Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool

NCT06533111 | Recruiting

• 2 other identifiers: HSC-MS-24-05521K12TR004908-01
• Study Type: interventional
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-operative Complications

Keywords

Intraoperative anesthesia handoffs

Outcome Measures

Primary Outcomes (9)

• Number of participants that have Myocardial Injury after Non-Cardiac Surgery/Myocardial Infarction

  upto 30 days after surgery

• Number of participants that have Acute Kidney Injury

  from baseline upto 30 days after surgery

• Number of participants that need Post-op blood transfusion

  upto 24 hours after surgery

• Number of participants that need Prolonged intubation

  end of surgery(about 180 minutes after start of surgery)

• Number of participants that have Pneumonia

  within 30 days after surgery

• Number of participants that need reintubation

  within 24 hours after surgery

• Number of participants that need Rapid Response Team Activation

  within 24 hours after surgery

• Number of participants that need Readmission

  within 30 days after surgery

• Number of participants that die after surgery

  30 days after surgery

Secondary Outcomes (4)

• Number of participants that have Postoperative Hypotension

  within 24 hours after surgery

• Number of participants that have Hypoxia

  within 2 hours after surgery

• Number of participants that have Uncontrolled pain

  within 2 hours after surgery

• Number of participants that have Intraoperative hypotension

  at least 15 minutes intraoperatively following first intraoperative anesthesia handoff

Study Arms (2)

Epic Health Record semi-structured handoff cognitive aid

EXPERIMENTAL

Other: Epic Health Record semi-structured handoff cognitive aid

Usual care

ACTIVE COMPARATOR

Other: Usual care

Interventions

Epic Health Record semi-structured handoff cognitive aid OTHER

Epic Health Record cognitive aid will be used for intraoperative anesthesia handoff

Epic Health Record semi-structured handoff cognitive aid

Usual care OTHER

Epic Health Record cognitive aid will not be used for intraoperative anesthesia handoff

Usual care

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• American Society of Anesthesiologists (ASA) Physical Status 6 (organ donors)

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• Samost-Williams A, Green CE, Kao LS, Sridhar S, Sessler DI, Turan A, Thomas EJ. Assessing the impact of a semi-structured intraoperative anaesthesia handoff cognitive aid on surgical patient outcomes: study protocol for a cluster randomised trial. BMJ Open. 2025 Nov 4;15(11):e110401. doi: 10.1136/bmjopen-2025-110401.

  PMID: 41248419 DERIVED

Study Officials

• Aubrey Samost-Williams, MD, MS

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aubrey Samost-Williams, MD, MS

CONTACT

(713) 500-6200; Aubrey.SamostWilliams@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Non-Tenure Clinical

Model Details: The non-cardiac adult operating rooms at Memorial Hermann Hospital are split into 2 floors, Sarofim 2 and Sarofim 3. These floors will be the unit of clustering. One floor will be randomized to the intervention arm and the other to the control arm. Every 4 weeks both floors will be re-randomized again to either arm for a total of 18 weeks.

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: November 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)