NCT02168192

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2014

Completed
Last Updated

March 17, 2016

Status Verified

March 1, 2016

Enrollment Period

7 months

First QC Date

June 18, 2014

Last Update Submit

March 15, 2016

Conditions

Breaking Bad News SkillsCommunications SkillsMedical EducationObstetricsSimulation

Keywords

Breaking bad news skillsCommunications skillsMedical educationObstetricsSimulation

Outcome Measures

Primary Outcomes (1)

  • BBN skills

    As evaluated by IRB-approved evalution

    Immediate

Secondary Outcomes (1)

  • Subject BBN confidence

    Immediately and 6 months post-intervention

Study Arms (2)

Traditional Lecture

PLACEBO COMPARATOR

These subjects received a 10 minute power point lecture on BBN skills.

Behavioral: Traditional lecture

Simulation-Debrief

EXPERIMENTAL

These subjects received a formal debrief process, reviewing their prior baseline simulation.

Behavioral: Simulation-Debrief

Interventions

Simulation-DebriefBEHAVIORAL

Subjects underwent a formal debrief, reviewing the BBN skills exhibited in their prior simulation of an obstetrical communication skills scenario.

Simulation-Debrief
Traditional lectureBEHAVIORAL

Control group underwent lecture for approximately 10 minutes reviewing BBN skills.

Traditional Lecture

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Montefiore Medical Center Obstetrics/Gynecology department house staff.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

Study Officials

  • Cynthia Chazotte, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 20, 2014

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

July 1, 2013

Last Updated

March 17, 2016

Record last verified: 2016-03

Locations

US(1)