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

NCT03006549 | Completed

• 1 other identifier: 2014P000133
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Safety Issues

Keywords

Emergency Manual; Crisis Checklist

Outcome Measures

Primary Outcomes (1)

• Correct Diagnosis identified during the simulation by the participants through a grading scale tool

  through scenario completion, an average of 1 hour

Secondary Outcomes (1)

• Clinical actions taken during the scenario evaluated by a grading scale tool

  through scenario completion, an average of 1 hour

Study Arms (2)

Emergency Manual

EXPERIMENTAL

emergency manual present

Behavioral: Emergency Manual (Crisis Checklist)

No Emergency

NO INTERVENTION

NO emergency manual present

Interventions

Emergency Manual (Crisis Checklist) BEHAVIORAL

participants will have an Emergency Manual available to them during the crisis simulation scenario.

Emergency Manual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Those unwilling to be recorded during the simulation scenario

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Anesthesia Patient Safety Foundation: collaborator
• Massachusetts General Hospital: collaborator
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02116, United States

Location

Study Officials

• Richard Urman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: December 30, 2016
• Study Start: January 10, 2015
• Primary Completion: March 15, 2018
• Study Completion: May 13, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Locations

US (3)