NCT04983329

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,506

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 30, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

November 8, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2022

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

July 16, 2021

Last Update Submit

April 26, 2023

Conditions

Keywords

TelemedicineQuality-Improvementsurgical antibiotics

Outcome Measures

Primary Outcomes (3)

  • Improvement in administration of surgical antibiotic prophylaxis- intervention period

    1a. Increase the rate of on-time surgical antibiotic prophylaxis administration prior to incision during the intervention period.

    3 months

  • Improvement in administration of surgical antibiotic prophylaxis-after quality improvement intervention

    1b. Increase the rate of on-time surgical antibiotic prophylaxis administration prior to incision six weeks after the quality improvement intervention is completed.

    2 months

  • Improvement in administration of surgical antibiotic prophylaxis

    1c. Increase the rate of on-time re-dosing of antibiotic prophylaxis throughout the duration of the trial.

    8 months

Secondary Outcomes (1)

  • Surgical site infection rate

    8 months

Study Arms (1)

Improvement in administration of surgical antibiotic prophylaxis.

OTHER

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.

Other: Telemedicine intervention

Interventions

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.

Improvement in administration of surgical antibiotic prophylaxis.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having procedures at Barnes-Jewish Hospital in suites not part of the TECTONICS trial will be included.

You may not qualify if:

  • Patients enrolled in the ongoing TECTONICS intraoperative Anesthesiology Control Tower telemedicine trial at Barnes-Jewish Hospital will be excluded from this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Study Officials

  • Troy Wildes, MD

    Washington Univeristy School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof of Anesthesiology

Study Record Dates

First Submitted

July 16, 2021

First Posted

July 30, 2021

Study Start

November 8, 2021

Primary Completion

June 12, 2022

Study Completion

September 10, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations