Using appropriateness criteria to identify opportunities to improve perioperative urinary catheter use

Using appropriateness criteria to identify opportunities to improve perioperative urinary catheter use

Journal Pre-proof Using appropriateness criteria to identify opportunities to improve perioperative urinary catheter use Ana C. De Roo, Samantha Hendr...

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Journal Pre-proof Using appropriateness criteria to identify opportunities to improve perioperative urinary catheter use Ana C. De Roo, Samantha Hendren, Jessica M. Ameling, Jennifer Meddings PII:

S0002-9610(20)30009-X

DOI:

https://doi.org/10.1016/j.amjsurg.2020.01.008

Reference:

AJS 13633

To appear in:

The American Journal of Surgery

Received Date: 8 November 2019 Revised Date:

6 January 2020

Accepted Date: 7 January 2020

Please cite this article as: De Roo AC, Hendren S, Ameling JM, Meddings J, Using appropriateness criteria to identify opportunities to improve perioperative urinary catheter use, The American Journal of Surgery (2020), doi: https://doi.org/10.1016/j.amjsurg.2020.01.008. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Inc.

Running Head: Improving perioperative catheter use 1 2

Using Appropriateness Criteria to Identify Opportunities to Improve Perioperative Urinary Catheter Use

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Ana C De Roo MD MSc1,2

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Samantha Hendren MD MPH1,2

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Jessica M Ameling MPH3,7

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Jennifer Meddings MD MSc3-7

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Department of Surgery, University of Michigan, Ann Arbor, MI Center for Healthcare Outcomes and Policy, Institute for Healthcare Policy and Innovation, University of

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Michigan, Ann Arbor, MI

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Arbor, MI

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MI

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System, Ann Arbor, MI

Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI Department of Pediatrics and Communicable Diseases, University of Michigan Medical School, Ann

Department of Medicine, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, MI Center for Clinical Management Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor,

Patient Safety Enhancement Program for the University of Michigan and VA Ann Arbor Healthcare

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Corresponding author and reprints:

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Ana C De Roo, MD North Campus Research Complex 2800 Plymouth Road, Building 14-G100 Ann Arbor, MI 48109 Tel: +1 734-647-4844; Fax: 734-647-3301 Email: [email protected]

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Brief Title: Perioperative Catheter Criteria

Presented as a poster at: Academy Health 2019 Annual Research Meeting, Washington DC, June 2019.

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ABSTRACT

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Background: The Michigan Appropriate Perioperative (MAP) criteria provide guidance regarding urinary

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catheter use. For Category A (e.g., laparoscopic cholecystectomy), B (e.g., hemicolectomy), and C (e.g.,

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abdominoperineal resection) procedures, recommendations are to avoid catheter, remove POD 0 or 1,

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and remove POD 1-4, respectively. We applied MAP criteria to statewide registry data to identify

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improvement targets.

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Methods: Retrospective cohort study of risk-adjusted catheter use and duration for appendectomy,

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cholecystectomy, and colorectal resections in 2014-2015 from 64 Michigan hospitals.

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Results: 5.5% of 13,032 Category A cases used urinary catheters, including 26.9% of open

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appendectomies. 94.5% of 1,624 Category B cases used catheters (31.2% remained after POD 1). 98.3%

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of 700 Category C cases used catheters (4.6% remained POD5+). Variation in duration of use persisted

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after risk adjustment.

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Conclusions: Perioperative urinary catheter use was appropriate for most simple abdominal

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procedures, but duration of use varied in all categories.

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Summary: We applied perioperative urinary catheter appropriateness criteria to real world clinical data

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for appendectomy, cholecystectomy, and colorectal procedures. The 3 categories of appropriateness

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recommended: (A) avoid urinary catheter if possible; (B) consider removing catheter before leaving the

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operating room, or on postoperative day (POD) 1; and (C) appropriate to use until at least POD1.

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Perioperative urinary catheter use was appropriate for most simple abdominal procedures, but duration

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of use varied in all categories.

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Keywords: Urinary catheter; perioperative care; patient safety; general surgery; appropriateness

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Research Highlights: • • • •

94.5% of appendectomy and cholecystectomy cases did not use urinary catheters 68.9% of segmental colon resections removed urinary catheters by POD1 69.3% of complex colorectal procedures removed urinary catheters by POD2 Variation persists in risk adjusted catheter removal after colorectal operations

Running Head: Improving perioperative catheter use 62 63

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INTRODUCTION: Perioperative urinary catheter use serves multiple purposes: to assist measurement of urine

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output, prevent incontinence or over-distention of the bladder during anesthesia, decompress the

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bladder for improved visibility during pelvic operations, and minimize risk of postoperative urinary

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retention, particularly after pelvic operations that may temporarily disrupt bladder innervation.1 Urinary

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catheters, however, are also associated with harms including: infectious complications, urethral trauma,

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limited patient mobility after surgery, and prolonged length of stay.2-4 Although catheter-associated

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urinary tract infection (CAUTI) is a major patient safety focus, the non-infectious harms of catheters are

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even more common. While only about 5% of catheter patients experience infection, over 50% of

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patients develop non-infectious catheter complications when followed prospectively after short-term

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catheter use. These include urinary urgency, bladder spasms, urine leakage, difficulty starting or

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stopping the urine stream, and pain and burning with urination.5 In addition, catheter use accounts for

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over a third of iatrogenic urethral strictures, which can cause permanent voiding difficulties.5,6

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In previous work, the Ann Arbor criteria were developed to assess appropriateness of catheter

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use in medical patients.7 Similar methods were used to assess appropriateness of catheter use in

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surgical patients8 in the setting of perioperative protocols advocating for brief use of urinary catheters,

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or avoidance altogether.9 The Michigan Appropriate Perioperative (MAP) criteria were developed to

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provide urinary catheter use and removal guidance for routine surgical procedures.8 The MAP criteria

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are organized into three categories, by procedural appropriateness: (A) avoid catheter if possible (e.g.,

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laparoscopic cholecystectomy, open appendectomy, and laparoscopic appendectomy without

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suprapubic trocar), (B) consider removing catheter before leaving the operating room, or on

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postoperative day (POD) 1 (e.g., open and laparoscopic colorectal procedures without rectal resection),

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(C) appropriate to use until at least POD1, with further guidance on timing of the first trial of void by

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procedure (e.g., more complex colorectal resections including rectal resections). These guidelines were

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created using the RAND/UCLA Appropriateness Method, which incorporates the best available scientific

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evidence with expert panel judgement.10 Although a representative panel of experienced, practicing

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general surgeons, nurses and nurse practitioners, urologists, and hospitalists agreed upon these

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guidelines, how and whether current practice aligns with MAP criteria is unknown.

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Therefore, we aimed to identify areas of opportunity to decrease catheter use in accordance

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with the newly developed appropriateness criteria. The objective of this study was to understand recent

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urinary catheter use patterns, and their alignment with the MAP criteria, in order to establish baseline

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perioperative urinary catheter use and identify targets for quality improvement using the MAP criteria.

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We used Michigan Surgical Quality Collaborative (MSQC) registry data, which samples surgical cases

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from every major surgical hospital in Michigan and collects information on utilization of urinary

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catheters and date of catheter removal.11 This study is the first application of the MAP criteria to real-

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world clinical data.

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METHODS: We performed a retrospective cohort study of patients undergoing common surgical procedures

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in MSQC hospitals. The MSQC registry is a collaborative effort between Michigan hospitals and Blue

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Cross Blue Shield of Michigan that began in 2004 and is focused on quality improvement.12-14 The

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registry included 64 community and academic hospitals during the study period, representing nearly

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every major surgical hospital in the state.11 Trained nurses manually abstract registry data from paper

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and electronic medical records, as well as administrative records. The registry is audited regularly for

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validity. Cases abstraction occurs on an 8-day cycle to ensure systematic sampling and each site collects

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the first 25 consecutive cases meeting inclusion criteria.15 The registry captures both inpatient and

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outpatient procedures. The MAP criteria include a broad scope of operations, including general surgery,

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bariatric, and orthopedic operations. The MSQC registry primarily captures general surgery operations,

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therefore we evaluated MAP criteria adherence only for the subset of procedures captured in MSQC.

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The MAP criteria also provide guidance for appendectomy, but application of the MAP criteria to MSQC

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data was limited by inability to determine whether a suprapubic laparoscopic trochar was utilized. We

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therefore included all laparoscopic appendectomy cases, but compared to open appendectomy in order

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to evaluate catheter use in the two surgical approaches.

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The University of Michigan Medical School Institutional Review Board deemed this study “not regulated” due to the minimal risk associated with using de-identified registry data.

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Inclusion Criteria

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We included patients ages 18 and older undergoing the procedures listed in Table 1 from May 1,

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2014 to April 30, 2015. We used data from 2014-2015, because the registry ceased collection of detailed

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catheter use data after that time period and more recent data was not available. The MAP criteria

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divides surgical procedures into three categories, by catheter appropriateness: (A) avoid catheter if

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possible; (B) consider removing catheter before leaving the operating room, or on postoperative day

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(POD) 1; and (C) appropriate to use until at least POD1. Category C represents a heterogeneous group of

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operations for which the MAP criteria panel was able to recommend a catheter discontinuation date for

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most cases, but these ranged from POD1 through POD4. In those cases, an upper limit of appropriate

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POD of removal is provided, though the maximum upper limit is POD4 for all Category C procedures

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[Table 1].8

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Exclusion Criteria

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We excluded urgent and emergent operations for Categories B and C, because patients

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undergoing these procedures emergently represent a different population than the MAP panel

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considered when creating their recommendations. For Category A procedures, urgent and emergent

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operations were not excluded because appendectomy and cholecystectomy procedures are often

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performed in the urgent/emergent setting due to the nature of underlying disease. We excluded

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patients who were admitted post-operatively to the intensive care unit (ICU), as the MAP criteria do not

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address appropriateness for these more complex patients. We also excluded open subtotal colectomy

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(CPT 44150 and 44151) because the cohort had low baseline functional independence, high rates of ICU

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admission after surgery and was not representative of the patient population identified by the MAP

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panel.

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Additional procedures addressed by the MAP criteria [Table 1] were not included due to the

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inability to identify these specific procedures using registry data or due to the sampling frame of MSQC.

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For example, reducible inguinal hernia repair is identified in the MAP criteria, but reducibility is not

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delineated in CPT codes. Elective groin hernia and open umbilical hernia operations are irregularly

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sampled by the MSQC and bariatric surgery cases are not captured by the MSQC dataset and therefore

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excluded.

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Measures:

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Our primary outcomes were catheter use and POD of catheter removal, both predefined

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variables in MSQC. Predefined covariates included patient demographics, body mass index (BMI),

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comorbid conditions (chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD),

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congestive heart failure (CHF), diabetes), functional status prior to surgery (dependent/independent),

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blood transfusion, and hospital characteristics including bed size, teaching status, and case volume.

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Surgical priority (elective, urgent, and emergent) is also a predefined MSQC variable, though we

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dichotomized it into elective and urgent/emergent (non-elective) for Category A. We also dichotomized

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operative duration, a continuous variable in the dataset, into ≥2 hours and <2 hours, based on MAP

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criteria identifying that routine catheter use is inappropriate for operations lasting less than 2 hours.

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American Society of Anesthesiologists (ASA) class was dichotomized into classes 1/2 (healthy/mild

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systemic disease) and 3/4 (severe systemic disease with functional limitation/severe systemic disease

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with constant threat to life).16

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We calculated total intraoperative fluid administration using the crystalloid and colloid volumes

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recorded in the registry and adding 300 mL for each unit of packed red blood cells transfused. Total

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intraoperative fluid administration was then dichotomized to ≥2 liters and <2 liters, as the MAP panel

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identified that routine catheter use is inappropriate for cases with less than 2 liters of fluid

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administration.

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Missing Data:

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Post-operative day (POD) of catheter removal was missing for 158 cases (5.2%) in which urinary

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catheters were used. If length of stay was 4 days or less, we replaced day of catheter removal with day

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of discharge, based on the MAP criteria demonstrating that the upper limit of catheter removal

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appropriateness is POD4.8 This replacement accounted for day of removal in 30 of the 158 cases,

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decreasing the missing data to 4.2% for POD of removal. The remaining missing data (4.2%) were

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excluded from the multivariable analysis.

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Statistical Analysis: We used descriptive statistics and chi-squared analysis to characterize catheter use by patient,

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hospital, and surgical characteristics [Table 2]. We used median and interquartile ranges to report day of

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catheter removal. Bivariate analysis of a priori defined factors and their association with catheter use

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and duration of use were used to inform the model development. A priori factors were included in the

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final models if the p value was <0.10 in bivariate analysis.

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We sought to evaluate the variation of catheter use and duration of catheter use, and to see

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how these varied by patient and procedure characteristics. Accordingly, for each MAP category, we

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developed two risk adjusted models: one to evaluate catheter use and another to evaluate POD of

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catheter removal. To develop the catheter use model and expected catheter use at the hospital and

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patient levels, we used logistic regression of observed catheter use adjusted for a priori risk factors of

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catheter use (ASA class, age, sex, interaction between age and sex, BMI, COPD, CHF, CAD, diabetes,

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functional independence, surgical priority, hospital case volume, intraoperative fluid administration ≥2

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liters, operative duration ≥2 hours, and MAP appropriateness category). To develop the POD of catheter

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removal model, we used linear regression to develop observed and expected duration of catheter use at

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the hospital and patient levels, adjusting for the same risk factors as the catheter use model. Through

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these models, hospitals were partitioned into quartiles based on risk adjusted performance for both

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catheter use rate and duration. As a sensitivity analysis, we added length of stay to the models for POD

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of catheter removal.

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All statistical tests were two-sided, with a p value of <0.05 used as significance threshold. All analyses were conducted using Stata 15.1, StataCorp, College Station, TX.

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RESULTS: A total of 15,450 cases met inclusion criteria. Of those, 3,032 (19.6%) used urinary catheters. [Table 2].

Running Head: Improving perioperative catheter use 202 203

Category A During the study period, 13,032 Category A procedures were performed [Table 2]. Urinary

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catheters were used in 721 (5.5%) cases. However, there was wide variation by procedure, with 26.9%

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of open appendectomies using catheters, as compared to 8.9% for laparoscopic appendectomy and

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3.1% for laparoscopic cholecystectomy. Of 13,032 cases, 4,998 (38.4%) were outpatient procedures.

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Median day of removal was POD1 (interquartile range (IQR) 0-1 days) for all Category A

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procedures: open appendectomy (IQR 1-2 days), laparoscopic appendectomy (IQR 0-1 days), and

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laparoscopic cholecystectomy (IQR 1-2 days) [Table 2]. Of catheters used, only 24.8% were removed

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POD0 [Figure 1]. Compared to the laparoscopic appendectomy cohort, the open appendectomy cohort

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used urinary catheters more frequently, was older with more comorbidities, more likely be an elective

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operation, and operative duration was longer.

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Our model results identified the following associations with urinary catheter use: age (OR 1.01

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per year, 95% CI 1.01-1.02), urgent/emergent case priority (OR 2.67, 95% CI 2.2-3.2), dependent

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functional status (OR 3.23, 95% CI 2.21-4.71), ASA Class 3/4 (OR 1.88, 95% CI 1.54-2.30), receiving ≥2

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liters of intraoperative fluids (OR 3.3, 95% CI 2.63-4.17), and operative duration ≥2 hours (OR 3.06, 95%

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CI 2.32-4.02). Factors associated with decreased use of urinary catheters include non-academic hospitals

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(OR 0.75, 95% CI 0.59-0.95), diabetes (OR 0.79, 95% CI 0.62-0.99), and female sex (OR 0.78, 95% CI 0.66-

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0.91). After risk adjustment, expected catheter use remained similar to observed rates among all

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hospital quartiles. In the model for POD of catheter removal, expected removal was much earlier than

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observed, at less than 0.13 days in all hospital quartiles after risk adjustment [Figure 2]. In the sensitivity

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analysis, each additional day in hospital length of stay was associated with an effect size of 0.17 days

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(95% CI 0.14-0.20) of catheter use.

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By this analysis, MAP criteria for catheter use were met in 94.5% of Category A cases, leaving

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5.5% of cases in which catheter use may have been inappropriate. In cases that did use catheters, less

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than 25% were removed POD0, which is the optimal timing for removal defined by the MAP criteria.

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After risk adjustment, observed time to removal greatly exceeded expected time to removal.

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Category B Of the 1,718 Category B procedures performed, 1,624 (94.5%) cases used urinary catheters.

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Median POD of removal was 1 day (IQR 1-2 days). Removal by POD1, in accordance with MAP criteria,

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occurred in 1,085 (68.9%) cases. Removal on POD0 was met in 42 (2.7%) cases. When examining POD

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removal by procedure, using CPT code, there was no single or group of procedures that

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disproportionately accounted for the variation. Of 1,718 cases, 5 (0.3%) were outpatient procedures.

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Our multivariable model identified the following factors associated with increased rates of

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urinary catheter use: fluid administration ≥2 liters (OR 1.57, 95% CI 1.01 -2.45) and operative duration

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≥2 hours (1.62, 95% CI 1.03-2.53). After risk adjustment, expected rates of catheter use varied by

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hospital quartile: ranging from 84.1-101.7%. Factors independently associated with POD of catheter

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removal included increasing age (0.012 days per year of age, 95% CI 0.006-0.017 days) and operative

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duration ≥2 hours (0.19 days, 95% CI 0.05-0.32 days). After risk adjustment, expected POD of catheter

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removal was less than 1 day in 75% of hospitals. [Figure 2]

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Category C Nearly all of the 700 Category C procedures performed used urinary catheters (687 cases, 98.1%) and all cases were inpatient procedures. Median POD removal was 2 days (IQR 1-3 days).

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Running Head: Improving perioperative catheter use

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Catheter removal by POD2 was achieved in 69.3% of cases. Catheter removal by POD4, the upper limit

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of MAP criteria removal day, was achieved in 95.4% of cases [Figure 1]. When examining catheter

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removal by POD and procedure (using CPT code), two of the 13 procedures accounted for 41.0% of the

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catheters in place after POD4: partial colectomy with low pelvic anastomosis (CPT 44145) and

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abdominoperineal resection (CPT 45110).

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In the multivariable model for catheter removal, increasing age (0.013 days per year of age, 95%

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CI 0.005-0.02) and increasing operative duration (0.28 days per hour of operation, 95% CI 0.20-0.36)

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were associated with longer duration of catheter use. After risk adjustment, observed and expected

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postoperative day of removal were similar, but variation persisted by hospital quartile: ranging from

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removal at POD1 for hospital quartile 1 and POD3 for hospital quartile 4. [Figure 2].

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DISCUSSION This is the first study applying the MAP criteria8 to real-world surgical patients to better

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understand the current status of urinary catheter use, as a needs assessment to inform the need for

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intervention development to reduce urinary catheter overuse. We found that most laparoscopic

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appendectomies and cholecystectomies are performed without urinary catheters in Michigan, in

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alignment with MAP criteria. However, for Category B colorectal surgery, catheter use is not consistent

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with criteria in one-third of cases. Furthermore, catheter duration varies by hospital quartile in Category

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B and C procedures, after adjustment for patient and procedural characteristics. This suggests both

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existing appropriate use for most Category A procedures and important opportunities for developing

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interventions to reduce duration of urinary catheter use for several procedure types, particularly for

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Category B and C procedures.

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We identified the following specific opportunities for improvement. First, 5.5% of Category A

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cases are still using urinary catheters, and even if these have underlying clinically appropriate reasons

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for use, POD of removal could still be improved (i.e. removal on POD0 rather than POD1). Second,

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postoperative catheter use for many colorectal procedures was often longer than MAP criteria goals.

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The POD1 goal for catheter removal for Category B cases was met in about two thirds of cases.

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Furthermore, the catheters removed on POD1 could be shifted to earlier removal on POD0 or in the

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operating room. Lastly, while catheter use in Category C is appropriate, removal time could also be

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improved for these cases. Nearly 70% of Category C cases removed catheters by POD2, and critical

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assessment of catheter appropriateness could continue to strive for shorter duration.

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While an expert panel of providers can agree on ideal criteria for catheter use, variation still

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persists. Patient, disease, provider, and hospital factors may drive variation. For open appendectomy,

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patient factors may drive variation. The expert panel likely envisioned the ideal open appendectomy

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patient, while our comparison between open and laparoscopic appendectomy highlighted that open

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appendectomy patients in this cohort were older with more comorbidities, and had less-straightforward

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operations, as evidenced by longer operative time. Disease factors may drive variation in pelvic

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operations: potential for postoperative urinary retention in pelvic operations which may disrupt bladder

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innervation.17 This aligns with our finding of two procedures accounting for a large proportion of

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prolonged catheter use: partial colectomy with low pelvic anastomosis and abdominoperineal resection.

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Provider and hospital factors may influence overuse as well. The association of non-academic hospitals

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with decreased Category A catheter use may represent a consequence of large academic patient-care

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teams: frequent trainee rotation in addition to a variety of providers and preferences. Community

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hospitals may have more nurse-driven catheter management.18 Hospital factors may account for

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variation in Category C, as we found large variation among hospital quartiles for POD of removal, which

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highlights potential for institution-based quality improvement efforts. We acknowledge that clinical

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judgment should remain a factor in urinary catheter use; however, the identified variation in all

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categories, which account for patient, surgical, and hospital factors, suggest there are many targets for

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improvement.

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Future efforts to address these targets for improvement may provide a variety of benefits. For

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Categories A and B, following the MAP criteria has the potential to decrease the risk of urinary tract

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infections, as catheter use for more than two days has been associated with higher rates of UTI.19 Even

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for pelvic surgery and patients with epidurals, fewer than 20% of patients will experience urinary

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retention, limiting rationale for one-size-fits-all catheter duration.20,21 Older surgical patients with

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catheters have higher complication rates, rates of readmission, and risk of death than those without,22

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and our study found longer catheter use duration for cohorts with older adults. This was true for open

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appendectomy, as well as Category B and C procedures.

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Utilization of appropriateness criteria, whether through retrospective assessment to identify

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quality improvement targets or real-time to assess adherence, represents a new paradigm in patient

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safety and quality improvement. Previously, perioperative catheter use changed due to the Surgical Care

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Improvement Project (SCIP) recommendation of urinary catheter removal by POD1 or 2.23 The SCIP

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measures were limited quickly by ceiling effects and did not improve outcomes in the end.24,25 A major

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limitation of SCIP was the ease of excluding patients from SCIP criteria by documenting a reason for

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continued use of a urinary catheter.24 There have been no further guidelines to spur surgeons to

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continually assess urinary catheter use. While current metrics regarding catheter use focus on

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postoperative duration of use or hospital-acquired CAUTI, catheter appropriateness may be another

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useful metric. Catheters are likely overused due to reliance on tradition and outdated practice,

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therefore the levels of appropriateness, rather than one-size-fits-all approach, proposed by the MAP

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criteria are of real value. From a policy standpoint, this work may help inform future modifications of

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the Standardized Utilization Ratio, a metric by the Centers for Disease Control and Prevention that

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compares actual use to predicted use of a device currently adjusted for facility and unit-level factors , to

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one that could also account for appropriateness of catheter use by categories of surgical procedure.26

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This study has several limitations. First, we used a statewide registry from a quality

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improvement collaborative, which has already encouraged early catheter discontinuation for colorectal

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procedures, therefore we may underestimate other states’ rates and duration of urinary catheter use,

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preventing generalizability to other areas of the country. Therefore, the potential targets for

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improvement may be even greater in other states and health systems.27 However, this is a large,

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regional registry that provides baseline information for future interventions and is an established

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mechanism for such interventions. Second, POD of catheter removal remains missing for nearly 5% of

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patients in all categories, despite our efforts to account for removal date, though the large sample size

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from statewide registry data remains a strength. Third, we were unable to assess the complete MAP

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criteria using this single data source. However, the MAP criteria are very comprehensive, and efforts to

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improve perioperative catheter use will likely begin in subsets of surgery such as general surgery,

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bariatric surgery, and orthopedics, each of which have their own quality improvement clinical registries

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in Michigan.13,28,29 Additionally, we applied new criteria to older data, due to limitations in available

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data. As such, we may have overestimated the targets for improvement if progress has been made in

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the intervening years. Finally, there may be additional confounding variables that are not captured by

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the registry data including individual surgeon and patient preferences, nursing practices, indications for

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catheter use (including preexisting urinary incontinence), and postoperative urinary retention, among

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others.

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CONCLUSIONS

337 338

Michigan surgeons are avoiding or minimizing perioperative urinary catheter use in common abdominal procedures, though important variation and overuse persist with regard to open

Running Head: Improving perioperative catheter use

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appendectomy and colorectal procedures. Thus, this study identifies opportunities to reduce urinary

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catheter use and its associated harms, through future targeted intervention using the MAP criteria. To

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successfully change practice, MAP criteria application will likely involve a multimodal intervention, with

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surgeon engagement as a key component. We intend to use this information on rates of use and POD of

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urinary catheter removal to inform participating MSQC hospitals and to assist them in quality

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improvement efforts.

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Leuck AM, Wright D, Ellingson L, Kraemer L, Kuskowski MA, Johnson JR. Complications of Foley catheters--is infection the greatest risk? J Urol. 2012;187:1662-6.

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Greco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced Recovery Program in Colorectal Surgery: A Meta-analysis of Randomized Controlled Trials. World J Surg. 2014;38:153141.

Running Head: Improving perioperative catheter use

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10. Fitch K BS, Aguilar MD, Burnand B, LaCalle JR, Lazaro P, et al. The RAND/UCLA Appropriateness Method User’s Manual. Santa Monica: RAND Corporation; 2001. 11. Nikolian VC, Regenbogen SE. Statewide Clinic Registries: The Michigan Surgical Quality Collaborative. Clin Colon Rectal Surg. 2019;32:16-24. 12. Campbell DA, Englesbe MJ, Kubus JJ, et al. Accelerating the pace of surgical quality improvement: the power of hospital collaboration. Arch Surg-Chicago. 2010;145:985-91. 13. Campbell DA, Kubus JJ, Henke PK, Hutton M, Englesbe MJ. The Michigan Surgical Quality Collaborative: a legacy of Shukri Khuri. Am J Surg. 2009;198:S49-S55. 14. Share DA, Campbell DA, Birkmeyer N, et al. How a regional collaborative of hospitals and physicians in Michigan cut costs and improved the quality of care. Health Affairs (Millwood). 2011;30:636-45. 15. Michigan Surgical Quality Collaborative 2.0 Data Collection Manual: MSQC-PSO; 2014. 16. Wolters U, Wolf T, Stutzer H, Schroder T. ASA classification and perioperative variables as predictors of postoperative outcome. Brit J Anaesth. 1996;77:217-22. 17. Ghuman A, Kasteel N, Karimuddin AA, Brown CJ, Raval MJ, Phang PT. Urinary retention in early urinary catheter removal after colorectal surgery. Am J Surg. 2018;215:949-52. 18. Durant DJ. Nurse-driven protocols and the prevention of catheter-associated urinary tract infections: A systematic review. Am J Infect Control. 2017;45:1331-41. 19. Wald HL, Ma A, Bratzler DW, Kramer AM. Indwelling urinary catheter use in the postoperative period: analysis of the national surgical infection prevention project data. Arch Surg. 2008;143:5517. 20. Zmora O, Madbouly K, Tulchinsky H, Hussein A, Khaikin M. Urinary bladder catheter drainage following pelvic surgery--is it necessary for that long? Dis Colon Rectum. 2010;53:321-6.

Running Head: Improving perioperative catheter use

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21. Stubbs BM, Badcock KJ, Hyams C, Rizal FE, Warren S, Francis D. A prospective study of early removal of the urethral catheter after colorectal surgery in patients having epidural analgesia as part of the Enhanced Recovery After Surgery programme. Colorectal Dis. 2013;15:733-6. 22. Wald HL, Epstein AM, Radcliff TA, Kramer AM. Extended use of urinary catheters in older surgical patients: a patient safety problem? Infect Control Hosp Epidemiol. 2008;29:116-24. 23. Bratzler DW. The Surgical Infection Prevention and Surgical Care Improvement Projects: promises and pitfalls. Am Surg. 2006;72:1010-6. 24. Kaplan JA, Carter JT. Near-perfect compliance with SCIP Inf-9 had no effect on catheter utilization or urinary tract infections at an academic medical center. Am J Surg. 2018;215:23-7. 25. Rosenberger LH, Politano AD, Sawyer RG. The Surgical Care Improvement Project and prevention of post-operative infection, including surgical site infection. Surg Infect. 2011;12:163-8. 26. Centers for Disease Control and Prevention. “The NHSN Standardized Utilization Ratio (SUR): a guide to the SUR.” 2018. Available from: https://www.cdc.gov/nhsn/pdfs/ps-analysisresources/nhsn-sur-guide-508.pdf. 27. Greene MT, Fakih MG, Fowler KE, et al. Regional variation in urinary catheter use and catheterassociated urinary tract infection: results from a national collaborative. Infect Control Hosp Epidemiol. 2014;35 Suppl 3:S99-S106. 28. Birkmeyer NJ, Dimick JB, Share D, et al. Hospital complication rates with bariatric surgery in Michigan. JAMA. 2010;304:435-42. 29. Hughes RE, Zheng H, Igrisan RM, Cowen ME, Markel DC, Hallstrom BR. The Michigan Arthroplasty Registry Collaborative Quality Initiative Experience: Improving the quality of care in Michigan. J Bone Joint Surg Am. 2018;100:e143.

Table 1: Michigan Appropriate Perioperative (MAP) criteria for urinary catheter use, and how they were studied in the MSQC registry. 8

MAP Recommendation Category A Avoid placing indwelling urinary catheter for these procedures: inappropriate to use a catheter or risks outweigh benefits

Category B Consider removing indwelling urinary catheter before leaving the operating room

MSQC procedures studied (CPT codes) Laparoscopic cholecystectomy (47562) Open appendectomy (44950) Laparoscopic appendectomy (44970) without suprapubic port

Ways in which the cohort differs from the original MAP criteria Inclusions: 1. MAP criteria state that routine catheter use is not appropriate for Category A procedures with operative duration of <2 hours, or intraoperative fluid administrative of <2 liters. For this study cases were not excluded based on operative duration or fluid administration. 2. Laparoscopic appendectomy (44970) was specified as “without suprapubic port” in MAP criteria, but port placement is unknown, so all cases included Exclusions: *,† Exclusions: *,†

Open hemicolectomy (44140, 44141, 44144) Open sigmoidectomy (44141, 44143, 44144, 44147) Open ileocecectomy (44160) Laparoscopic hemicolectomy (44204) Laparoscopic sigmoidectomy (44206) Laparoscopic ileocecectomy (44205) Laparoscopic subtotal colectomy (44205, 44210) Category C Laparoscopic low anterior resection (44207, 44208) (§ POD3) Inclusions: Upper one third of rectum is unable to be delineated Catheter use in operating Open abdominoperineal resection (45110) (§ POD2) by CPT code, therefore inclusive CPT code 45111 (proctectomy, room and until at least Laparoscopic abdominoperineal resection (45395, 45397) (§ POD4) partial resection of rectum, transabdominal approach) was POD1 is appropriate, Open total proctocolectomy (44155, 44156, 44157, 44158) (§ included. heterogeneous by POD4) Exclusions: ‡ procedure§ Laparoscopic total proctocolectomy (44212) Open subtotal colectomy (44145, 44146) Open or laparoscopic rectal resection of the upper one third of the rectum (45111) (§ POD1) Abbreviations: CPT (Current Procedural Terminology); MAP (Michigan Appropriate Perioperative); MSQC (Michigan Surgical Quality Collaborative); POD (postoperative day) * Hernias: For two reasons we excluded hernias from this study. 1. The sampling frame of MSQC requires inclusion of ventral hernias and emergency groin 13 hernias, but only includes elective groin hernias and open umbilical hernias if case abstraction numbers are not met for a hospital. 2. CPT code limitations

(inability to identify reducibility of hernias; inability to delineate laparoscopic transabdominal preperitoneal (TAPP) and totally extraperitoneal (TEP) approaches. Category A: Laparoscopic or open reducible umbilical or epigastric hernia repair; Open reducible inguinal or femoral hernia repair; Laparoscopic reducible inguinal or femoral hernia repair by TAPP approach, if bladder emptied before surgery Category B: Laparoscopic reducible inguinal or femoral hernia by TEP approach † Bariatric Procedures: the MSQC does not sample bariatric procedures, therefore the following procedures were excluded from this study: Category A: Laparoscopic adjustable gastric banding Category B: Laparoscopic Roux-en-Y gastric bypass; Laparoscopic sleeve gastrectomy; laparoscopic biliopancreatic diversion with duodenal switch ‡ Did not meet MAP criteria: The MAP expert panel identified open subtotal colectomy (CPT 44150, 44151) as a Category C procedure and recommended POD1 as an appropriate day for catheter removal. However, upon analysis we found these patients to have low rates of baseline functional independence, with high rates of ICU admission after surgery, and therefore not representative of the patient population identified by the MAP panel. § For these procedures the panel was unable to recommend a POD of removal, but agreed upon upper limits of POD of removal, as listed.

Table 2. Characteristics of Patients, Hospitals, and Surgical Cases Category A Procedures*†: perform surgery without urinary catheter use

Open Appendectomy n (%)

Laparoscopic Appendectomy *+ n (%)

389

3807

105 (27.0%) 1 day IQR 1-2

340 (8.9%) 1 day IQR 0-1

<45

187 (48.0)

2434 (63.9)

45 to 64

149 (38.2)

1053 (27.7)

Characteristics

Cases Urinary Catheter Use Median POD removed IQR days of use Age:

65 +

P-value, comparing Open and Laparoscopic Appendectomy

p<0.001

p<0.001

Category B Procedures: Category C Procedures: remove catheter in OR or keep catheter until at least POD 1, with more POD1 guidance for timing of removal by procedure type More complex colorectal cases Open or laparoscopic including laparoscopic low anterior resection colorectal surgery (POD3), open or laparoscopic abdominoperineal Laparoscopic without rectal resection resection (POD2, POD4, respectively), open or Cholecystectomy e.g., Ileocectomy, laparoscopic total proctocolectomy (POD4 open), Hemicolectomy, open subtotal colectomy, resection of upper 1/3 Sigmoidectomy rectum (POD1) 8826 1718 700 276 (3.1%) 1 day IQR 1-2 3829 (43.4)

1624 (94.5%) 1 day IQR 1-2

687 (98.3%) 2 days IQR 1-3

173 (10.1)

75 (10.7)

3245 (36.7)

779 (45.3)

382 (54.6)

1759 (19.9)

766 (44.6)

243 (34.7)

2490 (28.2)

775 (45.1)

323 (46.1)

53 (13.9)

322 (8.5)

Gender: Female

170 (43.6)

1877 (49.3)

Race:

319 (81.8)

3183 (83.6)

7221 (81.8)

1486 (86.5)

614 (87.8)

1068 (12.1)

169 (9.8)

55 (7.9)

544 (6.2)

63 (3.7)

30 (4.3)

White

p=0.03

Black

42 (10.8)

353 (9.3)

Other

29 (7.4)

272 (7.1)

Obese (BMI >30)

133 (34.3)

1343 (36.0)

p=0.51

4781 (54.4)

663 (38.8)

265 (37.9)

ASA Class: 3/4

90 (23.1)

580 (15.2)

p<0.001

2772 (31.4)

838 (48.8)

326 (46.6)

Diabetes

34 (8.7)

240 (6.3)

p=0.07

1318 (14.9)

325 (18.9)

115 (16.4)

8 (2.1)

82 (2.2)

p=0.90

452 (5.1)

133 (7.7)

47 (6.7)

1 (0.3)

0 (0)

p=0.002

26 (0.3)

3 (0.2)

0 (0)

17 (4.4)

131 (3.4)

p=0.35

730 (8.3)

208 (12.1)

60 (8.6)

69 (17.7)

815 (21.4)

p=0.09

1714 (19.6)

519 (30.4)

232 (33.3)

Academic Hospital

59 (15.1)

613 (16.1)

p=0.62

1349 (15.4)

347 (20.4)

168 (24.1)

Surgical Priority: Elective

51 (13.1)

250 (6.6)

p<0.001

5217 (59.1)

1718 (100.0)

700 (100.0)

Chronic Obstructive Pulmonary Disease Congestive Heart Failure Coronary Artery Disease Hospital size >=500 beds

p=0.26

Urgent/Emergent Functionally Independent Blood Transfusion Intraoperative fluid administration >2L Operative duration >2 hours

0 (0)

0 (0)

8621 (97.6)

1682 (97.9)

689 (98.4)

p=0.75

9 (0.1)

29 (1.7)

11 (1.6)

202 (5.3)

p<0.001

530 (6.0)

1053 (61.3)

537 (76.7)

46 (1.2)

p<0.001

371 (4.2)

957 (55.7)

556 (79.4)

339 (86.9)

3559 (93.4)

3616 (40.9)

381 (97.7)

3769 (99.0)

p=0.04

0 (0)

1 (0.03)

63 (16.2) 41 (10.5)

Abbreviations: OR (operating room), POD (postoperative day), IQR (interquartile range), BMI (body mass index), ASA (American Society of Anesthesiologists) *The MAP Criteria assessed open appendectomy and laparoscopic appendectomy without use of suprapubic port as Category A procedures, in which avoiding urinary catheter use was recommended for routine procedures, in which intraoperative time <=2 hours, with <= 2 liters of intravenous fluids, when patients have no other medical indication for urinary catheter use. Experts generating the MAP criteria ratings were unable to provide recommendations for procedures that involved a suprapubic port, given large variation in practice. †The available MSQC data did not include data on whether a suprapubic port was used for the laparoscopic appendectomies, so all laparoscopic appendectomies are included in this table, without respect to type of ports used.

Table 3: Results of the bivariate and multivariable logistic regression model using patient and procedure factors to risk adjust catheter use and linear regression model to predict postoperative day (POD) of catheter removal, by Michigan Appropriateness Perioperative (MAP) Criteria categories. NS – not significant (p>0.05). ASA – American Society of Anesthesiologists. Catheter Use

POD of Catheter Removal Mul+variable‡ Odds 95% CI Ratio 1.01 1.01-1.02 2.67 2.2-3.2 0.75 0.62-0.99 NS 3.23 2.21-4.71 1.88 1.54-2.30 NS NS 0.79 0.62-0.99 0.78 0.66-0.91 3.3 2.63-4.17 3.06 2.43-4.02 NS

Category A Risk Factor

Bivariate† Coefficient 95% CI

Multivariable§ Coefficient 95% CI

Age Urgent/Emergent Non-Academic Hospital Hospital Size <500 beds Functional Dependence ASA 3/4 COPD CAD Diabetes Female Total fluid ≥2L Operative duration ≥2 hours BMI (continuous)

Bivariate* Odds 95% CI Ratio 1.02 1.02-1.03 2.75 2.30-3.29 0.58 0.49-0.70 0.75 0.63-0.89 6.71 4.79-9.40 2.43 2.08-2.93 1.58 1.16-2.17 2.1 1.66-2.65 1.35 1.09-1.66 0.62 0.53-0.72 4.38 3.59-5.35 5.47 4.32-6.92 0.99 0.98-1.00

Age (per year) COPD CAD Functional Dependence Diabetes ASA 3/4 Total fluid ≥2L Operative duration ≥2 hours

0.03 1.88 1.54 2.04 0.94 1.07 0.13 0.17

0.01 1.43 0.73 1.48 NS NS NS NS

Category B Non-academic hospital Functional Dependence Total fluid ≥2L Operative duration ≥2 hours

0.57 0.40 1.79 1.85

Bivariate* 0.31-1.06 0.14-1.16 1.17-2.72 1.21-2.84

Mul+variable‡ NS NS 1.56 1.01-2.45 1.62 1.03-2.53

Category B Age Hospital Size <500 beds Diabetes ASA 3/4 Total fluid ≥2L Operative duration ≥2 hours

0.011 0.12 0.22 0.108 0.03 0.031

Bivariate† 0.0065-0.015 -0.02-0.26 0.058-0.38 -0.02-0.24 0.009-0.052 0.01-0.053

0.012 NS NS NS NS 0.19

0.0099 0.26 0.92 -0.17

Bivariate† 0.0013-0.019 0.18-0.34 0.059-1.78 -0.24-0.09

Multivariable§ 0.013 0.005-0.022 0.28 0.20-0.36 0.99 0.15-1.84 NS

Category A Risk Factor

Category C Obese (categorical)

6.8

Bivariate* 0.87 - 53.23

Mul+variable‡ NS

Category C Age Operative duration (per hour) Functional Dependence Blood Transfusion

0.02-0.04 1.22-2.53 1.05-2.03 1.34-2.74 0.53-1.40 0.77-1.38 0.12-0.15 0.15-0.19

0.00-0.02 0.80-2.07 0.21-1.24 0.80-2.17

Multivariable§ 0.006-0.017

0.05-0.32

*Bivariate regression was performed using all covariates for each category to identify associations with catheter use; reported results have p<0.1 and were included in the multivariable model

†Bivariate regression was performed using all covariates to iden+fy associa+ons with POD of catheter removal; reported results have p<0.1 and were included in the multivariable model ‡Mul+variable logis+c regression was performed using the covariates iden+fied using bivariate regression to iden+fy associations with catheter use; reported results have p<0.05 §Multivariable linear regression was performed using the covariates identified using bivariate regression to identify associations with POD of catheter removal; reported results have p<0.05

Funding: This work was supported by AHRQ T32HS000053 and the National Clinician Scholars Program (ADR). Dr. Meddings’s research was supported by an AHRQ grant K08HS019767 from 2010-2015 and is currently supported by AHRQ grants P30HS024385 and R01HS018334 as well as funding from the VA National Center for Patient Safety and the Centers for Disease Prevention and Control. Dr. Meddings’s research has recently been supported by contracts with the Health Research & Education Trust (HRET) involving the prevention of CAUTI, funded by AHRQ and the Centers for Disease Prevention and Control, and the Centers for Medicare and Medicaid Services. Dr. Meddings was also a recipient of the 2009– 2015 National Institutes of Health (NIH) Clinical Loan Repayment Program. Dr. Meddings is a salaried employee of the University of Michigan and the VA Ann Arbor Healthcare System.

Potential Conflicts of Interest: Honoraria: Dr. Meddings has reported receiving honoraria from hospitals and professional societies devoted to complication prevention for lectures and teaching related to prevention and value-based purchasing policies involving catheter-associated urinary tract infection and hospital-acquired pressure ulcers.

Intellectual Property/Product Development: The research of Dr. Meddings involves the development of products to improve patient safety by reducing hospital-acquired complications. Dr. Meddings has an issued patent on one product that aims to reduce urinary catheter associated complications. Dr. Meddings and Ms. Ameling recently applied for a patent involving a device to reduce hospital-acquired pressure ulcers.