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

Use of Simulation-Based Mastery Learning for Resident Thoracentesis Training to Improve Patient 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 Overview

• Status: Completed
• Conditions: Misadventure During Thoracentesis
• Intervention / Treatment: Other: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 1000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simulation based mastery learning for resident thoracentesis training will increase patient satisfaction and safety.	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).	30 months

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Jeffrey H. Barsuk, MD, Northwestern University

Publications and helpful links

General Publications

• Barsuk JH, Cohen ER, Williams MV, Scher J, Feinglass J, McGaghie WC, O'Hara K, Wayne DB. The effect of simulation-based mastery learning on thoracentesis referral patterns. J Hosp Med. 2016 Nov;11(11):792-795. doi: 10.1002/jhm.2623. Epub 2016 Jun 8.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 5, 2013
• First Submitted That Met QC Criteria: July 11, 2013
• First Posted (Estimate): July 12, 2013

Study Record Updates

• Last Update Posted (Actual): July 14, 2017
• Last Update Submitted That Met QC Criteria: July 13, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Medical Education; Thoracentesis; Length of Stay; Cost of Care; Simulation Based Mastery Learning
• Other Study ID Numbers: STU00069024