Medical EducationNCT02401711
How Should Surgical Residents Be Educated About Patient Safety
A study testing Education - BIPS course, Formal safety curriculum and Ongoing evaluation and feedback in people with Medical Education and Patient Safety, run by The University of Texas Health Science Center, Houston.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Medical Education, Patient Safety, Educational Safety Curriculum
- What is being tested?
- Education - BIPS course, Formal safety curriculum and Ongoing evaluation and feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All surgery residents at the University of Texas Health Science Center at Houston, from post-graduate year (PGY)-1 to PGY-5.
Who cannot join
- Non-surgery residents at the University of Texas Health Science Center at Houston.
About this study
Official title: 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.
- Being tested
- Education - BIPS course, Formal safety curriculum, Ongoing evaluation and feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education - BIPS courseBehavioural
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
Formal safety curriculumBehavioural
The educational program is designed to improve patient safety by informing residents about safe operating room behaviors.
Ongoing evaluation and feedbackBehavioural
The feedback program is designed to encourage the use of safe behaviors and to discourage unsafe behaviors taught in the workshops.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Education - BIPS course; Behavioral: Formal safety curriculum; Behavioral: Ongoing evaluation and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in safety culture as measured by the Safety Attitudes Questionnaire (SAQ)
Measured: Baseline, One year
Secondary outcomes (1)
Learner satisfaction, knowledge, and behaviors as measured by the Oxford Non-Technical Skills (NOTECHS) system
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startFeb 2014
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KuoJen Tsao, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401711
- Sponsor's protocol ID
- HSC-MS-14-0073
- Status last verified
- Oct 2017
- First submitted
- 23 Mar 2015
- Last updated
- 30 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Should Surgical Residents Be Educated About Patient Safety in the Operating Room: a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT02401711
- Acronym / sponsor ID
- HSC-MS-14-0073
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online training | Active comparator | Behavioral: Education - BIPS courseResidents 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. |
| Online training & Safety curriculum & Evaluation and feedback | Experimental | Behavioral: Education - BIPS course, Behavioral: Formal safety curriculum, Behavioral: Ongoing evaluation and feedbackThose 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All surgery residents at the University of Texas Health Science Center at Houston, from post-graduate year (PGY)-1 to PGY-5.
Key exclusion criteria (1 listed)
- Non-surgery residents at the University of Texas Health Science Center at Houston.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education - BIPS courseThe 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 | Behavioural | Online training, Online training & Safety curriculum & Evaluation and feedback |
| Formal safety curriculumThe educational program is designed to improve patient safety by informing residents about safe operating room behaviors. | Behavioural | Online training & Safety curriculum & Evaluation and feedback |
| Ongoing evaluation and feedbackThe feedback program is designed to encourage the use of safe behaviors and to discourage unsafe behaviors taught in the workshops. | Behavioural | Online training & Safety curriculum & Evaluation and feedback |
Primary outcome
Changes in safety culture as measured by the Safety Attitudes Questionnaire (SAQ)
Time frame: Baseline, One year
1 secondary outcome
Learner satisfaction, knowledge, and behaviors as measured by the Oxford Non-Technical Skills (NOTECHS) system
Time frame: One year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Education - BIPS course, Formal safety curriculum and Ongoing evaluation and feedback in people with Medical Education and Patient Safety, run by The University of Texas Health Science Center, Houston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in safety culture as measured by the Safety Attitudes Questionnaire (SAQ) (time frame: Baseline, One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017.