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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
|Official Title:||Use of Simulation-Based Mastery Learning for Resident Thoracentesis Training to Improve Patient Outcomes|
- Simulation based mastery learning for resident thoracentesis training will increase patient satisfaction and safety. [ Time Frame: 30 months ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
No Intervention: Traditionally-trained Procedures
Patients who undergo thoracentesis procedures by traditionally-trained residents who have not undergone simulation-based mastery learning.
Experimental: Simulator-trained Procedures
Patients who undergo thoracentesis procedures by residents who have undergone simulation-based mastery learning.
Other: Simulation-based mastery learning
Internal Medicine residents are randomly selected to undergo simulation-based mastery learning.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01898247
|Contact: Jeffrey H. Barsuk, MD, MSemail@example.com|
|Contact: Sarah E. Kozmic, BSfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Jeffrey H. Barsuk, MD, MS 312-926-3680 email@example.com|
|Contact: Sarah E. Kozmic, BS 312-926-0621 firstname.lastname@example.org|
|Principal Investigator: Jeffrey H. Barsuk, MD, MS|
|Sub-Investigator: Diane B. Wayne, MD|
|Principal Investigator:||Jeffrey H. Barsuk, MD||Northwestern University|