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Effectiveness of insertion and maintenance bundles in preventing peripheral intravenous catheter-related complications and bloodstream infection in hospital patients: A systematic review
Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Nathan, AustraliaSchool of Nursing and Midwifery, Griffith University, Nathan, 4111, AustraliaQEII Jubilee Hospital, Coopers Plains, Queensland, 4108, AustraliaRoyal Brisbane and Women's Hospital, Herston, Queensland, 4029, AustraliaPrincess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia
Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Nathan, AustraliaLogan Hospital, Meadowbrook, Queensland, 4131, Australia
Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Nathan, AustraliaSchool of Nursing and Midwifery, Griffith University, Nathan, 4111, AustraliaRoyal Brisbane and Women's Hospital, Herston, Queensland, 4029, Australia
Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Nathan, AustraliaSchool of Nursing and Midwifery, Griffith University, Nathan, 4111, Australia
Alliance for Vascular Access Teaching and Research (AVATAR), Menzies Health Institute Queensland, Griffith University, Nathan, AustraliaSchool of Nursing and Midwifery, Griffith University, Nathan, 4111, AustraliaRoyal Brisbane and Women's Hospital, Herston, Queensland, 4029, AustraliaPrincess Alexandra Hospital, Woolloongabba, Queensland, 4102, Australia
Many hospitals are implementing peripheral intravenous catheter (PIVC) insertion and maintenance bundles with the goal of preventing PIVC-related complications and infection.
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The effectiveness of implementing peripheral intravenous catheter insertion and maintenance bundles is unclear.
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This is the first systematic review of PIVC insertion and maintenance bundles
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A lack of standardization of bundle components precludes meaningful comparison of reported outcomes
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Further research is needed to identify which bundle components are effective in reducing PIVC-related complications and infection.
Abstract
Background
Evidence-based bundles have reduced central line bloodstream infection rates in adult intensive care units. To tackle peripheral intravenous catheter (PIVC) bloodstream infection, many hospitals have implemented PIVC insertion and maintenance bundles. However, the efficacy of PIVC bundles in preventing PIVC complications and infection in hospital patients is uncertain. The aim of this paper is to synthesize evidence on the effectiveness of PIVC insertion and maintenance bundles on preventing adverse events.
Methods
In this systematic review, we searched multiple electronic databases, trial registries, and grey literature for eligible studies published in English (January 2000–December 2018) to identify intervention studies evaluating PIVC insertion or maintenance bundles with two or more components. Search terms: peripheral intravenous catheter/cannula, insertion, maintenance, bundle, infection, infiltration, extravasation, dislodgement, thrombosis, occlusion, and phlebitis. Two reviewers independently conducted data extraction and quality assessments using the Downs and Black checklist.
Results
Of 14,456 records screened, 13 studies (6 interrupted time-series, 7 before-and-after) were included. Insertion and maintenance bundles included multiple components (2–7 items per bundle). Despite testing different bundles, 12 studies reported reductions in phlebitis and bloodstream infection, and one study reported no change in bloodstream infection and an increase in phlebitis rate. Methodological quality of all studies ranked between ‘low’ and ‘fair’.
Conclusions
The effect of PIVC bundles on PIVC complications and bloodstream infection rates remains uncertain. Standardisation of bundle components and more rigorous studies are needed. PROSPERO registration number: CRD42017075142.
]. Yet PIVC complications (infiltration and extravasation, blockage, dislodgement, and phlebitis) result in premature access failure in up to 69% of hospital patients [
Observational study of peripheral intravenous catheter outcomes in adult hospitalized patients: a multivariable analysis of peripheral intravenous catheter failure.
], requiring the insertion of a new device, with delays in treatment and increased costs. Furthermore, catheter-associated bloodstream infection (BSI) is a threat to healthcare outcomes worldwide [
Despite evidence-based guidelines, the uptake of recommendations into clinical practice can be difficult. The introduction of care bundles that simplify lengthy guidelines into point-of-care reminders has improved staff compliance with best practice [
]. Bundles for central venous access device (CVAD) insertion and maintenance demonstrate reductions in BSI when implemented with compliance monitoring [
Effectiveness of insertion and maintenance bundles to prevent central-line-associated bloodstream infections in critically ill patients of all ages: a systematic review and meta-analysis.
]. Infection prevention measures in CVAD bundles include hand hygiene, optimal insertion site selection, maximal sterile barriers for line insertion, chlorhexidine skin disinfection, and daily review of device necessity with prompt removal of unneeded lines [
]. While compliance with CVAD bundles has resulted in BSI reductions in adult intensive care units (ICU), the impact of PIVC insertion and maintenance bundles is unclear.
This systematic review aimed to: (i) systematically critique (and meta-analyse, if possible) evidence for the effectiveness of PIVC insertion and maintenance bundles to prevent BSI and catheter-related complications in hospital patients of all ages, and (ii) describe components of bundles, implementation strategies, and reported compliance.
Methods
Protocol
The systematic review was conducted in accordance with the Cochrane EPOC guidelines [
Prospective intervention studies reporting multimodal strategies or bundles with two or more components for PIVC insertion or management in hospital patients of all ages to reduce BSI or catheter-related complications published in English (January 2000–December 2018) were included. Eligible study designs included randomised controlled trials, interrupted time series (ITS), before-and-after studies (BA), and cohort studies only. Studies that reported implementing a single intervention were excluded. Articles that did not define the strategy or bundle components or report outcome measures were excluded. Conference abstracts, letters, and articles unable to be accessed in full-text were excluded.
An insertion bundle was defined a priori as at least two evidence-based practices for insertion, including but not limited to: hand hygiene [
]. A maintenance bundle was defined a priori as at least two evidence-based practices for maintenance, including but not limited to: daily evaluation of need [
Observational study of peripheral intravenous catheter outcomes in adult hospitalized patients: a multivariable analysis of peripheral intravenous catheter failure.
Tools, clinical prediction rules, and algorithms for the insertion of peripheral intravenous catheters in adult hospitalized patients: a systematic scoping review of literature.
Observational study of peripheral intravenous catheter outcomes in adult hospitalized patients: a multivariable analysis of peripheral intravenous catheter failure.
The cost-effectiveness of quality improvement projects: a conceptual framework, checklist and online tool for considering the costs and consequences of implementation-based quality improvement.
Searches were imported into EndNote X9 (Clarivate Analytics, Philadelphia) to screen for relevance and identify duplicates. Two reviewers (GRB, HX) independently screened all titles and abstracts to select potentially relevant articles for the review. Full text papers of relevant citations were reviewed and independently assessed for eligibility for inclusion. Reference lists of retrieved articles were examined, and relevant articles were sourced and reviewed. Data from included studies were extracted into a pre-defined data extraction spreadsheet by two reviewers independently, summarised into an evidence table, and cross-checked for accuracy. Minor disagreements were resolved with discussion between reviewers; arbitration via a third reviewer was not required.
Data extracted included: title, author, year, country of study, aims and objectives, study design, number of data collection time-points, duration, setting, population (adult/paediatric/neonate), sample size, unit of measurement (PIVC or participant), person collecting data, frequency of data collection, bundle users, guidelines used for bundle development, insertion bundle components, maintenance bundle components, implementation strategies, primary outcomes, secondary outcomes, outcome assessor, blinding of outcome assessor, definitions (CLABSI, phlebitis, complications, compliance, insertion success), use of phlebitis/infiltration scale, reported findings (CLABSI, phlebitis, complications, compliance, insertion success, cost), sustainability, trial registration, ethics approval, and funding source.
Risk of bias assessment
Two reviewers independently completed the quality assessment of each study and compared results. Discrepancies were resolved with discussion. The Downs and Black checklist was used to assess study methodology risk of bias [
The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions.
]. The checklist has 27 questions which evaluate study quality of reporting, external validity, internal validity (bias), internal validity–confounding (selection bias) and power. Quality assessment of studies is determined by the following cut-points: excellent (26–28), good (20–25), fair (15–19), and poor (≤14) [
]. An overall quality score was assigned to individual studies.
Synthesis of results
A narrative synthesis of the characteristics and reported outcomes of the included studies was undertaken. Where possible, outcome measures of ITS and BA studies were reported as relative risk, confidence intervals (95% CI), per cent change relative to baseline and probability (p-values). We planned to pool results across studies for meta-analysis where possible; however, we prespecified that the expected number and heterogeneity of care bundle components and implementation strategies could make this unfeasible. Given the predicted heterogeneity of the study populations, the following subgroup analyses were planned: (1) Bundle components that increase or reduce the intervention effect; (2) Electronic medical records vs paper-based bundles; and (3) Adult vs paediatric vs neonate bundle components and implementation strategies.
Results
Database and grey literature searches identified 14,456 records; from this, 4161 duplicates were removed, and 10,295 records were screened by title or abstract. Of 45 full-text articles assessed for eligibility, 32 were excluded and 13 studies were included in the final review. A PRISMA flow diagram [
] depicts the number of articles obtained in the searches, subsequent exclusions and final numbers included in the review to maximise transparency and clarity (See Fig. 1).
The characteristics and outcomes of the 13 included studies are provided in Table 1. Excluded studies are displayed in Table 2. We identified six interrupted time-series studies [
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
]. All included studies reported implementing a PIVC care bundle for insertion (n = 9) or maintenance (n = 10), or both (n = 8) in an acute care hospital inpatient setting. Studies were conducted in a range of countries, including Australia [
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
ITS, 14 years, multiple Inpatients: 227 patients with BSI. No denominator given.
2003–2005:
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2% CHG skin prep
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sterile gloves
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transparent dressing
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extension tubing
2010–2016:
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integrated closed catheters
2003–2005:
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dressing integrity checks
•
extension tubing
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routine replacement 72 h & prn replacement
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48 h replacement for ED-insertion
2006–2009:
•
pre-filled syringes
2010–2016:
•
unscheduled replacement
•
daily microbiology meetings
•
prospective PIVC-BSI surveillance
•
PIVC training
•
review hospital guidelines
•
pocket card guidelines for all staff
•
wall charts
•
compliance audits
•
feedback to staff after every PIVC-BSI
•
Relative reduction in PIVC-BSI per 10,000 patient days: pre 1.17; post 0.36 (RR 0.92; 95% CI 0.90–0.96)
•
Relative reduction in phlebitis rate: pre 0.7%; post 0.5%
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Relative reduction in extravasation rate: pre 0.7%; post 0%
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Relative reduction in 30-day mortality rate per 10,000 patient days: pre 0.27; post 0.00 (RR 0.82; 95% CI 0.74–0.91)
•
2011–2016: Compliance data reported for 3119 PIVCs (dressing, PIVC site, extension tubing, documentation, replacement as per policy): pre 95.8%; post 98.7%
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
A survey of compliance with the peripheral vascular cannula (PVC) care bundle as implemented by St. Vincent's University Hospital in order to reduce the incidence of blood stream infections by ensuring appropriate PVC care.
Beyond the bundle: health care associated (HCA) peripheral intravenous device (PIVD) related bloodstream infection (BSI), Royal Adelaide Hospital (RAH) Infection Prevention and Control Unit (IPCU) improvement intervention.
Sustained improvements in peripheral venous catheter care in non–intensive care units: a quasi-experimental controlled study of education and feedback.
Effects of computer reminders on complications of peripheral venous catheters and nurses' adherence to a guideline in paediatric care--a cluster randomised study.
Missing outcomes data. Did not match criteria of primary or secondary outcomes in the search protocol. The study measured compliance with documentation only.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
]. Each insertion bundle comprised two to seven items, with some overlap among bundles. The most often reported items were 2% chlorhexidine gluconate (CHG) skin prep [
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
]. Each maintenance bundle comprised two to seven items, again with occasional overlap among bundles. The most prevalent maintenance bundle items included daily review of need for PIVC (7 studies) [
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
] also included 48-h replacement for emergency department-inserted PIVCs. Two studies reported implementing a checklist as part of the maintenance bundle [
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
] reported the strategies used to implement the bundles, which included education, audits, and feedback. Education strategies included a mix of: PIVC site selection and insertion training, in-service sessions, nursing huddles, bedside training, lectures, online modules, PowerPoint, posters, booklets/leaflets, and case studies. One study [
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
] reported no change in PIVC-BSI rates after implementing a bundle. All studies reporting PIVC-BSI provided Staphylococcus aureus data, and one study [
] reported 30-day mortality rates, which showed a significant decrease following introduction of the PIVC bundle. Phlebitis reporting entailed a variety of phlebitis scales and definitions; six studies [
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
] reported a 3.5% relative reduction in PIVC infiltration rates with the introduction of an infiltration-focused insertion and maintenance bundle (with site assessment and infiltration grading tool) for paediatric patients. Another study [
] reported a 4.8% decrease in infiltration rates in paediatric patients post-implementation of a maintenance bundle (daily review of PIVC need, hand hygiene, site assessment and dressing checks). One study [
] reported a 0.62% relative reduction in all PIVC adverse events (including line obstruction, dislodgment, line mismanagement, and phlebitis). Only one study [
] reported insertion success rates (number of attempts), and in that study, implementation of an insertion bundle (comfort plan, venous assessment grading tool, and nurse self-assessed insertion skill and self-assessment to continue or stop) did not improve first attempt PIVC success or overall success rates; indeed, successful insertion after two attempts tended to decrease. However, after an unsuccessful first attempt, numbers of overall attempts decreased, which the authors attributed to the success of empowering nurses to stop-the-line [
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
] estimated the economic costs and benefits of PIVC bundle implementation. In that study, the authors reported project costs of AU$185,000 (nursing resources and standardized equipment) and estimated a reduction in 10 S. aureus bacteraemia events in 12 months (approximately AU$290,000). Therefore, the authors estimated cost savings of AU$105,000 over 12 months following the bundle implementation [
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
] reported relative risk and confidence intervals for the data, with most providing simple percentages and probability values but without numerators and denominators, therefore the calculations could not be checked. Furthermore, the variable time intervals reported in each study did not enable incidence risk ratios for BSI and phlebitis to be calculated. Several subgroup analyses were originally planned but could not be undertaken due to the variability in bundle components and reporting, and therefore it was not possible to estimate which bundle items showed the most effect. No studies reported on electronic versus paper-based bundles, so the effect of electronic medical records on implementation of PIVC bundles is unknown.
Reported compliance
Auditing of bundle compliance (partial or total) was reported in nine studies; four studies [
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
] did not report compliance. Compliance data was reported as a percentage rather than numerators and denominators by most studies, making the completeness of the compliance estimates unclear. Two studies reported total bundle compliance achieved of 54.5% [
], was reported as high (>80%). However, compliance with daily site assessment and documentation interventions was variable, with studies reporting only minimal-modest improvements [
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
] reported an increase in dwell time with no increase in complications or bloodstream infection, following implementation of the insertion bundle. One study [
] reported compliance with all hospital PIVC care policies for insertion site assessments, line labels, line changes, removal of 3-way taps, and phlebitis documentation, but only documentation was included in the reported implemented bundle. Sustainability of the bundle intervention was only reported in three studies: one study [
] reported annual audits of the bundle components.
Risk of bias
All included studies had methodological limitations, and the reporting of the risk of bias variables was limited across studies. Studies with ITS and BA designs have inherent risk of bias which cannot be minimised (e.g., no randomisation, no blinding of outcome assessment, data collection at different time periods, possible indirect outcomes due to concurrent events), and therefore the Downs and Black quality scores were fair [
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
] (See Supplementary file 2). As no study scored highly on the quality assessment, a reporting bias is possible, considering that 12 out of 13 studies reported positive results.
None of the included studies reported trial registration. Ethics committee or institutional review board approval was reported by five studies [
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
] noting that approval was not required for quality improvement studies without collection of patient identification. Funding for the studies was provided by the product manufacturer in one study [
This is the first systematic review to examine the effects of PIVC insertion and maintenance bundles on PIVC complications and PIVC-related BSI. Although all studies included in the review used similar study designs (ITS or before-after), it was difficult to compare findings due to diverse bundle components, different endpoints, time periods, and the use of a range of definitions and reporting measures. For instance, some before-after studies did not report the frequency or number of data collection points, some studies did not report the overall sample size, and while three studies reported using a phlebitis scale, all used different scales. Follow-up periods were generally brief, and sustainability effects are unclear. The quality assessment of included studies ranged from low to fair, which is not unexpected for non-randomised studies [
]. While six studies each reported a reduction in BSI and phlebitis rates following the implementation of a PIVC bundle, all these bundles differed in components and outcome measurement, thus effects may not be generalisable outside the study setting. One study reported no change in BSI and an increase in phlebitis following PIVC bundle implementation. Therefore, the current evidence to support the introduction of a PIVC bundle to reduce adverse patient outcomes is promising but not robust.
CVAD bundles were initially introduced to improve adherence to best practice guidelines for catheter care [
] published their findings that CVAD insertion bundles significantly reduced CLABSI incidence in adult ICUs, implementation of bundles has become widespread in many healthcare settings. To date, several systematic reviews and meta-analyses have examined the effects of CVAD bundle interventions on patient outcomes and strategies to improve bundle compliance. Ista et al. [
Effectiveness of insertion and maintenance bundles to prevent central-line-associated bloodstream infections in critically ill patients of all ages: a systematic review and meta-analysis.
] conducted a systematic review and meta-analysis confirming that CVAD insertion and maintenance bundles can reduce the incidence of CLABSI in ICU patients. Similarly, Blot et al. [
] conducted a systematic review and meta-analysis of quality improvement interventions to prevent CVAD-BSI and found infection rates decreased most in studies that implemented a bundle or checklist. The success of the CVAD bundle in ICU patients can be attributed to standardisation of the bundle components and consistency in their application.
Standardisation and consistency are less evident in PIVC bundle studies, which report a much greater variability in composition of bundle components. The number of items in PIVC insertion and maintenance bundles varies from two to seven, with little similarity between bundles. Standardisation of PIVC insertion and management is desirable to reduce variations in care and the potential for adverse outcomes; however, at present, the ideal components of a PIVC insertion and/or maintenance bundle are unclear. There are fewer published RCTs in PIVCs than CVADs, and while CVAD bundles are generally based on components supported by RCT evidence, this is not the case for PIVC bundles, which are rarely based on RCT evidence. The majority of papers in this review reported consulting evidence-based guidelines before compiling and implementing a PIVC bundle – presumably the remaining studies chose bundle items based on local opinion or need.
Bundles attempt to simplify lengthy guidelines into a short point-of-care reminder to improve staff compliance with best practice; therefore, bundle components should be based on high quality evidence [
]. Bundle items such as hand hygiene, chlorhexidine skin prep, disinfection of needleless connectors, PIVC site checks, PIVC dressing checks, daily review of PIVC need, and documentation of insertion and removal are all recommended in guidelines and clinical standards [
Integrated versus nOn-integrated Peripheral inTravenous catheter. Which Is the most effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM study): a randomised controlled trial protocol.
], and these devices are not yet referenced in existing guidelines, so their inclusion in a bundle appears somewhat premature.
A range of implementation strategies were reported in the included studies, including policy updates, documentation revisions, introduction of checklists, posters, bedside education, training workshops, regular meetings, PIVC audits, compliance audits, feedback, and reminders. In a 2015 systematic review of effective strategies for implementation and compliance for a variety of bundles for ICU patients, Borgert et al. [
] reported the heterogeneity of bundle elements and time periods for interventions made it impossible to identify the most effective implementation strategy. However, Ista et al. [
Effectiveness of insertion and maintenance bundles to prevent central-line-associated bloodstream infections in critically ill patients of all ages: a systematic review and meta-analysis.
] demonstrated successful implementation of CVAD bundles required a combination of strong leadership, processes in place to support the bundle (protocol or checklist compliance), and empowerment of nurses to stop physicians if they observed a protocol violation. Green et al. [
] list four factors to support successful intervention of care bundles: availability of resources and training; perceived sustainability of the initiative by stakeholders; senior leadership support for the intervention; and practitioner incentives (such as financial incentives to attain quality targets). Understanding the contextual factors that affect the uptake of interventions and address the barriers and facilitators to implementation are integral facets of effectiveness and sustainable change [
]. Surprisingly, most studies in our review did not report contextual factors, such as leadership support for the project, which can greatly affect success of an intervention. None of the papers in this review discussed practitioner incentives, and only three papers reported on sustainability.
Notably, only the two paediatric studies reported considering the patients' comfort and activity needs prior to device selection and insertion. While cannulating a child can be both physically and psychologically challenging, recognition of the adult patient's needs should also receive priority, with patients reporting their personal needs and PIVC experiences are too often ignored by healthcare providers [
Not "just" an intravenous line: consumer perspectives on peripheral intravenous cannulation (PIVC). An international cross-sectional survey of 25 countries.
The cost-effectiveness of quality improvement projects: a conceptual framework, checklist and online tool for considering the costs and consequences of implementation-based quality improvement.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
], and how compliance was achieved or measured was not always clear. Uneven compliance with bundles, guidelines and protocols is a recognised universal problem in health care [
Effectiveness of insertion and maintenance bundles to prevent central-line-associated bloodstream infections in critically ill patients of all ages: a systematic review and meta-analysis.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
Our findings have implications for clinical practice. While the beneficial effect of CVAD bundles is without doubt, particularly in ICU patients, PIVC bundles so far have not demonstrated similar success, primarily due to broad variability in bundle components. We hope the review findings provide useful guidance for policy makers and healthcare clinicians interested in implementing an evidence-based PIVC bundle. Firstly, healthcare settings considering implementing a PIVC bundle are recommended to consult the evidence-based guidelines before compiling the bundle. Each bundle item should be based on evidence. Secondly, engagement with relevant stakeholder groups (nurses, physicians, infection control and quality personnel, consumer advisory groups) is strongly recommended, and strong leadership support is crucial to the success and sustainability of the intervention. Thirdly, an interrupted time-series study with multiple time-points pre- and post-intervention with a follow-up period after study completion is recommended to obtain reliable baseline data and evaluate the sustainability of the intervention. For instance, ongoing regular audits for PIVC complications are highly recommended [
], in addition to BSI monitoring. Next, when reporting the outcomes of bundle interventions, authors should provide details of the individual bundle components, process of implementation, and some description of context. Providing this level of information will assist other centres to replicate successful implementation of evidence-based practices. Finally, we found many conference abstract presentations reporting PIVC bundle success; however, most have not been published as full-text papers, so we could not examine those studies. Judging by the numbers of studies and conference abstracts reporting bundle implementation published in the past decade, motivation in this area of research is high and has potential for improving clinical practice and patient outcomes. We encourage nurses and other healthcare professionals to publish their research findings so that others may learn from their work.
Limitations
Several limitations are evident in this review. It is possible that we missed some relevant studies due to different terminology for care bundles. However, we did use a broad search strategy to search numerous databases and grey literature, as well as hand-searching of reference lists. We restricted our searching to English language papers, and therefore we could have missed relevant studies published in other languages. All studies included in this review were quasi-experimental designs and no randomised trials were found, therefore, reported improvements could have been caused by unstated factors or seasonal trends. A lack of reporting of context in the majority of studies precludes generalisation of the findings. Although we limited this review to studies that included two or more bundle components, the wide variability in bundle components, study duration, and reporting measures made meaningful comparisons between the PIVC bundles challenging. Meta-analysis was not feasible due to the variability between bundle components and implementation strategies. Meta-analysis might have been possible if we had limited the bundle components to a smaller group of evidence-based practices; however, we intentionally cast a wide net to identify the spread of bundles and components being implemented. We did not contact the primary authors for further information because it was agreed that the variability in bundles and study time periods prohibited direct comparison of outcomes.
Conclusion
Implementing an evidence-based bundle could lead to improved guideline adherence for PIVC care and better patient outcomes, but wide variation currently exists among PIVC bundles reported in the literature. Current PIVC insertion and maintenance bundles include diverse components (not all evidence-based), and study quality is low to fair. The effect of PIVC care bundles on PIVC-related bloodstream infection rates appears promising but remains uncertain. Standardisation of evidence-based bundle components, and more rigorous studies with compliance, sustainability and cost reporting are needed.
Ethics
Ethics approval not required as this is a review paper.
Authorship statement
GR and HX conceived the study and drafted the research protocol. GR, NM, MC and CR provided critical review of and approved the study design. GR and HX conducted the database searches. GR and HX made the primary selection of eligible papers including data extraction. GR and NM checked the study selection process and data extraction. GR and HX analysed the data. All authors contributed to interpretation of the analysis. GR wrote the manuscript. All authors provided critical review and approved the final manuscript.
Conflict of interest
GRB: Griffith University has received on her behalf unrestricted investigator-initiated research grants (3M, BD, Smiths Medical) and consultancy payments (3M, BD, Medline, ResQDevices). HX: Nil. NM: Griffith University has received on her behalf: unrestricted research and educational grants from: 3M, Adhezion, Becton Dickinson, Centurion Medical Products, Cook Medical, Entrotech and Teleflex; and consultancy payments for educational lectures from Becton Dickinson. MC: Griffith University has received on her behalf unrestricted investigator-initiated research or educational grants (3M, Baxter, BD, Entrotech). CMR: Griffith University has received on her behalf unrestricted investigator-initiated research or educational grants (3M, Adhezion, Angiodynamics, Bard, Baxter, BBraun, BD, Centurion Medical Products, Cook Medical, Entrotech, Medtronic, Smiths Medical) and consultancy payments (3M, Bard, BBraun, BD, ResQDevices, Smiths Medical). No commercial entity had any role whatsoever in the conception, design or funding of this study, or in the preparation of this manuscript.
Funding
During the writing of this paper, GRB was supported by a Griffith University postdoctoral fellowship, Menzies Health Institute Queensland New Researcher Grant, Menzies Health Institute Queensland Incentive Quality Development Scheme, and Australian College for Infection Prevention and Control 2017 Early Career Research Grant.
No funding entities had any involvement whatsoever in the design or conduct of this review.
Provenance and peer review
Not commissioned; externally peer reviewed.
Acknowledgements
Nil.
Appendix A. Supplementary data
The following are the Supplementary data to this article:
Observational study of peripheral intravenous catheter outcomes in adult hospitalized patients: a multivariable analysis of peripheral intravenous catheter failure.
Effectiveness of insertion and maintenance bundles to prevent central-line-associated bloodstream infections in critically ill patients of all ages: a systematic review and meta-analysis.
Tools, clinical prediction rules, and algorithms for the insertion of peripheral intravenous catheters in adult hospitalized patients: a systematic scoping review of literature.
The cost-effectiveness of quality improvement projects: a conceptual framework, checklist and online tool for considering the costs and consequences of implementation-based quality improvement.
The feasibility of creating a checklist for the assessment of the methodological quality both of randomised and non-randomised studies of health care interventions.
Reducing Staphylococcus aureus bloodstream infections associated with peripheral intravenous cannulae: successful implementation of a care bundle at a large Australian health service.
The implementation of an evidence-based bundle for bloodstream infections in neonatal intensive care units in Germany: a controlled intervention study to improve patient safety.
Plastic in patient study: prospective audit of adherence to peripheral intravenous cannula monitoring and documentation guidelines, with the aim of reducing future rates of intravenous cannula-related complications.
A survey of compliance with the peripheral vascular cannula (PVC) care bundle as implemented by St. Vincent's University Hospital in order to reduce the incidence of blood stream infections by ensuring appropriate PVC care.
Beyond the bundle: health care associated (HCA) peripheral intravenous device (PIVD) related bloodstream infection (BSI), Royal Adelaide Hospital (RAH) Infection Prevention and Control Unit (IPCU) improvement intervention.
Sustained improvements in peripheral venous catheter care in non–intensive care units: a quasi-experimental controlled study of education and feedback.
Effects of computer reminders on complications of peripheral venous catheters and nurses' adherence to a guideline in paediatric care--a cluster randomised study.
Integrated versus nOn-integrated Peripheral inTravenous catheter. Which Is the most effective systeM for peripheral intravenoUs catheter Management? (The OPTIMUM study): a randomised controlled trial protocol.
Not "just" an intravenous line: consumer perspectives on peripheral intravenous cannulation (PIVC). An international cross-sectional survey of 25 countries.
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