Effect of Early Recognition of Sepsis on Morbidity and Mortality – Research Proposal

Background and Significance

Efficient, aggressive, and timely recognition and treatment of patients with sepsis, severe sepsis, and septic shock is central to effective care and a happier society, especially with the rising healthcare costs and disease burden. The United States records 1.5 million new cases of sepsis and about 250,000 resultant deaths annually (Fleischman et al., 2016). This creates the need to develop ways of reducing the burden and loss caused by sepsis. Recent research has provided evidence of how early recognition and therapy can improve outcomes for various complications. The first study supporting the benefit of early therapy for sepsis patients was conducted by Rivers et al. (2001) who concluded that early goal-directed therapy can enhance care and improve outcomes for sepsis patients. Many more studies have shown that small improvements and early therapy are associated with better outcomes, particularly in terms of mortality and morbidity (Rivers, Coba, & Whitmill, 2008). However, overall compliance to early therapy protocols remains low and a significant number of patients receive late treatment (Bruce, Maiden, Fedullo & Kim, 2015). Some studies have found no benefits of early therapy (Prism Investigators, 2017). Hence, there is a gap in research concerning the true outcomes of early recognition and therapy. Without timely treatment, Sepsis can lead to tissue damage, organ failure, and even death. One significant step in reducing the burden inflicted by condition is conducting scientific further investigation on the effectiveness of early recognition. This study fulfills this necessity.

Statement of the Problem and Purpose

Sepsis is a deregulated systemic inflammatory and immune response to invasion of microbes that results in organ injury (Fisher, A. P. (2014). Septic shock is characterized by hyperlactataemia and concurrent hypotension which often necessitate the patient to undergo vasopressor therapy (Hotchkiss et al., 2016). The study of sepsis reflects progress in understanding hosts and human pathophysiology. While early studies focused on microorganisms and their pathogenicity, later research concentrated more on host response to invading pathogens rather than pathogenicity with the help of sequencing of human inflammatory genes and molecular cloning technologies. The understanding of sepsis has been dramatically improved by the discovery on how hosts distinguish themselves self from non-self (Reinhart, Meisner, & Brunkhorst, 2006). The ‘danger’ hypothesis suggests that the immune system recognizes unique host cellular products and microbial patterns as “danger signals or alarms of tissue injury or microbial invasion. Nevertheless, research reveals a more complex progression process of sepsis that extends beyond host pattern recognition and inflammation.

The illness also involves influence on microcirculation and endothelial tissues, parenchymal tissues, coagulation, as well as neurological disturbances. Today, the origins, progression, and recovery or death are present complex problems in the healthcare system with the ability to intervene and alter progression remaining partially successful. In general, increased understanding on pathogenesis has failed to improve outcome substantially (Reinhart, Meisner, & Brunkhorst, 2006). In-hospital mortality may have reduced in the past decades, but such improvement is attributed to early recognition and supportive therapies (Westphal & Lino, 2015). Even so, research on the effects of early recognition and protocols is inconclusive. Additionally, diagnosis of sepsis in critically ill people is demanding since it can be obscured by inflammation and other processes in disease progression. Given these gaps in research, it is necessary to investigate how early recognition influences mortality and morbidity. The findings of this research will add to the growing body of research on early therapy in management of sepsis.

Literature Review

A larger share of experimental studies on early identification of sepsis have relied on Early Goal Directed Therapy (EGDT). A study by Rivers et al. (2011) divided 263 participants’ intro two groups. The researchers administered EGDT to the treatment group. The outcomes were significantly improved in the EGDT group in terms of mortality. Another study reported a reduction of 16% in risk of mortality in an older population that followed the sepsis bundle. The treatment group received lower doses of vasopressors and a higher volume of intravenous fluids six hours of treatment. Nevertheless, the study had limited generalizability because of the small sample size and single setting.

            Nguyen et al. (2012) evaluated the effect of using SSC guidelines in a community-based health center. The treatment protocol accorded both treatment and control groups with similar care with regard to early antibiotic administration. Yet, the treatment group reported a higher survival rate. The observed differences were attributed to early fluid resuscitation, but the study was severely limited by the retrospective control group and small sample size.

            Research by Yealy et al. (2014) found contrasting findings after conducting a randomized controlled trial of protocol-based care. The researchers collected data from 31 emergency departments in the United States (N =1341). The participants were randomly assigned to three groups: a protocol-based EGDT group, a protocol standard based therapy group, and a usual care group. There were no significant differences in the outcomes of the three groups. The study concluded that protocol-based therapy did not improve outcomes. Other studies have produced inconclusive findings regarding early identification and treatment. A majority of these studies reveal improved outcomes. However, they are limited by sample size and setting.

            In conclusion, no conclusive evidence of improved outcomes has been gathered thus far, but a larger percentage of studies lean towards perceived benefits. Studies guided by the sepsis bundle showed improved outcomes, particularly lower mortality. The bundle emphasizes administration of higher IVFs, which lessen the need for vasopressors. A few studies have reported no beneficial aspects of early protocol treatment. There is a need for further research using large sample sizes and multiple settings.

Research Question

The following focal research question will guide this research “what is the effect of early recognition on morbidity and mortality of sepsis patients”? The question focuses on identification of the difference between outcomes of early recognition in patients treated with an early alert tool and patients treated via an ordinary protocol.

Hypothesis

The study is based on the following hypotheses:

Null hypothesis H0: “Early recognition does not have any effect on morbidity and mortality in sepsis patients.”

Alternative Hypothesis H1: “Early recognition has effect on morbidity and mortality in sepsis patients.”

The researcher hypothesizes that early recognition will significantly improve outcomes. May studies published in the last decade show the benefit of early recognition and goal-directed therapy with pieces of evidence exposing recued mortality among patients with septic shock and severe sepsis (Levy et al., 2010; Westphal & Lino, 2015).

Variables

The study variables will comprise the outcomes and parameters of the treatment protocol. Outcomes comprise the death rate, length of hospitalization, restoration while parameters of the treatment protocol will include time, methods of treatment, and processes and tools used in treatment and management.

Theoretical Framework

Kolb’s Learning Theory is most fitting for this study because of its holistic outlook on research. Developed by David A. Kolb in 1984, the model outlines four stages of learning and four separate learning styles. The stages include concrete learning, reflective observation, abstract conceptualization, and active experimentation (Kolb, Boyatzis, & Mainemelis, 2001). Concrete learning involves acquisition of new experiences or further deduction of existing experiences. Reflective observation embroils reflecting on the experiences from a personal point of view. The process results in abstract visualization or formation of new ideas and modification of exiting ideas. Finally, the learner applies the generated ideas to their surroundings to further modify a future experience. This leads to the next concrete experience. Learning is only attained when all four stages are complete.

            This study will progress through all four stages of the cycle. Researchers have observed the current rate of unsatisfactory outcomes in Sepsis treatment. They feel there is a need to advance treatment and improve outcomes. This can be achieved by conducting experiments to test the effects of proposed treatment protocols. This study especially focuses on early identification which is a critical factor in treatment (Boyle, Chandler, Stonestreet, & Oh, 1978).  The current study will utilize an experimental method to observe these effects on sample and assimilate the acquired knowledge into abstract data which will be interpreted to improve sepsis treatment. Nguyen et al. (2009) reported significant benefits of applying Kolb’s Learning Theory in Sepsis research. Hence, its application in this investigation is expected to yield value.

Methodology

Sampling Strategy

The study will involve hospitalized pediatric patients from birth to the age of eighteen. The sampling method that will be used is stratified sampling technique. The participants will be divided into two groups based on their age and similarity of their symptoms (Nguyen et al, 2012). Treatments will then be administered to the groups. The results will be compared and reported. The report will include its findings on what group records higher morbidity and mortality rate. However, the study had limited generalizability because of the single setting and small sample size.

Research Design

A post-test only experimental design will be adopted. The researcher will assign participants randomly to two groups: experimental and control groups. Neither of these groups will be pretested before implementation of treatment. Rather, treatment will be applied after treatment to test the effect of the manipulation.

Extraneous Variables

Extraneous variables are factors that the researcher will not be intending to study or test (Maner, 2016). The foremost aim of the experiment is to assess how early recognition affects morbidity and immortality in sepsis patients. However, several extraneous variables may influence the results (Baños, 2017). They include setting-specific factors, investigator effects, and participant variables. For the researcher to conclude confidently that a change in the independent variable will affect a change in the dependent variable, potential extraneous variables need to be controlled. The study will focus on health centers with similar situational characteristics. Some characteristics to be considered are resources, hospital size, and expertise. Investigator effects will be eliminated by conducting the study by disconnecting the researcher and elements of research from the participants as much as possible. This will ensure that the treatment protocol is adhered as naturally as possible. Participants who will not adhere to the treatment will not be considered in data analysis. Finally, the researcher will minimize differences between participants in order to control for participant variables. The age of participants, for instance, will be controlled by focusing attention on a specific age group.

Instruments

The primary instrument will measure the results of an early recognition sepsis protocol, hence the need to construct a customized tool. The new instrument will measure key identifiers of health status and mortality rates in experimental and control groups. Key variables to be measured comprise temperature, Oxygen saturation, respiratory rate, and blood pressure. The researcher will conduct a small preliminary study to test whether the instrument works as intended (Heale & Twycross, 2015). Internal consistency and inter-rater agreement will be measured and assessed.

Intervention

Intervention for the study will comprise an early identification protocol where individuals experiencing earliest stages of sepsis will be identified. Early identification refers to identification of vital signs that precede diagnosis of sepsis (Torsvik at al., 2016). The control group will undergo standardized care and will provide a benchmark for measuring how experimental test subjects will respond to the intervention. The theory behind early identification and management is that early recognition of signs will lead to a more timely clinical intervention to prevent further deterioration of the condition. Basic observations to be made include physiological markers.

Data Collection Procedures

The independent variables will consist observation-rate of vital signs, sepsis-related Sequential Organ Failure Assessment scores, infection focus in terms of organ, bloodstream infection, and length of stay in care, among other physiological measurements (Torsvik at al., 2016). The dependent variables will be represented by specific outcomes, which include mortality and morbidity. A majority data will be sourced from existing databases in respective healthcare centers. The Electronic Health Record will prove useful in providing demographic information and past admissions. Specific departments for which data will be useful to the study are the Emergency department and Intensive Care Unit (ICU). To supplement the data, the researcher will provide questionnaires to administrative units on which they will offer qualitative data.

Data Analysis Plans

The study will utilize a range of descriptive and inferential statistics to present the findings. Descriptive statistics will be used to describe and comprehend the features of collected datasets. Specific types to be used include means, median, standard deviation and modes. These will be used along with charts to present and summarize basic features of demographics data such as age, medical history, comorbidity, and frequencies.

On the other hand, inferential statistics will be used to make conclusions about the general population based on the study sample. This takes account of relationships between variables and comparison between experimental and control groups. Paired sample t-tests will be utilized to determine the mean difference between experimental and control groups while correlation coefficients and linear regression will be used to expose relationships between early detection of sepsis and health outcomes.

Ethical Issues

Key foreseeable ethical issues involve confidentiality and autonomy (Truog 2015). Patients deserve the right to privacy and autonomy. The researcher will avoid violation of these fundamental privileges by communicating all details, taking account of benefits, risks, and procedures. In practice, a consent form will be exploited not only as a means for respecting autonomy but also a legal mechanism for protecting the researcher from assault charges.

Limitations and Implications for Practice

The study will be limited to specific settings in which the study will occur. Additionally, it will constrained by adherence to treatment protocols. The study relates to how the healthcare community approaches the treatment of sepsis. Early identification of sepsis and forecasting of cases of severe sepsis could inspire the creation of new sepsis protocols intended to improve outcomes.

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