TelemedicineSQUIRESNCT04983329
Systematic Quality Improvement With Realtime Event Support
A study testing Telemedicine intervention in people with Telemedicine, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Telemedicine
- What is being tested?
- Telemedicine intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,506 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 10 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients having procedures at Barnes-Jewish Hospital in suites not part of the TECTONICS trial will be included.
Who cannot join
- Patients enrolled in the ongoing TECTONICS intraoperative Anesthesiology Control Tower telemedicine trial at Barnes-Jewish Hospital will be excluded from this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine/Barnes Jewish Hospital
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Telemedicine
- Being tested
- Telemedicine intervention
- Keywords
- Telemedicine, Quality-Improvement, surgical antibiotics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Telemedicine intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8 months
Secondary outcomes (1)
Surgical site infection rate
Decrease the proportion of patients which develop surgical site infections throughout the duration of the trial.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start8 Nov 2021
- Primary completion12 Jun 2022
- Study completion10 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelemedicineStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25,506 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Kerby, Washington University School of Medicine
- Investigators
- Troy Wildes, MD, Principal investigator, Washington Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983329
- Sponsor's protocol ID
- 202107031
- Acronym
- SQUIRES
- Status last verified
- Apr 2023
- First submitted
- 16 Jul 2021
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Quality Improvement With Realtime Event Support
- ClinicalTrials.gov ID
- NCT04983329
- Acronym / sponsor ID
- SQUIRES / 202107031
- Conditions
- Telemedicine
- Keywords
- Telemedicine, Quality-Improvement, surgical antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25,506 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 10 Sep 2022 (actual)
- First posted
- 30 Jul 2021 (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 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Improvement in administration of surgical antibiotic prophylaxis. | Other | Other: Telemedicine interventionThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having procedures at Barnes-Jewish Hospital in suites not part of the TECTONICS trial will be included.
Key exclusion criteria (1 listed)
- Patients enrolled in the ongoing TECTONICS intraoperative Anesthesiology Control Tower telemedicine trial at Barnes-Jewish Hospital will be excluded from this study
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 |
|---|---|---|
| Telemedicine interventionFollowing 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. | Other | Improvement in administration of surgical antibiotic prophylaxis. |
Primary outcome
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.
Improvement in administration of surgical antibiotic prophylaxis-after quality improvement intervention
Time frame: 2 months
1b. Increase the rate of on-time surgical antibiotic prophylaxis administration prior to incision six weeks after the quality improvement intervention is completed.
Improvement in administration of surgical antibiotic prophylaxis
Time frame: 8 months
1c. Increase the rate of on-time re-dosing of antibiotic prophylaxis throughout the duration of the trial.
1 secondary outcome
Surgical site infection rate
Time frame: 8 months
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 28 Apr 2023.
- 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.
Troy Wildes, MD principal investigator
Washington Univeristy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine intervention in people with Telemedicine, run by Washington University School of Medicine 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 1 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 28 Apr 2023. 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?
Improvement in administration of surgical antibiotic prophylaxis- intervention period (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2023.