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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03006549
Other study ID # 2014P000133
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2015
Est. completion date May 13, 2019

Study information

Verified date August 2019
Source Brigham and Women's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Despite increasing interest in emergency manuals (EMs), relatively little is known about their effectiveness and limitations in the perioperative setting. Prior studies have been limited in that they evaluated EMs using crises that were tailor-made to match one of their chapters, and there has been minimal participation by attending surgeons and other experienced personnel. The Investigators' preliminary experience suggests less-than-expected EM use and suboptimal usage, which may be due to the simulation scenario falling "halfway between" two different chapters of the EM, raising the question of whether limitations were due to the EM content, team dynamics, or inadequate training in the EM use. In this randomized, prospective, two-center simulation-based study, the investigators utilize clinical scenarios specifically designed to observe the patterns of use and to test the limitations of the EMs. The hypothesis is that EMs may not improve, and may even worsen, clinical performance in situations that do not exactly match a specific chapter of that EM, and that EM usage patterns will identify both strengths and limitations of the tools and its implementation. The participating healthcare providers consisting of experienced surgeons, anesthesiologists, and nurses will be randomized into four experimental groups, each exposed to either a "specific" or "non-specific" simulation scenario, along with or without the availability of the EM. The major experimental endpoint will be how many "critical actions" each team performs, scored as the percentage of actions taken from a pre-determined list. The goal of this study is to improve EM content and use by understanding its limitations during interprofessional team-training simulations and to study whether EMs enhance or detract from clinical performance. This is especially a concern in situations that do not exactly match a specific chapter of the EM, such as cases that are vague and represent multi-factorial diagnostic dilemmas such as hypotension and hypoxemia. The ultimate goal is to strengthen patient safety by providing guidance for improving EM content, use, and training protocols.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date May 13, 2019
Est. primary completion date March 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Healthcare providers (anesthesiologists, surgeons, nurses) participating in the crisis management curriculum at each participating simulation site

Exclusion Criteria:

- Those unwilling to be recorded during the simulation scenario

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Emergency Manual (Crisis Checklist)
participants will have an Emergency Manual available to them during the crisis simulation scenario.

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (4)

Lead Sponsor Collaborator
Brigham and Women's Hospital Anesthesia Patient Safety Foundation, Beth Israel Deaconess Medical Center, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Correct Diagnosis identified during the simulation by the participants through a grading scale tool through scenario completion, an average of 1 hour
Secondary Clinical actions taken during the scenario evaluated by a grading scale tool through scenario completion, an average of 1 hour
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