Liver cirrhosis is characterised by a silent, asymptomatic course, often referred to as ‘compensated cirrhosis’ (Ballinger, 2012; Angeli et al, 2018). The hallmark of advanced disease is the development of portal hypertension, which manifests in patients as ascites, variceal bleeding, hepatic encephalopathy and jaundice (Porth, 2011). This is termed decompensated liver cirrhosis and is associated with higher mortality when compared with patients who are still in the compensated stage (Porth, 2011; Ballinger, 2012; Harrison, 2015).
The main causes of liver cirrhosis in the UK are alcohol-related liver disease (ARLD), viral hepatitis (B and C) and non-alcohol-related fatty liver disease (NAFLD) (British Association for the Study of the Liver (BASL) and British Society of Gastroenterology (BSG), 2009; Williams et al, 2014). Recent studies and national mortality alerts have identified rates of liver disease to be steadily increasing in the UK over the last two decades and is ranked as the fifth most common cause of death in the UK (Williams et al, 2014; Harrison, 2015; British Liver Trust, 2019). It is a silent killer as most people with liver disease do not have obvious symptoms until the disease is at an advanced stage. In most cases, the chances of successfully managing it are slim as there are limited options for management in the later phase of the disease (BASL, 2009; Williams et al, 2014; British Liver Trust, 2019). Among all digestive diseases, liver disease was reported to be the second leading cause of death in the UK and USA (Everhart, 2008; British Liver Trust, 2019) and has been highlighted by the World Health Organization (2022) as the leading cause of death among digestive diseases. Furthermore, there is an increase in liver-related hospital admissions, which is associated with a high mortality rate. The National Confidential Enquiry into Patient Outcome and Death (2013) report on patients with ARLD, Measuring the Units, found significant variations in the management of patients admitted with complications of liver cirrhosis. The review highlighted various avoidable factors that might have contributed to patients' death. Although the review only looked at patients with ARLD, it is plausible that the findings would be similar for other aetiologies too. Based on this report and its recommendations, BSG and BASL (2019) devised a ‘care bundle’, which is widely available. This details a step-by-step management guide for patients admitted to hospital with decompensated cirrhosis, with key interventions to be made within the first 24 hours of admission.
In conjunction with the increasing trend of mortality related to liver disease nationally, the Trust local data in 2019 showed that showed that liver disease was an area of concern in the Summary Hospital-level Mortality Indicator (SHMI) dataset (https://tinyurl.com/ysz32dvp) and deemed an outlier when compared with other aetiologies. This led to the formation of a working group consisting of hepatologists, acute care physicians, the hepatology advanced clinical practitioner (ACP), senior nurse on the acute medical unit (AMU) and the quality improvement team. The key stakeholders undertook a collaborative quality improvement project with the main aim of improving patient care and reducing the mortality rate for patients admitted with decompensated liver cirrhosis.
Aims and objectives
This quality improvement project had a focus on the evidence-based care of patients with decompensated liver disease, which could potentially impact on safety outcomes and mortality rate. The aim was to improve liver services through staff education, training of procedural skills and implementation of the BASL-BSG liver cirrhosis care bundle in the AMU at The Royal Wolverhampton NHS Trust. The care bundle provides a simple checklist of key investigations, and clear guidance on the management of cirrhosis-related complications, such as spontaneous bacterial peritonitis (SBP), variceal bleeding and acute kidney injury (Dyson et al, 2016; BSG and BASL, 2019). Moreover, the bundle is designed to help doctors, nurses and non-specialists provide effective and safe care for these patients, who frequently have complex medical needs, in the first 24 hours, when specialist advice may not be available. In addition, care bundles have proven to be effective in improving clinical outcomes (McPherson et al, 2014; Dyson et al, 2016; BSG and BASL, 2019; Siau et al, 2020).
It was hoped that this service improvement initiative would increase the proportion of admitted patients with cirrhosis and ascites who undergo timely ascitic tap or paracentesis as recommended by previous studies (O'Brien et al, 2017), appropriate gastroenterology/liver specialist review, and receive correct treatment when diagnosed with SBP or variceal bleed.
Project site and local context
The Royal Wolverhampton NHS Trust was established as an NHS Trust in 1994. It is a major acute Trust, comprising community, secondary and tertiary services for a catchment population of over 300 000. The Trust is a large teaching hospital and regional centre, providing teaching and training for doctors, nurses, midwives, and health professionals. During the first quarter of 2020, local mortality rate of patients with liver disease was above the process limit of 50%, raising special cause of concern within the Trust (NHS Digital, 2020).
The Trust has one gastroenterology inpatient ward alongside its outpatient services, which includes a nurse-led day case unit. Patients with liver disease requiring hospital admission could be admitted to the speciality ward from home or outpatient clinics, but in most cases were admitted following attendance at the emergency department (ED). Most patients with decompensated chronic liver disease are admitted to the AMU following ED attendance, where acute medical physicians initially manage them for the first 24 to 48 hours while waiting for the appropriate medical speciality beds to become available. It is for this reason that the AMU was the focus for staff education and the implementation of the cirrhosis care bundle.
Review of local mortality statistics and case review was conducted by three hepatology consultants. This identified areas of clinical practice that could be improved as well as those that were done well, with special emphasis on the initial care of patients, within the first 24 hours of admission. These findings were shared with representatives from the directorates of gastroenterology and acute medicine alongside colleagues from the quality improvement team so that lessons could be learned and improvements could be made. The action effect methodology, with the use of driver diagrams and action plan templates, was employed, detailing the interventions the key stakeholders thought could have a positive impact on clinical management for this patient cohort (Reed et al, 2014). In addition, this method provided a systematic and structured process to identify and illustrate the QI initiatives, interventions and outcomes through a diagrammatic representation of hypothesised and evidenced cause–effect relationships (Figure 1). The Trust's research and development department and clinical audit team were approached to discuss the project proposal and ethics approval was sought. The initiative was classed as a service/quality improvement project and as per the Trust guidelines, it did not require Health Research Authority or research ethics committee approval. Instead, permission from the clinical area manager and consultant lead was sought regarding the implementation of the project and it was registered as a service improvement project in the research and development database.
The project was divided into four stages: staff education and training (theoretical and clinical skills), introduction and implementation of the BSG-BASL cirrhosis care bundle, a retrospective review of the management of patients admitted between July 2019 to July 2020 (pre-intervention) and a repeat audit to compare prospective data following service change against baseline data.
Five key interventions were made. A senior nurse on AMU was approached and enrolled as a ‘Liver Champion Nurse’, who facilitated in devising and implementing the change in practice. Focused educational sessions were delivered by the hepatologists to consultants, junior doctors, physician associates and nurses on AMU. The BSG-BASL cirrhosis care bundle was rolled out and made part of the standard admission document, with some modifications, in conjunction with the medical team, to make it easier to follow. Training of procedural skills, ascitic tap and abdominal paracentesis (an invasive procedure wherein a large volume of ascitic fluid is drained from the abdomen), was carried out by the hepatology ACP and delivered to the nurses, doctors and physician associates on AMU. Lastly, a hepatology in-reach service was devised to provide specialist review within 24 hours of patient admission.
For objective analysis, a monthly rolling audit was conducted, which was based on key performance indicators as per the Improving Quality in Liver Services (IQILS) recommendations. IQILS is an accreditation scheme for liver service providers in the UK that aims to improve the quality of medical liver services throughout the UK (https://www.iqils.org). Four clinical parameters were evaluated: ascitic tap in emergency admissions with ascites to be performed within 24 hours of admission, albumin and antibiotic prescription and administration in patients diagnosed with SBP within 12 hours of its diagnosis, antibiotic prescription in acute variceal bleeding 12 hours either side of the endoscopic procedure and gastroenterologist/hepatologist review within 24 hours of hospital admission.
Formation of a working group
A separate working and evaluation group collaborated to implement the initiative. Having organisational support was deemed crucial for the success of the project. The working group consisted of three hepatologists, an acute medicine consultant and link nurses, while the evaluation group was composed of an ACP, liver clinical nurse specialist and QI project team lead. Teamwork, integration and collaboration was vital; both directorates showed a shared vision and commitment to support the project. Involvement and communication with key stakeholders were essential. A monthly progress meeting or report was agreed and considered to ensure transparency, credibility, and validity of progress and project evaluation.
The intervention involved running a staff training programme about decompensated liver disease. The initial training programme was directed towards the AMU consultants wherein a consultant-liver lead for AMU was identified. The appointment was voluntary, and the designated clinician showed a strong interest in this patient cohort and medical specialisation. The theoretical aspect of the training includes the pathophysiology of liver cirrhosis, its critical complications ie, ascites, spontaneous bacterial peritonitis, hepatorenal syndrome to name a few, and the clinical management of the disease particularly within the first 24 hours of hospital admission as defined in the BSG-BASL cirrhosis care bundle. Succeeding training sessions were attended by the AMU liver link nurse, physician associates and junior doctors. From the date of agreed implementation in August 2020 to January 2021, a total of five theoretical training sessions were held, attended by around 30 health professionals: nurses, physician associates, foundation year doctors and consultants from the acute medical unit. The same training was repeated on different occasions to ensure staff were given adequate opportunity to attend at least one session. Succeeding training sessions have been carried out according to junior doctors' placement rotation (April, August and December), that is, at least two training sessions every 4 months.
In addition to these training sessions, the gastroenterology nurses, being specialists in their field, offer simulation and bedside clinical skills in the gastroenterology day case unit on a one-to-one basis following the theoretical sessions (Menon et al, 2016; Tan et al, 2017). This enabled all junior doctors and physician associates to be trained in ascitic tap or paracentesis. During the clinical skills training, knowledge and clinical competencies were also assessed.
The Trust QI project officer played a key role, undertaking the monitoring and recording of the project development, progress and data analysis, while the first author performed the documentary review and data collection. A monthly meeting was arranged to ensure the project's progress was discussed and monitored. Staff feedback, clinical compliance, and patient outcomes were reported to evaluate any impact on the existing service and shared on the respective directorate's governance meeting.
Data collection and analysis
Following the intervention, prospective data of patients admitted from August 2020 to January 2021 were evaluated and compared against the baseline. No direct patient contact was made, instead data were obtained from the hospital's electronic health records. Identifiable data was not used in reports, instead, the subjects were allocated numbers, and the four major elements of the care bundle were explored and formed part of the headings of the Excel data collection spreadsheet. Subjects were determined by the clinical coding/information department using an in-house system database with the following inclusion criteria: patients admitted to the AMU with a primary diagnosis of liver disease, and secondary diagnosis of ascites. However, if the patients were diagnosed with these clinical codes during their hospital stay but the coding was different during their stay in AMU, these patients were excluded. Following the generation of the patient list, patient hospital numbers were provided to the named auditor including their admission dates. Patients were allocated ascending numbers and stored in an Excel data spreadsheet that could only be accessed within the Trust and stored in an encrypted computer hard drive. To further establish accuracy and integrity, data collected were checked for validation by two other key stakeholders.
Aside from the feedback collected during the training and staff discussions, while undertaking the review of health records there emerged documented narrative and clinical circumstances that provided rich insight on patients' journey. It was agreed that this information would be useful to fully understand potential clinical issues and provide direction for future improvement interventions and it was therefore collated during the review.
The data were analysed and presented using two statistical analysis tools. A descriptive and narrative presentation of patient demographics were analysed along with the aetiology of liver disease cases using descriptive statistics (IBM SPSS statistics tool) – frequencies, crosstabs and chi-squared test. A 95% confidence interval was set on these tests. In addition, statistical process control charts were used to analyse and evaluate statistical significance. NHS Improvement (2011) introduced these charts to analyse data over time and the format is widely used within the NHS to analyse whether service change results in improvement. A statistical process control chart is a way of mapping variation and observing if any activity is outside of the limit of what is expected to happen and whether interventions made have had any effect and not just by chance (Wheeler, 2010; NHS Improvement, 2011).
A total of 182 patients (113 pre-intervention, 68 post-intervention) hospital admissions and health records were included of which 120 (66%) were male, 95 (52%) were aged between 41 and 60 years and 155 (85%) had ARLD (Table 1). These demographic findings are in line with the patterns of prevalence in the national data on liver disease (Williams et al, 2014; British Liver Trust, 2019).
Table 1. Patient demographics
|Age range||40 and under||15 (8.2%)|
|Over 70||30 (16.5%)|
|Disease aetiology||ARLD||155 (85.2%)|
ARLD=alcohol-related liver disease; NASH/NAFLD=non-alcoholic steatohepatitis/non-alcohol-related fatty liver disease
Comparative analysis showed an improvement from baseline in all but one of the pre-defined key parameters (Table 2). Patients with ascites undergoing ascitic tap within 24 hours of admission (71% vs 87 %, P=0.033) was significant. Ascitic taps were performed within 24 hours of admission in 87.3% of patients with ascites post-intervention compared with 71.3% pre-intervention, yielding a 16 percentage point improvement in ascitic tap performance. The ascitic tap compliance was statistically significant with a P value of 0.033. In addition, diagnostic tests were accurately requested and completed; an improvement from 90% to 98%. Intravenous antibiotics (87% vs 100%, P=0.159) and 20% albumin infusion (18.5% vs 100% P=0.004) were administered within 12 hours of diagnosis of SBP. Patients who underwent gastroscopy due to variceal bleed were given intravenous antibiotics within 12 hours (50% vs 100%, P=0.029). However, there was a reduction of patients being reviewed within 24 hours of admission (87% vs 82%, P=0.008). A review of case notes revealed that 12 patients were reviewed by a GI specialist after 24 hours of admission because of patient movement to another clinical area (50%) and delay in GI referral (50%).
Table 2. Comparative analysis of clinical parameters pre and post intervention
|Metrics||Pre intervention (n=108)||Post intervention (n=63)||P value|
|Ascitic tap performed within 24 hours of admission||77 (71.3%)||55 (87.3%)||0.033|
|Patients with SBP
||117 (87.5%)2 (18.5%)||4 (100%)4 (100%)||0.1590.004|
|Antibiotics in variceal bleed||4 (50% n=8)||7 (100% n=7)||0.029|
|Specialist review||99 (86.8%)||56 (82.4%)||0.008|
SBP=spontaneous bacterial peritonitis
Statistical process control charts also show a sustained improvement in the clinical parameters (Figure 2) and an improvement in crude mortality (Figure 3). Figure 2 demonstrates that the group managed to maintain compliance with the different aspects of the bundle. The team demonstrated 100% compliance with antibiotics and albumin use within 24 hours. The improvement in compliance with albumin administration is deemed to be a ‘statistically significant’ change having a run of over 7 points above average compliance. The use of ascitic taps was above average for 6 of the 7 months after the intervention. However, the GI team review within 24 hours has not seen a statistically significant improvement in the same period.
One of the highlights noted in this project is that pre intervention there was a wide variation in the clinical management of decompensated liver cirrhosis, patients were not receiving the optimal standard of care during the first 24 hours of hospital admission (Ximenes et al, 2016; O'Brien et al, 2017). The care bundle proved to be an invaluable tool to guide non-specialist doctors and nurses in the management of decompensated liver disease, reducing variability in the management of decompensated liver cirrhosis, and potentially facilitating early administration of life-saving and evidence-based treatments (McPherson et al, 2014; Mansour et al, 2018). However, this appeared to be best achieved in conjunction with appropriate staff training and education.
For audit purposes, it would also be helpful if formal use of the cirrhosis care bundle is documented (Tapper et al, 2016). During the retrospective review of patients' documents, elements of the care bundle were noted to have been carried out. However, the cirrhosis care bundle itself was not necessarily completed as these were not found in some of the patients' health records. Introduction and implementation of the cirrhosis care bundle in the local hospital is at an early stage but is seen to be crucial for the success of the project. Although not all patients had a standardised care bundle completed in their health records, increased bundle use and compliance with clinical management standards was noted. It is therefore vital to include staff education on liver cirrhosis and its management as part of the staff induction training programnme. Furthermore, the low patient numbers and the 6-month timeframe in the post-intervention data collection require acknowledgment in the interpretation of results to avoid bias. Despite this, a consistent improvement is seen over the post-intervention run charts, which provide some confidence in the findings. Moreover, staff awareness appears to have increased and engagement is evident.
Nonetheless, there are still clear areas for improvement. For one, the patient flow management was seen to be challenging during the COVID-19 pandemic period. The reduction in the GI specialist review despite the implementation of the service was highlighted. It is therefore deemed essential to evaluate the impact on clinical management over longer time periods and in normal clinical situations. It is also vital to include the Trust's capacity team in the key stakeholders' monthly meeting to ensure the allocation of patients to appropriate specialty beds including reasonable transfer times and consideration of patients' clinical needs. Timely GI specialist review and appropriate bed allocation following the transfer from AMU is paramount to optimal patient care and outcomes. Perhaps a review of the local processes and policies in terms of patient allocation to speciality wards following AMU attendance, with the involvement of other key stakeholders, would be a start.
Before the service change, ascitic taps were not consistently performed. During the teaching session feedback, health professionals noted a lack of confidence and training causing procedural delays including concerns regarding coagulopathy. This concern was addressed by providing opportunities for clinical skills training and competency assessment on ascitic tap and abdominal paracentesis including the standardisation of cut-off blood result levels and safe parameters to be able to perform taps.
In addition, the QI project identified the need for education of health professionals regarding the care bundle, including when it should be used and its subsections. The requirement to upskill clinicians on ascitic taps, including the appropriate diagnostics tests to be requested, appears to be vital. The use of the care bundle following education and training corresponded with a trend of increased ascitic taps at the time of admission. More point-of-care training opportunities for junior doctors and nurses are essential to sustain clinical competencies and clinical management compliance.
Recommendations and next steps
Sustaining the changes and improvements in patient care will be the next challenge. Frequent and continuous audits and local feedback would help with clinical management adherence. Ongoing review and continuous evaluation of patient outcomes including mortality rates, particularly with the continued rise in health burden from liver disease would be a start. Despite a number of studies demonstrating improved clinical management of liver disease patients using the care bundle, including this study, patient outcomes and mortality rate have not been fully reported (Dyson et al, 2016; Shahid et al, 2016; Yuong et al, 2016Sheikh et al, 2019). Additionally, there have been not enough substantial subsequent published studies of its use. Although several studies have showed reduced mortality and hospital readmission in patients more closely adherent to the BSG-BASL cirrhosis care bundle, most studies could have possibly not reach statistical significance due to the small sample size (Thiagarajan et al, 2016Yuong et al, 2016). Reporting mortality rates in future reviews would be a valuable contribution to the body of research and evidence-based practice, and one which the authors intend to further pursue for future publications.
Finally, sustained improvement in the use of the cirrhosis care bundle is key. Regular education and clinical skills training for junior doctors at the changeover of clinical placements, normally in April, August and December, and other health professionals – ie, senior nursing staff and physician associates – would be a feasible programme to ensure training sustenance. Training and adoption of ascitic tap in the ED and other outlier wards as well as in the AMU could be another way forward. The cirrhosis and clinical skills training have been formalised and included as part of the induction programme for foundation year doctors and senior nurses. This included additional opportunities for point-of-care clinical skills training and competencies via the day case unit. In addition, the use of the cirrhosis care bundle should continue to be widely reported to standardise and improve inpatient morbidity and mortality in liver disease. Emphasis should be placed on the importance of re-audit on an annual basis to ensure that patients with decompensated liver cirrhosis are receiving the necessary investigations and treatment in the first 24 hours of admission.
There are three key issues and limitations for consideration. First, a two-fold review of the clinical management pre- and post-change. It is essential to consider the number of retrospective cases reviewed in comparison with the prospective data to avoid result bias. Second, the launch of the service change was in August 2020. Quarterly junior doctor rotation was expected around this period, however, due to the clinical climate brought about by the COVID-19 pandemic, normal rotations did not occur. It is essential that staff training is conducted every 2 months to ensure equal training opportunities for staff, and that training leads are identified including training dates. The COVID-19 pandemic climate within the NHS may also have had an effect on implementation of change and presented difficulties, including affecting the patient flow within AMU. Various adjustments to clinical activities, workforce and bed management have to be taken into consideration.
The quality improvement project illustrates that collaboration between hepatology and medical teams, with emphasis on education and training, benefits patients who present to hospital with decompensated liver cirrhosis. Collaboration with the members of the multidisciplinary team not only facilitated a more structured approach to the planning and service delivery but also provided a better way of managing patients. The project delivered four target outcomes and supports the use of the care bundle to improve the clinical management of patients with decompensated liver disease in AMU. The project team have demonstrated that engagement of the appropriate teams with targeted training and support at an intensive level can significantly improve the delivery of care for decompensated cirrhosis patients by non-specialist/emergency care teams. This has the potential to dramatically improve the outcome of these patients. It provides an opportunity to further explore this initiative in terms of its impact on patient outcomes including length of hospital stay and mortality rates for future research. With hindsight, there is a strong need to focus on improving quality service and deliver better-value care by continually ensuring safety, effectiveness and better experience of care. Quality improvement should be at the heart of every local plan for redesigning and improving healthcare services including individual professional practice.
- The cirrhosis care bundle proved to be important tool to guide non-specialist doctors in the management of decompensated liver disease but only with the appropriate staff training and education.
- Following staff training on liver disease and the use of the cirrhosis care bundle, improvement in the clinical management of patient with decompensated liver disease was noted.
- With the continued rise of liver disease, continuous review and evaluation of clinical management and patient outcomes would be vital.
- Close collaboration between general and specialist groups is vital to the success of quality improvement projects
CPD reflective questions
- How can the specialist teams collaborate with general/medical teams to improve patient journey and outcomes?
- Consider other improvement projects within your speciality areas that could be shared with other areas and Trusts to improve care standards.
- Explore areas where clinicians and nurses could be encouraged to develop and expand the boundaries of their roles.
- Are there any clinical practice within your service that could potentially improve if trainings and/or care bundles are incorporated?