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Anesthesiology Control Tower (ACTFAST)

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ClinicalTrials.gov Identifier: NCT02830126
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to implement an Anesthesiology Control Tower (ACT). This pilot study will employ the existing information technology infrastructure at Barnes Jewish Hospital to create a remote monitoring and alerting system for the operating rooms. Similar to "telemedicine" methods employed in critical care, the ACT will support operating room clinicians in adhering to best-practice principles.

Condition or disease Intervention/treatment
Health Information Technology Other: Anesthesiology Control Tower Feedback

Detailed Description:
The study will logically build on our previous work and utilize the already established infrastructure and resources of the intra-operative electronic medical record and the AlertWatch® alerting system. In conceptualizing this pilot study, as well as a larger follow-up trial focused on clinical outcomes, we have been mindful of challenges put forward to investigators by the National Institutes of Health, which seek to support low-cost, pragmatic, patient-centered randomized controlled trials.91 Specifically in relation to ACTFAST, (1) the highly developed, specialized IT infrastructure limits the investment required for embarking on this study; (2) the study will be conducted entirely within the context of routine clinical care, negating the need for dedicated trial-related visits; (3) access to registries with granular data on complications and patient-reported outcomes obviates the need for a new and costly infrastructure to track patient outcomes; (4) inclusion of large numbers of broadly representative patients in this study will be highly efficient with a waiver of informed consent.91 The design for this pilot proof-of-concept study will be a randomized clinical effectiveness trial. It will include a 6-month pre-intervention period during which time the ACT will be staffed but no alerts will be sent. This will allow for the training of controllers, refinement of alerts, and optimization of processes for obtaining and filtering information from diverse electronic sources. Following this period, the trial will begin and run for 12 months. On a daily basis during the study period (weekdays from 7am to 5pm), each operating room in Barnes-Jewish Hospital (BJH) will be eligible for randomization, which will occur using computer-generated assignment. Anesthesiology teams in ORs allocated to the experimental arm will receive the additional support of the ACT in the form of control-tower alerts that complement the AlertWatch® system. The outcomes of interest in this pilot study will be the usability and usefulness of the ACT, clinician adherence to recommendations for monitoring, documentation and therapeutic interventions, key physiologic variables such as temperature and blood pressure. We will also document patient outcomes including duration of postoperative hospital stay, incidence of postoperative morbidity (myocardial infarction, surgical site infection), functional recovery, and postoperative quality of life. Data on these endpoints will inform the design of a subsequent trial focused on clinically relevant outcomes, which will logically follow the current pilot randomized trial. All of the alerts included in this study will be chosen because they follow proven best intraoperative management practice and are in line with national metrics for quality and safety.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Other
Official Title: Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)
Actual Study Start Date : November 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: Anesthesiology Control Tower Control
Patients managed by anesthesia teams without feedback alerts from the ACT
Experimental: Anesthesiology Control Tower Feedback
Patients managed by anesthesia teams with feedback alerts from the ACT
Other: Anesthesiology Control Tower Feedback
Clinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room.


Outcome Measures

Primary Outcome Measures :
  1. Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite [ Time Frame: 2 years ]
    Usability and usefulness are key features of successful implementation of new information technologies 24,99,100. The success of the proof-of-concept ACT implementation and its perceived usefulness and usability depend on participation and support of the entire anesthetic team. Our usability testing procedure will explore the 5Es (effectiveness, efficiency, engagement, error tolerance, ease of learning) needed to develop a useful and usable resource.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On a daily basis during the study period (weekdays from 7am to 5pm), each operating room of Barnes-Jewish Hospital (BJH) will be eligible for randomization, which will occur at the level of the operating room using computer-generated assignment.

Exclusion Criteria:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830126


Contacts
Contact: Sherry McKinnon, BS 314-286-1768 smckinnon@wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Sherry McKinnon, BS    314-286-1768    mckinnos@anest.wustl.edu   
Principal Investigator: Michael S. Avidan, MBBCh, FCASA         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Michael S Avidan, MBBCh Washington University School of Medicine
Study Director: Daniel Helsten, MD Washington University School of Medicine
Study Director: Anshuman Sharma, MD Washington University School of Medicine
Study Director: Richard Benzinger, MD Washington University Shcool of Medicine
Study Director: Yixin Chen, PhD Washington University School of Medicine
Study Director: Mitchell Fingerman, MD Washington University School of Medicine
Study Director: Jason Gillihan, MD Washington University School of Medicine
Study Director: Ryan Guffey, MD Washington University School of Medicine
Study Director: Rocco Hueneke, MD Washington University School of Medicine
Study Director: Joseph F Kras, MD, DDS, MA Washington University School of Medicine
Study Director: Anand Lakshminarasimhachar, MD Washington University School of Medicine
Study Director: Teresa Murray, MD Washington University School of Medicine
Study Director: Rashmi Rathor, MD Washington University School of Medicine
Study Director: Tracey Stevens, MD Washington University School of Medicine
Study Director: Martha Z Szabo, MD Washington University School of Medicine
Study Director: Swarup S Varaday, MD Washington University School of Medicine
Study Director: Troy Wildes, MD Washington University School of Medicine
Study Director: Branden E Yee, MD Washington University School of Medicine
Principal Investigator: Bradley Fritz, MD Washington University School of Medicine
Principal Investigator: Mary C Politi, PhD Washington University School of Medicine
Principal Investigator: Stephen Gregory, MD Washington University School of Medicine
Principal Investigator: Frances Wallace, BS Washington University School of Medicine
Study Director: Menelaos Karanikolas, MD Washington University School of Medicine
Study Director: Helga Komen, MD Washington University School of Medicine
Study Chair: Ivan Kangrga, MD Washington University School of Medicine
Study Director: Justin Knittel, MD Washington University School of Medicine
Study Director: Jonathan Zoller, MD Washington University School of Medicine
Study Director: Jessica Zenga, MD Washington University School of Medicine
More Information

Responsible Party: Michael Avidan, Professor of Anesthesiology and Surgery, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02830126     History of Changes
Other Study ID Numbers: 201603038
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael Avidan, Washington University School of Medicine:
Outcomes
Information technology

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs