Study protocol for the Anesthesiology Control Tower-Feedback Alerts to Supplement Treatments (ACTFAST-3) trial: a pilot randomized controlled trial in intraoperative telemedicine

Abstract

Background: Each year, over 300 million people undergo surgical procedures worldwide. Despite efforts to improve outcomes, postoperative morbidity and mortality are common. Many patients experience complications as a result of either medical error or failure to adhere to established clinical practice guidelines. This protocol describes a clinical trial comparing a telemedicine-based decision support system, the Anesthesiology Control Tower (ACT), with enhanced standard intraoperative care. Methods: 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. Primary outcomes include blood glucose management and temperature management. Secondary outcomes will include surrogate, clinical, and economic outcomes, such as incidence of intraoperative hypotension, postoperative respiratory compromise, acute kidney injury, delirium, and volatile anesthetic utilization. Ethics and dissemination: The ACTFAST-3 study has been approved by the Human Resource Protection Office (HRPO) at Washington University in St. Louis and is registered at clinicaltrials.gov ( NCT02830126). Recruitment for this protocol began in April 2017 and will end in December 2018. Dissemination of the findings of this study will occur via presentations at academic conferences, journal publications, and educational materials.

Keywords: decision support; protocol; randomized controlled trial; telemedicine.

Figure 1.. Flow diagram of study population.

Figure 2.. Interface of the AlertWatch ^® Control Tower system.

( A) AlertWatch ^® Control Tower Census View. This view shows summary information for operating rooms with ongoing procedures. Physiological alerts (e.g., low blood pressure) are shown as black or red squares, depending on the severity of the derangement, with red indicating a more severe abnormality. Checkmarks appear inside an operating room when an alert is triggered that has been classified as actionable and requires a response on the part of the clinicians in the Control Tower (see Figure 3). Control rooms are indicated with a “Do Not Contact” symbol. ( B) AlertWatch ^® Control Tower Patient Display View. This deidentified intraoperative patient display demonstrates organ-specific information individualized to each patient. Colors outlining organs indicate normal (green), marginal (yellow) or abnormal function (red). Orange would indicate an organ system at risk due to pre-existing conditions. The left side of the display shows patient characteristics and the case information. Lab values, if available, are listed beneath the kidneys. Alerts generated by the AlertWatch ^® system are listed on the right-hand side of the display. Specific alerts, determined by the study team to be clinically significant and actionable, trigger a checkmark to appear at the bottom left of the screen. This informs the Anesthesiology Control Tower (ACT) clinician that an alert is present that must be addressed. Clicking on this checkmark allows clinicians in the ACT to review and address these alerts ( Figure 3).

Figure 3.. AlertWatch ^® Control Tower Case Review dialogue.

Clinicians in the Anesthesiology Control Tower (ACT) use the Case Review window to address actionable Control Tower alerts, indicated by checkmarks on the Census View and the Patient Display. Within this Case Review window, clinicians document their assessment of the significant of each alert, what action they would recommend, and, in the case of intervention operating rooms (ORs), the reaction of the clinician in the OR to the ACT support.