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

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.

Study Overview

• Status: Completed
• Conditions: Safety Issues
• Intervention / Treatment: Behavioral: Emergency Manual (Crisis Checklist)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02116
      • Massachusetts General Hospital

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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Emergency Manual; emergency manual present	Behavioral: Emergency Manual (Crisis Checklist); participants will have an Emergency Manual available to them during the crisis simulation scenario.
No Intervention: No Emergency; NO emergency manual present

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correct Diagnosis identified during the simulation by the participants through a grading scale tool	through scenario completion, an average of 1 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical actions taken during the scenario evaluated by a grading scale tool	through scenario completion, an average of 1 hour

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: Massachusetts General Hospital; Beth Israel Deaconess Medical Center; Anesthesia Patient Safety Foundation
• Investigators: Principal Investigator: Richard Urman, MD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2015
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): May 13, 2019

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: December 29, 2016
• First Posted (Estimate): December 30, 2016

Study Record Updates

• Last Update Posted (Actual): August 5, 2019
• Last Update Submitted That Met QC Criteria: August 2, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Emergency Manual; Crisis Checklist
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2014P000133