Central Venous Catheter Insertion Train the Trainer

September 5, 2019 updated by: Jeffrey Barsuk, Northwestern University

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  1. Trainees undergoing simulation-based mastery learning for CVC insertion
  2. De-identified patient information from patients with a CVC.

Description

Inclusion Criteria:

  1. Previously (or prospectively) collected de-identified data on trainee skill and experience
  2. Previously (or prospectively) collected de-identified data on patients in the VA ICU with CVCs
  3. Previously (or prospectively) collected de-identified data on mechanical complications in the ICUs

Exclusion Criteria:

  1. Data not de-identified
  2. Data on pts on non-ICU units
  3. Data on pts without CVCs

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: CVC Train the Trainer
Trainees receive a simulation-based mastery learning intervention and train-the-trainer program on central venous catheter insertion

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The effectiveness of simulation based mastery learning for CVC insertion on mechanical complications
Time Frame: 3 years
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.
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
Using simulated checklist data and trainee surveys, the investigators will assess the effectiveness of our intervention at the learner level.
2 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northwestern University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medical Error Reduction and Certification, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jeffrey H Barsuk, MD, MS, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 30, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STU00089190

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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