- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04195178
Understanding the Cognition and Decision Making of Community Anesthesiologists
Understanding the Cognition and Decision Making of Community Anesthesiologists in Their Management of End-of-case Neuromuscular Blockade: A Mixed Methods Study
The investigators are interested in studying why experienced clinicians make specific decisions regarding the monitoring of patients' physiological states and why clinicians might make decisions that are contrary to current best practices or known evidence. More generally, the program objective is to refine and validate a novel methodology to delineate clinicians' decision-making strategies. More specifically, the investigators will study the decision to reverse neuromuscular blockade at the end of an anesthetic. This clinical decision will be studied in this project because: 1) it has been well documented that a substantial percentage of practitioners do not follow best practices; 2) the variables are relatively circumscribed and well described; and 3) it can be framed as a binary decision.
The investigators propose to conduct an observational mixed-methods study developing and using clinical vignettes and cognitive interviews to better understand the decision-making approaches and preferences of clinically active anesthesia providers with regard to their decision-making during clinical anesthesia cases. After developing clinical vignettes and related questions, the investigators will first obtain detailed demographic and clinical practice variables from the participants via a survey. Participants will then review multiple vignettes that present different clinical situations that focus on decisions to reverse neuromuscular blockade and/or extubate the patient. Each participant will provide their decisions for each vignette. The investigators will then conduct an audiotaped interview, using cognitive task analysis methods, to ascertain the factors that played a role in these decisions.
Study Overview
Status
Conditions
Detailed Description
The investigators propose to conduct a 3-site prospective observational mixed-methods study using clinical vignettes and cognitive interviews to better understand the decision making approaches and preferences of practicing community anesthesiologists with regard to the management of non-depolarizing neuromuscular blockade (NMB) at the end of general endotracheal anesthesia cases.
The objectives of this initial study is to begin to understand:
- When and why do community anesthesiologists choose to reverse NMB?
- What are the decision preferences of community anesthesiologists with regard to their decisions to reverse NMB, and what are the clinician and clinical case factors that influence those decisions?
- What are the operational knowledge gaps of anesthesia professionals with regard to their ability to follow best-practice evidence for the reversal of NMB? More generally, the program objective is to refine and validate a novel methodology to delineate clinicians' decision making strategies and triggers.
2.1.2. Study Hypotheses
For this initial study, the investigators hypothesize that:
- There will be a significant distribution of clinical variables across community anesthesiologists' decision to reverse NMB.
- There will be measurable differences in participant demographics and practice attributes between those who closely follow evidence-based expectations for reversal of NMB and those who do not. The investigators expect community practitioners who do not reverse NMB in accordance with current best evidence to be older, to not be fellowship trained or subspecialty certified, and to practice in lower acuity settings.
This will be a remotely conducted national prospective observational simulation study of 36 experienced community anesthesiologists using a clinical vignette and cognitive interviews to better understand the decision making approaches and preferences of practicing community anesthesiologists with regard to the management of neuromuscular blockade (NMB) at the end of general endotracheal anesthesia cases.
Cognitive interview transcript coders and analysts will be blinded to the identity and attributes of the participants.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Matt Weinger, MD
- Phone Number: 615-936-6598
- Email: matt.weinger@vumc.org
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37203
- Recruiting
- Vanderbilt University Medical Center
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Contact:
- Jason Slagle, PhD
- Phone Number: 615-936-5519
- Email: jason.slagle@vumc.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinically active experienced anesthesia providers
Exclusion Criteria:
- Anesthesia providers who are no longer practicing or clinically active
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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Anesthesia Providers
Clinically active anesthesia providers
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average Decision Thresholds: Pharmacological measure of neuromuscular blocking drug effect
Time Frame: 10 minutes
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The average decision threshold is the average across all participant's decision threshold for this measure.
The decision threshold is calculated by sequentially varying values of the pharmacological variables (i.e., doses and timing) within the context of a clinical scenario.
Each participant's decision threshold is the equivalent of an ED50 or a MAC value (i.e., the equipoise point for their clinical decision based on that variable).
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10 minutes
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Average Decision Thresholds: Muscle strength
Time Frame: 10 minutes
|
The average decision threshold is the average across all participant's decision threshold for this measure.
The decision threshold is calculated by sequentially varying values of muscle strength within the context of a clinical scenario.
Each participant's decision threshold is the equivalent of an ED50 or a MAC value (i.e., the equipoise point for their clinical decision based on that variable).
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10 minutes
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Average Decision Thresholds: Respiratory parameters
Time Frame: 10 minutes
|
The average decision threshold is the average across all participant's decision threshold for this measure.
The decision threshold is calculated by sequentially varying values of the respiratory parameters (i.e., variables contributing to minute ventilation) within the context of a clinical scenario.
Each participant's decision threshold is the equivalent of an ED50 or a MAC value (i.e., the equipoise point for their clinical decision based on that variable).
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10 minutes
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 181711
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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