Anesthesiology Control Tower

Health Information Technology Clinical Trial

— ACTFAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02830126
• Other study ID #: 201603038
• Secondary ID: 1R21HS024581-01A
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 30, 2019

Study information

• Verified date: January 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15158
• Est. completion date: June 30, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Health Information Technology

Intervention

Other:
• Anesthesiology Control Tower Feedback
Clinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Intraoperative blood pressure management	Mean duration of time spent with Mean Arterial Pressure < 60 mmHg	1 day
Secondary	Temperature monitoring	Proportion of procedures lasting greater than 1 hour with documented temperature	1 day
Secondary	Antibiotic dosing	Proportion of procedures with appropriate administration of repeat doses of antibiotics	1 day
Secondary	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
Secondary	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
Secondary	Ventilator management	Proportion of cases with median tidal volume less than 10 mL/kg ideal body mass	1 day
Secondary	Volatile anesthetic utilization	Mean and standard deviation of fresh gas flow rates for cases with volatile anesthetic use > 80% of case duration	1 day
Secondary	Postoperative acute renal failure	Incidence of individual outcomes	30 days
Secondary	Postoperative atrial fibrillation	Incidence of individual outcomes	30 days
Secondary	Postoperative respiratory failure	Incidence of individual outcome	30 days
Secondary	Postoperative delirium	Incidence of individual outcome	30 days
Secondary	Intraoperative awareness	Incidence of individual outcomes	30 days
Secondary	Surgical site infection	Incidence of individual outcomes	30 days
Secondary	30-day readmission	Incidence of individual outcomes	30 days
Secondary	30-day mortality	Mortality will be assessed at 30 days	30 days