Breaking Bad News in Obstetrics: A Trial of Simulation-Debrief Based Education

March 15, 2016 updated by: Montefiore Medical Center

The purpose of this study is to assess the utility of training in Breaking Bad News (BBN) skills. We hypothesize that given little or no formal training in breaking bad news, obstetric providers will benefit from a curriculum of teaching breaking bad news techniques, but will benefit more from a simulation teaching technique than from a lecture in breaking bad news techniques.

The investigators also hypothesize that providers who have undergone breaking bad news simulation will receive improved scores after the simulation debriefing compared to their pre-simulation scores, and their improvement with be greater than the control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators' study is part of a planned educational initiative on breaking bad news communication skills, planned for house staff in the department of Obstetrics and Gynecology. All subjects will undergo both a baseline and post-education simulation. The investigators' study intervention is a personalized review and debriefing of the simulation, as compared with a conventional lecture in order to assess the best curriculum for teaching this skill set.

The investigators' study design will be described, consent obtained and consenting house staff will be randomized to participate in a simulation-based education session/debrief or to attend lecture. Randomization will be achieved using sequential opaque envelopes containing allocation cards, designating group assignment. A physician who is not involved in the study will randomly insert allocation cards into the envelopes and group assignment will be concealed until after enrollment is complete.

Subjects will be assigned a study number. The list of subject identifiers and study numbers will be kept separate from other study data, and destroyed after all phases of the study are complete. All other study data will have identifying information deleted, and will be stored in a password protected database.

The investigators plan to have subjects assess baseline characteristics and breaking bad news skills using a self-assessment tool. Subsequently all house staff will be evaluated on their management of breaking bad news through a baseline SP scenario, with assessments by physician-teachers as well as the SPs . These SPs are non-physicians, and do not have supervisory control over the study subjects. The physician-teachers are the co-investigators on this study: Drs. Chazotte, Dayal, Landsberger, Bernstein, Goffman, and Karkowsky.

After this baseline assessment, the intervention group will debrief their baseline simulation with a physician educator. The control group will instead undergo a conventional lecture about "Breaking Bad News" techniques. Finally, both groups will undergo a second simulation, which will be assessed by SPs and physician-teachers

After this step, subjects will fill out self-assessment tools on BBN. House staff who did not undergo the conventional curriculum will then attend the lecture; similarly, those subjects who were not in the intervention group will then have the opportunity to review their simulation in a personal debriefing session.

Six months after the study, we plan to have all subjects fill out a self-assessment form to assess if any long-term change to their BBN skills has been sustained.

SPs will be formally trained in the scenario and in their responses, as well as in standardized assessment of the subjects.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

-Montefiore Medical Center Obstetrics/Gynecology department house staff.

Exclusion Criteria:

  • House staff that were unable to attend at least two sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Traditional Lecture
These subjects received a 10 minute power point lecture on BBN skills.
Behavioral: Traditional lecture
Control group underwent lecture for approximately 10 minutes reviewing BBN skills.
Experimental: Simulation-Debrief
These subjects received a formal debrief process, reviewing their prior baseline simulation.
Behavioral: Simulation-Debrief
Subjects underwent a formal debrief, reviewing the BBN skills exhibited in their prior simulation of an obstetrical communication skills scenario.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BBN skills
Time Frame: Immediate
As evaluated by IRB-approved evalution
Immediate

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject BBN confidence
Time Frame: Immediately and 6 months post-intervention
Subject BBN confidence about their communications skills in the setting of Breaking Bad news was evaluated immediately post-intervention and 6-months post-intervention
Immediately and 6 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Cynthia Chazotte, MD, Montefiore Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

June 18, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 20, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2016

Last Update Submitted That Met QC Criteria

March 15, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 10-08-275

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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