Health Information TechnologyACTFASTNCT02830126
Anesthesiology Control Tower
A study of Health Information Technology, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Information Technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,158 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)
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.
Read the 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.
- Conditions
- Health Information Technology
- Being tested
- Anesthesiology Control Tower Feedback
- Keywords
- Outcomes, Information technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesiology Control Tower FeedbackOther
Clinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Anesthesiology Control Tower Feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 2 years
Secondary outcomes (15)
Intraoperative blood pressure management
Mean duration of time spent with Mean Arterial Pressure < 60 mmHg
Measured: 1 day
Temperature monitoring
Proportion of procedures lasting greater than 1 hour with documented temperature
Measured: 1 day
Antibiotic dosing
Proportion of procedures with appropriate administration of repeat doses of antibiotics
Measured: 1 day
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
Measured: 1 day
Train of four documentation
Proportion of cases with a train of four documented prior to extubation if a nondepolarizing neuromuscular blocking agent was administered
Measured: 1 day
Ventilator management
Proportion of cases with median tidal volume less than 10 mL/kg ideal body mass
Measured: 1 day
Volatile anesthetic utilization
Mean and standard deviation of fresh gas flow rates for cases with volatile anesthetic use > 80% of case duration
Measured: 1 day
Postoperative acute renal failure
Incidence of individual outcomes
Measured: 30 days
Postoperative atrial fibrillation
Incidence of individual outcomes
Measured: 30 days
Postoperative respiratory failure
Incidence of individual outcome
Measured: 30 days
Postoperative delirium
Incidence of individual outcome
Measured: 30 days
Intraoperative awareness
Incidence of individual outcomes
Measured: 30 days
Surgical site infection
Incidence of individual outcomes
Measured: 30 days
30-day readmission
Incidence of individual outcomes
Measured: 30 days
30-day mortality
Mortality will be assessed at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startNov 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Health Information TechnologyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 15,158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Michael Avidan, Washington University School of Medicine
- Investigators
- Michael S Avidan, MBBCh, Principal investigator, Washington University School of MedicineDaniel Helsten, MD, Study director, Washington University School of MedicineAnshuman Sharma, MD, Study director, Washington University School of MedicineRichard Benzinger, MD, Study director, Washington University School of MedicineYixin Chen, PhD, Study director, Washington University School of MedicineMitchell Fingerman, MD, Study director, Washington University School of MedicineJason Gillihan, MD, Study director, Washington University School of MedicineRyan Guffey, MD, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02830126
- Sponsor's protocol ID
- 201603038
- Other IDs
- 1R21HS024581-01A1
- Acronym
- ACTFAST
- Status last verified
- Jan 2020
- First submitted
- 7 Jul 2016
- Last updated
- 22 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37738052Gregory 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.
PubMed 30026931Murray-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.
PubMed 29416871
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)
- ClinicalTrials.gov ID
- NCT02830126
- Acronym / sponsor ID
- ACTFAST / 201603038
- Conditions
- Health Information Technology
- Keywords
- Outcomes, Information technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,158 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Nov 2016 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthesiology Control Tower Control | No intervention | –Patients managed by anesthesia teams without feedback alerts from the ACT |
| Anesthesiology Control Tower Feedback | Experimental | Other: Anesthesiology Control Tower FeedbackPatients managed by anesthesia teams with feedback alerts from the ACT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesiology Control Tower FeedbackClinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room. | Other | Anesthesiology Control Tower Feedback |
Primary outcome
Compliance with recommendations for intraoperative temperature management
Time frame: 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
Time frame: 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
Time frame: 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.
15 secondary outcomes
Intraoperative blood pressure management
Time frame: 1 day
Temperature monitoring
Time frame: 1 day
Antibiotic dosing
Time frame: 1 day
Intraoperative blood glucose management
Time frame: 1 day
Train of four documentation
Time frame: 1 day
Ventilator management
Time frame: 1 day
Volatile anesthetic utilization
Time frame: 1 day
Postoperative acute renal failure
Time frame: 30 days
Postoperative atrial fibrillation
Time frame: 30 days
Postoperative respiratory failure
Time frame: 30 days
Postoperative delirium
Time frame: 30 days
Intraoperative awareness
Time frame: 30 days
Surgical site infection
Time frame: 30 days
30-day readmission
Time frame: 30 days
30-day mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Derived from this study: PubMed 37738052King 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.
- Derived from this study: PubMed 30026931Gregory 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.
- Derived from this study: PubMed 29416871Murray-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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Avidan, MBBCh principal investigator
Washington University School of Medicine
Daniel Helsten, MD study director
Washington University School of Medicine
Anshuman Sharma, MD study director
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Health Information Technology, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with recommendations for intraoperative temperature management (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830126, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020; AzTrials last refreshed its copy on 28 Oct 2026.