of Care | Active comparator | Procedure: Non-cardiac surgeryafter non-cardiac surgery, patients will have current standard-of-care anesthesia handover during anesthesia transitions in care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non-cardiac surgery
Key exclusion criteria (1 listed)
- under 18 years of age
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 |
|---|---|---|
| Non-cardiac surgerypatients having non-cardiac surgery | Procedure or surgery | Checklist, Standard of Care |
Primary outcome
a composite of in-hospital mortality and 6 major morbidities including serious cardiac, respiratory, gastrointestinal, urinary, bleeding, and infectious complications
Time frame: 5 days
Results and safety
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.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
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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.
Leif Saager, M.D. principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
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.