- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04983329
Systematic Quality Improvement With Realtime Event Support (SQUIRES)
April 26, 2023 updated by: Paul Kerby, Washington University School of Medicine
The goal of this study is to improve perioperative quality metric performance in patients receiving anesthesia care provided by Washington University Department of Anesthesiology.
In this protocol, we describe (1) the use of telemedicine-augmented quality improvement interventions to enhance on-time dosage of surgical prophylactic antibiotics, while (2) carrying out large scale monitoring of surgical site infection incidence in the target population.
If this quality improvement framework is found to be feasible and successful, we plan subsequently to study its application to additional perioperative quality metrics, including many pertinent to surgical site infection incidence such as perioperative glucose monitoring and management, and intraoperative temperature management.
Study Overview
Study Type
Interventional
Enrollment (Actual)
25506
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
-
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine/Barnes Jewish Hospital
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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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients having procedures at Barnes-Jewish Hospital in suites not part of the TECTONICS trial will be included.
Exclusion Criteria:
- Patients enrolled in the ongoing TECTONICS intraoperative Anesthesiology Control Tower telemedicine trial at Barnes-Jewish Hospital will be excluded from this study
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: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Improvement in administration of surgical antibiotic prophylaxis.
The eight-month module will include a baseline phase, educational interventions, real-time guidance from a remote telemedicine center, regular feedback regarding adherence to protocols related to that module, and continued silent monitoring.
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Following education, the telemedicine center will subsequently monitor operating rooms included in this trial for protocol adherence for three-months.
The telemedicine center is staffed by attending anesthesiologists, resident anesthesiologists, certified registered nurse anesthetists (CRNAs) and student registered nurse anesthetists (SRNAs) and is currently providing evidence-based support to clinicians in a subset of operating rooms and post-anesthesia care unit (PACU) beds at Barnes-Jewish Hospital.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improvement in administration of surgical antibiotic prophylaxis- intervention period
Time Frame: 3 months
|
1a. Increase the rate of on-time surgical antibiotic prophylaxis administration prior to incision during the intervention period.
|
3 months
|
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Improvement in administration of surgical antibiotic prophylaxis-after quality improvement intervention
Time Frame: 2 months
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1b. Increase the rate of on-time surgical antibiotic prophylaxis administration prior to incision six weeks after the quality improvement intervention is completed.
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2 months
|
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Improvement in administration of surgical antibiotic prophylaxis
Time Frame: 8 months
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1c. Increase the rate of on-time re-dosing of antibiotic prophylaxis throughout the duration of the trial.
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8 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgical site infection rate
Time Frame: 8 months
|
Decrease the proportion of patients which develop surgical site infections throughout the duration of the trial.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this 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 8, 2021
Primary Completion (Actual)
June 12, 2022
Study Completion (Actual)
September 10, 2022
Study Registration Dates
First Submitted
July 16, 2021
First Submitted That Met QC Criteria
July 29, 2021
First Posted (Actual)
July 30, 2021
Study Record Updates
Last Update Posted (Actual)
April 28, 2023
Last Update Submitted That Met QC Criteria
April 26, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 202107031
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
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.