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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168192
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : March 17, 2016
Sponsor:
Information provided by (Responsible Party):
Montefiore Medical Center

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
BBN skills [ Time Frame: Immediate ]
As evaluated by IRB-approved evalution
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2014)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breaking Bad News in Obstetrics: A Trial of Simulation-Debrief Based Education
Official Title  ICMJE Breaking Bad News in Obstetrics: A Trial of Simulation-Debrief Based Education
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE
  • Breaking Bad News Skills
  • Communications Skills
  • Medical Education
  • Obstetrics
  • Simulation
Intervention  ICMJE
  • Behavioral: Simulation-Debrief
    Subjects underwent a formal debrief, reviewing the BBN skills exhibited in their prior simulation of an obstetrical communication skills scenario.
  • Behavioral: Traditional lecture
    Control group underwent lecture for approximately 10 minutes reviewing BBN skills.
Study Arms  ICMJE
  • Placebo Comparator: Traditional Lecture
    These subjects received a 10 minute power point lecture on BBN skills.
    Intervention: Behavioral: Traditional lecture
  • Experimental: Simulation-Debrief
    These subjects received a formal debrief process, reviewing their prior baseline simulation.
    Intervention: Behavioral: Simulation-Debrief
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 19, 2014)
36
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

-Montefiore Medical Center Obstetrics/Gynecology department house staff.

Exclusion Criteria:

  • House staff that were unable to attend at least two sessions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168192
Other Study ID Numbers  ICMJE 10-08-275
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Montefiore Medical Center
Study Sponsor  ICMJE Montefiore Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cynthia Chazotte, MD Montefiore Medical Center
PRS Account Montefiore Medical Center
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP