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Line Sepsis in Home Parenteral Nutrition Patients: Are There Socioeconomic Risk Factors? A Canadian Study

Albert Chang, MSc^*, Robert Enns, MD, Olivia Saqui, RN^*, Nazira Chatur, MD, Scott Whittaker, MD and Johane P. Allard, MD^*

From the ^* University of Toronto, Ontario, Canada, and Division of Gastroenterology, Department of Medicine, Toronto General Hospital, Toronto, Ontario, Canada; Division of Gastroenterology, Department of Medicine, St. Paul's Hospital, University of British Columbia, Vancouver, British Columbia, Canada; and the Division of Gastroenterology, Department of Medicine, Vancouver General Hospital, University of British Columbia, Vancouver, British Columbia, Canada

Correspondence: Johane P. Allard, MD, 585 University Avenue, Room 9N-973, Toronto, Ontario, M5G 2C5 Canada. Electronic mail may be sent to johane.allard{at}uhn.on.ca.

Background: Line sepsis complicates home parenteral nutrition (HPN). This study examined nonmedical risk factors that may contribute to line sepsis and compared 2 HPN programs with different administrative structures (Ontario and British Columbia [BC]) in terms of line sepsis and patient satisfaction. Methods: A survey was developed to evaluate possible correlation between line sepsis and (1) patients' perceptions of HPN care, (2) family support, (3) community support, and (4) socioeconomic status. Data were analyzed by categorizing into high- and low-risk groups using a cutoff point. A second method analyzed the incidences of line sepsis as a continuous variable. Results: Sixty-eight patients responded to the survey: 33 from Ontario (62%), 35 from BC (44%). Community agency, socioeconomic and educational status were not significant in determining line sepsis. Patients who had (1) medication or blood work done through the catheter, (2) a higher number of dependents, or (3) had a trained family member involved in HPN were in the high-risk category for line sepsis, in addition to patients who were part-time students or receiving social assistance. When comparing the provinces, there was no difference in line sepsis. However, significant differences between the provinces include (1) BC patients rate their level of care lower; (2) Ontario patients rely more on family members for HPN; and (3) Ontario patients have more community support. Conclusions: Line sepsis may be increased by some nonmedical risk factors. However, when comparing the 2 programs, rates of line sepsis were not influenced by different administrative structures.

Home parenteral nutrition (HPN) is an essential, lifesaving method of outpatient support for patients with severe gastrointestinal disorders. In Canada, HPN is typically managed by a dedicated health care team, who oversee all aspects of medical care, including training and patient education. Although there are many benefits associated with HPN, there are also associated complications. Line sepsis or infection has been documented as the major complication with HPN.¹ The etiology of line sepsis is multifactorial: medical risk factors leading to venous access complications in HPN patients have been well studied and reviewed,² and these include insertion site, type of catheter, underlying disease, and duration of HPN.^3–5 Preparation of substrates using chlorhexidine-based solutions and antimicrobial-impregnated catheters has also been shown to be helpful in reducing colonization⁶; however, the use of prophylactic antibiotics does not, and in fact may encourage the emergence of bacterial resistance.⁷ Risk factors for bloodstream infection in patients receiving home infusion therapy have also been examined.⁸ Other studies were not restricted to HPN alone, and may have involved other factors such as severe immunocompromised state (eg, HIV, bone marrow transplants).^8,9 The type of administration was also important; for example, using mixtures containing glucose–amino acid vs glucose–amino acid–lipid solutions.¹⁰

Reported mean line sepsis rates in HPN patients have been between 0.38 and 0.50 episodes/year.¹¹ Complications of subclavian venous catheterization were documented to be 1.2 infections per 1000 catheter-days.⁶ A study by O'Keefe et al¹² has examined and concluded septicemia is the major cause of morbidity in HPN patients, accounting for approximately 70% of rehospitalizations. The number of hospitalizations due to complications of HPN therapy was positively correlated with length of time receiving HPN, with the most common reason for hospitalization being line catheter sepsis.¹³ However, catheter sepsis is not invariably associated with long-term IV feeding but with a combination of host factors (Crohn's, jejunostomy, central vein thrombosis) and possibly environmental factors (eg, catheter-management techniques).² For the latter, there were very few studies examining whether nonmedical factors (eg, home and socioeconomic background) play a role in the maintenance of PN equipment and supplies. Hence, there are 2 aims to this study. The first was to determine whether other risk factors exist for line sepsis in HPN. In particular, socioeconomic factors such as home environment, income, education, and social relations were evaluated to determine whether they may contribute to the incidence of line sepsis for patients. These factors may play an integral role in proper HPN management. We hypothesize that HPN patients may have certain significant nonmedical risk factors that contribute to increased incidence in line sepsis. The second aim of this study was to compare 2 different provincial HPN programs that have different administrative, clinical, and nursing structures in regard to infection rate.

	METHODOLOGY

Top METHODOLOGY RESULTS DISCUSSION

 
Survey Design and Data Collection
We conducted a cross-sectional observational study on the largest 2 HPN programs in the provinces of Ontario and British Columbia (BC). Patient criteria in the study included outpatient HPN patients who had been receiving HPN for >5 months and were consistently receiving HPN for >4 days of the week. For the province of Ontario, there were 52 HPN patients that met these criteria at the time of the study; for BC, there were 82.

The first component of the study was to design the survey examining nonmedical risk factors for HPN. The objectives to this part included conducting a focus group, obtaining ethics approval, and conducting a review of literature. In Ontario, some patients have other community support means, such as Community Care Access Centers (CCACs), which also facilitate nursing care and home care support for these patients. This survey would also evaluate such support networks. Other differences between Ontario and BC are noted in Table I.

After ethical approval, a pilot study was conducted to examine the preliminary draft. This pilot study was composed of 6 patients who had various incidences of line sepsis. Patients reviewed the entire questionnaire and provided feedback and suggestions. Revised surveys were also reviewed by a biostatistician for feasibility in performing statistical analysis. The revised draft was also reviewed independently in BC for consistency. The final draft passed research ethical approval from the Toronto General Hospital (Ontario) and St. Paul's Hospital (BC). Table II provides a detailed description of the final draft.

The survey was administered via post in both provinces. A cover letter, consent form (a patient consent signature sheet for BC was required as part of ethical approval guidelines), copy of the survey, and self-addressed return envelope were mailed to qualified patients in each province. For BC patients, telephone calls were made to ascertain whether or not the outpatient was actively receiving PN and to determine the duration of HPN treatment. For both provinces, a follow-up letter was sent after 3 weeks, either thanking patients for their involvement or reminding them to voluntarily complete the survey. Completed surveys were input to a confidential database. Surveys were checked for errors, inconsistencies, and omissions, and data entry was double checked for accuracy.

Statistical Analysis
Statistical analysis was performed using 2 methods. These 2 methods were documented by other study groups as the most conventional means of evaluating risk of line sepsis in HPN patients.^3,8 The first method used a cutoff point in which patients were grouped into high- and low-risk categories. As noted earlier, previous studies have suggested that the rate of line sepsis is approximately 1.2 incidences per 1000 catheter-days.⁶ Patient incidence of line sepsis was calculated as a ratio between the incidence of line sepsis over the 3 years. Then, the cutoff of 1.2 incidences per 1000 catheter-days was used to separate the 2 groups into high- and low-risk categories. ² or Fisher's exact test was used to investigate the relationships between the severity of line sepsis (high- vs low-risk groups) and the other categorical variables. The second method analyzed each question as a continuous variable (rather than low-risk and high-risk group). For this method, and for the ordinally scaled response variables, we used the Mann-Whitney test to examine whether the distribution in the 2 provincial groups is the same.

	RESULTS

Top METHODOLOGY RESULTS DISCUSSION

 
The response rates in Ontario and BC were 33/52 (63.4%) and 35/82 (42.6%), respectively. Significantly more women answered the questionnaire in BC (24/35, vs in Toronto, 14/33, p < .05). Underlying diseases and indications for PN are similar for both groups (functional short bowel syndrome). The majority of Ontario PN patients use Hickman catheters (91%), whereas BC patients use mainly Hickman or Groshong (80%). However, different catheters were not compared statistically because a previous study by Tokars et al⁸ suggested no significant difference in risk among types of catheters used.

Analysis of Entire HPN Population
Using the cutoff method to separate patients in a low- vs high-risk category, the following 2 observations were noted to be statistically significant at higher risk for line sepsis: (1) patients who had medication or blood work done through the catheter (p = .011); and (2) those patients with a higher number of dependents (p = .0083). Using the continuous variable method, the following 3 observations were noted to be statistically significant: (1) patients with family members with PN training were at higher risk to have line sepsis (p = .0067); (2) patients who were part-time students, compared with the rest of the HPN population (p = .020); and (3) if PN patients were receiving social assistance or welfare (p = .045).

Factors that are not associated with line sepsis (using both methods) are noted in Table III.

Differences Between Ontario and BC
The apparent difference between the 2 provincial administrative structures was evident by the defined role of each HPN team member. In BC, HPN falls under the home IV infusion program, one of 7 programs offered in the hospital. The understood role of the 2 nurses was to educate HPN patients on techniques. Once trained, patients were discharged from the hospital. HPN supply management was provided by 1 company in charge of PN production and delivery. If a medical situation arose, the HPN patient had to call the gastroenterologist or 2 nurses directly. There may have been time delays. This can be seen through 2 ways: (1) family physicians had to manage some of the care, especially on a more emergent basis (personal communication of 5 BC patients), and (2) most BC patients did not meet with the gastroenterologist on a regular basis. However, in Ontario, there is a nurse clinician whose role is to coordinate the HPN training, supplies, and clinical management. The HPN clinic meets weekly, and includes support from the gastroenterologist, dietitian, and pharmacist. Medical situations were closely monitored, and if patients had any problems, the nurse clinician was available to address the issue (more quickly than the BC staff members).

Statistically significant differences between the 2 provinces are noted in Table IV. In general, Ontario patients were more satisfied with the level of HPN care, having external support and involvement.

Similarities Between Ontario and BC
Although the Ontarian and BC patients had some differences with respect to HPN management, there were some similarities observed between the population groups. The first (and most important) was the similar (ie, nonsignificant) rate of line sepsis between the 2 provinces. The mean incidence of line sepsis was 2.2 ± 0.4 for Ontario and 3.2 ± 1.1 for BC. The median incidence of line sepsis was 0.91 in Ontario, 1.21 in BC (p = .10).

In addition, patients in the 2 provinces were similar in that they understood why they need PN and the procedures involved. Another similarity observed was that the 2 patient groups found themselves similar in terms of happiness with living environment and family support. Patients of the 2 groups tended to have caregivers that provided for them emotionally and financially. Finally, the patients in both provinces were similar in terms of HPN preparation: in particular, where the HPN mixture is prepared, hand hygiene and disinfection of the surface areas.

Last, data analysis examined how long patients have been receiving PN. In particular, patients were grouped according to whether patients had >10 years of HPN experience vs 10 years or less. Similarly, data were analyzed with patients receiving HPN >5 years vs 5 years. There was no difference between number of line sepsis per 1000 days between patients who were receiving either (1) >10 years PN or (2) >5 years of PN for either Ontario or BC. Combining data from the 2 provinces, there was a borderline difference for the 10-year mark (p = .068), and for the 5 year-mark there was significant difference (p = .013) (ie, patients who had 5 years experience had increased incidence of line sepsis).

	DISCUSSION

Top METHODOLOGY RESULTS DISCUSSION

 
The purpose of this retrospective study was to examine risk factors in line sepsis for HPN patients. We determined factors such as community agency involvement, alcohol and smoking, education level, employment, housing and income status do not appear to be related to an increased risk of line sepsis. A previous European study examined personal and environmental hygiene and analysis and adherence of preparation methods.³ In that study, age, sex, clinical condition, and cultural level did not seem to have a role for predicting line infection.³ It was found that HPN patients need clear information about infectious complications and concise and ongoing instruction on line care.³ However, there was a lower risk of line sepsis found in training outside the hospital rather than in hospital.¹⁰ Provided that adequate instruction and follow-up is maintained, a low risk of line sepsis would be obtained in HPN patients.¹⁰ As both groups had approximately the same incidences of line sepsis (and were within the average incidences of line sepsis), our study confirms the importance of training patients to maintain a low rate of line sepsis. However, our study may also suggest that the importance of professional care involvement post–follow-up is not necessarily advantageous in further lowering the rates of line sepsis.

In addition, another study by Reimund et al⁹ suggested that rate of line sepsis may be considered an efficient marker to determine quality of education and patient's compliance to doctors' or nurses' advice. These factors may be more important than education and income status, which were found to be nonsignificant factors in our study. As both Ontario and BC populations found their understanding of HPN to be similar and both were trained similarly before first discharge with HPN, our study appears to be in accordance to Reimund et al.⁹ It also suggests the level of training given by the support staff was similar among the 2 provincial groups, as exemplified by the similarities with HPN preparation techniques and the similar information booklets provided on HPN care.

To our knowledge, this study is the first in Canada to examine socioeconomic risk factors in line sepsis for HPN patients. There are different clinical and administrative structures in different provinces in Canada and also in the United States and European countries. Community agency involvement, such as home care nursing, provides help for patients and their families with various aspects of HPN care, including preparation, infusion, and capping. Our study suggests that there is no demonstrable improvement with community agency involvement. It also suggests that assistance from nonmedical professionals may not be beneficial, because even trained family members seemed to contribute to a higher rate of line sepsis. It is possible additional family members performed assistance intermittently, perhaps limiting their expertise; however, this was not assessed extensively in this study.

The major weaknesses to this study include (1) that patients were asked to recall the number of line sepsis events; (2) the relative small sample size, and (3) its retrospective nature. With respect to data collection, the main reason why patients were asked to recall the incidence of line sepsis was because their infections could be treated at peripheral hospitals, and reviewing chart data at these institutions can be challenging and at remote locations. We felt that a reasonable timeframe for line sepsis recall was 3 years according to discussion with patients. In theory, because this was not a prospective assessment of line sepsis, there is limited power within the line infection rate data. On the other hand, most other studies have also used retrospective data to assess line sepsis because most patients require hospital/outpatient visitation.^3,4,10

As this is a Canadian study, the HPN patient population in each province is small. We have chosen the 2 largest provincial programs in Canada in order to have a good sample size. We also chose Ontario and BC because their administrative structure is different and would allow us to compare the effect of 2 different systems on a clinical outcome such as line sepsis. To expand the sample size would have been challenging because other HPN programs are much smaller in size, and their structures may vary due to different provincial health systems. Also, it is recognized that large HPN patient studies are difficult because these patients tend to be dispersed among many different institutions. We are fortunate in our situation to have the bulk of provincial patients within 2 large centers.

In conclusion, this study suggests that there are several socioeconomic factors contributing to line sepsis for HPN patients. The rate of line sepsis may be affected by some nonmedical risk factors such as being a part-time student, receiving social assistance/welfare, having family member performing HPN, care and increasing number of dependents.

In comparing the 2 provincial programs, the incidence of line sepsis in the 2 groups was not influenced by different administrative, nursing, or clinical structures. However, patient satisfaction was significantly higher in Ontario compared with BC, owing to the various differences in the aforementioned structures. However, cost-effectiveness and overall morbidity and mortality have not been examined. Such topics are goals for future comparative studies.

We thank Dr Lorraine Ferris (Institute of Clinical Evaluative Sciences, University of Toronto) and Dr Peggy Millson (Department of Community Health, University of Toronto) for help in survey design. Part of this project was a component of the Determinants of Community Health undergraduate medicine course at the University of Toronto for AC.

Received for publication June 2, 2005. Accepted for publication August 4, 2005.

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Journal of Parenteral and Enteral Nutrition, Vol. 29, No. 6, 408-412 (2005)
DOI: 10.1177/0148607105029006408


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