Anesthesiology Control Tower (ACTFAST)

Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)

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.

Study Overview

• Status: Completed
• Conditions: Health Information Technology
• Intervention / Treatment: 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. 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
• Enrollment (Actual): 15158
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance with recommendations for intraoperative temperature management	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.	1 day
Compliance with recommendations for intraoperative blood glucose management	Proportion of cases with blood glucose <=180 mg/dL upon arrival to the anesthesia recovery area	1 day
Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood pressure management	Mean duration of time spent with Mean Arterial Pressure < 60 mmHg	1 day
Temperature monitoring	Proportion of procedures lasting greater than 1 hour with documented temperature	1 day
Antibiotic dosing	Proportion of procedures with appropriate administration of repeat doses of antibiotics	1 day
Intraoperative blood glucose management	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	1 day
Train of four documentation	Proportion of cases with a train of four documented prior to extubation if a nondepolarizing neuromuscular blocking agent was administered	1 day
Ventilator management	Proportion of cases with median tidal volume less than 10 mL/kg ideal body mass	1 day
Volatile anesthetic utilization	Mean and standard deviation of fresh gas flow rates for cases with volatile anesthetic use > 80% of case duration	1 day
Postoperative acute renal failure	Incidence of individual outcomes	30 days
Postoperative atrial fibrillation	Incidence of individual outcomes	30 days
Postoperative respiratory failure	Incidence of individual outcome	30 days
Postoperative delirium	Incidence of individual outcome	30 days
Intraoperative awareness	Incidence of individual outcomes	30 days
Surgical site infection	Incidence of individual outcomes	30 days
30-day readmission	Incidence of individual outcomes	30 days
30-day mortality	Mortality will be assessed at 30 days	30 days

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: 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 and helpful links

General Publications

• Gregory S, Murray-Torres TM, Fritz BA, Ben Abdallah A, Helsten DL, Wildes TS, Sharma A, Avidan MS; ACTFAST Study Group. Study protocol for the Anesthesiology Control Tower-Feedback Alerts to Supplement Treatments (ACTFAST-3) trial: a pilot randomized controlled trial in intraoperative telemedicine. F1000Res. 2018 May 22;7:623. doi: 10.12688/f1000research.14897.2. eCollection 2018.
• Murray-Torres TM, Wallace F, Bollini M, Avidan MS, Politi MC. Anesthesiology Control Tower: Feasibility Assessment to Support Translation (ACT-FAST)-a feasibility study protocol. Pilot Feasibility Stud. 2018 Jan 25;4:38. doi: 10.1186/s40814-018-0233-4. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: July 7, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimate): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 21, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Outcomes; Information technology
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 201603038; 1R21HS024581-01A1 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No