BACKGROUND/RATIONALE:
Urinary catheters and peripherally inserted central venous catheters (PICCs) are commonly placed in the hospital and are important for the care of many patients. Both devices, however, are also associated with infectious and non-infectious complications. Unfortunately, little work has been done to characterize the frequency and types of complications. Thus, the full scope of potential problems, including those that may occur outside the hospital, are not yet known.

Strategies to prevent these harms are also in their infancy. Most safety initiatives related to the use of catheters focus on preventing infectious complications (i.e., catheter-associated urinary tract infection, central line-associated bloodstream infection), while largely ignoring the non-infectious complications. As a result, important opportunities exist for further improving Veteran safety by reducing potential device-associated harm.

OBJECTIVE(S):
The primary objective of this study was to determine rates and types of infectious and noninfectious complications associated with urinary catheters and PICCs/midline catheters. Interventions to prevent these complications were also developed and pilot-tested. Specifically, our aims were:

1) To determine the type and frequency of complications associated with the use of urinary catheters (primarily indwelling urethral catheters) placed in acute care settings from insertion up to 30 days.

2) To determine the type and frequency of complications associated with the use of PICCs and midlines placed in acute care settings from insertion up to 70 days.

3) To identify factors (patient, provider, or device) associated with complications from the use of urinary catheters, PICCs, and midlines.

4) To develop and pilot test at least one strategy to reduce urinary catheter-related complications and one strategy to reduce PICC/midline-related complications.

METHODS:
We conducted a prospective observational study of patients at four medical centers, two Veterans Health Administration (VHA) medical centers and two non-VHA facilities, who had either a urinary catheter or a PICC/midline placed during an acute care hospitalization. Data about both infectious and non-infectious device-related complications during the 30-day surveillance period for urinary catheters and 70-day surveillance period for PICCs/midlines were collected by patient self-report, through a series of brief assessments and interviews, and from the medical record.

The initial target sample size for assessing complications from indwelling urethral catheters was 3,200 patients, with 2,227 (70%) recruited for participation during the study period. For PICCs/midlines, the target sample was at least 800 patients, with 539 (67%) recruited for participation.

The primary outcome for Aims 1-3 was the frequency of infectious and non-infectious complication events for each type of device. Specifically, we assessed the percentage of patients who experienced a complication event, overall and by type, related to a urinary catheter or PICC.

Our secondary outcomes of interest were the potential consequences of both infectious and non-infectious complications related to catheter use, such as the use of antibiotics to treat an infection, and the effect on activities of daily living and social activities.

Our pilot work for Aim 4 focused on implementing appropriateness criteria for both devices. Although indwelling urinary catheters and PICCs are clearly indicated for some patients, strategies that promote appropriate use are critical for reducing unnecessary device use and thus the risk of both infectious and non-infectious device-associated complications.

FINDINGS/RESULTS:
Of the 2,076 patients with indwelling urinary catheters included in the analysis, the mean age was 62 years and the majority were men (71%). Most patients had short-term catheters placed for surgical procedures (80%). During the month after urethral catheter use, 57.0% of patients reported at least one complication due to the indwelling urethral catheter. Infectious complications were reported by 10.5% of patients, while non-infectious complications (e.g., blood in urine, pain or discomfort, sense of urinary urgency) occurred in 55.4% of patients. Women were more likely to report an infectious complication than men (15.5% vs. 8.6%; P<0.001), while men were more likely to report a non-infectious complication than women (58.6% vs. 47.3%; P<0.001). Restrictions in activities of daily living (39.5%) or social activity (43.9%) were commonly reported by patients with catheters still in place, while sexual problems were reported by 4.9% of patients after catheter removal.

Of 438 evaluable patients with PICCs only, two-thirds were male with a mean age of 56 years. The most common reason for PICC placement was long term antibiotic therapy (43.4%). During the 70-day follow-up period, over half (53.4%) of participating patients reported signs and symptoms of at least one medical complication. Of the 53 patients with symptoms of an infection, 43% were told by a doctor that it might be PICC-related or were admitted to a hospital and more than 70% were prescribed antibiotics. Among the 31 patients who were told they have a bloodstream infection, 77% reported a doctor indicated that it might be due to the PICC or were admitted to a hospital and 87% received antibiotics. A recorded indication of a central line-associated bloodstream infection was identified via medical record review for 7 patients, 3 of whom were patients who reported a possible bloodstream infection as described above. Of the 134 patients with signs of a possible deep vein thrombosis, 13.0% reported redness, pain or swelling in the arm where the line was inserted, 8.5% chest pain or shortness of breath requiring them to seek care, and 18.3% had pain, swelling or redness in either of their legs or calves. Documentation of deep vein thrombosis was identified in the medical record for 31 patients, including 14 of those with reported symptoms. Nearly one third (27.9%) of patients reported experiencing minor complications, such as redness around the insertion site and discomfort, inadvertent removal, migration, or a difficult removal (8.5%).

IMPACT:
This study provides critical information about infectious and noninfectious complications associated with urinary catheters and PICCs, including complications as reported and experienced by patients and not just those identified through traditional data sources. This information provides the basis for identifying and testing strategies to prevent these complications and improve the patient experience. Given the frequent use of these devices, efforts to improve both urinary catheter and PICC use resulting from these findings will have a direct impact on the safety and well-being of Veteran and non-Veteran patients.

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External Links for this Project

NIH Reporter

Grant Number: I01HX001101-01A2
Link: https://reporter.nih.gov/project-details/8675370

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PUBLICATIONS:

Journal Articles

1. Saint S, Trautner BW, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Hollingsworth JM, Krein SL. A Multicenter Study of Patient-Reported Infectious and Noninfectious Complications Associated With Indwelling Urethral Catheters. JAMA internal medicine. 2018 Aug 1; 178(8):1078-1085. [view]
2. Saint S, Krein SL, Fowler KE, Colozzi J, Ratz D, Lescinskas E, Chrouser K, Trautner BW. Condom Catheters versus Indwelling Urethral Catheters in Men: A Prospective, Observational Study. Journal of hospital medicine. 2019 Mar 20; 14:E1-E4. [view]
3. Trautner BW. Observational Evidence Calls for Deimplementation of Routine Preoperative Urine Screening. JAMA surgery. 2019 Mar 1; 154(3):248-249. [view]
4. Krein SL, Saint S, Trautner BW, Kuhn L, Colozzi J, Ratz D, Lescinskas E, Chopra V. Patient-reported complications related to peripherally inserted central catheters: a multicentre prospective cohort study. BMJ quality & safety. 2019 Jul 1; 28(7):574-581. [view]
5. Trautner BW, Naik AD. Taking a Ride on the Stewardship Side of Long-term Care: The Cadillac and the Camry. JAMA Network Open. 2019 Sep 4; 2(9):e199515. [view]
6. Lescinskas EH, Trautner BW, Saint S, Colozzi J, Evertsz K, Chopra V, Krein SL. Use of and patient-reported complications related to midline catheters and peripherally inserted central catheters. Infection control and hospital epidemiology. 2020 May 1; 41(5):608-610. [view]
7. Trautner BW, Saint S, Fowler KE, Van J, Rosen T, Colozzi J, Chopra V, Lescinskas E, Krein SL. What do patients say about their experience with urinary catheters and peripherally inserted central catheters?. American journal of infection control. 2019 Sep 1; 47(9):1130-1134. [view]

Journal Other

1. Trautner BW. Fluoroquinolones for urinary tract infection and within-household spread of resistant Enterobacteriaceae: the smoking gun. Clinical Microbiology and Infection : The Official Publication of The European Society of Clinical Microbiology and Infectious Diseases. 2018 Sep 1; 24(9):929-930. [view]

Conference Presentations

1. Trautner B. Differentiating asymptomatic bacteriuria from UTI. Presented at: Infectious Diseases Week; 2016 Oct 27; New Orleans, LA. [view]
2. Grigoryan L, Zoorob R, Nash S, Trautner B. Non-prescription antimicrobial use in the general population: evidence for action. Presented at: Society of Teachers of Family Medicine Spring Conference; 2016 Apr 1; Minneapolis, MN. [view]

DRA: Infectious Diseases
DRE: Pathology
Keywords: none
MeSH Terms: none