Clinical trial NCT02830126: Anesthesiology Control Tower
Official title: Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Information Technology
Keywords: Outcomes
Information technology
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2016-07-12
Enrollment: 15158
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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:

-

Primary outcomes:
measure: Compliance with recommendations for intraoperative temperature management
timeFrame: 1 day
measure: Compliance with recommendations for intraoperative blood glucose management
timeFrame: 1 day
measure: Assess the usability of the Anesthesiology Control Tower (ACT) for an operating suite
timeFrame: 2 years
Secondary outcomes:
measure: Intraoperative blood pressure management
timeFrame: 1 day
measure: Temperature monitoring
timeFrame: 1 day
measure: Antibiotic dosing
timeFrame: 1 day
measure: Intraoperative blood glucose management
timeFrame: 1 day
measure: Train of four documentation
timeFrame: 1 day
measure: Ventilator management
timeFrame: 1 day
measure: Volatile anesthetic utilization
timeFrame: 1 day
measure: Postoperative acute renal failure
timeFrame: 30 days
measure: Postoperative atrial fibrillation
timeFrame: 30 days
measure: Postoperative respiratory failure
timeFrame: 30 days
measure: Postoperative delirium
timeFrame: 30 days
measure: Intraoperative awareness
timeFrame: 30 days
measure: Surgical site infection
timeFrame: 30 days
measure: 30-day readmission
timeFrame: 30 days
measure: 30-day mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael S Avidan, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Daniel Helsten, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Anshuman Sharma, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Richard Benzinger, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Yixin Chen, PhD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Mitchell Fingerman, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Jason Gillihan, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Ryan Guffey, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Rocco Hueneke, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Joseph F Kras, MD, DDS, MA
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Anand Lakshminarasimhachar, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Teresa Murray, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Rashmi Rathor, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Tracey Stevens, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Martha Z Szabo, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Swarup S Varaday, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Troy Wildes, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Branden E Yee, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Bradley Fritz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Mary C Politi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Stephen Gregory, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Menelaos Karanikolas, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Helga Komen, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Ivan Kangrga, MD
role: STUDY_CHAIR
affiliation: Washington University School of Medicine
name: Justin Knittel, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Jonathan Zoller, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.