NCT02401711

Brief Summary

The purpose of this study is to compare the effectiveness of two methods, safety curriculum in addition to online training alone, for teaching patient safety to surgery residents. Despite multiple studies evaluating educational safety curricula, the best methods for teaching residents about patient safety is unknown. It is hypothesized that empowering surgery residents to actively engage in behaviors to increase patient safety may lead to a higher quality perioperative care and communication.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2014

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 30, 2017

Status Verified

October 1, 2017

Enrollment Period

1.5 years

First QC Date

March 23, 2015

Last Update Submit

October 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in safety culture as measured by the Safety Attitudes Questionnaire (SAQ)

    Baseline, One year

Secondary Outcomes (1)

  • Learner satisfaction, knowledge, and behaviors as measured by the Oxford Non-Technical Skills (NOTECHS) system

    One year

Study Arms (2)

Online training

ACTIVE COMPARATOR

Residents randomized to the control group will only participate in the Breakthroughs in Patient Safety (BIPS) online training (Education - BIPS course). All residents in the comparison arm will receive evaluations on their non-technical skills, but the results will not be fed back to them until after the study has been completed.

Behavioral: Education - BIPS course

Online training & Safety curriculum & Evaluation and feedback

EXPERIMENTAL

Those in the intervention group will participate in a formal safety education curriculum in addition to the currently required Breakthroughs in Patient Safety (BIPS) online training. The intervention will have three components: (1) the mandatory online BIPS course (Education - BIPS course), (2) the formal safety curriculum, and (3) ongoing evaluation and feedback of operating room performance.

Behavioral: Education - BIPS courseBehavioral: Formal safety curriculumBehavioral: Ongoing evaluation and feedback

Interventions

The guiding principles behind the BIPS program include: (1) explaining how complex systems cause human error and how human error can lead to patient harm in complex systems; (2) diagnosing human error and identifying a prevention behavior for each of the three types: skill, rule, and knowledge; and (3) preventing error by promoting safety behaviors, such as having attention to detail, communicating clearly, having a questioning attitude, and speaking up for safety

Online trainingOnline training & Safety curriculum & Evaluation and feedback

The educational program is designed to improve patient safety by informing residents about safe operating room behaviors.

Online training & Safety curriculum & Evaluation and feedback

The feedback program is designed to encourage the use of safe behaviors and to discourage unsafe behaviors taught in the workshops.

Online training & Safety curriculum & Evaluation and feedback

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All surgery residents at the University of Texas Health Science Center at Houston, from post-graduate year (PGY)-1 to PGY-5.

You may not qualify if:

  • Non-surgery residents at the University of Texas Health Science Center at Houston.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & The Children's Fund, Inc. Distinguished Professorship in Pediatric Surgery

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 30, 2015

Study Start

February 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

October 30, 2017

Record last verified: 2017-10