How Should Surgical Residents Be Educated About Patient Safety

October 26, 2017 updated by: KuoJen Tsao, The University of Texas Health Science Center, Houston

How Should Surgical Residents Be Educated About Patient Safety in the Operating Room: a Pilot Randomized Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Online training
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.
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
Experimental: Online training & Safety curriculum & Evaluation and feedback
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.
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
The educational program is designed to improve patient safety by informing residents about safe operating room behaviors.
The feedback program is designed to encourage the use of safe behaviors and to discourage unsafe behaviors taught in the workshops.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in safety culture as measured by the Safety Attitudes Questionnaire (SAQ)
Time Frame: Baseline, One year
Baseline, One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Learner satisfaction, knowledge, and behaviors as measured by the Oxford Non-Technical Skills (NOTECHS) system
Time Frame: One year
One year

Collaborators and Investigators

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

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

February 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 27, 2015

First Posted (Estimate)

March 30, 2015

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 26, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • HSC-MS-14-0073

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.

Clinical Trials on Medical Education

Clinical Trials on Education - BIPS course

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