NCT02830126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

2.7 years

First QC Date

July 7, 2016

Last Update Submit

January 21, 2020

Conditions

Health Information Technology

Keywords

OutcomesInformation technology

Outcome Measures

Primary Outcomes (3)

  • 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this calculation we assumed a standard deviation of core temperature of 0.9 degrees Celsius for both groups based on an unpublished EMR audit.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 Outcomes (15)

  • Intraoperative blood pressure management

    1 day

  • Temperature monitoring

    1 day

  • Antibiotic dosing

    1 day

  • Intraoperative blood glucose management

    1 day

  • Train of four documentation

    1 day

  • +10 more secondary outcomes

Study Arms (2)

Anesthesiology Control Tower Control

NO INTERVENTION

Patients managed by anesthesia teams without feedback alerts from the ACT

Anesthesiology Control Tower Feedback

EXPERIMENTAL

Patients managed by anesthesia teams with feedback alerts from the ACT

Other: Anesthesiology Control Tower Feedback

Interventions

Anesthesiology Control Tower FeedbackOTHER

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

Anesthesiology Control Tower Feedback

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

  • King CR, Gregory S, Fritz BA, Budelier TP, Ben Abdallah A, Kronzer A, Helsten DL, Torres B, McKinnon S, Goswami S, Mehta D, Higo O, Kerby P, Henrichs B, Wildes TS, Politi MC, Abraham J, Avidan MS, Kannampallil T; ACTFAST Study Group. An Intraoperative Telemedicine Program to Improve Perioperative Quality Measures: The ACTFAST-3 Randomized Clinical Trial. JAMA Netw Open. 2023 Sep 5;6(9):e2332517. doi: 10.1001/jamanetworkopen.2023.32517.

    PMID: 37738052DERIVED

  • 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.

    PMID: 30026931DERIVED

  • 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.

    PMID: 29416871DERIVED

Study Officials

  • Michael S Avidan, MBBCh

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

  • Menelaos Karanikolas, MD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Helga Komen, MD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Ivan Kangrga, MD

    Washington University School of Medicine

    STUDY CHAIR

  • Justin Knittel, MD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Jonathan Zoller, MD

    Washington University School of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology and Surgery

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 12, 2016

Study Start

November 1, 2016

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

January 22, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)