HealthyNCT02402257
Central Venous Catheter Insertion Train the Trainer
An observational study of Healthy, run by Northwestern University at 1 site in United States.
Trial summary
The investigators previously successfully implemented a central venous catheter (CVC) simulation-based mastery learning (SBML) curriculum at Northwestern University. As a result, trainee skill improved, complications, including central line associated bloodstream infections (CLABSIs) decreased and the curriculum was… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healthy
- What is being tested?
- CVC Train the Trainer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 226 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Dec 2018
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Trainees undergoing simulation-based mastery learning for CVC insertion 2. De-identified patient information from patients with a CVC.
Who may be able to join
- Previously (or prospectively) collected de-identified data on trainee skill and experience
- Previously (or prospectively) collected de-identified data on patients in the VA ICU with CVCs
- Previously (or prospectively) collected de-identified data on mechanical complications in the ICUs
Who cannot join
- Data not de-identified
- Data on pts on non-ICU units
- Data on pts without CVCs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dissemination of a Simulation-based Mastery Learning Curriculum for Central Venous Catheter Insertion at Veterans Affairs Hospitals: A Quantitative Study
The investigators previously successfully implemented a central venous catheter (CVC) simulation-based mastery learning (SBML) curriculum at Northwestern University. As a result, trainee skill improved, complications, including central line associated bloodstream infections (CLABSIs) decreased and the curriculum was proven cost-effective. Therefore the Veterans Administration Medical Centers (VAMC) decided to implement this training at some of their sites as a quality improvement project. The investigators will train faculty at these locations to implement the same curriculum at their individual sites. Outcome data will be collected to evaluate the outcomes of the quality improvement (QI) project (complications, infections, skills).
Read the detailed description
Beginning in 2006, Northwestern University Internal Medicine and Emergency Medicine residents completed simulation-based mastery learning in central venous catheter (CVC) insertion before clinical rotations in the Medical Intensive Care Unit (MICU). This comprehensive program in central line training used repetitive practice and simulation technology to train residents to mastery standards. This study had important patient safety implications. This program resulted in improved trainee skill and reduced CVC insertion complications, including a significant decrease in the rate of central line associated bloodstream infections (CLABSI). In addition, the investigators showed that the in CVC insertion was highly cost-effective suggesting that investment in simulation training can produce significant medical care cost savings.
This curriculum has now been successfully implemented at a few other sites. Due to the investigators' success, the VA has requested that Medical Error Reduction and Certification, Inc.(MERCI) along with Northwestern University, implements the curriculum at its sites across the county as a quality improvement project. Using a train the trainer course in CVC placement, the investigators are interested in analyzing the data that the VAMC will provide to MERCI and studying the outcomes.
Four Northwestern faculty completed a CVC insertion Master trainer curriculum. One master trainer travels to each VA facility in the program to facilitate a two-day train-the-trainer course on CVC insertion SBML. Each VA facility selects one or two "faculty champions" who complete CVC insertion SBML course and learn how to teach the curriculum on day 1 and are observed training and assessing peer healthcare providers at their institution on day 2. Course materials include standardized videos and lectures, role-playing and practice with sample learners and CVC insertion assessments. In addition to the onsite master trainer, each VA facility receives necessary training materials (standardized video lectures, data collection forms, assessment tools) and equipment (CentralLineMan simulators, ultrasound) to implement the curriculum at their institution. All participants complete pre and post testing and a course evaluation questionnaire. Quantitative outcome data on learner skills and CVC insertion quality measures are collected to measure the overall success of the project.
- Conditions
- Healthy
- Being tested
- CVC Train the Trainer
- Keywords
- Central Venous Catheter, Simulation-based Mastery Learning, Medical Education, Patient Outcomes, Bloodstream Infection Due to Central Venous Catheter, Pneumothorax, Inadvertent Arterial Puncture
- Medical subject headings
- Pneumothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVC Train the TrainerBehavioural
Trainees receive a simulation-based mastery learning intervention and train-the-trainer program on central venous catheter insertion
| Study group | Role | What they receive |
|---|---|---|
| Traditionally-trained | Patients who undergo CVC procedures by traditionally-trained providers who have not undergone simulation-based mastery learning. This could be retrospective (before the study started) or at a site where the training was not implemented. | |
| CVC Train the Trainer | Patients who undergo CVC procedures by providers who have participated in simulation-based mastery learning. Receives: Behavioral: CVC Train the Trainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effectiveness of simulation based mastery learning for CVC insertion on CLABSIs
Data from infection control on central line associated bloodstream infections will be reported for all sites each month. The investigators plan to compare the trained ICU's infection rates with other ICUs at other sites in addition to comparing the trained period versus the untrained period while trainees were rotating through the MICU.
Measured: 3 years
Secondary outcomes (2)
The effectiveness of simulation based mastery learning for CVC insertion on mechanical complications
ICUs will collect information on actual CVC insertions including complications (need for line adjustment, arterial puncture, pneumothorax). The investigators plan to compare the trained ICU's complication rates with other ICUs at other sites in addition to comparing the trained period versus the untrained period while trainees were rotating through the MICU.
Measured: 3 years
The effectiveness simulation based mastery learning for CVC insertion at the learner level using simulated checklist data and trainee surveys
Using simulated checklist data and trainee surveys, the investigators will assess the effectiveness of our intervention at the learner level.
Measured: 2 years
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 startJan 2014
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Error Reduction and Certification, Inc.
- Responsible party
- Principal investigator, Jeffrey Barsuk, Northwestern University
- Investigators
- Jeffrey H Barsuk, MD, MS, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402257
- Sponsor's protocol ID
- STU00089190
- Status last verified
- Sep 2019
- First submitted
- 25 Mar 2015
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Barsuk JH, Cohen ER, Feinglass J, McGaghie WC, Wayne DB. Use of simulation-based education to reduce catheter-related bloodstream infections. Arch Intern Med. 2009 Aug 10;169(15):1420-3. doi: 10.1001/archinternmed.2009.215.
PubMed 19667306Barsuk JH, McGaghie WC, Cohen ER, O'Leary KJ, Wayne DB. Simulation-based mastery learning reduces complications during central venous catheter insertion in a medical intensive care unit. Crit Care Med. 2009 Oct;37(10):2697-701.
PubMed 19885989Barsuk JH, McGaghie WC, Cohen ER, Balachandran JS, Wayne DB. Use of simulation-based mastery learning to improve the quality of central venous catheter placement in a medical intensive care unit. J Hosp Med. 2009 Sep;4(7):397-403. doi: 10.1002/jhm.468.
PubMed 19753568Cohen ER, Feinglass J, Barsuk JH, Barnard C, O'Donnell A, McGaghie WC, Wayne DB. Cost savings from reduced catheter-related bloodstream infection after simulation-based education for residents in a medical intensive care unit. Simul Healthc. 2010 Apr;5(2):98-102. doi: 10.1097/SIH.0b013e3181bc8304.
PubMed 20389233Barsuk JH, Cohen ER, Potts S, Demo H, Gupta S, Feinglass J, McGaghie WC, Wayne DB. Dissemination of a simulation-based mastery learning intervention reduces central line-associated bloodstream infections. BMJ Qual Saf. 2014 Sep;23(9):749-56. doi: 10.1136/bmjqs-2013-002665. Epub 2014 Mar 14.
PubMed 24632995
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of a Simulation-based Mastery Learning Curriculum for Central Venous Catheter Insertion at Veterans Affairs Hospitals: A Quantitative Study
- ClinicalTrials.gov ID
- NCT02402257
- Acronym / sponsor ID
- STU00089190
- Conditions
- Healthy
- Keywords
- Central Venous Catheter, Simulation-based Mastery Learning, Medical Education, Patient Outcomes, Bloodstream Infection Due to Central Venous Catheter, Pneumothorax, Inadvertent Arterial Puncture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Medical Error Reduction and Certification, Inc.
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (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 investigators previously successfully implemented a central venous catheter (CVC) simulation-based mastery learning (SBML) curriculum at Northwestern University. As a result, trainee skill improved, complications, including central line associated bloodstream infections (CLABSIs) decreased and the curriculum was proven cost-effective. Therefore the Veterans Administration Medical Centers (VAMC) decided to implement this training at some of their sites as a quality improvement project. The investigators will train faculty at these locations to implement the same curriculum at their individual sites. Outcome data will be collected to evaluate the outcomes of the quality improvement (QI) project (complications, infections, skills).
Detailed description
Beginning in 2006, Northwestern University Internal Medicine and Emergency Medicine residents completed simulation-based mastery learning in central venous catheter (CVC) insertion before clinical rotations in the Medical Intensive Care Unit (MICU). This comprehensive program in central line training used repetitive practice and simulation technology to train residents to mastery standards. This study had important patient safety implications. This program resulted in improved trainee skill and reduced CVC insertion complications, including a significant decrease in the rate of central line associated bloodstream infections (CLABSI). In addition, the investigators showed that the in CVC insertion was highly cost-effective suggesting that investment in simulation training can produce significant medical care cost savings.
This curriculum has now been successfully implemented at a few other sites. Due to the investigators' success, the VA has requested that Medical Error Reduction and Certification, Inc.(MERCI) along with Northwestern University, implements the curriculum at its sites across the county as a quality improvement project. Using a train the trainer course in CVC placement, the investigators are interested in analyzing the data that the VAMC will provide to MERCI and studying the outcomes.
Four Northwestern faculty completed a CVC insertion Master trainer curriculum. One master trainer travels to each VA facility in the program to facilitate a two-day train-the-trainer course on CVC insertion SBML. Each VA facility selects one or two "faculty champions" who complete CVC insertion SBML course and learn how to teach the curriculum on day 1 and are observed training and assessing peer healthcare providers at their institution on day 2. Course materials include standardized videos and lectures, role-playing and practice with sample learners and CVC insertion assessments. In addition to the onsite master trainer, each VA facility receives necessary training materials (standardized video lectures, data collection forms, assessment tools) and equipment (CentralLineMan simulators, ultrasound) to implement the curriculum at their institution. All participants complete pre and post testing and a course evaluation questionnaire. Quantitative outcome data on learner skills and CVC insertion quality measures are collected to measure the overall success of the project.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditionally-trained | – | –Patients who undergo CVC procedures by traditionally-trained providers who have not undergone simulation-based mastery learning. This could be retrospective (before the study started) or at a site where the training was not implemented. |
| CVC Train the Trainer | – | Behavioral: CVC Train the TrainerPatients who undergo CVC procedures by providers who have participated in simulation-based mastery learning. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Trainees undergoing simulation-based mastery learning for CVC insertion 2. De-identified patient information from patients with a CVC.
Key inclusion criteria (3 listed)
- Previously (or prospectively) collected de-identified data on trainee skill and experience
- Previously (or prospectively) collected de-identified data on patients in the VA ICU with CVCs
- Previously (or prospectively) collected de-identified data on mechanical complications in the ICUs
Key exclusion criteria (3 listed)
- Data not de-identified
- Data on pts on non-ICU units
- Data on pts without CVCs
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 |
|---|---|---|
| CVC Train the TrainerTrainees receive a simulation-based mastery learning intervention and train-the-trainer program on central venous catheter insertion | Behavioural | CVC Train the Trainer |
Primary outcome
The effectiveness of simulation based mastery learning for CVC insertion on CLABSIs
Time frame: 3 years
Data from infection control on central line associated bloodstream infections will be reported for all sites each month. The investigators plan to compare the trained ICU's infection rates with other ICUs at other sites in addition to comparing the trained period versus the untrained period while trainees were rotating through the MICU.
2 secondary outcomes
The effectiveness of simulation based mastery learning for CVC insertion on mechanical complications
Time frame: 3 years
The effectiveness simulation based mastery learning for CVC insertion at the learner level using simulated checklist data and trainee surveys
Time frame: 2 years
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 6 Sep 2019.
- Background: PubMed 19667306Barsuk JH, Cohen ER, Feinglass J, McGaghie WC, Wayne DB. Use of simulation-based education to reduce catheter-related bloodstream infections. Arch Intern Med. 2009 Aug 10;169(15):1420-3. doi: 10.1001/archinternmed.2009.215.
- Background: PubMed 19885989Barsuk JH, McGaghie WC, Cohen ER, O'Leary KJ, Wayne DB. Simulation-based mastery learning reduces complications during central venous catheter insertion in a medical intensive care unit. Crit Care Med. 2009 Oct;37(10):2697-701.
- Background: PubMed 19753568Barsuk JH, McGaghie WC, Cohen ER, Balachandran JS, Wayne DB. Use of simulation-based mastery learning to improve the quality of central venous catheter placement in a medical intensive care unit. J Hosp Med. 2009 Sep;4(7):397-403. doi: 10.1002/jhm.468.
- Background: PubMed 20389233Cohen ER, Feinglass J, Barsuk JH, Barnard C, O'Donnell A, McGaghie WC, Wayne DB. Cost savings from reduced catheter-related bloodstream infection after simulation-based education for residents in a medical intensive care unit. Simul Healthc. 2010 Apr;5(2):98-102. doi: 10.1097/SIH.0b013e3181bc8304.
- Background: PubMed 24632995Barsuk JH, Cohen ER, Potts S, Demo H, Gupta S, Feinglass J, McGaghie WC, Wayne DB. Dissemination of a simulation-based mastery learning intervention reduces central line-associated bloodstream infections. BMJ Qual Saf. 2014 Sep;23(9):749-56. doi: 10.1136/bmjqs-2013-002665. Epub 2014 Mar 14.
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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.
Jeffrey H Barsuk, MD, MS principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Northwestern University at 1 site in United States.
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 3 inclusion and 3 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The effectiveness of simulation based mastery learning for CVC insertion on CLABSIs (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02402257, which also lists 5 linked publications.
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 6 Sep 2019; AzTrials last refreshed its copy on 27 Oct 2026.