Anesthesiology Control Tower
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/14/2019 |
| Start Date: | November 2016 |
| End Date: | July 2019 |
| Contact: | Sherry McKinnon, BS |
| Email: | smckinnon@wustl.edu |
| Phone: | 314-286-1768 |
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.
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.
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.
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.
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:
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Michael S. Avidan, MBBCh, FCASA
Phone: 314-286-1768
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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