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Central line-associated bloodstream infections (CLABSIs)

Chapter 3: Methodology

Aspen University 

Project Planning

February 21, 2022

Chapter 3: Methodology

Central line-associated bloodstream infections (CLABSIs) are nosocomial events that threaten patient safety and inhibit the quality of health care delivery by causing complications such as prolonged hospital length of stay, increased healthcare costs, and carry considerate risk for escalated morbidity and mortality (Islam & Li, 2019). Critically ill patients often require central lines for the management of disease processes and the majority of CLABSIs are preventable by means of appropriate catheter maintenance, the incorporation of aseptic technique, and dynamic surveillance strategies (Haddadin et al., 2020). These are provided by nurses at the bedside who spend the most time with patients and are often responsible for managing the catheters, effective prevention relies strongly on nursing interventions and practice (Jarding et al., 2021).

Quantitative and qualitative research may be used by nurses to discover which therapies are most beneficial for their patients. In order to gather information, they may carry out both quantitative and qualitative research. To help their patients, nurses utilize the information they acquire to make decisions. This study will be both quantitative and qualitative research. As a quantitative research that will be utilized, it will best answer the research questions on the cause and effect, monitoring the increase or decrease in CLABSI during the study period.  In general, quantitative research aims to test hypotheses in order to discover the causal or correlative link between variables. 

There are catastrophic repercussions if the central line-associated bloodstream infection (CLABSI) infection is not treated promptly, hence a qualitative technique will be employed to track the health of patients affected by this illness. In nursing, qualitative research focuses on the perspectives of patients and nurses who have been through the process of care. Among disease patients, qualitative research has shown some of the processes they go through and what it is like to live with illness in the open. Changes in behavior will be observable and noted as nurses are expected to adhere to recommended central line insertion practices, such as in addition to hand cleanliness and skin hygiene, proper sterile barrier measures include verifying the skin preparation agent has completely dried prior placing the central line, as well as applying all five of the best practices. A wide range of information may be gleaned by the use of mixed methodologies. When qualitative and quantitative methodologies are used together, they may give a deeper knowledge of the factors that contribute to both quantitative numerical conclusions and qualitative measures. The outcomes of the study are richer and of a high qualitative value when both methodologies are utilized. 

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Project Design 

As the blueprint for gathering, measuring, and analyzing data, the research design refers to the overarching method you use to combine the many study components in a consistent and logical manner. The project will be designed in a quasi - experimental quantitative manner in order to focus on cause and effect. Nonequivalent groups design is the quasi-experimental that will be used to test the hypotheses stated that the interventions by the unit nurses will lead to decrease in CLABSI. There will be two similar groups of patients in the same setting where one group will be under the study while the other does not. Analysis of statistical information, whether descriptive, correlational or quasi-experimental is the emphasis of quantitative design. (Winston-Salem State University, n.d.). Quantitative research designs rely on convergent reasoning and explanations are thereby generated (Babbi, 2011).  In quasi-experimental research, an independent variable is recognized but not manipulated by the research coordinator.  Determine the impact of the independent variable on the explanatory variables.  Conclusions and determining causes may be identified in consideration of additional variables (Winston-Salem State University, n.d.). The quasi-experimental quantitative approach is practical and useful as the proposed project seeks to initiate change by means of intervention and improve practice for the purpose of quality improvement (Moran et al., 2019).

The quasi – experimental quantitative research study is furthermore appropriate for the proposed study because data will be gathered by means of structured research instruments including laboratory equipment.  A large sample size may be obtained in order to representation the population being studied and enhance capacity for replication although the sample may be not truly randomized as patients included will be all adult patient admitted to the ICU with central venous catheters in place. The study seeks to answer a clearly defined research question and investigate causal relationships. The outcomes may be used to aid in the prediction of future results (Babbie, 2011). The design chosen will ensure that the data acquired allows for successful dealing with the research issue logically and plainly as possible, and that a research design fulfills its intended purpose. In the social sciences, it is typical for researchers to specify the kind of evidence they need in order to test hypotheses, evaluate a program, or appropriately characterize and assess relevance in an observed phenomenon.

The subject matter, CLABSI rates, will be measures before and after the intervention. The intervention under investigation includes the utilization of unit nurse champions for the purpose of reducing CLABSIs. Cause is the introduction of unit nurse champions to daily central venous catheter care in the intensive care unit and the anticipated effects are the reduction of CLABSI occurrences and subsequent complications.  The quantitative design will be utilized as data will be transcribed in numerical values.   CLABSI rates will then be calculated according to the Center of Disease Control guidelines which includes an algorithm listed as follows: (# of CLABIs) divided by (# of central line days) multiplied by 1000.  The audit of additional strategies including daily CHG bathing, the use of disinfectant caps on CVC hubs, and administration tubing exchanges will also be converted into percentages based on compliance during the study period.  Data and outcomes will be interpreted and transcribed in a deductive manner to either prove or disprove the hypothesis that the incorporation of unit nurse champions in the intensive care unit for central venous catheter care may reduce the occurrence of CLABSIs. 

Sample and Setting

The target population will contain all adult CLABSI patients in the hospital as they are all participants of interest. It is from all the patients that we will draw the sample. Each participant in the research should have an equal probability of being randomly chosen from a sample that is representative of the population we are interested in investigating. Selective sampling or purposive sampling will be employed as it relies on the researchers' own judgment to pick participants in their study. In this case, only patients that meet a set out criteria will be included in the study. The electronic medical records of the rural access community hospital will be audited to determine all adult patient admitted to the intensive care unit from August 1, 2019 until December 31, 2021. Charts will be reviewed to identify utilization of central venous catheter (CVC) in adult patients having been placed by the critical care nurse practitioners. The database will be generated from this data to establish the number of catheter days. Each chart will be audited to determine if the patient developed positive blood cultures during any period 48 hours after the insertion of the CVC.  Each case will further be reviewed, noting the timing of the CVC placement, where placement occurred, and duration of CVC use.  Positive blood cultures will be identified if CLASBSI occurred according to the definition outlined by the Center for Disease Control.  CLABSI rates will be then calculated for years 2019, 2020, and 2021 for the purpose of establishing a comparator group and labeled as the control. 

Inclusion criteria for the control group include all adult patients as determined as greater than 18 years of age admitted to the intensive care unit with CVCs. CLABSIs will be determined according to the definition outlined by the Center for Disease Control and the CLABSI rates will be calculated.  Exclusion criteria include pediatric patients as determined by age less than 18, patients managed outside of the intensive care unit, patients without CVC, and patients with peripherally inserted central venous catheters. Patients with positive blood cultures that may not be attributed to CVC placement, duration, or maintenance technique will also be excluded. 

Twenty patients who meet the selection criteria will be chosen from all patients under CLABSI treatment. Ten will be under the experiment group and the other ten will be the control group.  Patients will be randomly included in either of the two groups. The sample size will be established accordingly in order to augment generalizability and yield adequate confidence levels and intervals. During the study period of only 12 weeks, all patients meeting inclusion criteria will be included in order to create a variable group capable of allowing a power analysis.  Statistical power analyses will be determined by means of a selected software program. 

The location for the research will take place in the healthcare setting delivering basic medical, and other specialist services where all the nurses carry out their duties. The study will take place in the intensive care unit of UVA Culpeper Medical Center in Culpeper, Virginia.  The medical center is a rural access community hospital within the University of Virginia Health System. The medical center has 70 beds and includes an emergency department, operating room, and radiology department. Inpatient specialty services include cardiology, general surgery, anesthesia, critical care, internal medicine, obstetrics, nephrology, and hematology/oncology. The facility has a laboratory that includes basic equipment. Blood cultures requires special sensitivities are transferred to the UVA Medical Center, a tertiary, academic center in Charlottesville, Virginia. 


Observation and biophysical measurements will be used to collect data in this research as quantitative instruments. Data will be gathered using interviews, observation forms, medical charts and records, checklists, and an experiment. For the duration of the study, all patients with meeting inclusion criteria will be entered into a database and tracked throughout the ICU stay. Blood cultures will be monitored and collected from peripheral sites in patients with suspected infection as evidence by fever and/or clinical suspicion. The blood cultures bottles utilized include both aerobic and anaerobic with at least 10 ml of blood introduced to each bottle.  All blood culture bottles will then be immediately transferred to the laboratory for processing and incubation. The bottles will be stored in the Bact/Alert ® 3D Blood Culture System. Bacterial identification will be performed using standard procedures. If fungal invasion is suspected, an additional aerobic bottle will be obtained specifically for fungal observation.  Results will be tracked and documented at day 2, 5, and 7 days after collection. Blood cultures suspected of contamination will be flagged for further review. 

Presently the majority of laboratories use instruments that continuously monitor for the development of carbon dioxide within the culture bottles as indicative of bacterial or fungal growth (Doern, 2022).  Bacteria that are clinically significant are most often identified within 48 hours of blood culture collection during incubation period although fungus and certain fastidious organisms may take up to five days (Doern, 2022). Extended incubation periods are reserved for selected organisms when suspicions are concerning for legionella, francisella, bartonella, brucella, mycobacteria, and certain fungal species. (Doern, 2022). Organisms will be identified according to gram stain morphology and biochemical reactions and antimicrobial susceptibility testing will be complicated using reference standard methods (Doern, 2022). Should further identification and/or sensitivities need to be established, blood culture samples will be transferred by currier to the laboratory at UVA Medical Center for analysis.  

An additional instrument to be generated and incorporated during the proposed study include an auditing tool.  The tool in the form of a checklist will document compliance efforts with standardized best practice recommendations of CVC maintenance including daily assessment of potential removal of CVC, Chlorhexidine baths, administration set exchanges, and disinfectant caps at catheter hubs. The facility does not currently incorporate the utilization of an auditing tool. The checklist will be completed daily by the unit nurse champions. A checklist was chosen for utilization as such tools have demonstrated effectiveness and are fairly simple to use (Gupta et al., 2021).  For the purpose of this study, the checklist will not be maintained as a permanent part of the patient record. 

Data Collection 

During the study period, interviews conducted by nurses will be recorded in the forms that will be provided. Observation forms will contain information on the observed behavior of the patients such as improved or deteriorating health, medical records and checklists will also contain integral data. All critical care nurse practitioners will alert the study coordinator at the time of CVC insertion by means of email. The email notification will include name of patient, data of birth, and medical record number in order to allow the coordinator to locate the patients’ electronic medical records in Meditech. Personal identifying information will not be retrained for publication of the study. Once identified, the research coordinator will enter the patients into the database, an Excel spreadsheet maintained by the coordinator, for tracking. The unit nurse champions will be notified by email with an attached checklist for the purpose of beginning daily CVC care and facilitating dressing changes. Blood cultures will be reviewed by the research coordinator and results appraised and documented at days 2, 5, and 7 after collection.  Data elements retrieved from the electronic medical record are limited to date and location of CVC insertion and subsequent blood culture results. The electronic medical records may also be reviewed for results of Funtigell ® assay to inform the research coordinator to monitor for fungal blood cultures in addition to bacteria. 

Routine surveillance blood cultures will be ordered in Meditech by the research coordinator to be collected peripherally by the phlebotomist during the duration of the CVC utilization.  Results will be documented in the research coordinator’s database in order to calculate CLABSI rates during the study period.  Permission to utilize the research coordinators current practice site has been obtained and was granted by the hospital Chief Executive and Medical Officers. Additional approval has been granted by the manager of the healthcare center’s Student Program. The chosen methods of data collection align with current standardized practices utilized for the detection of bacteremia when CVCs also present.  After the study all data will remained protected as patient information and other identifying data will be purged and not retained.  Consent for participation will be obtained in conjunction with consent for CVC placement. 

Data Analysis Methods

Qualitative data analysis will use information on the observation forms and checklists, addresses questions that may be found in narratives, which may also incorporate that describe phenomena. Quantitative analysis is concerned with quantifying phenomena via the use of numerical values such as data on checklists and medical records. There is a wide range of statistical manipulations that may be applied to the data here. As the purpose of this study is to determine whether or not unit nurse champions have the ability to reduce CLABSI rates in the intensive care unit, CLABSI rates will be calculated according to the Center for Disease Control definition over a three-year period prior to the introduction of the unit nurse champions. CLABSI rates will be calculated according to infection per catheter days. The baseline number it will be established as comparator with the intended intervention bringing infections per catheter days to zero during the 12 weeks study period.  All data collection will be entered by the research coordinator into an Excel spreadsheet with headings listed as follows: patient medical record number, date of CVC insertion, location of CVC, date of first blood culture, blood culture results on day 2, blood culture results on day 5, blood culture results on day 7, suspected contaminant, Funtigell ® level, and compliance with standardized best practice recommendations as documented by checklist completion. Once the study has been completed, patient medical record numbers will be deleted from the database in order to ensure anonymity. 

Statistical analysis techniques such as SPSS will be incorporated in analyzing data at the recommendation of a statistician and results presented in an acceptable format like correlation analysis and trend analysis. Descriptive statistics and inferential statistics would be used to interpret results where appropriate. Rates will be calculated before the intervention and during the study period while the intervention is underway. An analysis of the collected data will then be completed in conjunction with the audit daily compliance. The level of significance that will be used to accept or reject the hypothesis includes a p value of less than or equal to 0.05. Trends will also be determined and used for decision making purposes.  

Data Management Methods

Data will be managed by means of secure encrypted avenues. The electronic medical record will be accessed and reviewed in real time without replication or paper generation of documentation. The critical nurse practitioners will communicate the insertion of a central venous catheters with the research coordinator by means of hospital regulated, protected email accounts.  The research coordinator will also utilize the same email accounts to transfer patient information unit nurse champions.  The research coordinator will store the Excel spreadsheet with data during the study on a locked computer behind the hospital firewall. Immediately following the completion of the study, patient medical record numbers will be eliminated from the spreadsheet.  

The daily checklists will be maintained in the patient’s chart while in the intensive care unit for the duration of the central venous catheter utilization.  The checklists will be collected upon completion and stored by the research coordinator in the locked file cabinet within a locked office only accessible to critical care nurse practitioners. No patient identifiers will be recorded on the checklist to ensure patient confidentiality and to protect from any sort of data breach.  The checklists will be transferred the hospital confidential disposal containers for elimination upon the completed of the study. 

Ethical Considerations

In consideration of the quality improvement nature of the project, Institutional Review Board approval may not necessarily be required (Moran et al., 2019). In order to avoid complications and delays, it is expected that the study will be sent to the Institutional Review Board (IRB) as an exempt project. The project will most likely be considered exempt as it is absent of invasive procedures, incorporates secondary documents, and involves methods with data that will avoid retention of identifiable information (Moran et al., 2019).  Patients will be included in the study on a voluntary basis after informed consent has been obtained. Anonymity will be preserved, and confidentiality will be maintained. Minimal risks are associated with the research, and the possibility that any injury or pain will be larger than that normally experienced in everyday life or during regular medical or psychological exams or tests is not more than that. The participants will have access to all of the study's findings.

Internal and External Validity

Internal validity would be demonstrated in this study if the unit nurse champions utilizing standardized best practice recommendation are able to effectively reduce the occurrence of CLABSIs and related complications.  Potential threats to internal validity with regards to the proposed study include testing effects, selection biases, and experimental mortality.  Testing effects may be demonstrated by the unit nurse champions during the study period if experimental fatigue is experienced.  Physical or mental fatigue may lead to poor performance during dressing changes, lack of adherence to compliance, and incorrect documentation of checklist completion. Selection biases may occur inadvertently as patients enrolled in the study will be the patients available in intensive care unit during the time of the study. Underlying comorbidities will not be considered; therefore, the final sample study may be rather homogeneous. Experimental mortality may also threaten internal validity should death occur in participants.  Concerns for external validity as they related to the proposed study include the inability to establish internal validity and thus causing a failure to generate meaning and applicability.    Subsequently there is the possibility of not being able to truly represent the intended population of critically ill patients in the chosen setting for the purpose of generalizability. 


The purpose of this presentation was to explore the methodology of the proposed study by illustrating the project design, identifying the sample and setting, discussing instrumentation and data collection, and reviewing data analytical methods. During the 12-week study period, unit nurse champions will perform all central catheter dressing changes utilizing standardized best practice recommendations and complete daily checklists of compliance.  Blood cultures will be trended for the duration of central venous catheter use to capture any possible infections. Electronic medical records will be monitored in real time and documented by the research coordinator in an Excel spreadsheet to allow for data synthesis upon completion. In order to ensure patient confidentiality and privacy, data management methods were considered and analyzed for completeness.  Patient identifies will be promptly eliminated upon the completion of the study and data will be communication and maintained on an encrypted computer behind the hospital firewall. Ethical considerations including the proposed application for the Institutional Review Board review were identified.  Enrollment in the study will be completely voluntary and patients will provide informed consent prior to initiation. Patients will not be subject to harm or discomfort and risk of participation is exceedingly low. All available resources and precise methods will be incorporated throughout the study to ensure both internal and external validity.


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