Use of Simulation-Based Mastery Learning for Thoracentesis to Improve Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01898247
Recruitment Status : Completed
First Posted : July 12, 2013
Last Update Posted : July 14, 2017
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Jeffrey Barsuk, Northwestern University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Misadventure During Thoracentesis Other: Simulation-based mastery learning Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Use of Simulation-Based Mastery Learning for Resident Thoracentesis Training to Improve Patient Outcomes
Study Start Date : December 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01898247

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
Principal Investigator: Jeffrey H. Barsuk, MD Northwestern University

Responsible Party: Jeffrey Barsuk, Associate Professor of Medicine, Northwestern University Identifier: NCT01898247     History of Changes
Other Study ID Numbers: STU00069024
First Posted: July 12, 2013    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017

Keywords provided by Jeffrey Barsuk, Northwestern University:
Simulation Based Mastery Learning
Medical Education
Length of Stay
Cost of Care