- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06533111
Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool
June 1, 2026 updated by: Aubrey Samost-Williams, The University of Texas Health Science Center, Houston
The purpose of this study is to assess the impact of a semi-structured intraoperative anesthesia handoff tool on patient outcomes and to assess the validity of the 5-Factor Perceived Shared Mental Model Scale (5-PSMMS) in a healthcare setting and whether the perception of Shared Mental Model (SMM) mediates the effect of the intraoperative handoff tool on postoperative outcomes
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3763
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Undergoing non-cardiac surgery in the main operating rooms (e.g. not the endoscopy suite or labor and delivery ward)
- Undergoing at least one permanent (e.g. end of shift) anesthesia clinician handoff
Exclusion Criteria:
- American Society of Anesthesiologists (ASA) Physical Status 6 (organ donors)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual care
|
Epic Health Record cognitive aid will not be used for intraoperative anesthesia handoff
|
|
Experimental: Epic Health Record semi-structured handoff cognitive aid
|
Epic Health Record cognitive aid will be used for intraoperative anesthesia handoff
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of participants that die after surgery
Time Frame: 30 days after surgery
|
30 days after surgery
|
|
Number of participants that have Myocardial Injury after Non-Cardiac Surgery/Myocardial Infarction
Time Frame: upto 30 days after surgery
|
upto 30 days after surgery
|
|
Number of participants that have Acute Kidney Injury
Time Frame: from baseline upto 30 days after surgery
|
from baseline upto 30 days after surgery
|
|
Number of participants that need Post-op blood transfusion
Time Frame: upto 24 hours after surgery
|
upto 24 hours after surgery
|
|
Number of participants that need Prolonged intubation
Time Frame: end of surgery(about 180 minutes after start of surgery)
|
end of surgery(about 180 minutes after start of surgery)
|
|
Number of participants that have Pneumonia
Time Frame: within 30 days after surgery
|
within 30 days after surgery
|
|
Number of participants that need reintubation
Time Frame: within 24 hours after surgery
|
within 24 hours after surgery
|
|
Number of participants that need Rapid Response Team Activation
Time Frame: within 24 hours after surgery
|
within 24 hours after surgery
|
|
Number of participants that need Readmission
Time Frame: within 30 days after surgery
|
within 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants that have Postoperative Hypotension
Time Frame: within 24 hours after surgery
|
within 24 hours after surgery
|
|
|
Number of participants that have Hypoxia
Time Frame: within 2 hours after surgery
|
within 2 hours after surgery
|
|
|
Number of participants that have Uncontrolled pain
Time Frame: within 2 hours after surgery
|
Pain score average >/= 5 on a 10-point scale
|
within 2 hours after surgery
|
|
Number of participants that have Intraoperative hypotension
Time Frame: at least 15 minutes intraoperatively following first intraoperative anesthesia handoff
|
Mean Arterial Pressure < 65 mmHg
|
at least 15 minutes intraoperatively following first intraoperative anesthesia handoff
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aubrey Samost-Williams, MD, MS, The University of Texas Health Science Center, Houston
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2024
Primary Completion (Actual)
May 16, 2026
Study Completion (Actual)
May 16, 2026
Study Registration Dates
First Submitted
July 29, 2024
First Submitted That Met QC Criteria
July 29, 2024
First Posted (Actual)
August 1, 2024
Study Record Updates
Last Update Posted (Actual)
June 3, 2026
Last Update Submitted That Met QC Criteria
June 1, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC-MS-24-0552
- 1K12TR004908-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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