Anesthesiology Control Tower

Not Applicable

Completed

• Conditions: Health Information Technology

• Registration Number: NCT02830126
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2016-07-07
• Study First Submitted QC: 2016-07-07
• Study First Posted: 2016-07-12
• Study Start: 2016-11
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-21
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States