A rural hospital in the mid-Atlantic region of the United States merged with a larger hospital system, resulting in peripheral intravenous catheter (PIVC) standardization. Previously, the hospital was using a closed-system PIVC, which is an integrated catheter (ie, intravenous catheter and extension tubing are assembled as 1 piece), while the new product was an open-system PIVC, which is a nonintegrated catheter (ie, the intravenous catheter and extension tubing are separate components requiring assembly).1 After product conversion from a closed to an open PIVC system, the Quality and Patient Safety Department immediately began receiving clinician reports of PIVC complications and patient complaints. Complications and complaints were related to safety issues such as blood leakage and multiple reinsertions and quality issues such as reports of increased patient pain during insertion. The increase in PIVC complications and patient complaints warranted an in-depth analysis.
PIVCs are inserted in approximately one-third of patients admitted to hospitals.2 These devices are widely used and are essential in the care of today's hospitalized patients to ensure timely and successful intravenous therapy.3 Therefore, it is important that hospitals carefully consider the selection of PIVCs that minimize adverse clinical and economic implications for hospitals and their patients.3–5 Literature suggests that using a closed-system PIVC can be more beneficial than an open-system PIVC.4,5 González-López and colleagues5 showed that closed systems increase PIVC dwell time, which translates to fewer PIVC reinsertions, reduction in patient pain, and decreased costs. Although extended PIVC dwell times have been associated with risks for complications, the Infusion Nurses Society (INS) has shifted practice standards to support rotating PIVC when clinically indicated in the absence of complications.3,6
Alongside the revised recommendations by the INS, 2 studies evaluated the use of PIVC stabilization devices to reduce PIVC complications, while increasing dwell time.4,7 Both studies indicated that a closed-system PIVC with a built-in stabilization platform was superior to an open-system PIVC in terms of dwell time. The evidence provided by Bausone-Gazda and colleagues4 was used to inform the 2011 and 2016 INS Standards of Practice for PIVC stabilization.6,8
Quality and safety considerations
Inserting PIVCs jeopardizes the safety of clinicians, placing them at risk for exposure to blood and other transmittable pathogens, such as hepatitis B, hepatitis C, and human immunodeficiency virus, through needle stick injury and blood leakage on insertion.9 Yet, in the United States, underreporting blood exposures can be as high as 82%.10 PIVC failure, an unplanned catheter removal, due to dislodgement, occlusion, phlebitis, and infection, poses another safety and quality concern.4 PIVC failure rates and unscheduled reinsertions have been shown to range from 33% to 69% and lead to lowered patient product satisfaction due to PIVC failure.11
Providing high-quality patient care while maintaining cost-effectiveness is a balancing act, and hospitals today are challenged with growing emphasis on patient safety, satisfaction, and the need to contain cost, while minimizing waste and inefficiencies.12 Therefore, the selection criteria for PIVCs must be multifaceted and include consideration of device engineering as recommended by the Centers for Disease Control and Prevention (CDC)13 and INS8 guidelines, including use of stabilization devices and eliminating elective site changes when clinically appropriate.14 With these new guidelines, selecting the best PIVC product for a health care system can prove to be challenging due to the cost of the supplies. Secondary to labor costs, supply costs account for the largest expense for hospitals and dictate the standardization of supplies across health care systems.15 Product standardization and bundled education are current strategies to reduce waste, control supply costs, and improve buying power.3,16 A concern with standardization to reduce costs, however, is the consideration of the relationship cost has to quality measures, such as complications and satisfaction.
Our literature review showed evidence that closed systems had increased dwell time.5 However, there is a gap in the literature evaluating open versus closed PIVC systems. The purpose of the current project was to ascertain whether open or closed PIVCs are best for patients, staff, and the health care system. As a result, the 3 main aims of this project were to evaluate and compare the quality (aim 1), safety (aim 2), and cost (aim 3) of 1 open and 2 closed-system PIVCs available in our organization.
Within 7 months of product standardization to an open-system PIVC, the Quality and Patient Safety Department received a total of 551 staff event reports and 102 patient comment cards. The number of comment cards was unprecedented, as historically no single issue or product conversion had generated this volume of patient complaints. Department staff and nurses in the hospital that had recently merged (hospital A) decided that the complaints warranted specific attention, and a project was designed to gain further insight and to generate possible solutions. A second hospital site (hospital B), familiar with the open-system PIVC product, was invited to participate in the project. Hospital A was a 238-bed rural facility, whereas hospital B was a 224-bed urban facility, and both were Magnet-designated by the American Nurses Credentialing Center.17
Study of the intervention
Eligible clinicians from each of the participating units were identified by their manager. Those clinicians who worked a minimum of 20 hours per week were invited to participate as PIVC insertion clinicians. Thirty-two clinicians were educated at both facilities. Insertion education included bias training, how to report adverse events, consent process, inclusion/exclusion criteria, data collection instruments, and a successful return demonstration on PIVC insertion.
A prospective, 2-site randomized controlled trial (RCT) was used to compare outcomes. Patients in the emergency department, inpatient units, and outpatient treatment centers from hospitals A and B were invited to participate in the project during weekday hours of 8:00 AM to 4:30 PM, when a trained consenting clinician was available to review the consent form with them. Patient eligibility criteria included being at least 18 years or older, ability to read and write in English, and have an available site for PIVC insertion that was not in an area of flexion or in an area of skin affected by other lesions or tattoos. Patients receiving outpatient surgical treatment were excluded, as well as those who were experiencing an emergency situation, who were pregnant, or who could not provide consent themselves. Once a patient consented to participate, the randomization procedure involved rolling a die to determine which PIVC to use. A total of 292 patients were enrolled, with 290 patients participating in the project. Five patients were not included in the analysis because of PIVC placement in an area of flexion.
Approval involving human subjects was obtained from the 2 institutional review boards (IRBs) governing the project sites. Both the patient and clinician informed consent forms were reviewed and approved by the 2 IRBs. Continuing review permission was granted at 1 year post–initial approval at hospitals A and B.
The 3 PIVCs being compared exhibited different features but were all produced and supplied by the same company. PIVC A (n = 74) was a power-rated, open-system PIVC (ie, has no blood control feature and no integrated extension tubing) without an integrated stabilization device requiring add-on power-rated extension set. PIVC B (n = 104) was a first-generation, closed-system PIVC (ie, designed to prevent blood leaking out during or after insertion) that included an integrated extension set. PIVC C (n = 107) was a second-generation, power-rated, closed-system PIVC with a built-in stabilization device and integrated extension set. All 3 PIVC types required the addition of a needless connector for ease of use between intermittent medication administrations. Each PIVC was inserted by a trained clinician, secured in place, and covered with a transparent dressing.
A clinician questionnaire was created to capture data about the nurses' PIVC insertion experience. Three nurse experts in quality improvement and research worked together to develop the questionnaire. Characteristics of the insertion experience were asked (eg, how many insertion attempts for success and whether blood leaked out of the PIVC during or after insertion). PIVC type, extension set and needless connector used during the insertion experience, and the quantity were also tracked on the questionnaire. The questionnaire prompted the clinician to ask and document the patient's pain rating (0 = no pain to 10 = severe pain) for the pain during PIVC insertion. The second section of the questionnaire included 10 items, with Likert-type response options from 1 (disagree) to 5 (agree). The items were statements about the insertion experience such as the flashback visualization was effective in assisting with insertion and the PIVC threads easily without kinking or bending. Items were created following model PIVC evaluation tools from the CDC18 and the Emergency Care Research Institute.19 Responses to each of the 10 items were summed and averaged for a clinician satisfaction score. The internal consistency of this scale was strong (Cronbach α = 0.85). The clinician questionnaire concluded with an open-ended area for the inserting clinician to provide additional comments.
To capture the patient perspective, a patient questionnaire was administered to each patient after the PIVC was removed. The questionnaire asked what was the average pain rating during the PIVC's dwell time (0 = no pain to 10 = severe pain) and what was the patient's satisfaction level (0 = extremely dissatisfied to 10 = extremely satisfied). The patient questionnaire concluded with an open-ended area for the patient to provide additional comments.
Data collected from the electronic health record (EHR) for each PIVC included the insertion and removal date and time, insertion location, and the reasons for removal. Clinicians could select from a drop-down menu for removal reasons that included infiltration and grade, phlebitis, site rotation, no longer needed, not present, not working, patient request, and other. If no removal reason was selected, then the date and time for PIVC removal were the patient's discharge from the hospital, and the discharge date and time were used for validation.
Cost measures included total PIVC insertion cost reflected by the combined cost of the PIVC, the needleless connector, a non–pressure-rated extension set, or a pressure-rated extension set (dependent on the type of PIVC used). The PIVC start kit cost was added according to whether the PIVC was an open or closed system—the start kit for the open-system PIVC was slightly more costly because it included a surgical towel for possible blood leakage during insertion. A reinsertion cost was also added for any patient with a PIVC who had an early or unplanned removal documented in the removal reason field in the EHR. The total cost was generated by summing the insertion cost with the cost of reinsertion. No indirect costs, such as clinician time or laundry services related to blood leakage cleanup, were calculated.
Completeness and accuracy of data
Paper questionnaires were labeled with a de-identified participant ID code for tracking purposes and collected in a centralized locked box on each unit. The primary investigators (PIs) at hospitals A and B collected clinician and patient questionnaires routinely and entered information into an Excel file managed by and accessible only to the PIs. The PIs were responsible for reviewing enrolled patient consent forms and their questionnaires weekly to identify missing data. If missing data were identified within 7 days of the PIVC removal, attempts were made to contact the patients and obtain missing data points. If attempt was not successful, missing data were coded accordingly.
Upon entry of abstracted EHR, clinician, and patient questionnaire data into an Excel spreadsheet, data were verified and coded according to the measurement plan. One researcher entered data into the spreadsheet, and a second researcher reviewed all entries against the paper documentation, checking for accuracy of the entry. Data were analyzed using Statistical Package for the Social Sciences, version 24 (IBM SPSS Statistics for Windows; IBM Corp, Armonk, New York). Descriptive statistics were used to describe the PIVC differences, check the distribution of continuous data points, clinician responses, and patient responses. The Pearson χ2 statistic was used to compare categorical data between the 3 PIVCs. Analysis of variance (ANOVA) (or Kruskall-Wallis H test for nonparametric data) was used to compare the clinician satisfaction scores, patient pain ratings, and patient satisfactions scores between the 3 PIVCs. The significance level was set at <.05. Qualitative comments from the clinician and patient questionnaires were entered into a “wordle” clustering program20 to identify frequently repeated words, and a content analysis was performed and validated by 2 independent nurse researchers.
Of the 285 patients in the project, 187 came from hospital A and 98 came from hospital B. The final sample was mostly female (56.8%), with an average age of 61.9 (SD = 17.59) years. PIVC A was placed in 74 patients (25.9%), PIVC B in 104 patients (36.5%), and PIVC C in 107 patients (37.5%). Patient questionnaires were completed by 117 patients (40.7%). Two hundred eighty-five clinician satisfaction questionnaires were completed, and of them, 40 questionnaires (14%) were missing the flashback visualization rating item.
Aim 1: Quality outcomes
Median dwell time for the PIVCs was between 24 to 29 hours and did not vary significantly by PIVC (H = 1.95, P = .38). Dwell time can influence the risk for PIVC complications, such as infiltration and extravasation.8 The PIVC complication rate was very low overall (12.5%), and there were no significant differences in complication rates between PIVCs. PIVC B had the fewest complications (n = 11; 10.6%), whereas PIVC C had the most complications (n = 16; 15%). Phlebitis occurred only twice, both times in PIVC A. Infiltration and occlusion were the most common complications and occurred most often in PIVC C.
Average patient satisfaction ratings varied nonsignificantly between PIVCs (Table). There were no statistically significant differences in patient pain levels during PIVC insertion depending on PIVC (F = 1.58, P = .21). Average pain during insertion for PIVC A was 2.76 (SD = 2.16), for PIVC B 2.19 (SD = 2.15), and for PIVC C 2.38 (SD = 2.11).
Aim 2: Safety outcomes
Of the 3 PIVCs, there was no significant variation in unsuccessful first attempt at PIVC insertion (χ2 = 0.39, P = .83). However, blood leaked out at a significantly higher rate during insertion of PIVC A (24.3%) compared with PIVC B (2.9%) and PIVC C (0.9%) (χ2 =38.83, P < .01). Aim results are reported in the Table.
The clinician satisfaction with the PIVC device features was on average 4.07 (SD = 0.83) for PIVC A, 4.82 (SD = 0.38) for PIVC B, and 4.90 (SD = 0.26) for PIVC C. PIVC A was rated significantly lower than PIVCs B and C, but there were no significant differences in clinician ratings between PIVCs B and C (H = 118.54, P < .01). Overall, clinicians were statistically significantly dissatisfied with PIVC A (H = 118.54, P < .01). Breakdown of the comparisons between each clinician satisfaction item is available in the Supplemental Digital Content Table (available at: http://links.lww.com/JNCQ/A615).
Aim 3: Cost outcomes
When comparing average total costs of the PIVCs, PIVC C was significantly more expensive ($6.84, SD = $2.43 per insertion) than PIVC A ($5.07, SD = $1.97) and PIVC B ($4.79, SD = $1.72) (H = 46.10, P < .01). PIVCs A and B did not significantly differ in cost (Table).
The word-clouds and content analysis of the qualitative comments provided by clinicians and patients did not contrast significantly between PIVCs. Both clinicians and patients reported various perceptions about the pain and discomfort occurring during PIVC insertion, and patients reported various perspectives about pain during the dwell time of the PIVC. Clinicians and patients also reported varying ideas about satisfaction and preference for a specific PIVC, but no PIVC appeared to have significantly more strengths or weaknesses than another. Clinicians did describe more instances of blood leakage during or after insertion of PIVC A.
The current project aimed to evaluate and compare the available PIVCs in our health system. To our knowledge, this project was the first to investigate and compare outcomes of an open-system PIVC (A) to 2 closed-system PIVCs (B and C) in terms of quality, safety, and cost. The project's significant findings were 3-fold. Our project did not find significant differences for complication development in relation to dwell time of the PIVCs, likely due to the low incidence of complications in our overall sample. PIVCs were not always inserted at the beginning of the patient's stay; therefore, dwell times were much shorter than anticipated. Our findings are consistent with current literature suggesting that longer dwell times may increase the risk of complications. The average dwell time for patients in this project was 20 to 60 hours; therefore, it is possible that there was not enough time allowed for complications to occur.
The open-system catheter, PIVC A, had significantly more blood leakage during insertion than the other 2 PIVCs. Furthermore, clinicians were least satisfied with PIVC A. The inability of PIVC A to stop the flow of blood upon insertion was the feature with which most clinicians were dissatisfied. Clinicians were also dissatisfied with the need to cleanup blood as part of the insertion process, and perceived that patient discomfort was increased when using PIVC A. While not statistically significant, it was clinically relevant that patient dissatisfaction and discomfort were higher for PIVC A, aligning with the clinician's perceived patient discomfort.
PIVC C was significantly more expensive than the other 2 PIVCs. However, after accounting for the cost of add-ons during the insertion process and more reinsertion attempts for the open-system catheter (PIVC A), the gap in cost was reduced. There was no statistically significant cost difference between PIVCs A and B. When considering overall cost for implementation of a closed- versus open-system PIVC, it may be more cost-effective and safer to use a closed-system device.
Limitations and future directions
This project was initiated in a facility where there was a mandatory product conversion, to an open PIVC system, for the purposes of standardization. It is possible that reporting bias may have threatened the internal validity of the findings, as this project was partially conducted in the same facility where initial negative reports related to product conversion occurred. It is possible that the significantly lower clinician and patient preference scores are related to bias from a difficult product conversion experience. In anticipation of this potential bias, this project included in its design a second sister hospital that had historically used the mandatory product. Implementation at a second facility helped increase sample size. However, sample size of each type of catheter used remained small. Replication of this project at other facilities could aid in validating and expanding the current findings. Future research should focus on expanding the cost analysis to include indirect costs of reinsertion, such as staff time and linen services. Finally, future research may further evaluate the impact product conversion has on workflow.
The findings of this project support current literature's clinical recommendation that a closed-system PIVC is not only safer and cost-effective but also preferred by patients and clinicians. The current RCT helped inform recommendations for a clinical practice change within the health care system. The results of this RCT suggest that clinical leaders should carefully consider quality, safety, cost, and alignment with regulatory bodies (eg, INS, Occupational Safety and Health Administration) when determining PIVC product selection.
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