Effect of PDCA on Improving the Compliance of Sepsis Bundles

Background To explore the application effect of plan, do, check and action circulation management mode in improving the compliance of sepsis bundle treatment. Methods 132 patients with sepsis admitted from January 1 to December 31, 2018 were selected as the control group, and the bundle treatment measures of sepsis were routinely implemented, that is, the nurses received the conrmation notice of sepsis, measured the body temperature, blood pressure, central venous pressure (CVP), central venous oxygen saturation (S cv O 2 ), indwelling catheter, etc., and the doctor ordered the infusion of antibiotics, rehydration, application of pressor drugs, blood culture and blood gas analysis, blood routine test, procalcitonin and other sample medical orders were immediately implemented by nurses, and the improvement of blood pressure, urine volume and skin endings was closely observed, Doctors and nurses reminded each other to complete the above treatment measures within 6 hours; 138 patients with sepsis admitted from January 1 to December 31, 2019 were selected as the observation group. The Department established a sepsis treatment group. All medical staff, under the leadership of the medical and nursing team leaders, took the same measures as the control group, supplemented by PDCA cycle management. Objective to compare the changes of compliance of medical staff to sepsis bundle treatment before and after the implementation of PDCA cycle management. Results Compared with the control group, the observation group achieved the completion rate of sepsis bundle treatment in 1 hour was 76.8% (65.9%), the completion rate in 3 hours was 82.6% (69.7%), and the completion rate in 6 hours was 87.7% (77.3%). The difference was statistically signicant (P < 0.05). Conclusions The implementation of PDCA cycle management mode can effectively improve the compliance of medical staff to the bundle treatment of sepsis, improve the treatment eciency of sepsis, and improve the quality of medical care.


Background
The Chinese Guidelines for the Emergency Treatment of Sepsis/Septic Shock (2018) de nes sepsis as life-threatening organ dysfunction caused by a dysregulated host response to infection [1] . Prompt diagnosis and treatment of sepsis is very important, and according to the World Health Organization, sepsis should be treated as a priority by global health systems [2] . More than 80% of patients survive when shock is treated within one hour; if shock is diagnosed and treated after six hours, the survival rate drops to 30% [3][4] . The Saving Sepsis Campaign (SSC) is a joint initiative by the European Society of Intensive Care Medicine and the Society of Critical Care Medicine that is dedicated to reducing the morbidity and mortality of sepsis and septic shock worldwide. Sepsis bundles have always been the core strategy of the SSC guidelines. It emphasizes the necessity and importance of timely and effective implementation of cluster therapy within three hours and six hours of diagnosis of sepsis or septic shock. It has been proven by many countries that it can signi cantly improve the prognosis of patients with sepsis and septic shock and has been considered a cornerstone for improving the quality of treatment of Page 3/13 sepsis and septic shock since 2005 [5][6][7] . However, health care workers, especially nurses, are not aware of the guidelines. The overall compliance during the course of cluster therapy is low and there is a large variation in the attainment rate among the items of the treatment bundles recommended by the guidelines with a completion rate of 23.5% (16/68) for cluster therapy within three hours after septic shock and 33.3% (20/68) within six hours. There is also a large gap between the effective implementation of cluster therapy and the requirements [8] . Poor adherence to guidelines and poor implementation by medical staff directly affect and increase the 28d mortality of patients with severe sepsis and septic shock [9] . At present, the methods to improve the compliance of sepsis bundles include the establishment of departmental medical and nursing teams for sepsis treatment, the use of checklists, training, assessment and educational supervision, but the highest rate of adherence to the standard is only at 81% [10][11] . The Plan, Do, Check, Act (PDCA) Cycle, also known as the Deming Cycle, can assist medical and nursing staff in clinical work to proactively identify problems, strictly link quality control and management and optimize work ow [12][13] . The PDCA method gradually improves the quality of work through a closed loop system and circular management of improvement projects in four stages: Plan, Do, Check, and Act [14] . This kind of quality management method has the characteristics of "big ring sets small ring, small ring ensures big ring, step-by-step promotion and continuous improvement". The clinical use of PDCA for management can not only ensure more rigorous and effective medical and nursing practices, but also improve medical and nursing quality [15] . PDCA cycle management is effective in improving the compliance of medical staff to sepsis bundles.

Inclusion criteria:
Meeting the diagnostic criteria of the Chinese Guidelines for the Treatment of Severe Sepsis/Septic Shock (2014) by the Chinese Society of Intensive Care Medicine Branch [3] , and admission to the ICU to con rm the diagnosis of sepsis with a duration of stay longer than six hours.

Exclusion criteria:
Termination of treatment, discharge or death within six hours after admission.

Ethics:
The study was approved by the hospital's medical ethics committee; approval number (2020), ethical review No. 108. The Informed Consent Form was signed with the patient's family and the subject could voluntarily terminate their participation in the study at any time and would not be prevented from receiving further treatment.

Study methods:
A prospective cohort study was used.

Control group:
As required by the Chinese Guidelines for the Treatment of Severe Sepsis/Septic Shock and the Professional Quality Control Index for Critical Care Medicine (2015), the physician diagnosed sepsis and noti ed the nurse. The nurse immediately measured temperature, blood pressure, central venous pressure (CVP), and central venous oxygen saturation (S cv O 2 ) and inserted an indwelling urinary catheter. The doctor gave medical orders for antimicrobial infusion, rehydration, application of antihypertensive drugs, collection of blood culture, blood gas analysis, blood routine, calcitonin, and other specimens. The nurse immediately carried out these orders and closely observed the improvement of blood pressure, urine volume, skin endings, etc. The doctors and nurses reminded each other to complete the above treatment measures within six hours.

The sepsis treatment team
for observation group A was established in the department and all medical and nursing staff under the leadership of medical and nursing team leaders applied PDCA cycle management to the problems in the sepsis bundles.

Plan (P):
132 cases of sepsis from January to December 2018 were retrospectively investigated. The problems identi ed in the process of cluster therapy were that antibiotics could not be given in time, the retention rate of blood culture before the application of antibiotics was low, the measurement of S cv O 2 and CVP was delayed or not measured, the measurement of lactic acid was delayed, and the volume of uid and dosage did not meet the guideline requirements (see Table 1). The main reasons for poor adherence were analyzed as busy medical and nursing staff, insu cient knowledge of guidelines, poor awareness of S cv O 2 and CVP measurement, lack of antimicrobial stockpiles in the department, and a delay in medical record transfer and order creation resulting in a medication time greater than one hour. The causes of poor adherence were plotted into a shbone diagram of cause analysis (see Fig. 1). Group members used evaluation methods and other means to identify the main causes and highlighted them with red circles on the shbone diagram.

Development (D):
From January 2019, corresponding improvement strategies were formulated for different causes and medical staff continued to implement the cluster therapy strategies for sepsis on the basis of improvement. Speci c improvement measures are shown in Table 2.

Check (C):
After the implementation of improvement measures, the completion rates of the sepsis bundles for one hour, three hours, and six hours were calculated, respectively.

Assessment (A):
Standardize the process of sepsis cluster treatment (see Table 3) and continuously evaluate future implementation processes to ensure the scienti city and effectiveness of the measures.

An evaluation index
was used to compare the completion rates for one hour, three hours, and six hours for sepsis bundles in the observation and control groups.

Statistical methods:
The data used in this study were analyzed using SPSS 18.0. The comparison of the count data was performed by the χ2 test and the mean ± standard deviation (± s) was used for statistical description. The t-test and ANOVA (with necessary correction in case of variance) were used for the comparison of differences between groups, F-values were calculated, and a P-value under 0.05 was considered statistically signi cant.  2. Communicate with the pharmacy department to be able to temporarily borrow medication when the department's reserve is insu cient or cannot meet treatment needs, and then return the borrowed medication after the medical records are transferred and the medical orders are promptly made up.
3. When the preparation is insu cient, the nursing team leader is responsible for having the antimicrobial agent ready at the rst time after the diagnosis of sepsis is con rmed.
4. For antimicrobials requiring skin tests, the deputy team leader on duty is responsible for the con guration of the skin test solution, implementation of the skin test and observation of the results. Lack of process system 1. Develop a departmental management system for improving compliance with sepsis bundle.
2. Formulate a ow chart of sepsis bundle.
3. Dedicated person is responsible for supervision and quality control of the implementation of the established system and process.
4. Set up a sepsis treatment team including doctors and nurses, and have team members on duty in every shift to ensure the timeliness and effectiveness of sepsis bundle.  Table 4):

General information (see
There was no statistically signi cant difference between the two groups in terms of age, gender and APACHE II score; P > 0.05. 2.2 Completion rates of one hour, three hours and six hours of sepsis bundles in both groups (see Table 5): After the implementation of PDCA cycle management in the observation group, the completion rate of the one-hour sepsis bundles increased from 65.9-76.8%, the three-hour completion rate increased from 69.7-82.6%, and the six-hour completion rate increased from 77.3-87.7%. These produced a P-value < 0.05, meaning the differences were statistically signi cant. The compliance of the sepsis bundles had signi cantly improved in the observation group compared with the control group.

Discussion
Since 2004, international sepsis guidelines have been updated four times, domestic guidelines have been launched successively, quality control standards for sepsis diagnosis and treatment have been improved and the optimal time period for cluster therapy has been adjusted from three hours and six hours to one hour. This was proposed in 2018, which has put forward higher requirements for standardized diagnosis and treatment of sepsis, comprehensive management of critically ill patients by medical institutions, and coordination among hospital departments [16][17] . The completion rate of sepsis bundles has become one of the criteria for quality control of critical care by hospital management [18] . The New York Centers for Medicare and Medicaid Services in the United States require hospitals to report sepsis cluster therapy performance rates to them as part of the inpatient quality reporting program and as a condition of payment [19] . Therefore, it is necessary to correctly calculate the completion rates of sepsis cluster therapy at one hour, three hours, and six hours, and to take effective measures to continuously improve the completion rates. Despite the various measures taken to improve compliance for sepsis cluster therapy, the attainment rate is still unsatisfactory [10][11] . In this study, the PDCA cycle management model was adopted, in which the medical and nursing team leaders regularly informed and analyzed data on the compliance of sepsis bundles, summarized the problems and di culties in the implementation process and the sepsis treatment team members then discussed and formulated corresponding countermeasures. According to the inspection, additional points were rewarded or deducted on the basis of the original performance. This cycle is repeated, which promotes the effective operation of PDCA cycle management, improves the sense of responsibility and urgency of medical and nursing staff and ensures the improvement of sepsis bundle compliance. The compliance rates of one hour, three hours and six hours for sepsis cluster treatment reached 76.8%, 82.6%, and 87.7%, respectively, which is related to the fact that the department has repeatedly trained staff and emphasized the importance of cluster treatment for three years. Additionally, the compliance of treatment has improved to a certain extent through methods such as checklists. However, due to the existence of objective reasons, such as low bed-to-nurse ratios and delayed transfer of medical records, further improvement of medical and nursing staff compliance to sepsis cluster therapy needs to be addressed in terms of rationalization and maximization of ICU human resource allocation, optimization of the referral process and medication pick-up process.
One-hour cluster therapy can achieve the goal of reducing 28d morbidity and mortality rate [20] , but mandatory rapid use of broad-spectrum antimicrobials, especially in patients without shock, may lead to their overuse [21] , a viewpoint that in uences some physicians' prescription of broad-spectrum antimicrobials and contributes to the low overall treatment adherence rate.

Conclusion
The PDCA cycle management model, in which existing and potential problems are identi ed in clinical work, a problem-based improvement plan is developed, corresponding measures are implemented strictly according to the recti cation plan and the results of implementation and execution are checked, standardized, or process-oriented, and the above links are cycled back and forth to better highlight the advantages of continuous improvement in quality management, continuously improve the quality of medical care and ensure medical safety [22] . However, objective reasons hindering the implementation of cluster therapy and subjective factors exist, such as cognitive bias and poor practice of cluster therapy by medical personnel, which makes 100% compliance of sepsis cluster therapy di cult to reach. The sample size of this study is relatively small and regional in nature, and as an observational cohort study it also has its inherent limitations and biases. We will continue to conduct in-depth multidisciplinary and multicenter studies on adherence to the processes for sepsis bundles to provide more bases for clinical decisions.

Availability of data and materials
All data generated or analyzed during this study are included in this published article

Competing interests
All of the authors had no any personal, nancial, commercial, or academic con icts of interest separately.

Funding
Not applicable.
Authors' contributions LCX and LY conceived of the study, and TYQ, ZK, HGZ and SLM participated in its design and coordination and DQS helped to draft the manuscript. All authors read and approved the nal manuscript. Figure 1 Financial trouble and di culties to make use of PICCO and so on for target capacity resuscitation;