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

NCT ID: NCT03006549

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-10
• Study Completion Date: 2019-05-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Emergency Manual

emergency manual present

Group Type: EXPERIMENTAL

Emergency Manual (Crisis Checklist)

Intervention Type: BEHAVIORAL

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

No Emergency

NO emergency manual present

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Emergency Manual (Crisis Checklist)

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Anesthesia Patient Safety Foundation

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Richard D Urman

Associate Professor of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Urman, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2014P000133

Identifier Type: -

Identifier Source: org_study_id