Running head: SCHOLARLY PAPER (PROJECTED IDEA) 1

Scholarly Paper (Projected Idea)

Kayla Azari
Barry University
 Projected Idea
Project Overview and Design
The idea behind this project is to use POC Procalcitonin (PCT) in ERs to aid in the early

detection of bacterial sepsis. Also, POC PCT will help to distinguish between bacterial and non-

bacterial sepsis will, in turn, reduce unnecessary use of one-hour sepsis bundle on patients with

non-bacterial infections. If the findings of the projects correspond with the projected idea, then

there will be a breakthrough in the treatment of bacterial sepsis as well as non-bacterial sepsis.

Consequently, there will be a reduction in mortality rates among sepsis patients as the infection

is known to be among the leading causes of death in ERs. Also, non-bacterial sepsis patients will

not have to suffer the consequences of receiving unnecessary one-hour sepsis bundle which is

likely to increase their stay in the ERs.

The projected design for this project is a prospective cohort study. The advantages of

using the design are that it is ethically safe, easier to establish directionality and timing of events,

allows standardization of outcome assessments and eligibility criteria, and cheaper than other

designs that can fit in this kind of project such as a randomized controlled trial. Patients will be

classified into two diagnostic groups: bacterial sepsis and non-bacterial sepsis. The patients’

level of PCT will be measured immediately after admission. Higher levels of PCT levels will be

used to indicate the presence of bacterial sepsis while lower PCT levels will indicate non-

bacterial infections. The tool for measuring PCT will be the Vidas Biomerieux immunoassay

system (Rosanova et al., 2015). In both groups, the outcomes will be measured based on the

length of stay in the ER and mortality rate. A follow-up card for each participating patient shall

be developed where data will be recorded based on the following variables: type of infection,

age, length of stay and patient mortality.

 The primary outcome is expected to be the presence of a bacterial infection or a non-

bacterial infection. A descriptive statistical analysis will be conducted. Quantitative variables

will be expressed as median and quartile range (Belle et al., 2011). Categorical variables will be

reported as percentages. In addition, quantitative variables will be compared between those

patients with proven bacterial and non-bacterial sepsis using the non-parametric Mann-Whitney

U test/Wilcoxon test/Kruskal-Wallis test whichever available (Belle et al., 2011). On the other

hand, for categorical variables, patient characteristics will be compared by Fisher’s exact test or

chi-square test system (Rosanova et al., 2015). In the end, statistical analysis will be conducted

using the latest SPSS software version for windows or the latest software package of SAS.

The overall plan of the project is to observe the outcomes of the two groups of patients

between 2019 and 2021. During the period, more emphasis will be documenting the effects of

one-hour sepsis on both bacterial and non-bacterial sepsis patients. In addition, patients who will

not have received one-hour sepsis bundle in both groups will also be recorded and their

outcomes documented. The results after the project will help in determining the effectiveness of

POC PCT in the distinction of bacterial from non-bacterial sepsis infections. Afterwards, there

will be a comparison of health outcomes based on the prescription of one-hour sepsis bundle to

the patients in both groups to test whether the prescription has negative effects on non-bacterial

sepsis patients.
Project Goals (Smart Format)

Goal 1

Key Component Goal

Specific To use POC PCT in the ER as a biomarker for

early recognition of bacterial sepsis to

distinguish between bacterial and non-

bacterial sepsis before the implementation of

the one-hour sepsis bundle.

Measurable Number of patients diagnosed with bacterial

and non-bacterial sepsis in the ER per day

Achievable Yes. If the PCT levels of the patients will be

determined before the one-hour sepsis bundle

is implemented.
Realistic There is a screening tool in the ER that can

determine PCT levels in patients.

Time-Bound Within 1 hour after admission.

This goal will be evaluated through conducting an extensive review of literature on the

usefulness of PCT in the detection of bacterial sepsis infection.

Goal 2

Key Component Goal

Specific To decrease unnecessary use of sepsis bundle
 on non-bacterial infected patients.
Measurable The number of sepsis patients without sepsis

infection or septic shock discharged from the

hospital without having to receive the sepsis

bundle due to negative POC PCT.

Achievable Yes. If the detection of bacterial infection is

done within minutes with POC PCT on

patient arrival to the ER, patients without

sepsis infection will not have to receive the

sepsis bundle of fluids resuscitation, blood

cultures, and broad-spectrum antibiotics

within one hour of sepsis detection. This will

reduce the cost of unnecessary treatments, as

well as reduce the growing antibiotic

resistance.
Realistic There is a sepsis coordinator that implements

the compliance of the sepsis bundle in the ER

and meets monthly for the sepsis committee

that will help mentor me through this

scholarly project.
Time-Bound This project will be conducted from 2019 to

2021.

This goal will be evaluated by educating nurses about the use of POC PCT in the ER to evaluate

both bacterial and bacterial sepsis patients.

Setting

This project will be conducted in a clinical setting. Particularly, it will be done at an ER

in a hospital. The rationale for choosing the setting will be based on three things: proximity,

whether the hospital is open to research activities, and its admission capacity. Therefore, the

most preferable setting will be one that is in close proximity to minimize the cost of study.

Besides, it should be a teaching hospital and have the ability to admit as many patients as

possible. Access to the setting will be sought through a sending a formal letter to the hospital's

administration through the help of my school. The letter will aim to inform the hospitals of my

intention to conduct the study. My plan for entry to the setting will be dependent upon the

response of the hospital. If granted access, I will have to seek physicians and nurses who will be

willing to volunteer in my study throughout the whole project. To commence the project, I will

seek permission from the appropriate ethics committee and the hospital's review board or the

teaching committee as they must approve my project before I get to the ground.

Identification of Potential Participants in Project

Potential participants for this project will comprise of patients admitted to the ER. Their

participation will be voluntary. Thus, informed consent, either oral or written, will be required to

either from individual patients or the patient's next of kin. Throughout the project, the eligibility

of the patients shall be assessed on a daily basis and their PCT levels measured to categorize

them as bacterial sepsis, non-bacterial sepsis and no infection. Bacterial sepsis will be considered

present if PCT levels will be more than 0.5ng/ml, non-bacterial sepsis will be detected if PCT

levels will be less than 0.5ng/ml. For no infection group, PCT levels will have to be 0.05ng/ml

(Rosanova et al., 2015). Both bacterial and non-bacterial sepsis patients will be treated by their

physicians according to the standard guidelines for intervention in ERs. The patients’ clinical
parameters, microbiology data, comorbidities, and demographic data will be recorded upon

enrollment into the study.

The inclusion criteria will be based on a number of factors. The first criterion will be proof of no

history of prior antimicrobial treatment or hospitalization. In addition, the patients should not

have a clinical suspicion of any infection. The importance of ensuring no prior infection and

antimicrobial intervention is to get reliable results from the use of POC PCT in the detection of

bacterial sepsis. All patients who will be microbiologically tested by a physician to have an

infection, either bacterial or non-bacterial, will be included be eligible for inclusion. Besides, the

patients should have been admitted in between 2019 and 2021 during the duration of the study.

The minimum age for inclusion will be more than 1 year old.

The exclusion criteria will be used to remove the possibility of misleading results. For

instance, patients with solid cancers will not be included in the study because these malignancies

tend to trigger a spontaneous release of PCT even when there is no bacterial infection. Also,

palliative and hospice care patients shall be excluded from the study. Moreover, other patients

deemed for exclusion include; those who abandon treatment, death within 24hours after

admission, those with burn injuries, those transferred to or coming from other ER with bacterial

or non-bacterial sepsis, and those discharged within 24hrs of admission.

References

Bele, N., Darmon, M., Coquet, I., Feugeas, J. P., Legriel, S., Adaoui, N., ... & Azoulay, É.

(2011). Diagnostic accuracy of procalcitonin in critically ill immunocompromised

patients. BMC infectious diseases, 11(1), 224.

Rosanova, M. T., Tramonti, N., Taicz, M., Martiren, S., Basílico, H., Signorelli, C., ... & Lede,

R. (2015). Assessment of C-reactive protein and procalcitonin levels to predict infection

and mortality in burn children. Arch Argent Pediatr, 113(1), 36-41.