Health Information Technology Clinical Trial
— ACTFASTOfficial title:
Anesthesiology Control Tower: Feedback Alerts to Supplement Treatments (ACTFAST)
Verified date | January 2020 |
Source | Washington University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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: - |
Country | Name | City | State |
---|---|---|---|
United States | Washington University School of Medicine | Saint Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Washington University School of Medicine | Agency for Healthcare Research and Quality (AHRQ) |
United States,
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this calculation we assumed a standard deviation of core temperature of 0.9 degrees Celsius for both groups based on an unpublished EMR audit.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 |
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