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Journal of Evaluation in Clinical Practice ISSN 1365-2753
Evaluating catheter complications and outcomes in patients receiving home parenteral nutrition Sheryl L. Szeinbach PhD MS BSPharm,1 Jessica Pauline PharmD,2 Kathleen F. Villa MS,3 S. Renee Commerford PhD,4 Ann Collins RN5 and Enrique Seoane-Vazquez PhD6 1
Professor, College of Pharmacy, Ohio State University, Columbus, OH, USA Director and Manager of Pharmacy, Massachusetts Division, Pentech Health Mansfield, MA, USA 3 Senior Health Economist, Health Economics and Outcomes Research, Genentech, Inc., San Francisco, CA, USA 4 Medical Science Director, US Medical Affairs, Thrombolytics, Genetech, Inc., San Francisco, CA, USA 5 Registered Nurse, Deer Run Court, Philadelphia, PA, USA 6 Associate Professor, International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA 2
Keywords catheter-related infections, home parental nutrition, home care services, outcomes Correspondence Dr Sheryl L. Szeinbach College of Pharmacy Ohio State University Columbus, OH 43210 USA E-mail: [email protected] Accepted for publication: 18 July 2014 doi:10.1111/jep.12264
Abstract Rationale, aims and objectives We describe catheter complications and outcomes in patients who received home parenteral nutrition (HPN) therapy. Methods Retrospective chart data were obtained from Boston Home Infusion agency that provided HPN therapy to 212 patients [International Classification of Diseases, 9th revision (ICD-9) codes: gastrointestinal (GI)-related disorders and oncology] between 1 January 2005 and 30 September 2011. Results Of the 163 patients who represented 19 104 home-catheter days, 19 (11.7%) patients experienced 25 catheter complications (CCs; 12 occlusions, 11 central lineassociated bloodstream infections, one thrombosis and one line dislodgment). The overall CC rate was 1.30 per 1000 peripherally inserted central catheter (PICC)-line days. The mean number of PICC-line days (278.7 ± 335.0 vs. 95.9 ± 154.0) and patients with at least one hospital admission were significantly higher for patients with one or more CCs compared with patients with no CCs (P < 0.03). Conclusion Patients who experienced CCs had more PICC-line days, more hospital admissions and had an ICD-9 code for GI-related disorders compared with patients with oncology-related diagnoses.
Introduction An estimated 3 million central venous catheters (CVCs) are implanted yearly in the United States to deliver home parenteral nutrition (HPN) therapy, medications, blood products, intravenous fluids, as well as providing access for hemodialysis [1]. While standards of care and educational programmes have improved the use of CVCs, catheter complications (CCs) including central lineassociated bloodstream infections (CLABSIs), occlusions, thromboses and other catheter line-related issues carry risks that if not managed properly may lead to costly infections and compromise patient progress with therapy [2–4]. Given that approximately 41 000 CLABSIs occur annually in US hospitals, which results in an extra 7–21-day hospital stay, the Centers for Disease Control and Prevention (CDC) and the Infusion Nurses Society support educational and collaborative-based performance initiatives to improve compliance with evidence-based recommended practices regarding catheter management [5–7].
When considering CVC use in the home environment, the peripherally inserted central catheter (PICC) line is considered a mainstay for delivering HPN therapy for patients who may require less invasive options to provide nutritional therapy, antibiotics and short-term chemotherapy. Besides the accessibility and lower insertion complication rates offered by PICCs [8–10], opportunities to provide HPN in a home environment may be advantageous to patients and caregivers. However, with any of these CVC devices, the risk of CCs is always present and the development of CCs may be influenced by other risk factors such as the length of time a PICC line is used, level of care, multilumen catheters and microbial contamination at the catheter site or hub [11–13]. Despite the risks associated with PICC use, HPN therapy has been instrumental in reducing hospital-related length of stay by expediting the transition of patients from hospital to home care [14]. As more HPN therapy is provided outside the hospital, additional studies are needed to examine CCs as they occur over time in patients who complete HPN therapy provided from caregivers
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through home-care agencies. The four specific objectives of this study are to characterize CCs in patients [International Classification of Diseases, 9th revision (ICD-9) codes: for gastrointestinal (GI)-related disorders and oncology)] who received HPN through a PICC, to identify risk factors related to CCs, to follow the cohort of patients who developed CCs as they occur over time from initial PICC insertion and to examine the timeline for patient progress with CCs including thrombolytic use and outcomes during the course of HPN therapy. To address these objectives, researchers developed a data-collection tool to help standardize the extraction and documentation of data from patient medical records. Findings from this study will provide an opportunity to examine the catheter management process for CCs, patient outcomes and address the role of patient diagnoses when HPN therapy is provided in a home-care setting.
Methods Study sample The sample included a retrospective chart review for all 212 patients who received HPN services from Boston Home Infusion (BHI) agency, Boston, Massachusetts between 1 January 2005 and 30 September 2011. BHI provided infusion services for over 20 years and is accredited by the Joint Commission on Accreditation of Healthcare Organizations. Patients were included in the study if they received or started HPN therapy on 1 January 2005 and had electronic medical records. Patients were also included in the study if hospital medical records were provided to BHI during their transition between hospital and home care. Approximately 75% of patients who received services were covered under Medicare or Medicaid. Patients were grouped according to the ICD-9 codes [15]. Oncology-related diagnoses included ICD-9 codes 150.9, 151.3, 151.9, 152, 153.9, 154, 154.1, 157.1, 157.9, 159.8, 161.9, 170, 171.9, 180.9, 183, 194, 195 and 195.2. GI-related disorders included ICD-9 codes 251.5, 263.9, 269.9, 273.8, 507, 536, 536.3, 537, 537.89, 556, 556.1, 557, 560.89, 562.1, 564.2, 567, 569.81, 569.82, 569.89, 573.3, 574.21, 575.5, 577, 577.1, 577.2, 577.8, 578.9, 579.3, 579.3, 579.9, 643.1, 643.13, 750.7, 777.5, 879.2, 995.91 and 997.4. Patients were excluded from the study if their transition between hospital and home care could not be tracked, if they were less than 18 years of age and if the duration of therapy could not be determined (i.e. exceeded the study cut-off date). Patients were also excluded if medical record data were incomplete (i.e. missing 15% or more key variables), inconsistent (i.e. contained confusing notations), inaccurate or misplaced (i.e. medical records that did not make the transition from manual to electronic data entry). Data collection for the study was approved by the institutional review board of the University of Massachusetts College of Pharmacy and Health Sciences. All patient-specific information was de-identified prior to data entry and was unavailable to researchers throughout the study period.
Data-collection strategy This study assessed only patients who received HPN therapy in which double-lumen PICCs were inserted in veins of the upper extremities with tips that terminated in the superior vena cava or 154
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right atrium. Insertion of PICCs (multiple manufacturers) was performed at various hospitals. Radiographic procedures were used to ensure that tip placement was in accordance with current guidelines from the American Society for Parenteral and Enteral Nutrition, which recommends tip placement in the superior vena cava or adjacent to the right atrium [16]. Also, per standard protocol, PICCs in this study were used to deliver HPN therapy on a 12–16-hour cycle and were routinely cleared before and after each use with 10 U mL−1 of heparin. For the purposes of this study, CCs included occlusions, thromboses, CLABSIs, PICCs accidently removed or dislodged and mechanical issues. Catheter complications were defined as an occlusion if loss of line patency was attributed to a lack of blood flow, no blood return, or a partial line block, all of which resulted in the inability to flush the PICC. CCs were defined as thrombotic if a thrombus accumulation (i.e. presence of a blood clot identified through Doppler studies), which resulted in blood clots forming in the region surrounding the PICC, was determined by the nurse and noted in the patient chart. CLABSIs were defined as an infection that was documented in the patient charts as a catheter-related infection based on clinical evidence and quantitative blood culture data when appropriate. The two categories of tubing issues were PICCs accidently removed or dislodged and mechanical damage (e.g. breakage, leakage and malfunction) associated with catheter use. Although the CDC and the National Healthcare Safety Network guidelines provide no set-time period for a bloodstream infection (BSI) to be considered a CLABSI, BSIs were evaluated to determine if the CLABSIs were primary BSIs (i.e. no infections observed at other sites) or attributed to a secondary source (e.g. BSIs described separately as general bacteremia or by specific organisms from a secondary source as described in the patient chart). To avoid the overestimation of CLABSIs, BSIs occurring from a secondary source were not considered a CC [17,18]. Except where noted for patient demographic data, each observation that described a PICC-related complication as documented in the patient chart was considered a CC episode. Thus, a patient could have more than one CC episode. Data analyses concerning PICC-related complications were reported by the total number of episodes rather than by individual patients.
Data-collection tool An Excel® (Microsoft 2007, Microsoft Midwest District, Chicago, IL, USA) data-collection tool was developed for the study. Seven nurses and eight pharmacists were selected from a pool of professionals at BHI and nearby hospitals according to their expertise and experience in long-term care. Data collected from one-on-one interviews lasting an average of 30 minutes were transcribed using NVivo 9 qualitative analysis software (QSR International, Cambridge, MA, USA) to classify variables and consolidate themes identified with CCs. To determine the feasibility of extracting patient information from charts, the resulting 39-item variable list consisting of demographic characteristics, clinical information (e.g. infusion agency, HPN, and hospital admission and discharge data) and CCs (e.g. occlusion, infection, thrombosis and tubing issues) was pre-tested by comparing and aligning the wording of variables (e.g. use of common terminology, word descriptions and standard definitions) from the list with manually extracted data from a random sample of 20 medical charts of patients receiving
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HPN therapy services from the home-infusion agency. The main study was initiated after all data extracted from the 20 patient charts were validated (i.e. assessed for content validity) using the data-collection tool.
Main study data collection Data for 212 patients who underwent HPN therapy and used a PICC were extracted manually from BHI-patient charts and entered into the data collection Excel spreadsheet for use in a descriptive analysis. Data collection was conducted by trained researchers (e.g. Pharm D. residents, registered nurse and an accountant who was familiar with the use of spreadsheets for collecting clinical data) who worked with nursing staff members and a pharmacist at the home-infusion agency. Discrepancies were resolved by a primary investigator by re-examination of the medical chart. Data were examined a total of three times to ensure accuracy.
Statistical analysis The independent samples t-test was used to evaluate differences in the means between groups and the Chi-square test was used to evaluate differences in the frequencies for categorical variables for patients with and without CCs. The overall incidence rate for CCs was calculated using a standard approach as follows: the total number of complications (episodes) divided by the total number of PICC-line days multiplied by 1000. A time-flow chart analysis was performed for the cohort of patients with CCs to document the time points (i.e. date of episode) during HPN therapy when occlusions, infections, thromboses and tubing issues were detected for each patient from start to completion of HPN therapy. Data were analysed using Excel 2007, SPSS Statistics for Windows, version 17 (SPSS, Inc., Chicago, IL, USA), and SAS/STAT 9.2 Software and User’s Guide, Second Edition, 2008 (SAS Institute, Inc., Cary, NC, USA). Statistical significance was set at P < 0.05.
Catheter complications and patient outcomes
study period. Of the 163 patients, 98 (60.1%) were female. Patients’ ages ranged from 18 to 88 years. Nine patients had their PICC replaced, with one patient having the line replaced twice. Of the 163 patients, 19 (11.7%) patients experienced CCs. The primary ICD-9 codes for patients experiencing a CC were recorded as follows: gastrointestinal (n = 14) and other (n = 5), which included patients with non-specific GI ICD-9 codes for problems related to pregnancy. The most common primary diagnoses for patients according to ICD-9 codes were for GI disease, intestinal obstruction (13.2%), acute pancreatitis (9.6%), hyperemesis (9.6%) and regional enteritis (6.0%). Other diagnoses included intestinal disorders, malabsorption problems, enterocolitis and post-gastric surgery syndrome. Patients with oncology-related diagnoses (n = 33) did not experience CCs (Table 1).
Characterization and occurrence of CCs There were a total of 25 episodes of CCs reported over the total 19 104 catheter-line days. The complications included 12 occlusions, 11 infections, one thrombosis and one line dislodgment. The overall CC rate was 1.30 per 1000 PICC-line days and 0.47 for CLABSIs. While the hypothesized relationship between age and gender with respect to CCs was not significant, the mean number of PICC days used was significantly higher for patients with at least one CC (P = 0.03) (Table 1).
Patient hospitalization In Table 2, the hypothesized differences in the proportion of patients having at least one hospital admission were significantly higher for patients with CCs compared with patients with no CCs (P = 0.03). The relationship between the average number of hospital admissions per patient was higher for patients with CCs, but the t-test result was not significant (P = 0.07). There was no significant difference in the length of hospital stay when comparing patients with and without CCs.
Patient outcomes from CCs
Results Sample characteristics Of the 212 patients receiving HPN therapy services from BHI agency, 163 patients met the criteria for further analysis. A total of 39 patients were excluded from analysis because of multiple patient observations (e.g. data could not be obtained for some patients who were going back and forth between the infusion agency and the hospital, with other hospitals involved), HPN duration of therapy provided to 10 patients could not be determined, missing data, records misplaced or not available and unresolvable data inconsistencies. Two patients who had CCs, an ICD-9 code for regional enteritis, and long-term PICC-line use (1914 and 1940 days) were determined to be outliers (i.e. z-score exceeded the mean by 3 standard deviations) and were removed from the study. The average number of patient days for all 163 patients with a PICC was 117.2 ± 192.0 (Table 1). Use of a PICC ranged from 6 to 973 days, representing a total of 19 104 home PICC days for the
© 2014 John Wiley & Sons, Ltd.
Patient progress, thrombolytic use and outcomes for each of the 19 patients with CCs over time starting from the first day of PICC insertion are presented in Fig. 1: thrombolytic use and Fig. 2: no thrombolytic use. With the exception of two patients, all patients completed HPN therapy and were discharged from therapy. The patients in Fig. 1 received a thrombolytic within 24 hours of the documented occlusion that occurred after an average of 193.6 ± 263.3 days (range: 4.0–744.0) of PICC use. Two of the 10 patients presented in Fig. 1 developed a CLABSI subsequent to an occlusion. Another patient (ID = 4: Fig. 1) with a diagnosis of acute intestinal vascular insufficiency had a BSI 12 days after having an occlusion. The BSI was determined to be from a secondary source attributed to two gram-negative organisms Klebsiella pneumonia and Escherichia coli. This patient was discharged after 890 days of home care. Eight of the nine patients presented in Fig. 2 did not have an occlusion but developed an initial CLABSI after an average of 103.1 ± 244.0 days (range: 1.0–793.0) of PICC use. Patient (ID = 16) without a documented CLABSI had a thrombosis and 155
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Table 1 Characteristics of patients receiving home parenteral nutrition with respect to catheter complications
Characteristic Patients, number (%) Female, number (%) Age at initiation of HPN ± SD Days of HPN therapy (Average ± SD) Range Number of days to first occlusion (Average ± SD) Range Number of days to first CLABSI (Average ± SD) Range Primary indication for HPN, number (%) Intestinal obstruction Acute pancreatitis Hyperemesis metabolism Regional enteritis Intestinal disorders, ulceration Intestinal malabsorption Enterocolitis Sepsis Stomach ulceration with perforation Acute intestinal vascular insufficiency Intestinal fistula Gastroparesis Persistent vomiting, pneumonitis Other gastrointestinal issues, disturbances Oncology
With catheter complications
Without catheter complications
Total
P value
19 (11.7) 14 (73.7) 45.7 ± 18.6 278.7 ± 335.0 9.0–897.0 193.6 ± 263.3 4.0–744.0 103.1 ± 244.0 1.0–793.0
144 (88.3%) 84 (58.3) 50.4 ± 16.4 95.9 ± 154.0 6.0–973.0
163 (100.0) 98 (60.1) 49.8 ± 16.7 117.2 ± 192.0 6.0–973.0
0.20 0.41 0.03
17 (11.6) 13 (8.8) 13 (8.8) 10 (6.8) 2 (1.3) 1 (0.7)
22 (13.2) 16 (9.6) 16 (9.6) 10 (6.0) 4 (2.4) 3 (1.8) 1 (0.6) 1 (0.6) 1 (0.6) 1 (0.6) 7 (4.2) 6 (3.6) 5 (3.0) 40 (24.0) 33 (19.8)
5 (25.0) 3 (15.0) 3 (15.0) 2 (10.0) 2 (10.0) 1 (5.0) 1 (5.0) 1 (5.0) 1 (5.0)
7 (4.8) 6 (4.2) 5 (3.4) 40 (27.2) 33 (22.4)
ICD-9 codes for hyperemesis (643.13), enterocolitis (777.5) and sepsis (995.91) related to pregnancy placed these diagnoses in the ‘other’ category. CLABSI, central line-associated bloodstream infection; HPN, home parenteral nutrition; SD, standard deviation.
Table 2 Hospital admissions and length of stay by catheter complications*
Variable Patients with at least one hospital admission, number (%) Average hospital admissions per patient Range Average length of stay first hospitalization (days) Range
With catheter complications (n = 19)
Without catheter complications (n = 144)
Total (n = 163)
P value
10 (52.6)
40 (27.8)
50 (30.7)
0.03
1.1 ± 1.4 0.0–5.0 9.4 ± 6.5 4.0–28.0
0.4 ± 0.8 0.0–4.0 10.5 ± 11.1 1.0–55.0
0.5 ± 0.9 0.0–5.0 10.2 ± 10.1 1.0–55.0
0.07 0.65
*Hospital discharge information for three patients in the catheter complications group was not available because they were discharged from Boston Home Infusion when admitted to the hospital.
two BSIs from a secondary source; one infection (undetermined) occurred 60 days and another infection caused by Clostridium difficile occurred 30 days prior to the thrombosis documented on day 540. This patient was discharged on day 692. Although the two deceased patients (Fig. 1: ID = 6, 9) receiving HPN for 651 and 897 days, respectively, did not have a documented CLABSI, they did have serious GI disorders (e.g. intestinal obstruction).
Discussion This study provided an opportunity to document CCs and potential risk factors related to CCs in a cohort of patients who received 156
HPN through a PICC. One contribution of this study was the opportunity to identify and categorize CCs experienced by patients over time as part of the catheter management process while receiving HPN therapy. Besides the ability to distinguish CLABSIs from BSIs in this study, another contribution was the ability to identify other risks within the context of patient progress as CCs were examined in greater detail, over time with respect to thrombolytic use and patient outcomes during the course of HPN therapy. In summary, patients with CCs experienced more days of PICC-line use, had more hospitalizations and more likely had an ICD-9 code for GI-related disorders compared with patients with oncologyrelated diagnoses.
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Catheter complications and patient outcomes
Figure 1 Outcomes of patients with catheter complications who received a thrombolytic agent. *Patient #10 had a line pulled out at day 51.
Figure 2 Outcomes of patients with catheter complications who did not receive a thrombolytic agent. *Patient #12 had a catheter-related infection at day 1.
Evidence from the literature
Patient-level data and patient outcomes
When comparing these results to home-care data where a PICC was used, an examination of CCs in a prospective study of patients receiving HPN from four tertiary referral centres in Australia and New Zealand from 1 January 2009 and 12 March 2009 revealed that 53 patients had 49 episodes (36 line infections, five blocked catheters, one fractured line and seven line migrations) of CVCassociated complications, giving an incidence of 3.6 per 1000 CVC days [19]. In another study that examined 127 PICCs in children with cancer, the authors reported the median catheter life was 161 days with a total of 18 955 catheter days for 124 patients [20]. The CC rate was 2.41 per 1000 catheter days, occlusion rate was 0.06 and the infection rate was 1.27, respectively [20]. Comparing the results from these studies and the present study, the relatively low occurrence of CCs in this study could be related to differences in patient populations, location for nutritional therapy (e.g. hospital vs. home), exclusion of BSIs as a CC and changes in catheter management.
The 10 patients who had an occlusion (cause was non-drug related) and received a thrombolytic (Fig. 1) appeared to have fewer subsequent CLABSIs compared with the nine patients that did not have an occlusion and did not receive a thrombolytic (Fig. 2). The infections experienced by seven of these nine patients presented in Fig. 2 also appeared within or shortly after the first 30 days of PICC line insertion. These findings are consistent with a recent study in which the incidence of CLABSIs in children with short bowel syndrome who received HPN was highest during the first month post-hospital discharge [21]. Despite potential risks for infections from cyclic HPN use, weekly PICC dressing changes and weekly blood draws, the relatively short number of days to the first CLABSI experienced by patients may be attributed to a ‘learning curve’ effect as patients learned how to administer HPN therapy from their caregivers at BHI and nurses from the visiting nursing association. Patients can have infections that may not be related to PICC-line use. In this study, two patients developed BSIs that were unrelated
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(secondary) to the PICC according to data in the patient charts; one patient described in Fig. 1 and one patient described in Fig. 2. The BSIs occurred more than 30 days after insertion of the PICC. Consistent with reports in the literature identifying bacterial organisms responsible for systemic infections, patient 4 (Fig. 1) cultured two gram-negative organisms (K. pneumonia and E. coli). K. pneumonia is commonly associated with long-term use of HPN. With a diagnosis of acute pancreatitis and HPN use for 890 days, the infection in this patient was likely attributed to gut translocation [22]. While the management of CCs and BSIs is well documented in the literature [23], there remains a paucity of information that specifically addresses how CCs and BSIs may be influenced by patient diagnosis. As patients are likely to transition between hospitals and outpatient settings while receiving HPN, the inclusion of patient diagnosis in subgroup analyses may prove beneficial when comparing the effectiveness of catheter management strategies across different settings. However, realizing that patients may present with multiple disease conditions, disentangling this complex relationship between patient diagnosis and the duration of PICC-line use with respect to the development of CCs and BSIs may be challenging, yet should also provide opportunities to generate additional evidence-based recommendations to improve patient-care outcomes. Also noteworthy was the observation that patients with oncology-related diagnoses did not have CCs. Although interesting to posit that patients with oncology-related diagnoses received higher doses of heparin compared with patients with GI-related diagnoses, an examination of the patients’ chart data revealed that 10 U mL−1 of heparin was the standard dose used for catheter-line clearance in both groups. Nonetheless, considering the positive relationship between PICC duration of HPN therapy and the risk of developing CCs, catheters should be removed as soon as possible, especially in the presence of the first signs of infection [24]. However, additional studies are needed to further characterize this relationship and to investigate the pattern of CCs over a longer timeline (number of days) to determine if patient outcomes were influenced by ongoing improvements in catheter management (e.g. use of sterile techniques, patient monitoring efforts and other evidence-based practices).
Limitations Although every effort was made to ensure data accuracy, the possibility exists for coding errors when extracting data from patient charts. While researchers noted that patients who received thrombolytics were treated more recently (2006–2011) compared with patients who did not receive a thrombolytic (2005–2009), specific differences attributed to changes in protocol, procedure, antibiotic or ethanol lock use (very limited use in this study), insurance coverage or HPN therapy duration could not be isolated from the large overlap in timelines. In this study, one patient (ID = 2) had multiple hospitalizations (n = 5), yet without access to the hospital’s chart data for some patients who did not return to home care, the underlying reasons for hospital admissions or hospital visits in association with CCs could not be determined. The study outcomes could be influenced by patients who were excluded from the study. However, there were no differences in patient characteristics (e.g. diagnoses and age) between patients who were excluded compared with patients who were included in 158
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the analysis. Finally, considering the small sample size (n = 19), caution should be used when generalizing these findings to other practice settings and patient populations.
Conclusion Patients with CCs had more days of PICC-line use and more hospital admissions compared with patients without CCs. While CCs appeared to occur in patients with GI and GI-related diagnoses, additional studies are needed to examine the influence of patient diagnosis and PICC duration of use on CCs and BSIs. A heuristic model for risk assessment including educational workshops should be considered to help caregivers and clinicians identify patients that may be more susceptible to CCs.
Acknowledgement This study was supported by a scientific research grant from Genentech, Inc., South San Francisco, CA, USA.
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Journal of Evaluation in Clinical Practice ISSN 1365-2753
Evaluating catheter complications and outcomes in patients receiving home parenteral nutrition Sheryl L. Szeinbach PhD MS BSPharm,1 Jessica Pauline PharmD,2 Kathleen F. Villa MS,3 S. Renee Commerford PhD,4 Ann Collins RN5 and Enrique Seoane-Vazquez PhD6 1
Professor, College of Pharmacy, Ohio State University, Columbus, OH, USA Director and Manager of Pharmacy, Massachusetts Division, Pentech Health Mansfield, MA, USA 3 Senior Health Economist, Health Economics and Outcomes Research, Genentech, Inc., San Francisco, CA, USA 4 Medical Science Director, US Medical Affairs, Thrombolytics, Genetech, Inc., San Francisco, CA, USA 5 Registered Nurse, Deer Run Court, Philadelphia, PA, USA 6 Associate Professor, International Center for Pharmaceutical Economics and Policy, Massachusetts College of Pharmacy and Health Sciences, Boston, MA, USA 2
Keywords catheter-related infections, home parental nutrition, home care services, outcomes Correspondence Dr Sheryl L. Szeinbach College of Pharmacy Ohio State University Columbus, OH 43210 USA E-mail: [email protected] Accepted for publication: 18 July 2014 doi:10.1111/jep.12264
Abstract Rationale, aims and objectives We describe catheter complications and outcomes in patients who received home parenteral nutrition (HPN) therapy. Methods Retrospective chart data were obtained from Boston Home Infusion agency that provided HPN therapy to 212 patients [International Classification of Diseases, 9th revision (ICD-9) codes: gastrointestinal (GI)-related disorders and oncology] between 1 January 2005 and 30 September 2011. Results Of the 163 patients who represented 19 104 home-catheter days, 19 (11.7%) patients experienced 25 catheter complications (CCs; 12 occlusions, 11 central lineassociated bloodstream infections, one thrombosis and one line dislodgment). The overall CC rate was 1.30 per 1000 peripherally inserted central catheter (PICC)-line days. The mean number of PICC-line days (278.7 ± 335.0 vs. 95.9 ± 154.0) and patients with at least one hospital admission were significantly higher for patients with one or more CCs compared with patients with no CCs (P < 0.03). Conclusion Patients who experienced CCs had more PICC-line days, more hospital admissions and had an ICD-9 code for GI-related disorders compared with patients with oncology-related diagnoses.
Introduction An estimated 3 million central venous catheters (CVCs) are implanted yearly in the United States to deliver home parenteral nutrition (HPN) therapy, medications, blood products, intravenous fluids, as well as providing access for hemodialysis [1]. While standards of care and educational programmes have improved the use of CVCs, catheter complications (CCs) including central lineassociated bloodstream infections (CLABSIs), occlusions, thromboses and other catheter line-related issues carry risks that if not managed properly may lead to costly infections and compromise patient progress with therapy [2–4]. Given that approximately 41 000 CLABSIs occur annually in US hospitals, which results in an extra 7–21-day hospital stay, the Centers for Disease Control and Prevention (CDC) and the Infusion Nurses Society support educational and collaborative-based performance initiatives to improve compliance with evidence-based recommended practices regarding catheter management [5–7].
When considering CVC use in the home environment, the peripherally inserted central catheter (PICC) line is considered a mainstay for delivering HPN therapy for patients who may require less invasive options to provide nutritional therapy, antibiotics and short-term chemotherapy. Besides the accessibility and lower insertion complication rates offered by PICCs [8–10], opportunities to provide HPN in a home environment may be advantageous to patients and caregivers. However, with any of these CVC devices, the risk of CCs is always present and the development of CCs may be influenced by other risk factors such as the length of time a PICC line is used, level of care, multilumen catheters and microbial contamination at the catheter site or hub [11–13]. Despite the risks associated with PICC use, HPN therapy has been instrumental in reducing hospital-related length of stay by expediting the transition of patients from hospital to home care [14]. As more HPN therapy is provided outside the hospital, additional studies are needed to examine CCs as they occur over time in patients who complete HPN therapy provided from caregivers
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through home-care agencies. The four specific objectives of this study are to characterize CCs in patients [International Classification of Diseases, 9th revision (ICD-9) codes: for gastrointestinal (GI)-related disorders and oncology)] who received HPN through a PICC, to identify risk factors related to CCs, to follow the cohort of patients who developed CCs as they occur over time from initial PICC insertion and to examine the timeline for patient progress with CCs including thrombolytic use and outcomes during the course of HPN therapy. To address these objectives, researchers developed a data-collection tool to help standardize the extraction and documentation of data from patient medical records. Findings from this study will provide an opportunity to examine the catheter management process for CCs, patient outcomes and address the role of patient diagnoses when HPN therapy is provided in a home-care setting.
Methods Study sample The sample included a retrospective chart review for all 212 patients who received HPN services from Boston Home Infusion (BHI) agency, Boston, Massachusetts between 1 January 2005 and 30 September 2011. BHI provided infusion services for over 20 years and is accredited by the Joint Commission on Accreditation of Healthcare Organizations. Patients were included in the study if they received or started HPN therapy on 1 January 2005 and had electronic medical records. Patients were also included in the study if hospital medical records were provided to BHI during their transition between hospital and home care. Approximately 75% of patients who received services were covered under Medicare or Medicaid. Patients were grouped according to the ICD-9 codes [15]. Oncology-related diagnoses included ICD-9 codes 150.9, 151.3, 151.9, 152, 153.9, 154, 154.1, 157.1, 157.9, 159.8, 161.9, 170, 171.9, 180.9, 183, 194, 195 and 195.2. GI-related disorders included ICD-9 codes 251.5, 263.9, 269.9, 273.8, 507, 536, 536.3, 537, 537.89, 556, 556.1, 557, 560.89, 562.1, 564.2, 567, 569.81, 569.82, 569.89, 573.3, 574.21, 575.5, 577, 577.1, 577.2, 577.8, 578.9, 579.3, 579.3, 579.9, 643.1, 643.13, 750.7, 777.5, 879.2, 995.91 and 997.4. Patients were excluded from the study if their transition between hospital and home care could not be tracked, if they were less than 18 years of age and if the duration of therapy could not be determined (i.e. exceeded the study cut-off date). Patients were also excluded if medical record data were incomplete (i.e. missing 15% or more key variables), inconsistent (i.e. contained confusing notations), inaccurate or misplaced (i.e. medical records that did not make the transition from manual to electronic data entry). Data collection for the study was approved by the institutional review board of the University of Massachusetts College of Pharmacy and Health Sciences. All patient-specific information was de-identified prior to data entry and was unavailable to researchers throughout the study period.
Data-collection strategy This study assessed only patients who received HPN therapy in which double-lumen PICCs were inserted in veins of the upper extremities with tips that terminated in the superior vena cava or 154
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right atrium. Insertion of PICCs (multiple manufacturers) was performed at various hospitals. Radiographic procedures were used to ensure that tip placement was in accordance with current guidelines from the American Society for Parenteral and Enteral Nutrition, which recommends tip placement in the superior vena cava or adjacent to the right atrium [16]. Also, per standard protocol, PICCs in this study were used to deliver HPN therapy on a 12–16-hour cycle and were routinely cleared before and after each use with 10 U mL−1 of heparin. For the purposes of this study, CCs included occlusions, thromboses, CLABSIs, PICCs accidently removed or dislodged and mechanical issues. Catheter complications were defined as an occlusion if loss of line patency was attributed to a lack of blood flow, no blood return, or a partial line block, all of which resulted in the inability to flush the PICC. CCs were defined as thrombotic if a thrombus accumulation (i.e. presence of a blood clot identified through Doppler studies), which resulted in blood clots forming in the region surrounding the PICC, was determined by the nurse and noted in the patient chart. CLABSIs were defined as an infection that was documented in the patient charts as a catheter-related infection based on clinical evidence and quantitative blood culture data when appropriate. The two categories of tubing issues were PICCs accidently removed or dislodged and mechanical damage (e.g. breakage, leakage and malfunction) associated with catheter use. Although the CDC and the National Healthcare Safety Network guidelines provide no set-time period for a bloodstream infection (BSI) to be considered a CLABSI, BSIs were evaluated to determine if the CLABSIs were primary BSIs (i.e. no infections observed at other sites) or attributed to a secondary source (e.g. BSIs described separately as general bacteremia or by specific organisms from a secondary source as described in the patient chart). To avoid the overestimation of CLABSIs, BSIs occurring from a secondary source were not considered a CC [17,18]. Except where noted for patient demographic data, each observation that described a PICC-related complication as documented in the patient chart was considered a CC episode. Thus, a patient could have more than one CC episode. Data analyses concerning PICC-related complications were reported by the total number of episodes rather than by individual patients.
Data-collection tool An Excel® (Microsoft 2007, Microsoft Midwest District, Chicago, IL, USA) data-collection tool was developed for the study. Seven nurses and eight pharmacists were selected from a pool of professionals at BHI and nearby hospitals according to their expertise and experience in long-term care. Data collected from one-on-one interviews lasting an average of 30 minutes were transcribed using NVivo 9 qualitative analysis software (QSR International, Cambridge, MA, USA) to classify variables and consolidate themes identified with CCs. To determine the feasibility of extracting patient information from charts, the resulting 39-item variable list consisting of demographic characteristics, clinical information (e.g. infusion agency, HPN, and hospital admission and discharge data) and CCs (e.g. occlusion, infection, thrombosis and tubing issues) was pre-tested by comparing and aligning the wording of variables (e.g. use of common terminology, word descriptions and standard definitions) from the list with manually extracted data from a random sample of 20 medical charts of patients receiving
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HPN therapy services from the home-infusion agency. The main study was initiated after all data extracted from the 20 patient charts were validated (i.e. assessed for content validity) using the data-collection tool.
Main study data collection Data for 212 patients who underwent HPN therapy and used a PICC were extracted manually from BHI-patient charts and entered into the data collection Excel spreadsheet for use in a descriptive analysis. Data collection was conducted by trained researchers (e.g. Pharm D. residents, registered nurse and an accountant who was familiar with the use of spreadsheets for collecting clinical data) who worked with nursing staff members and a pharmacist at the home-infusion agency. Discrepancies were resolved by a primary investigator by re-examination of the medical chart. Data were examined a total of three times to ensure accuracy.
Statistical analysis The independent samples t-test was used to evaluate differences in the means between groups and the Chi-square test was used to evaluate differences in the frequencies for categorical variables for patients with and without CCs. The overall incidence rate for CCs was calculated using a standard approach as follows: the total number of complications (episodes) divided by the total number of PICC-line days multiplied by 1000. A time-flow chart analysis was performed for the cohort of patients with CCs to document the time points (i.e. date of episode) during HPN therapy when occlusions, infections, thromboses and tubing issues were detected for each patient from start to completion of HPN therapy. Data were analysed using Excel 2007, SPSS Statistics for Windows, version 17 (SPSS, Inc., Chicago, IL, USA), and SAS/STAT 9.2 Software and User’s Guide, Second Edition, 2008 (SAS Institute, Inc., Cary, NC, USA). Statistical significance was set at P < 0.05.
Catheter complications and patient outcomes
study period. Of the 163 patients, 98 (60.1%) were female. Patients’ ages ranged from 18 to 88 years. Nine patients had their PICC replaced, with one patient having the line replaced twice. Of the 163 patients, 19 (11.7%) patients experienced CCs. The primary ICD-9 codes for patients experiencing a CC were recorded as follows: gastrointestinal (n = 14) and other (n = 5), which included patients with non-specific GI ICD-9 codes for problems related to pregnancy. The most common primary diagnoses for patients according to ICD-9 codes were for GI disease, intestinal obstruction (13.2%), acute pancreatitis (9.6%), hyperemesis (9.6%) and regional enteritis (6.0%). Other diagnoses included intestinal disorders, malabsorption problems, enterocolitis and post-gastric surgery syndrome. Patients with oncology-related diagnoses (n = 33) did not experience CCs (Table 1).
Characterization and occurrence of CCs There were a total of 25 episodes of CCs reported over the total 19 104 catheter-line days. The complications included 12 occlusions, 11 infections, one thrombosis and one line dislodgment. The overall CC rate was 1.30 per 1000 PICC-line days and 0.47 for CLABSIs. While the hypothesized relationship between age and gender with respect to CCs was not significant, the mean number of PICC days used was significantly higher for patients with at least one CC (P = 0.03) (Table 1).
Patient hospitalization In Table 2, the hypothesized differences in the proportion of patients having at least one hospital admission were significantly higher for patients with CCs compared with patients with no CCs (P = 0.03). The relationship between the average number of hospital admissions per patient was higher for patients with CCs, but the t-test result was not significant (P = 0.07). There was no significant difference in the length of hospital stay when comparing patients with and without CCs.
Patient outcomes from CCs
Results Sample characteristics Of the 212 patients receiving HPN therapy services from BHI agency, 163 patients met the criteria for further analysis. A total of 39 patients were excluded from analysis because of multiple patient observations (e.g. data could not be obtained for some patients who were going back and forth between the infusion agency and the hospital, with other hospitals involved), HPN duration of therapy provided to 10 patients could not be determined, missing data, records misplaced or not available and unresolvable data inconsistencies. Two patients who had CCs, an ICD-9 code for regional enteritis, and long-term PICC-line use (1914 and 1940 days) were determined to be outliers (i.e. z-score exceeded the mean by 3 standard deviations) and were removed from the study. The average number of patient days for all 163 patients with a PICC was 117.2 ± 192.0 (Table 1). Use of a PICC ranged from 6 to 973 days, representing a total of 19 104 home PICC days for the
© 2014 John Wiley & Sons, Ltd.
Patient progress, thrombolytic use and outcomes for each of the 19 patients with CCs over time starting from the first day of PICC insertion are presented in Fig. 1: thrombolytic use and Fig. 2: no thrombolytic use. With the exception of two patients, all patients completed HPN therapy and were discharged from therapy. The patients in Fig. 1 received a thrombolytic within 24 hours of the documented occlusion that occurred after an average of 193.6 ± 263.3 days (range: 4.0–744.0) of PICC use. Two of the 10 patients presented in Fig. 1 developed a CLABSI subsequent to an occlusion. Another patient (ID = 4: Fig. 1) with a diagnosis of acute intestinal vascular insufficiency had a BSI 12 days after having an occlusion. The BSI was determined to be from a secondary source attributed to two gram-negative organisms Klebsiella pneumonia and Escherichia coli. This patient was discharged after 890 days of home care. Eight of the nine patients presented in Fig. 2 did not have an occlusion but developed an initial CLABSI after an average of 103.1 ± 244.0 days (range: 1.0–793.0) of PICC use. Patient (ID = 16) without a documented CLABSI had a thrombosis and 155
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Table 1 Characteristics of patients receiving home parenteral nutrition with respect to catheter complications
Characteristic Patients, number (%) Female, number (%) Age at initiation of HPN ± SD Days of HPN therapy (Average ± SD) Range Number of days to first occlusion (Average ± SD) Range Number of days to first CLABSI (Average ± SD) Range Primary indication for HPN, number (%) Intestinal obstruction Acute pancreatitis Hyperemesis metabolism Regional enteritis Intestinal disorders, ulceration Intestinal malabsorption Enterocolitis Sepsis Stomach ulceration with perforation Acute intestinal vascular insufficiency Intestinal fistula Gastroparesis Persistent vomiting, pneumonitis Other gastrointestinal issues, disturbances Oncology
With catheter complications
Without catheter complications
Total
P value
19 (11.7) 14 (73.7) 45.7 ± 18.6 278.7 ± 335.0 9.0–897.0 193.6 ± 263.3 4.0–744.0 103.1 ± 244.0 1.0–793.0
144 (88.3%) 84 (58.3) 50.4 ± 16.4 95.9 ± 154.0 6.0–973.0
163 (100.0) 98 (60.1) 49.8 ± 16.7 117.2 ± 192.0 6.0–973.0
0.20 0.41 0.03
17 (11.6) 13 (8.8) 13 (8.8) 10 (6.8) 2 (1.3) 1 (0.7)
22 (13.2) 16 (9.6) 16 (9.6) 10 (6.0) 4 (2.4) 3 (1.8) 1 (0.6) 1 (0.6) 1 (0.6) 1 (0.6) 7 (4.2) 6 (3.6) 5 (3.0) 40 (24.0) 33 (19.8)
5 (25.0) 3 (15.0) 3 (15.0) 2 (10.0) 2 (10.0) 1 (5.0) 1 (5.0) 1 (5.0) 1 (5.0)
7 (4.8) 6 (4.2) 5 (3.4) 40 (27.2) 33 (22.4)
ICD-9 codes for hyperemesis (643.13), enterocolitis (777.5) and sepsis (995.91) related to pregnancy placed these diagnoses in the ‘other’ category. CLABSI, central line-associated bloodstream infection; HPN, home parenteral nutrition; SD, standard deviation.
Table 2 Hospital admissions and length of stay by catheter complications*
Variable Patients with at least one hospital admission, number (%) Average hospital admissions per patient Range Average length of stay first hospitalization (days) Range
With catheter complications (n = 19)
Without catheter complications (n = 144)
Total (n = 163)
P value
10 (52.6)
40 (27.8)
50 (30.7)
0.03
1.1 ± 1.4 0.0–5.0 9.4 ± 6.5 4.0–28.0
0.4 ± 0.8 0.0–4.0 10.5 ± 11.1 1.0–55.0
0.5 ± 0.9 0.0–5.0 10.2 ± 10.1 1.0–55.0
0.07 0.65
*Hospital discharge information for three patients in the catheter complications group was not available because they were discharged from Boston Home Infusion when admitted to the hospital.
two BSIs from a secondary source; one infection (undetermined) occurred 60 days and another infection caused by Clostridium difficile occurred 30 days prior to the thrombosis documented on day 540. This patient was discharged on day 692. Although the two deceased patients (Fig. 1: ID = 6, 9) receiving HPN for 651 and 897 days, respectively, did not have a documented CLABSI, they did have serious GI disorders (e.g. intestinal obstruction).
Discussion This study provided an opportunity to document CCs and potential risk factors related to CCs in a cohort of patients who received 156
HPN through a PICC. One contribution of this study was the opportunity to identify and categorize CCs experienced by patients over time as part of the catheter management process while receiving HPN therapy. Besides the ability to distinguish CLABSIs from BSIs in this study, another contribution was the ability to identify other risks within the context of patient progress as CCs were examined in greater detail, over time with respect to thrombolytic use and patient outcomes during the course of HPN therapy. In summary, patients with CCs experienced more days of PICC-line use, had more hospitalizations and more likely had an ICD-9 code for GI-related disorders compared with patients with oncologyrelated diagnoses.
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Catheter complications and patient outcomes
Figure 1 Outcomes of patients with catheter complications who received a thrombolytic agent. *Patient #10 had a line pulled out at day 51.
Figure 2 Outcomes of patients with catheter complications who did not receive a thrombolytic agent. *Patient #12 had a catheter-related infection at day 1.
Evidence from the literature
Patient-level data and patient outcomes
When comparing these results to home-care data where a PICC was used, an examination of CCs in a prospective study of patients receiving HPN from four tertiary referral centres in Australia and New Zealand from 1 January 2009 and 12 March 2009 revealed that 53 patients had 49 episodes (36 line infections, five blocked catheters, one fractured line and seven line migrations) of CVCassociated complications, giving an incidence of 3.6 per 1000 CVC days [19]. In another study that examined 127 PICCs in children with cancer, the authors reported the median catheter life was 161 days with a total of 18 955 catheter days for 124 patients [20]. The CC rate was 2.41 per 1000 catheter days, occlusion rate was 0.06 and the infection rate was 1.27, respectively [20]. Comparing the results from these studies and the present study, the relatively low occurrence of CCs in this study could be related to differences in patient populations, location for nutritional therapy (e.g. hospital vs. home), exclusion of BSIs as a CC and changes in catheter management.
The 10 patients who had an occlusion (cause was non-drug related) and received a thrombolytic (Fig. 1) appeared to have fewer subsequent CLABSIs compared with the nine patients that did not have an occlusion and did not receive a thrombolytic (Fig. 2). The infections experienced by seven of these nine patients presented in Fig. 2 also appeared within or shortly after the first 30 days of PICC line insertion. These findings are consistent with a recent study in which the incidence of CLABSIs in children with short bowel syndrome who received HPN was highest during the first month post-hospital discharge [21]. Despite potential risks for infections from cyclic HPN use, weekly PICC dressing changes and weekly blood draws, the relatively short number of days to the first CLABSI experienced by patients may be attributed to a ‘learning curve’ effect as patients learned how to administer HPN therapy from their caregivers at BHI and nurses from the visiting nursing association. Patients can have infections that may not be related to PICC-line use. In this study, two patients developed BSIs that were unrelated
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(secondary) to the PICC according to data in the patient charts; one patient described in Fig. 1 and one patient described in Fig. 2. The BSIs occurred more than 30 days after insertion of the PICC. Consistent with reports in the literature identifying bacterial organisms responsible for systemic infections, patient 4 (Fig. 1) cultured two gram-negative organisms (K. pneumonia and E. coli). K. pneumonia is commonly associated with long-term use of HPN. With a diagnosis of acute pancreatitis and HPN use for 890 days, the infection in this patient was likely attributed to gut translocation [22]. While the management of CCs and BSIs is well documented in the literature [23], there remains a paucity of information that specifically addresses how CCs and BSIs may be influenced by patient diagnosis. As patients are likely to transition between hospitals and outpatient settings while receiving HPN, the inclusion of patient diagnosis in subgroup analyses may prove beneficial when comparing the effectiveness of catheter management strategies across different settings. However, realizing that patients may present with multiple disease conditions, disentangling this complex relationship between patient diagnosis and the duration of PICC-line use with respect to the development of CCs and BSIs may be challenging, yet should also provide opportunities to generate additional evidence-based recommendations to improve patient-care outcomes. Also noteworthy was the observation that patients with oncology-related diagnoses did not have CCs. Although interesting to posit that patients with oncology-related diagnoses received higher doses of heparin compared with patients with GI-related diagnoses, an examination of the patients’ chart data revealed that 10 U mL−1 of heparin was the standard dose used for catheter-line clearance in both groups. Nonetheless, considering the positive relationship between PICC duration of HPN therapy and the risk of developing CCs, catheters should be removed as soon as possible, especially in the presence of the first signs of infection [24]. However, additional studies are needed to further characterize this relationship and to investigate the pattern of CCs over a longer timeline (number of days) to determine if patient outcomes were influenced by ongoing improvements in catheter management (e.g. use of sterile techniques, patient monitoring efforts and other evidence-based practices).
Limitations Although every effort was made to ensure data accuracy, the possibility exists for coding errors when extracting data from patient charts. While researchers noted that patients who received thrombolytics were treated more recently (2006–2011) compared with patients who did not receive a thrombolytic (2005–2009), specific differences attributed to changes in protocol, procedure, antibiotic or ethanol lock use (very limited use in this study), insurance coverage or HPN therapy duration could not be isolated from the large overlap in timelines. In this study, one patient (ID = 2) had multiple hospitalizations (n = 5), yet without access to the hospital’s chart data for some patients who did not return to home care, the underlying reasons for hospital admissions or hospital visits in association with CCs could not be determined. The study outcomes could be influenced by patients who were excluded from the study. However, there were no differences in patient characteristics (e.g. diagnoses and age) between patients who were excluded compared with patients who were included in 158
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the analysis. Finally, considering the small sample size (n = 19), caution should be used when generalizing these findings to other practice settings and patient populations.
Conclusion Patients with CCs had more days of PICC-line use and more hospital admissions compared with patients without CCs. While CCs appeared to occur in patients with GI and GI-related diagnoses, additional studies are needed to examine the influence of patient diagnosis and PICC duration of use on CCs and BSIs. A heuristic model for risk assessment including educational workshops should be considered to help caregivers and clinicians identify patients that may be more susceptible to CCs.
Acknowledgement This study was supported by a scientific research grant from Genentech, Inc., South San Francisco, CA, USA.
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