Nosocomial Infections Clinical Trial
Official title:
General Surgery Residents Education in Maximum Barrier Precautions During Central Venous Catheter Placement: Effect of Simulation-Based Training
Central line associated bloodstream infection (CL-ABI) is an important and preventable cause of nosocomial infections and is responsible for considerable morbidity and mortality 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.
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 line (CVL)
infections at SLRHC with cumulative rate of infection of 3.8 per 1000 central line days.
These infection rate figures are above the benchmark experience. 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. Guzzo et al found
that mentors of trainees performing CVC placements in both emergent and non-emergent
situations were significantly less likely to consistently utilize maximum sterile
precautions [8]. Furthermore, in a study of a video-based training on sterile technique in
CVC insertion in a trauma resuscitation unit that evaluated only non-emergent CVC
placements, a total of 5 cases of central- catheter- related bacteremia were reported on
just 68 patients, and even with video based training, 26% of residents continued to have
infractions in their compliance with sterile precautions [9].
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 [10,11,12]. 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 [13]. This
is hypothesized to be of particular value in the proper acquisition of physical skills such
as maximum sterile precautions.
With this in mind, the Department of Surgery has recently approved a training policy in
aseptic technique during central venous access placement (see attached copy). All GS
residents will be trained in MBP techniques in the Sim Lab. Training will include baseline
assessment of residents skills in maintaining maximum sterile precautions using a
standardized scoring tool, videotape training, short exam, and individual simulated
debriefing on performance of correct MBP with follow up assessment and training as needed.
We plan to collect data prospectively on all GS residents who will undergo evaluation and
training in maximum barrier precaution during CVC placement. Data will be reviewed and
analyzed for future research publication
C METHODS:
I. Inclusion criteria:
General Surgery (GS) residents will be undergoing evaluation and training in MBP according
to their department training policy.
II. Design:
A. All GS residents undergoing evaluation and training in MBP during CVC placement as per
department policy are eligible for the study.
B. All data collected for the purpose of Education and Quality Improvement on all GS
residents, who are undergoing evaluation and training (as per standard department policy) in
MBP during CVC placement will be reviewed and analyzed after being deidentified for the
purpose of this study.
C. Waiver of Subject informed consent and HIPPA authorization is requested as this is a
minimal risk study and the data and thus conclusions would be greatly improved by using the
data from all subjects. There could be a selection bias if we only used the data from the
residents who felt they had done a good job. Other criteria needed to waiver of subject
informed consent and HIPPA authorization are listed below:
1. Minimal risk study: This is an observational, non-interventional study. The research
part of the study is the prospective data collection for the purpose of analysis of the
aggregate data and possible publication. Training of residents in MBP as per described
protocol is set according to approved hospital policy for the purpose of quality
improvement. The only risk to the subject is the potential loss of confidentiality, and
the investigators will minimize that risk by deidentifying the data as described below
in section III (Confidentiality) and all research data will be deleted once the six
month follow-up has been completed
2. There is no reason to believe that waiving the informed consent will affect the rights
and welfare of the subjects enrolled since these subjects will not be identified by
name or any form of identity. Also, all subjects will be informed that final project
results that include all subjects will be reviewed as a group and no personal
identifications will be included in the results.
3. This research may not be carried out without the waiver as the results and thus
conclusions would be greatly improved by using the data from all subjects. There could
be a selection bias if we only used the results from the residents who felt they had
done a good job
4. This research may benefit the subjects directly by understanding the limitations of
previous training (or lack of) in MBP if any noted after analyzing the results, and is
likely to yield generalizable knowledge that would be of benefit for subjects with
similar conditions.
5. This area of research is directly related to the condition of any potential subjects
who might not be able to give consent
6. Whenever appropriate the subjects will be provided with additional pertinent
information after participation as it has been stated in the protocol
7. Protections will be taken to protect the confidentiality of subjects as outlined below
in the Confidentiality section D. Information sheet will be provided to all residents
participating in this project explaining the purpose of this project, confidentiality
protection when data is potentially reported, and E. GS residents may have repeated
performance (3-6 months) in MBP technique for central line placement individually at
the discretion of their residency program director. If so, data collected will be
analyzed and reviewed.
III. Confidentiality:
All aggregate data will be kept secured as part of the research database and will be
password protected. No supervisor will have access to this aggregate data and he / she will
not be able to compare any individual resident's performance to the rest of the group in the
database.
All sessions in the sim lab are videotaped automatically. All videotapes sessions titles are
not identified by name but coded (i.e sim session medical code session 6 June 08). All
videotapes are reviewed periodically and deleted except for few that are kept for
educational purpose. These videotapes are identified by subject study number and phase only
(i.e. CVLN 01 phase 1). In this project, videotaping of all subjects performances is for the
purpose of training, and quality improvement. The research part of this project involves
review of the data collected by the instructor on the assessment tool and is unrelated to
videotaping.
IV. Data Analysis The overall performance score of MBP technique, including the overall
maximum and the seven components will be analyzed. The effects of simulation based training
on performance, realized in performance score improvement over baseline, will be evaluated
using Wilcoxon signed-rank test. A p-value less than 0.05 will be considered as
statistically significant
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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