- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02401711
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
Status
Completed
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.
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