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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 : May 10, 2018
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Michael Avidan, Washington University School of Medicine

Brief Summary:
This study is a pragmatic, comparative effectiveness trial that will randomize approximately 12,000 adult surgical patients on an operating room (OR) level to a control or to an intervention group. All OR clinicians will have access to decision support software within the OR as a part of enhanced standard intraoperative care. The ACT will monitor patients in both groups and will provide additional support to the clinicians assigned to intervention ORs.

Condition or disease Intervention/treatment Phase
Health Information Technology Other: Anesthesiology Control Tower Feedback Not Applicable

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. 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. 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 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 : December 2018
Estimated Study Completion Date : December 2019

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.




Primary Outcome Measures :
  1. Compliance with recommendations for intraoperative temperature management [ Time Frame: 1 day ]
    Proportion of patients with final recorded temperature in OR greater than 36 degrees Celsiustemperature, the target for this outcome was that the ACT intervention will increase the proportion of patients whose final recorded intraoperative temperature is above 36 degrees Celsius from 60% to 95%. For this calculation we assumed a standard deviation of core temperature of 0.9 degrees Celsius for both groups based on an unpublished EMR audit.

  2. Compliance with recommendations for intraoperative blood glucose management [ Time Frame: 1 day ]
    Proportion of cases with blood glucose <=180 mg/dL upon arrival to the anesthesia recovery area

  3. 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.


Secondary Outcome Measures :
  1. Intraoperative blood pressure management [ Time Frame: 1 day ]
    Mean duration of time spent with Mean Arterial Pressure < 60 mmHg

  2. Temperature monitoring [ Time Frame: 1 day ]
    Proportion of procedures lasting greater than 1 hour with documented temperature

  3. Antibiotic dosing [ Time Frame: 1 day ]
    Proportion of procedures with appropriate administration of repeat doses of antibiotics

  4. Intraoperative blood glucose management [ Time Frame: 1 day ]
    Proportion of cases with at least one dose of insulin administered for blood glucose greater than 180 mg/dL Intraoperative measurement of blood glucose in patients with type 1 diabetes undergoing cases >= 1 hour in length and patients with type 2 diabetes undergoing cases > 2 hours in length

  5. Train of four documentation [ Time Frame: 1 day ]
    Proportion of cases with a train of four documented prior to extubation if a nondepolarizing neuromuscular blocking agent was administered

  6. Ventilator management [ Time Frame: 1 day ]
    Proportion of cases with median tidal volume less than 10 mL/kg ideal body mass

  7. Volatile anesthetic utilization [ Time Frame: 1 day ]
    Mean and standard deviation of fresh gas flow rates for cases with volatile anesthetic use > 80% of case duration

  8. Postoperative acute renal failure [ Time Frame: 30 days ]
    Incidence of individual outcomes

  9. Postoperative atrial fibrillation [ Time Frame: 30 days ]
    Incidence of individual outcomes

  10. Postoperative respiratory failure [ Time Frame: 30 days ]
    Incidence of individual outcome

  11. Postoperative delirium [ Time Frame: 30 days ]
    Incidence of individual outcome

  12. Intraoperative awareness [ Time Frame: 30 days ]
    Incidence of individual outcomes

  13. Surgical site infection [ Time Frame: 30 days ]
    Incidence of individual outcomes

  14. 30-day readmission [ Time Frame: 30 days ]
    Incidence of individual outcomes

  15. 30-day mortality [ Time Frame: 30 days ]
    Mortality will be assessed at 30 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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:


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
Agency for Healthcare Research and Quality (AHRQ)
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 School 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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
1R21HS024581-01A1 ( U.S. AHRQ Grant/Contract )
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 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