Northwestern University
Chicago, Illinois, 60611, United States
Completed
NCT Number: NCT01898247
Use of Simulation-Based Mastery Learning for Thoracentesis to Improve Outcomes
The goal of the proposed research is to investigate the use a medical simulation and mastery learning (where all learners must reach a high standard before completion of training) curriculum to improve internal medicine residents' skills when performing thoracentesis procedures (remove fluid from around the lung) on patients. Additionally, we will evaluate how these skills affect patient outcomes by comparing thoracenteses performed by simulator-trained residents to those who have "traditional" training. This project will evaluate these overall hypotheses: simulation-based training using the mastery learning approach improves medicine resident's thoracentesis skills and improves patient outcomes and satisfaction.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Given medical procedures are the second most common cause of the complications that afflict 3% of hospitalized patients, simulation-based mastery learning should be applied to procedures done in all medical centers. In academic hospitals, bedside procedures such as thoracentesis procedures are often performed by unsupervised medical trainees. Traditionally, medical trainees learn procedures relying on the historic "see one, do one, teach one" mentality. Unfortunately, this approach subjects patients to procedures before trainees are competent.
Through the use of medical simulation, medical educators can increase the essential knowledge and skills of trainees while assuring procedural competence and reducing patient exposure to undue risk. Medical simulation training using the mastery learning model improves clinical skills and reduces the risk of procedure-associated injury. Our research group pioneered the use of this evidence-based approach for teaching medical trainees. Mastery learning requires that all trainees demonstrate a uniformly high level of skill before training completion. This ensures competence on a medical simulator before actual patient encounters.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Patients:
- undergoing a thoracentesis procedure
- on internal medicine or hospitalist ward service
- English or Spanish Speaking
- 2nd and 3rd year internal medicine residents
Exclusion criteria
- Cognitive impairment
Treatment and study plan
Simulation-based mastery learning
OtherInternal Medicine residents are randomly selected to undergo simulation-based mastery learning.
Primary outcomes
-
Simulation based mastery learning for resident thoracentesis training will increase patient satisfaction and safety.
Time frame: 30 months
Thoracentesis skills will be measured using a checklist on the simulator and on actual patients during direct observations. Satisfaction with procedures done by a referred service or at the bedside by simulator-trained residents will be measured by patient reported confidence levels in procedure performer, perception of delay, and comfort during the procedure. Patient safety will be measured by assessing documented complication rates such as: pneumothorax, bleeding, infection, reexpansion pulmonary edema, and significant pain. Additionally, length of stay and hospital costs will be compared between patients undergoing thoracentesis by simulator-trained residents versus referred services (or traditionally-trained residents).
Sponsors and collaborators
Lead sponsor
Northwestern University
Other
Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
Registry information
Official study title
Use of Simulation-Based Mastery Learning for Resident Thoracentesis Training to Improve Patient Outcomes
Important dates
- Study start
- 2012
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Jul 12, 2013
- Registry last updated
- Jul 14, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.