Post-operative ComplicationsNCT06533111
Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool
A study testing Epic Health Record semi-structured handoff cognitive aid in people with Post-operative Complications, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Post-operative Complications
- What is being tested?
- Epic Health Record semi-structured handoff cognitive aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,763 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to 16 May 2026
- 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 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- American Society of Anesthesiologists (ASA) Physical Status 6 (organ donors)
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
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
- Being tested
- Epic Health Record semi-structured handoff cognitive aid, Usual care
- Keywords
- Intraoperative anesthesia handoffs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epic Health Record semi-structured handoff cognitive aidOther
Epic Health Record cognitive aid will be used for intraoperative anesthesia handoff
Usual careOther
Epic Health Record cognitive aid will not be used for intraoperative anesthesia handoff
| Study group | Role | What they receive |
|---|---|---|
| Epic Health Record semi-structured handoff cognitive aid | Experimental | Not described Receives: Other: Epic Health Record semi-structured handoff cognitive aid |
| Usual care | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that have Myocardial Injury after Non-Cardiac Surgery/Myocardial Infarction
Measured: upto 30 days after surgery
Number of participants that have Acute Kidney Injury
Measured: from baseline upto 30 days after surgery
Number of participants that need Post-op blood transfusion
Measured: upto 24 hours after surgery
Number of participants that need Prolonged intubation
Measured: end of surgery(about 180 minutes after start of surgery)
Number of participants that have Pneumonia
Measured: within 30 days after surgery
Number of participants that need reintubation
Measured: within 24 hours after surgery
Number of participants that need Rapid Response Team Activation
Measured: within 24 hours after surgery
Number of participants that need Readmission
Measured: within 30 days after surgery
Number of participants that die after surgery
Measured: 30 days after surgery
Secondary outcomes (4)
Number of participants that have Postoperative Hypotension
Measured: within 24 hours after surgery
Number of participants that have Hypoxia
Measured: within 2 hours after surgery
Number of participants that have Uncontrolled pain
Pain score average >/= 5 on a 10-point scale
Measured: within 2 hours after surgery
Number of participants that have Intraoperative hypotension
Mean Arterial Pressure < 65 mmHg
Measured: at least 15 minutes intraoperatively following first intraoperative anesthesia handoff
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start1 Nov 2024
- Primary completion16 May 2026
- Study completion16 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative ComplicationsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,763 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Aubrey Samost-Williams, The University of Texas Health Science Center, Houston
- Investigators
- Aubrey Samost-Williams, MD, MS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06533111
- Sponsor's protocol ID
- HSC-MS-24-0552
- Other IDs
- 1K12TR004908-01
- Status last verified
- Jun 2026
- First submitted
- 29 Jul 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41248419
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool
- ClinicalTrials.gov ID
- NCT06533111
- Acronym / sponsor ID
- HSC-MS-24-0552
- Conditions
- Post-operative Complications
- Keywords
- Intraoperative anesthesia handoffs
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,763 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 16 May 2026 (actual)
- Study completion
- 16 May 2026 (actual)
- First posted
- 1 Aug 2024 (actual)
- 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) Physical Status 6 (organ donors)
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 |
|---|---|---|
| Epic Health Record semi-structured handoff cognitive aidEpic Health Record cognitive aid will be used for intraoperative anesthesia handoff | Other | Epic Health Record semi-structured handoff cognitive aid |
| Usual careEpic Health Record cognitive aid will not be used for intraoperative anesthesia handoff | Other | Usual care |
Primary outcome
Number of participants that have Myocardial Injury after Non-Cardiac Surgery/Myocardial Infarction
Time frame: upto 30 days after surgery
Number of participants that have Acute Kidney Injury
Time frame: from baseline upto 30 days after surgery
Number of participants that need Post-op blood transfusion
Time frame: upto 24 hours after surgery
Number of participants that need Prolonged intubation
Time frame: end of surgery(about 180 minutes after start of surgery)
Number of participants that have Pneumonia
Time frame: within 30 days after surgery
Number of participants that need reintubation
Time frame: within 24 hours after surgery
Number of participants that need Rapid Response Team Activation
Time frame: within 24 hours after surgery
Number of participants that need Readmission
Time frame: within 30 days after surgery
Number of participants that die after surgery
Time frame: 30 days after surgery
4 secondary outcomes
Number of participants that have Postoperative Hypotension
Time frame: within 24 hours after surgery
Number of participants that have Hypoxia
Time frame: within 2 hours after surgery
Number of participants that have Uncontrolled pain
Time frame: within 2 hours after surgery
Number of participants that have Intraoperative hypotension
Time frame: at least 15 minutes intraoperatively following first intraoperative anesthesia handoff
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Derived from this study: PubMed 41248419Samost-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.
- Individual participant dataSharing planned: No
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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.
Aubrey Samost-Williams, MD, MS principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epic Health Record semi-structured handoff cognitive aid in people with Post-operative Complications, run by The University of Texas Health Science Center, Houston 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 2 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: finished, as of the sponsor's last update on 3 Jun 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants that have Myocardial Injury after Non-Cardiac Surgery/Myocardial Infarction (time frame: upto 30 days after surgery). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06533111, which also lists 1 linked publication.
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 3 Jun 2026.