Trial record 1 of 2 for:    Thoracentesis | Open Studies | NIH, U.S. Fed
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Use of Simulation-Based Mastery Learning for Thoracentesis to Improve Outcomes

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Northwestern University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey Barsuk, Northwestern University
ClinicalTrials.gov Identifier:
NCT01898247
First received: July 5, 2013
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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 Intervention
Misadventure During Thoracentesis
Other: Simulation-based mastery learning

Study Type: Interventional
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

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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).


Estimated Enrollment: 1000
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898247

Contacts
Contact: Jeffrey H. Barsuk, MD, MS 312-926-3680 jbarsuk@northwestern.edu
Contact: Sarah E. Kozmic, BS 312-926-0621 sarah.rottman@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Jeffrey H. Barsuk, MD, MS    312-926-3680    jbarsuk@northwestern.edu   
Contact: Sarah E. Kozmic, BS    312-926-0621    sarah.rottman@northwestern.edu   
Principal Investigator: Jeffrey H. Barsuk, MD, MS         
Sub-Investigator: Diane B. Wayne, MD         
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Jeffrey H. Barsuk, MD Northwestern University
  More Information

No publications provided

Responsible Party: Jeffrey Barsuk, Associate Professor of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT01898247     History of Changes
Other Study ID Numbers: STU00069024
Study First Received: July 5, 2013
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 30, 2014