Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?

Safety Issues Clinical Trial

— EM  

Official title:

Using Emergency Manuals During Interprofessional Crisis Management: Are There Unintended Consequences?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03006549
• Other study ID #: 2014P000133
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Emergencies
• Safety Issues

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