Reaching One Peripheral Intravenous Catheter (PIVC) Per Patient Visit With Lean Multimodal Strategy: the PIV5Rights^™ Bundle

Learning Outcome

By applying Lean leadership, infusion therapy practices were transformed with the PIV5Rights Bundle resulting in approval for increased vascular access specialty team (VAST) headcount, providing patients with fewer peripheral intravenous catheter (PIVC) attempts, longer safe PIVC dwell time, greater patient satisfaction, while lowering complications and hospital costs associated with intravenous (IV) therapy.

Introduction

In published clinical evidence, PIVC failure rates and complication incidence are as high as 53%, with approximately 1 out of every 2 catheters failing to make it to 5 days or to the end of treatment.¹² Peripheral catheter sales per year exceed the estimated number of people in the United States (US), 350 million.³ With only 37 million US hospital patient admissions per year, these data indicate an average usage of 9.4 PIVCs per patient admission, suggesting a very high failure and very low success rate for PIVCs.⁴ Up to 90% of PIVCs are prematurely removed prior to planned replacement or before therapy completion owing to failure of the catheter.⁵⁶ Clinicians may make several attempts to insert a PIVC successfully, with each attempt involving a needle puncture of the skin to cannulate the desired vessel, increasing the risk of complications to the patient. Improvement has been associated with the use of specialty teams, visualization technology such as ultrasound and safety associated with extending dwell time of PIVCs to removal only when clinically indicated.⁷⁸

The use of a team approach for inserting PIVCs has increased first-time insertion success⁹ and decreased device-related complications.⁹¹⁰ This VAST centralized model for PIVC insertion and maintenance compares to the generalist nursing decentralized model for insertion and care of PIVCs. Higher levels of inserter confidence built upon training, experience, and procedural competence suggest a team approach has positive insertion outcomes for patients.^11–13 While some VAST models focus on PIVC insertion only, others include follow-up care, which can include clinical tasks such as dressing assessment and evaluation for catheter removal or replacement. Even in the scope of “insertion only,” teams have reported better outcomes for first-time insertion success.¹⁴ Reducing the number of failed needle insertions is a useful infection prevention strategy,¹⁵¹⁶ and one that can reduce patient stress, length of hospital stay, and cost to the health care system.¹⁷

Background

Hartford Hospital (Hartford, CT), an 867 bed, Level 1 trauma center, documented approximately 105,000 patients who entered the emergency department (ED) in 2017. Inspired by the Chief Executive Officer's vision of 1 registration, 1 bill, 1 medical record, 1 standard of care, the VAST proposed the study of 1 patient, 1 IV catheter insertion with 1 attempt using the principles of Lean and Six Sigma methodology.

Evidence demonstrates waste and inconsistency with the insertion and management of PIVC therapy.¹⁸ Peripheral intravenous catheter failures cost the US health care system millions of dollars each year in waste, redundancy, and inefficiency, leading to repeated PIVC attempts, wasted time from nurses, wasted PIVC supplies, and overall system inefficiency.¹⁸ Additionally, multiple replacements of PIVCs not only lead to patient distress and pain, but also results in delayed treatment, increased nursing and medical workload, raised hospital costs with multiple attempts, and increased risk for infection, vein injury, and other preventable PIVC complications.^19–21 Peripheral intravenous catheter failure due to complications of occlusion, phlebitis, infection, infiltration, and accidental dislodgment can be prevented with education, improved management, Anti-Reflux needleless connector (NC) technology, improved insertion techniques, and consistent disinfecting practices.

To demonstrate the goal of how 1 PIVC per patient could be achieved through a VAST, a study was initiated with a simple aim—to extend PIVC dwell time using a bundled approach that addressed common reasons for PIVC failure (infiltration, phlebitis, occlusion, infection, and accidental dislodgment). The standard model at Hartford Hospital had involved consulting a specialized IV team to handle patients with difficult IV access to place a peripherally inserted central catheter (PICC). Rather than progress to a PICC and central catheter placement, the VAST added ultrasound PIVC training and placement as part of the team responsibilities. The VAST yielded such high success that the need for PICCs was reduced by more than 30%.²²

Following hospital administrative support for the study and application of a Six Sigma process of define, measure, analyze, improve, control, 5 areas of opportunity emerged: PIVC proficiency, insertion, vein and catheter, technology, and assessment. Training for ultrasound-guided (USG) insertion, application of evidence for site selection, method of insertion, use of supplies with a PIVC insertion kit, longer catheter with optimized gauge, chlorhexidine (CHX) antimicrobial bordered securement dressing, along with implementation of a more efficient anti-reflux NC were all components selectively integrated into the methods that became the right approach for Lean PIV-5Rights Bundle.

Methods and Data Analysis

This single-center intent-to-treat, 2 group comparators of a multivariate intervention, current state (control arm = Group 1) versus VAST PIV5Rights^™ (experimental arm = Group 2) study was conducted in a preselected 47 bed medical unit from November 2016 through February 2018. This prospective comparator multimodal design study had the aim to define the best approach for improving PIVC dwell time and outcomes while reducing failure rates (infiltration, occlusion, phlebitis, infection, and accidental dislodgment). The study was performed at Hartford Hospital in Hartford, CT. Hartford Healthcare Institutional Review Board approval was received (HHC-2017-0001) for the study and a statistician/senior scientist assigned to monitor and assist with the study. Inclusion criteria consisted of adult (≥18 years old) consented patients admitted to 1 medical surgical unit in the hospital, requiring a PIVC. Group 1 consisted of catheters placed by the generalist nurse; Group 2 consisted of catheters placed by VAST using the PIV5Rights (Table 1).

Table 1 LEAN PIV5Rights

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The Lean technique used in this study followed Six Sigma steps to define, measure, analyze, improve, and control work processes in the clinical setting. Lean is a method taken from Lean manufacturing that relies on a collaborative team effort to improve performance by systematically removing variation of practice while also pinpointing areas of waste, leading to greater efficiency and cost reduction.²³²⁴ The situational analysis program of this study worked through process, protocol, practice, products, and patient with literature review to collect data from current practice to compare with study results. Through this integrated approach, problems were identified and a bundle created for the study to address and eliminate inefficiencies.

This process followed the following steps:

1. The first step of the PIV5Rights clearly defined the goal of 1 PIVC per patient visit.

2. The second step measured and determined catheter consumption at the hospital each year. Due to a lack of consistent or measurable PIVC usage in the Epic Systems Corporation (Epic, Verona, WI) electronic medical record, PIVC inpatient consumption was collected from annualized supply chain purchasing records.

3. The third step analyzed and compared the total Hartford Hospital patient admissions.

   1. The number of inpatient PIVCs purchased annually was divided by the number of patient admissions which provided the total and average PIVC per patient admission. This number was further tied to the Hartford Hospital average length of stay.

   2. Analysis of the published evidence produced a PIVC insertion algorithm which included a 10 step PIVC insertion process creating standard work time interval.

   3. Nursing labor costs were calculated based on standard work and average registered nurse (RN) salary for bedside versus VAST RN per 20 minute PIVC insertion.

   4. The calculation of PIVC supplies used with each insertion established a cost basis for Group 1 of average usage supplies and Group 2 with standard work supplies of IV start kit, skin disinfection, catheter, NC, transparent dressing, change of tubing when applicable, and ultrasound as needed. Ultrasound cost was not included.

   5. The annual PIVC consumption data multiplied by the cost per PIVC placement established the per PIVC insertion economic impact to the hospital.

4. The improve step involved the VAST implementing the PIV5Rights^™ approach (represented in Table 1, Figures 1 and 2).

   1. Right proficiency (competency of the inserter).

   2. Right insertion with the option of using ultrasound (VAST standardized method).

   3. Right vein and catheter (selection, vein, and catheter based on evidence).

   4. Right supplies and technologies: IV start kit, chlorhexidine gluconate/alcohol prep (Becton Dickinson, Chloraprep^™), 22g 1.75″ catheter (BBraun, Introcan^™ Safety), Anti-Reflux needleless connector (Nexus, TKO^™), CHX antimicrobial bordered securement dressing (entrotech life sciences, PrevahexCHX^™).

   5. Daily assessment, every 12–24 hours, of the insertion site with photo accountability.

5. The control process with standard work was established with a centralized VAST 1 PIVC per patient visit for all patients.

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For Group 2, the trained IV nurse assessed the veins, placed the PIVC using an USG vein visualization technology when needed based on vein depth and judgment of the nurse. The skills of these IV nurses were compared to Group 1 ED nurses who place PIVCs but were not trained as IV nurses and did not use vein visualization technology. Vein and catheter selection for Group 2 followed the Infusion Nurses Society Standards for avoidance of areas of flexion, preference of forearm, and assessment of vein size to catheter size. Site location preference was the forearm cephalic with corresponding catheter using a 22 gauge (0.711 mm outer diameter) and 1.75″ (3.8 cm) length. For Group 2, supplies of PIVC sterile start kits were used to standardize the procedure with consistent skin disinfection of alcohol chlorhexidine gluconate (CHG) and CHX antimicrobial bordered securement dressing. An Anti-Reflux NC was used in Group 2 as opposed to the neutral NC in Group 1. Vein selection and supplies used in Group 1 were variable, as was consistent with their current standard practice.

Postplacement PIVCs were managed in Group 2 with routine disinfection of the hub prior to IV access, consistent administration of saline flush, dressing changes every 7 days or as clinically indicated, and site assessment once or twice daily. A 3 mL push, pause saline flush was performed by the study nurse daily for Group 2 to check for patency and PIVC functionality. To ensure compliance, the bar code of the saline flush was scanned into the iPad app data field. Prior to all IV access and including flushing, the hub was disinfected with an alcohol wipe and capped with a passive alcohol impregnated port protector to monitor for compliance.

Assessment data collection by the study team nurses was performed using a validated collection tool integrated into a visual Cloud-based iPad (Apple, Inc. Cupertino, CA) Command app (Commandapp.com; Overland Park, KS) with photo documentation included in every assessment, consistent with the study requirements and parameters for assessment. The nurses evaluated and photographed the PIVC site with each assessment and followed a checklist assessing for complications, device discontinuation, or catheter failure. Documentation of 21 assessment inputs related to the patient's PIVC condition (i.e., phlebitis scale, redness scale, pain) were collected by a study team nurse over a brief (<5 minute) daily engagement. Data collected by study team nurses on dwell time, complications, and satisfaction were documented at least once per day using an iPad app that automatically uploaded the data to a HIPAA-compliant Cloud server.

The study was powered at 85% to detect a difference in mean dwell time of 1.5 days (6 versus 4.5). To achieve this power, the study sought to enroll 211 catheters, including a 5% anticipated attrition rate for postenrollment exclusions. All statistical analyses were conducted with SPSS version 21 (IBM, Armonk, NY) with an a priori α level of 0.05. Student's t test or Mann-Whitney U test was used to evaluate differences in continuous variables between groups. Spearman's ρ was used to evaluate the correlation with success rates.

Economic evaluation was performed by extracting consumption data for only the catheters used in inpatient units. Savings were then projected evaluating the subset of inpatient supplies. Therefore, this analysis excluded catheter consumption of all outpatient and EDs. The 10 step process was defined for insertion of a peripheral IV device, and supplies used in conjunction with the insertion were evaluated for cost. Time calculations were extracted from combined validation of time studies used at Hartford Hospital and published evidence of average insertion time for nursing time.²⁵ Labor costs were obtained from an employment human resource national database (Glassdoor).

Results

The study enrolled 125 patients with total catheter placements meeting inclusion criteria of 114. Within the 114 patients, 207 catheters were allocated to each group, 94 (45.4%) to Group 1 and 113 (54.6%) to Group 2 (Tables 2–4). Baseline demographics are represented in Table 2, demonstrating 54% male and 46% female with concentrated age grouping between 41 and 90. Each PIVC was evaluated as a separate event with 89% of Group 2 and 15% of Group 1 catheters reaching end of treatment. Patients transferred to another unit or who required a central catheter were ultimately excluded from the study (n = 11).

Table 2 Demographics With Vancomycin

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Table 3 PIV Insertion Location

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Table 4 Complication Results

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Location of insertion is represented in Table 3 with forearm used in 91% of Group 2 patients as part of the focus of the designated PIV5Rights; in Group 1, the forearm was used in only 34% of patients. Group 1 positioned 66% of PIVCs in areas of flexion/joints (Table 6), none in the upper arm, whereas the clinicians in Group 2 inserted 9% in areas other than the forearm (Table 7), with only 2% positioned in radial or other potential flexion areas.

Mean dwell time (±SD) for Group 2 (n = 113) was 71.4 ± 58.8 hours, with an upper level of 333.2 hours (13.88 days) versus Group 1 (n = 94) at 29.6 ± 18.0 hours with an upper level of 111.0 hours (4.6 days). The difference between Group 2 and Group 1 was statistically significant for dwell time (P < 0.001), noted in Table 5 with an overall average daily increase in Group 2 of 66.7% longer dwell of the catheters than Group 1, more than twice as long.

Table 5 Summary of Results for Dwell Time, Complications, and Cost

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Peripheral intravenous catheters lasting until therapy completion in Group 1 was 15% (n = 14 of 94) and in Group 2 was 89% (n = 101 of 113) 1 PIVC per patient visit, representing a statistically significant difference (P < 0.001; Table 4). Within Group 2, 89% (n = 101) of the 1 PIVC per patient admission demonstrated reduction of complications with 0% occlusions, 43% decrease in PIVC infiltrations, 61% decrease in PIVC phlebitis, 77% decrease in pain reported by patients. Reasons for catheter discontinuation included patient pain or complaints in Group 1 of 29% (n = 27) and 0% (n = 0) in Group 2; complications identified of a symptomatic site with Group 1 of 16% (n = 15) and Group 2 0% (n = 0); all other reasons for catheter removal with total catheter failure were statistically significant. Total catheter failure/removal in Group 1 of 85% (n = 80) and 11% (n = 12) in Group 2.

Specific catheter removals with individual complications of accidental dislodgment, catheter occlusion, infiltration, phlebitis, pain, and infection from Group 1 to Group 2 did not represent statistically significant differences; however, overall complication rate differences of 40% for Group 1 and 11% for Group 2 were statistically significant as noted in Table 5. The calculation of extended dwell time and reduced complication rate represented an economic difference of Group 1 generalist nurse cost per bed of $4781 versus $1405 cost per bed in Group 2 VAST.

Economic results for the total retrospective catheter consumption at Hartford Hospital, obtained from materials management review of purchasing records, was 247,000 PIVCs for all departments per year and 148,200 PIVCs used specifically with hospital patient admissions. The resultant average of 4.4 PIVCs per patient admission was calculated retrospective to the study, based on hospital PIVC insertion practices. The analysis of published evidence produced a PIVC insertion algorithm which included a 10 step PIVC insertion process created a work time interval of 20 minutes.^26–29 A calculated hourly nursing labor cost (group 1) of $16.17 (RN $48.50/hour) per 20 minute PIVC insertion was applied to Hartford Hospital nursing activities from projected nursing minutes for admitted patients during insertion of 2,964,000 or 49,400 hours (national average salary for this job title is $69,270).³⁰ Peripheral intravenous catheter supply costs of $11.80 for each PIVC insertion was formulated from the supply items generally used with each insertion in Group 1. Labor and supply costs for Group 1 for peripheral catheter placement were calculated by adding labor cost of $16.17 plus supply cost of $11.80 for a total PIVC insertion cost of $27.97. By multiplying the number of PIVCs consumed (148,200 catheters purchased) each year by the insertion cost of $27.97 equals the total baseline PIVC cost of $4.1 million for Hartford Hospital per year or $4781 per bed per year (divided by 867 beds; Table 8).

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This application of the multimodal best practice intervention bundle strategy named the PIV5Rights within Group 2 resulted in an 80% decrease in PIVC consumption (36,835 versus 148,200) from the baseline annual consumption. For Group 2, the first-time success of 96% and 1.1 PIVC per patient had a reduction of nursing time for hospitalized patients of 736,700, saving 37,122 hours in comparison to Group 1. The calculated hourly nursing labor cost was higher in Group 2 at $18.68 (VAST RN $56.01/hour) representing a 14% increase. Group 2 also had higher supply costs of $14.40 representing a 19% increase associated with the addition of standard work supplies using IV start kit, NC, IV tubing, and CHX antimicrobial bordered securement dressing (Figure 2). Labor and supply costs for Group 2 for PIVC placement cost was calculated by adding labor cost $18.68 plus supply cost $14.40 for a total PIVC insertion cost of $33.08. Calculation for admissions of 33,486, multiplied by 1.1 success rate to equal 36,835 catheters used, will demonstrate a cost basis for the 36,835 usage, multiplied by the insertion $33.08, for a total of $1.2 million. The decentralized Group 1 method of placement and management of PIVCs cost was $4781 per bed per year versus the VAST Group 2 at $1405, a 71% reduction in cost (Tables 8 and 9). The cost reduction per bed for house-wide implementation reflected a reduction of $3376 per bed per year and projected $2.9 million in annual savings.

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Discussion

The number one concern of patients is pain associated with how many times they will be stuck with a needle. Reducing the number of IV attempts and extending the functionality of a PIVC without complications are keys to reducing waste, improving efficiency, and increasing patient satisfaction of services. Recognizing that IV access is pivotal to the administration and delivery of treatment in acute care, efforts to evaluate, optimize, and successfully extend the dwell time of peripheral catheters should be considered by leadership as a strategy for hospital cost reduction options. The Lean and Six Sigma approach applied in this study was successful in addressing these issues with significant gains in reducing catheter failure and waste through the application of a bundle of evidence-based practices designed to improve efficiency, test the specialist model, and achieve safety with reduction of complications. The PIV5Rights approach resulted in a cost savings much higher than ever anticipated.

Ideally, hospitals would construct strategies to replicate this approach to achieve 1 PIVC per patient visit. Bundles of practices have been popular in the literature since the success of the Pronovost work in 2006 within Michigan intensive care units in application of the central line bundle.³¹ Application of the PIV5Rights Bundle results were not only tracked according to patient data collection, but also through materials and supply acquisition. The extended dwell of 89% versus 15% for Group 2 versus Group 1 represented a sevenfold improvement in IV management and an 80% reduction in catheters purchased/used. This level of improvement was attributed to the intentional applications of a specific bundle of practices. Combining previously studied practices into a bundle of best practices, clinicians are educated in standard work and trained to perform procedures consistently with measurable compliance. While this study was focused on peripheral catheter applications, the sheer volume of PIVC insertions makes these devices a pertinent area of study.

The goal of the PIV5Rights was to evaluate available evidence to establish a method and bundle to achieve the ideal of 1 PIVC per patient visit. As part of the Lean approach to continuous improvement, an evidence-based product bundle was selected. Each component of the PIV5Rights Bundle approach incorporated individual recommendations into a set of best practices, supported by research, systematic reviews, and recommendations that resulted in higher PIVC insertion success, longer dwell time without complications, reduced use of supplies and greater patient safety from improved outcomes (Fig. 2).

Limitations

Data analysis and direct comparison of number of attempts between the 2 groups was impaired due to the differing electronic medical record software and incomplete insertion documentation in the ED versus the medical/surgical areas. Cost analyses were based on material management supply costs, collected retrospectively and prospectively, based on annual consumption and other economic data calculations represented in the references noted within the figures.

Conclusions

By applying Lean leadership, infusion therapy practices were transformed with a PIV5Rights Bundle, resulting in fewer PIVC attempts, improved PIVC dwell time, greater patient satisfaction, while lowering complications and hospital costs associated with IV therapy. Hartford Hospital applied a PIV-5Rights methodology to infusion therapy and projected a $2.9 million annual savings or $3376 per bed per year. The savings were reported to administration as a justification for growing the VAST services. Dollars were attributed to an improvement in efficiency to the level of 89% success in achieving 1 PIVC per patient visit. Failure of IV access is all too common, resulting in multiple attempts, patient pain, and excessive use of supplies. Evidence demonstrates that it takes the right approach to achieve the right result when you set a goal to transform infusion therapy practices to 1 PIVC per patient visit, while also reducing cost.