Simulation-based Training for Surgery Residents in Aseptic Techniques
Condition: Nosocomial Infections
MeSH terms: Cross Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

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 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
    

Intervention name(s): simulation based training
Intervention type(s): Other
Intervention description(s): simulation based training in aseptic techniques that included specified AT categories
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: precaution technique during central venous catheter placement.