HealthyNCT00612131
Medical Residents Performance: Effect of Simulation-Based Training
An observational study of Healthy, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
I Hypothesis: 1. Simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement is superior to general videotape-based training 2. Baseline performance in maximal barrier precaution technique of PGY 2 and 3 Medical residents, certified in CVC placement, is poor 3. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jan 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: MEDICAL RESIDENTS
Who may be able to join
- Medical residents who completed one year training in internal medicine program who are certified by their program to place and supervise medical interns in placement of CVC
Who cannot join
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Hospital
New York, New York, 10019
About this study
Official title: Medical Residents Performance in Maximum Barrier Precautions During Central Venous Catheter Placement: Effect of Simulation-Based Training
I Hypothesis:
- Simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement is superior to general videotape-based training
- Baseline performance in maximal barrier precaution technique of PGY 2 and 3 Medical residents, certified in CVC placement, is poor
- PGY 2 and 3 medical residents have low self-perceived confidence in mastering maximal barrier precaution technique during central venous catheter (CVC) placement
- PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement have good recall after 3 months
Read the detailed description
Central line associated bloodstream infection (CL-ABI) is an important and preventable cause of nosocomial infections and is responsible for considerable morbidity and mortality. It is estimated that 5 to 26% of patients experience an infectious complication from their central venous catheter [1]. In the United States, it is estimated that nearly 50,000 patients develop central line associated bloodstream infections in the ICUs annually, at a rate of approximately 5 infections per 1000 catheter days [2] and as many as 15,000 deaths annually. Central line associated bloodstream infections are also associated with increased hospital and ICU lengths of stay in the ICU (2). Estimates of the cost of CL-ABI to hospitals range from $25,000 to $65,000 per patient [3, 4].
The Centers for Disease Control have published guidelines for the prevention of CL-ABI that represent a collaborative effort by a multidisciplinary coalition of professional organizations that provide evidence based recommendations to prevent catheter related infections [5]. The interventions emphasize five distinct practices, including: education and training of healthcare providers who place and care for catheters, utilizing maximum sterile barrier precautions during catheter placement, skin preparation using 2% chlorhexidine, avoiding routine replacement of central lines as a strategy to reduce infection, and using antiseptic or antibiotic coated lines in the event that infection rates remain high despite adherence to the above measures [5].
Several studies have demonstrated impressive reductions in CL-ABI from the application of these strategies, ranging from 18 to 100% reductions and realizing significant reductions in mortality and cost [2]. The simple introduction of maximum sterile barrier precautions to insert central lines has been observed to dramatically reduce infection rates for over a decade [6]. However, the CDC's guidelines, despite their seeming simplicity, have been found to be frequently insufficiently applied, whether by ignorance or omission (2) In the past 12 months there have been a total 24 documented central venous catheter (CVC) infections at SLRHC. At RH the total number of central line days since June 2005 was3,567 with a cumulative rate of infection of 2.8 per 1000 central line days and at SLH a total of 8,524 central line days with an infection rate of 4.3 per 1000 central line days. These infection rate figures are above the benchmark experience. The cost of CVC infections to hospitals in the United States is estimated to be $45,000 per infection (7). For SLRHC the cost incurred over the past 12 months is estimated to be $1,080,000.
Training and education of healthcare personnel and the utilization of maximum sterile precautions are two important areas. Residents still most frequently learn central line placement techniques by the "see one, do one, teach one" method, which by its very definition allows for a multitude of techniques in practice. While this teaching theoretically includes the utilization of maximal sterile precautions for central line placement, the focus of teaching, and of residents' anxieties, is most often focused on the proper placement of the line, not the sterile technique used to place it. Residents in non-surgical fields may not be comfortable with maximum sterile technique in bedside procedures, and surgical residents may be somewhat blasé about the need for such detail.
Medical simulators allow residents to practice skills in a realistic and interactive environment that minimizes risk to patients. Studies have found simulation to be an effective means for teaching skills as diverse as ACLS and airway management to laparoscopic surgical skills (8, 9, 10). Additionally, the use of audio-visual equipment in a medical simulator to record a resident's performance gives valuable firsthand feedback that is otherwise not available, as it allows residents to visualize their own missteps (11). This is hypothesized to be of particular value in the proper acquisition of physical skills such as maximum sterile precautions.
We plan to examine the utility of a medical simulation environment that replicates an ICU setting to first assess medical residents' ability to utilize and maintain maximum sterile precautions in the placement of central venous lines using a standardized scoring tool and subsequently, assess the impact of videotape training vs. individual simulated debriefing on performance of correct MBP.
We hypothesize that medical residents, who have baseline training in the placement of central venous lines, will show improvement following simulation and viewing of the training videotape, and that greatest improvement will be seen in the residents who go through a debriefing simulated method. We hypothesize that PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement will have good recall after 3 months
- Conditions
- Healthy
- Keywords
- medical residents PGY 2 and 3
What is being measured
The primary outcome is the main question the study is designed to answer.
-Primary outcome: Medical residents' performance in maximal barrier precaution (MBP) technique during central venous catheter (CVC) placement
Measured: 2 weeks
Secondary outcomes (1)
Secondary outcome: Medical residents' confidence level in maximal barrier precaution (MBP) technique during CVC placement
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Khouli, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00612131
- Sponsor's protocol ID
- 07-125
- Status last verified
- Sep 2007
- First submitted
- 28 Jan 2008
- Last updated
- 17 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Khouli H, Jahnes K, Shapiro J, Rose K, Mathew J, Gohil A, Han Q, Sotelo A, Jones J, Aqeel A, Eden E, Fried E. Performance of medical residents in sterile techniques during central vein catheterization: randomized trial of efficacy of simulation-based training. Chest. 2011 Jan;139(1):80-7. doi: 10.1378/chest.10-0979. Epub 2010 Aug 12.
PubMed 20705795
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Residents Performance in Maximum Barrier Precautions During Central Venous Catheter Placement: Effect of Simulation-Based Training
- ClinicalTrials.gov ID
- NCT00612131
- Acronym / sponsor ID
- 07-125
- Conditions
- Healthy
- Keywords
- medical residents PGY 2 and 3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Jan 2008 (actual)
- First posted
- 11 Feb 2008 (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.
I Hypothesis:
- Simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement is superior to general videotape-based training
- Baseline performance in maximal barrier precaution technique of PGY 2 and 3 Medical residents, certified in CVC placement, is poor
- PGY 2 and 3 medical residents have low self-perceived confidence in mastering maximal barrier precaution technique during central venous catheter (CVC) placement
- PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement have good recall after 3 months
Detailed description
Central line associated bloodstream infection (CL-ABI) is an important and preventable cause of nosocomial infections and is responsible for considerable morbidity and mortality. It is estimated that 5 to 26% of patients experience an infectious complication from their central venous catheter [1]. In the United States, it is estimated that nearly 50,000 patients develop central line associated bloodstream infections in the ICUs annually, at a rate of approximately 5 infections per 1000 catheter days [2] and as many as 15,000 deaths annually. Central line associated bloodstream infections are also associated with increased hospital and ICU lengths of stay in the ICU (2). Estimates of the cost of CL-ABI to hospitals range from $25,000 to $65,000 per patient [3, 4].
The Centers for Disease Control have published guidelines for the prevention of CL-ABI that represent a collaborative effort by a multidisciplinary coalition of professional organizations that provide evidence based recommendations to prevent catheter related infections [5]. The interventions emphasize five distinct practices, including: education and training of healthcare providers who place and care for catheters, utilizing maximum sterile barrier precautions during catheter placement, skin preparation using 2% chlorhexidine, avoiding routine replacement of central lines as a strategy to reduce infection, and using antiseptic or antibiotic coated lines in the event that infection rates remain high despite adherence to the above measures [5].
Several studies have demonstrated impressive reductions in CL-ABI from the application of these strategies, ranging from 18 to 100% reductions and realizing significant reductions in mortality and cost [2]. The simple introduction of maximum sterile barrier precautions to insert central lines has been observed to dramatically reduce infection rates for over a decade [6]. However, the CDC's guidelines, despite their seeming simplicity, have been found to be frequently insufficiently applied, whether by ignorance or omission (2) In the past 12 months there have been a total 24 documented central venous catheter (CVC) infections at SLRHC. At RH the total number of central line days since June 2005 was3,567 with a cumulative rate of infection of 2.8 per 1000 central line days and at SLH a total of 8,524 central line days with an infection rate of 4.3 per 1000 central line days. These infection rate figures are above the benchmark experience. The cost of CVC infections to hospitals in the United States is estimated to be $45,000 per infection (7). For SLRHC the cost incurred over the past 12 months is estimated to be $1,080,000.
Training and education of healthcare personnel and the utilization of maximum sterile precautions are two important areas. Residents still most frequently learn central line placement techniques by the "see one, do one, teach one" method, which by its very definition allows for a multitude of techniques in practice. While this teaching theoretically includes the utilization of maximal sterile precautions for central line placement, the focus of teaching, and of residents' anxieties, is most often focused on the proper placement of the line, not the sterile technique used to place it. Residents in non-surgical fields may not be comfortable with maximum sterile technique in bedside procedures, and surgical residents may be somewhat blasé about the need for such detail.
Medical simulators allow residents to practice skills in a realistic and interactive environment that minimizes risk to patients. Studies have found simulation to be an effective means for teaching skills as diverse as ACLS and airway management to laparoscopic surgical skills (8, 9, 10). Additionally, the use of audio-visual equipment in a medical simulator to record a resident's performance gives valuable firsthand feedback that is otherwise not available, as it allows residents to visualize their own missteps (11). This is hypothesized to be of particular value in the proper acquisition of physical skills such as maximum sterile precautions.
We plan to examine the utility of a medical simulation environment that replicates an ICU setting to first assess medical residents' ability to utilize and maintain maximum sterile precautions in the placement of central venous lines using a standardized scoring tool and subsequently, assess the impact of videotape training vs. individual simulated debriefing on performance of correct MBP.
We hypothesize that medical residents, who have baseline training in the placement of central venous lines, will show improvement following simulation and viewing of the training videotape, and that greatest improvement will be seen in the residents who go through a debriefing simulated method. We hypothesize that PGY 2 and 3 medical residents undergoing simulation-based training in maximal barrier precaution technique during central venous catheter (CVC) placement will have good recall after 3 months
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- MEDICAL RESIDENTS
Key inclusion criteria (1 listed)
- Medical residents who completed one year training in internal medicine program who are certified by their program to place and supervise medical interns in placement of CVC
Key exclusion criteria (1 listed)
- Refusal to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
-Primary outcome: Medical residents' performance in maximal barrier precaution (MBP) technique during central venous catheter (CVC) placement
Time frame: 2 weeks
1 secondary outcome
Secondary outcome: Medical residents' confidence level in maximal barrier precaution (MBP) technique during CVC placement
Time frame: 1 week
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 17 Oct 2012.
- Derived from this study: PubMed 20705795Khouli H, Jahnes K, Shapiro J, Rose K, Mathew J, Gohil A, Han Q, Sotelo A, Jones J, Aqeel A, Eden E, Fried E. Performance of medical residents in sterile techniques during central vein catheterization: randomized trial of efficacy of simulation-based training. Chest. 2011 Jan;139(1):80-7. doi: 10.1378/chest.10-0979. Epub 2010 Aug 12.
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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.
Hassan Khouli principal investigator
St. Luke's-Roosevelt Hospital Center
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 St. Luke's-Roosevelt Hospital Center 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 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 17 Oct 2012. 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?
-Primary outcome: Medical residents' performance in maximal barrier precaution (MBP) technique during central venous catheter (CVC) placement (time frame: 2 weeks). 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 NCT00612131, which also lists 1 linked publication.
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 17 Oct 2012.