This article describes the development of a dedicated isolation unit for patients with Clostridium difficile-associated disease. It outlines background information on the infection and the emergence of a new strain of C. difficile. The article discusses the unit’s aims, staff training, infection-control procedures, patient treatment and nursing care. The unit has resulted in improved standards of patient care and infection control, and reduced incidence of C. difficile-associated disease and mortality.
Johnson, J. (2008) Setting up an isolation and treatment unit for C. difficile. This is an extended version of the article published in Nursing Times; 104: 25, 30-31.
Julie Johnson, RN, is senior sister, Poplar Isolation Unit, Manor Hospital, Walsall Hospitals NHS Trust, West Midlands.
Clostridium difficile is an anaerobic Gram-positive spore-forming bacterium. This usually harmless bacillus is responsible for C. difficile-associated disease (CDAD). It commonly affects older people who have co-morbidities and receive antibiotics. Broad-spectrum antibiotics kill the normally protective colonic flora, allowing proliferation of this organism, whose toxins then affect the colonic mucosa, causing inflammation and diarrhoea. Spores survive ingestion and germinate in the colon to form vegetative bacilli capable of growth and toxin production.
The Department of Health outlined seven high-impact interventions to prevent and control health-care associated infections (HCAIs) in its Saving Lives: Reducing Infection, Delivering Clean and Safe Care document (DH, 2007a). It stated that implementing the Code of Practice for Prevention and Control of Healthcare Associated Infections (Health Act 2006) is now a legal requirement for acute hospitals and other care providers, and Saving Lives provides trusts with tools and resources for effective prevention and control of HCAIs.
High-impact intervention number 7 focuses on reducing the risk from C. difficile (DH, 2007b). Some key recommendations to prevent the spread of C. difficile infection include:
Prudent antibiotic prescribing;
Correct hand hygiene;
Personal protective equipment;
Isolation/cohort nursing (DH, 2007b).
The government also launched a national campaign earlier this year to remind health professionals about the problem of antibiotic resistance and combat overuse of antibiotics (DH, 2008; Hairon, 2008). The DH warned that resistance to antibiotics is still increasing, and action is necessary to preserve the efficacy of existing antibiotics.
According to figures from the Health Protection Agency, some 9,872 cases of C.difficile were reported from 166 trusts in the last quarter of 2007 for patients aged 65 years and over (HPA, 2008). This represents an 8% reduction on the previous quarter and an apparent reduction of 23% from the same period in 2006. Among patients aged 2-64 years, figures for the last quarter of 2007 from 170 trusts indicate a 12% reduction compared with the previous quarter.
A new strain
Pathogenic strains of C. difficile produce two distinct toxins: toxin A is an enterotoxin and toxin B is a cytotoxin. Both are high-molecular weight proteins, capable of binding to specific receptors on the intestinal mucosal cells.
In 2001, reports of severe disease attributed to C. difficile showed cause for concern across the US and Canada. Analysis of isolates from these outbreaks identified a new strain that has unusual toxigenic potential, producing 20 times more toxin A and toxin B in vitro than previously known strains. This strain also produces a ‘binary toxin’; however, its role is as yet unknown (McDonald, 2005). The new strain has been identified as ribotype 027.
In March and April 2006 Walsall Hospitals NHS Trust experienced an unexpected increase in the number of patients developing CDAD. This was due to the appearance of ribotype 027, which provoked extreme concern as this strain causes more severe disease, is more difficult to treat and has a high mortality rate. In addition to diarrhoea, other systemic features include anorexia, fever, weakness, dehydration, hypoalbuminaemia, electrolyte disturbances, abdominal cramps and inflamed gastrointestinal mucosa. In severe cases it can cause pseudomembraneous colitis, which can be life-threatening. Protein-losing enteropathy represents a multiplicity of abnormalities that result in the loss of plasma proteins from the gastrointestinal tract. The pathophysiology is directly related to the excessive leakage of plasma proteins into the lumen of the gastrointestinal tract. The liver and reticulaoendothelial system are unable to compensate for the loss. Patients have gross swelling of legs and peripheral oedema, secondary to decreased plasma oncotic pressure.
Other features are sepsis and electrolyte abnormalities of:
CDAD is transmitted from person to person by the faecal-oral route. Spores are acid-resistant and pass through the stomach, where they change to their active form in the colon. Spores are heat-resistant and can survive in the environment for long periods. The following are prevention and control measures:
Reducing the use of broad-spectrum antibiotics;
Rapid isolation and good infection-control practice;
Education of staff and public;
Enhanced environmental cleaning using chlorine-based disinfectants containing a sporicidal.
Action to control infection
The trust responded to this new strain by convening an outbreak committee. Traditional control measures for patients acquiring CDAD were based on side-room isolation, chlorine disinfection of ward environments and review of antibiotic prescribing guidelines. Although the weekly prevalence and incidence of new cases were initially encouraging, a second surge of CDAD cases emerged in the autumn/winter period. Radical measures were required and the trust decided to develop an isolation unit to which all patients who were affected would be transferred.
Specialised isolation and treatment unit
In December 2006, Poplar Ward opened as a designated isolation and treatment unit specifically for C. difficile. One of the first of its kind, its aim is to combat the spread of CDAD and improve treatment.
Aims of the unit
Caring for all patients affected by CDAD in one place allowed a coordinated approach to patient treatment involving several specialties and provided an opportunity to ‘deep clean’ and decontaminate affected wards. The project also allowed the development and refinement of particular skills in a dedicated team to optimise every element of care for all patients.
The objectives of the isolation unit were to:
Cohort all patients with CDAD within an isolation facility;
Prevent the spread of C. difficile spores throughout the hospital and reduce cross-infection;
Develop the highest standard of care and specific expertise in managing disease associated with the new strain;
Allow meticulous decontamination of wards;
Reduce the incidence of C. difficileinfection;
Improve patient and public awareness of CDAD, its cause and treatment.
Work so far
An operational policy was devised and implemented, which clearly outlined the unit’s operational management. The initiative has presented excellent opportunities for staff development in infection control and staff morale has risen considerably. The infection-control team (hospital microbiologist and infection-control surveillance nurse) have provided considerable support, including education, monitoring of standards and auditing progress. Through training sessions, they have provided ward staff with the knowledge base to care for patients with CDAD. A self-directed learning and information pack complemented the education process and acts as an ongoing resource for students, newly qualified nurses and agency workers. PowerPoint presentations, policies, a hand decontamination learning pack, an educational/infection-control noticeboard plus information leaflets for staff, patients, relatives and portering staff, further enhance the learning process.
A consultant microbiologist also visits to provide staff support, supervise treatment regimes and liase directly with the unit’s pharmacist.
Following transfer of affected patients to the isolation unit, all wards were meticulously cleaned and decontaminated before new patients were admitted.
Infection control measures in the unit
All staff - including nursing and medical staff and all workers who have direct contact with patients - wear scrubs while working in the unit. In addition, they are not allowed outside the unit in scrubs, to ensure cross-infection does not occur. Nurses’ uniforms have been found to be contaminated with pathogens (Perry et al, 2001).
Aprons and gloves are replaced immediately before each and every episode of direct patient contact or care and after any activity or contact that potentially results in hands and clothing becoming contaminated. Contamination of healthcare workers’ hands can lead to, and result from, contamination of the environment. Research has demonstrated that the level of healthcare worker hand contamination is proportional to the level of environmental contamination (Fawley and Wilcox, 2001; Samore et al, 1996).
The infection-control team gave initial advice on handwashing technique, with preparation requiring wetting hands under tepid running water before applying an antimicrobial preparation. The handwash solution must come into contact with all surfaces of the hand, paying particular attention to nails. There have been no skin reactions to date. Alcohol handscrub is ineffective against C. difficile spores (DH, 2007c).
Further infection-control measures included adopting the following single-use equipment:
Research has demonstrated environmental contamination with C. difficile spores, often widely dispersed, in 34-58% of sites in hospital wards (Fawley and Wilcox, 2001; Samore et al, 1996). Appropriate daily environmental cleaning of the ward is carried out using a liquid concentrate containing 2.1% sodium chloride for the generation of chlorine dioxide - this high-level disinfectant is sporicidal and the solution is designed for the cleaning of surfaces. Disposable mop heads and cloths are also used. Cleaning staff designated to the unit maintain the highest level of hygiene, and avoid duties that involve the handling of meals.
Transmission of infection can occur because of the large numbers of organisms shed by patients who are affected from spores that can survive on surfaces for prolonged periods. The environment around patients with C. difficile infection can be heavily contaminated and may contribute to transmission to other patients. When the new unit was set up, terminal cleaning of wards where patients developed CDAD was carried out. This extensive cleaning regime included the removal of heating and ventilation grills, light-fitting covers, all surfaces and medical equipment. In addition, each time a new patient develops CDAD, terminal cleaning of the bed area or side ward occurs after they have been transferred to the isolation unit and before a new patient is admitted to that area.
Medication regimens (see below) were established through consultation between consultants and the microbiologist team. The initial medication regimen of metronidazole 600-800mg tds showed disappointing results, with most patients needing to move to second-line treatment of oral vancomycin 250mg qds after 10 days. When patients appeared to respond to metronidazole, relapse occurred within 5-10 days of treatment. This data was obtained from direct monitoring of patients.
Vancomycin treatment following metronidazole was also problematic with relapses still occurring. To prevent this, a ‘trailing-off’ dose over four weeks on discharge was prescribed with improved success.
Prolonged episodes of debilitating diarrhoea resulted in further abnormalities in patients’ albumin, sodium, potassium and magnesium levels. Patients who were already very ill due to underlying critical illnesses and multiple co-morbidities were too weak survive. We recognised early in the treatment regimen that metronidazole was not effective against the new 027 strain of C. difficile.
The treatment regimen was changed to oral vancomycin 250mg tds with good results. Patients responded within 4-5 days of treatment in most cases, with rifaximin only used as a second-line treatment. However, this has only been required in isolated cases. There has also been a dramatic reduction in relapse and, due to a shorter duration of diarrhoea, abnormalities in electrolyte balance have reduced. Overall, patients’ general condition has improved with an intense, high level of nursing care. However, a number of patients were severely ill at the time of admission and did not recover.
Monitoring blood results is a vital part of caring for patients with CDAD and any underlying medical or surgical condition. All the unit staff received phlebotomy and cannulation training. Blood samples are initially taken daily while diarrhoea is in its active stage. Monitoring albumin levels and electrolyte balance allows for early correction where possible. Restoring electrolyte balance has been a major challenge, as will be detailed later.
Nutritional status is assessed using the Burton score. Monitoring dietary input allows early identification of any need to follow alternative routes of feeding, for example via nasogastric or percutaneous endoscopic gastrostomy (PEG) tube in some cases. All patients start a high-protein diet on admission to the unit, although dietary intake is problematic as many patients have had a reduced appetite for a long time.
Hydration is important due to the prevalence of liquid stool. The importance of monitoring fluid balance is paramount in early detection of dehydration. Patients’ clinical signs are monitored closely using an early warning tool to enable quick and timely action.
Bowel actions are monitored using the Bristol Stool Chart (Lewis and Heaton, 1997). Patients are not discharged until they have passed normal stool (graded 4-5 on this chart) for a minimum of 48 hours. In the early stages, when stools are in liquid form, a faecal collector is used for patients who are bed-bound and compliant. This allows volume to be measured for fluid replacement, reduces the risk of skin breakdown and also the risk of contaminated skin spores being transferred to the environment.
It is important to observe patients with CDAD for distended abdomen and the potential for paralytic illus. Other symptoms include pain and discomfort, and nausea and vomiting.
Patient dignity, privacy and respect are also high priorities. CDAD affects patients who are immunocompromised, elderly and frail. Patient hygiene is an important factor in their care. Feeling comfortable and knowing that prompt attention will be paid to their needs has made a significant difference to patients’ psychological experience and well-being.
Patients and visitors are given written information on admission to the isolation unit. This explains what CDAD is and how it is contracted and treated, using a question and answer format. We also discuss the care to be delivered with them. Patients and visitors are asked to read the leaflet and ask questions to aid understanding. They are fully informed of the risks and receive written information on treatment as well as after-care and hygiene requirements. Further laminated information is displayed on noticeboards to ensure that all visitors are aware of our policies and procedures to help compliance and understanding.
Communication with local and national media has helped to promote the isolation unit and the work the trust is undertaking to reduce the risk of the public contracting C. difficile.
Our preventative measures have virtually eradicated the old strain of C. difficile and, by August 2007, they reduced the 027 strain to just two cases in Walsall (Fig 1). All fluid stools were tested for C. difficile - this included all previous strains as well as 027. We identified early in the treatment that the old strain had disappeared.
We have seen a general reduction in the overall number of patients with CDAD, as well as improvements in standards of care and treatment, and decreased mortality. Between November 2007 and January 2008, an increase in the number of patients acquiring CDAD occurred. This was due to the emergence of winter flu, affecting older patients with co-morbidity who needed antibiotics for chest infections. The majority of these patients were admitted from home, having been treated initially in the community (Fig 2).
Improvement in clinical outcomes of patients with CDAD
In the long term the isolation unit has dramatically improved outcomes for patients with C. difficile infection. As soon as patients are found to have CDAD they are transferred to the isolation unit and treatment is started. Diagnosis of the presence of C. difficile toxins in stool specimens can be obtained within six hours of the sample being taken, on weekends as well as on weekdays.
Being able to concentrate nursing care on managing the effects of CDAD on patients has contributed to reducing the mortality rate. However, the mortality rate remains high for patients in the following groups:
Those who were already critically ill, and admitted initially with end-stage disease:
Chronic renal failure, congestive cardiac failure, COPD, renal disease;
Those with terminal illness or undergoing chemotherapy;
Patients with multiple co-morbidities.
The following observations were made regarding patients who developed CDAD:
All had received antibiotics for severe infection;
Patients had a history of poor appetite and weight loss over a number of years;
They had low protein and albumin levels (hypoalbuminaemia);
Patients had abnormal electrolyte balance;
Many were aged over 80 years.
All patients admitted had underlying co-morbidity, previous hospital admissions, and had received antibiotic therapy either in hospital or the community. These have been identified as risk factors for CDAD (Dharmarajan et al, 2000). Several patients were admitted with feed tubes in situ, which has also been associated with increased risk of C. difficile infection (Bignardi, 1998).
Several issues have emerged. These mainly concern the time it takes to successfully discharge patients. After recovery from CDAD, their original condition still needs treating. In addition, patients are weaker as a consequence of the infection.
During the planning stages of the unit, we decided that once patients were clear of CDAD (passing formed stool for a minimum of 48 hours), they should remain as a patient in the isolation unit until they were fit for discharge to an integrated rehabilitation unit, nursing or residential home, or their own home with services to meet their needs. Transfer to another ward was only considered when patients’ care plans (such as surgery) had been interrupted due to CDAD. When this was the case, patients were transferred to a side room to reduce any risk of spore transfer.
Although patients were clear of toxins, it is not known for how long spores can be passed in faeces. It has been suggested that this can be up to 12 months following treatment, although there is currently no research available to support this. Strict hygiene measures, therefore, need to be maintained in all areas. We established communication with care homes and social services, giving accurate information to reduce the risk of cross-contamination and infection to other patients and clients in the community. However, this information caused its own problems, namely resulting in long delays in securing placements in nursing and residential homes.
Our experience of the new strain of C. difficile has shown that the antibiotics previously recommended as safe are now those most likely to trigger the disease. This was demonstrated by an audit on inducers of CDAD, after restricting prescribing of high-risk antibiotics. The clinical dilemma is that many older patients who are acutely ill die without antibiotics but may contract CDAD if treated. The antibiotic policy needs continuous review.
Close daily working between the pharmacist and microbiologist in the isolation unit allows protocols to be optimised and changes to be piloted and evaluated quickly.
Analysis of the last quarter (November 2007-January 2008) indicates that 25% of new cases come from the community, some of which are relapses triggered by GP treatment of simple infections with antibiotics. An information leaflet is being developed, to be sent to GPs when patients are discharged, to warn doctors of risks and recommend the safest options and a helpline.
Implications for practice
In view of the results obtained through the opening of the isolation and treatment unit, several recommendations are made. Special emphasis is placed on the importance of commitment and compliance from staff. Knowledge of current infection-control policies and procedures is crucial - it is imperative that clinical staff are made aware of these and the need for compliance. If prevention and control of infection is to be achieved, appropriate strategies must be integrated into nursing practice.
The physical and emotional effects of C. difficileinfection range from mild to severe, and CDAD can be fatal. Looking at the wider implications of this disease and gaining the required competence in clinical skills was imperative in improving nursing practice and reducing mortality.
Communication is vital - excellent communication skills with the public, other professionals and departments, sharing knowledge and skills, and acting as role models throughout the trust have all played a part in this initiative.
The issue of C. difficile and consequences of CDAD should be taught to all staff grades from all disciplines continually. Attending infection-control lectures or seminars will not only improve practice and assist in the appropriate use of resources but will also contribute towards nurses’ professional profiles.
Develop commitment to infection-control nursing in this specialised area;
A high level of nursing care dedicated to improving patient experience both physically and emotionally is required;
Ensure the following to improve nursing practice: early recognition of abnormal electrolytes; cannulation; phlebotomy; better empathy skills; better understanding of the implications of malnutrition;
Ensure a high level of professionalism.
The unit has been successful in all its primary aims and objectives. The measures undertaken have virtually eradicated disease from the old strain, which has never been achieved before. Major improvements have also occurred in infection-control procedures. The increased virulence of the new strains, however, mean an even higher standard will be required. This will present challenges that we have not faced before, surrounding antibiotic prescribing in older patients who are acutely ill and vulnerable.
C. difficile infection has a serious and detrimental effect on patients’ well-being and, in some cases, a fatal outcome. However, the advantages of opening an isolation unit have been immense - as an example, freeing side wards for other infections has reduced MRSA rates.
These improved patient outcomes have established our groundbreaking approach as highly effective in the management of disease from the new strain and is now being followed by other NHS trusts. In April this year, the isolation unit won the Safety in Care Award in the Health and Social Care Awards 2008 in the West Midlands.
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