The Safe IVADs Project
Conditions: Phlebitis, Thrombophlebitis, Infiltration of Peripheral IV Therapy, Extravasation Injury, Infections Symtoms
Sponsor: Sahlgrenska University Hospital

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Implementing an evidence-based, standardized care bundle 
to enhance patient safety and quality of Safe Intravascular 
Access Device care management - (Safe-IVAD - project) 
Safe Intravascular Access Device (Safe-IVAD) - Bridging the gap to enhance patient safety 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Research Plan 
Implementing an evidence based, standardized care bundle to improve the patient safety and 
quality of care for Intravascular Access Devices (IVADs) Management: A mixed-methods 
implementation intervention embedded within a process evaluation framework. 
Summary 
This larger project aims to develop, test and implement evidence-based practices to improve 
the quality of IVAD care to prevent complications such as, thrombophlebitis, dislodgement 
and 
extravasation/infiltration, 
at 
Sahlgrenska 
University 
Hospital/Mölndal. 
These 
complications can delay or interrupt treatment, prolong length of hospital stay, increase costs 
and patients suffering, and in the worst case, mortality. In a previous study conducted by our 
Safe Hands research group, we found varied success in IVADs best practices. In 44-88% of 
cases, the nurses or anesthesiologists contaminated the IVAD or the insertion site, prior to 
insertion and hand disinfection before IVAD insertion varied between 21-64% of cases. Further 
findings from our quality improvement monitoring showed multiple unnecessary peripheral 
intravascular catheters (PIVCs), multiple insertion attempts, thrombophlebitis, dislodgment, 
and infiltration/extravasation. These findings will be the foundation of co-designed 
standardized best practices and e-learning activities (care bundles), to be implemented to 
prevent IVAD-related complications. This also involves validating a difficult vein access 
assessment tool, which serves as a critical step to avoid multiple insertion attempts and to 
ensure timely insertion of appropriate type of IVAD. A multidisciplinary team consisting of 
researchers, nurses, anesthesiologists, safety and care-developers, and development leaders 
will participate in this implementation project. Two hospitals will participate, one intervention 
hospital (I-hospital) and one control (C-hospital). The outcomes include evaluating changes in 
the quality of IVADs care and staff knowledge. It also includes a process evaluation which will 
contribute to new knowledge on barriers and enablers to improve safe IVAD-care for patients. 
This knowledge can guide decision- and policymakers when promoting safer care.

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Table of Contents 
Background ................................................................................................................................ 2 
Aims ........................................................................................................................................... 3 
Research questions ................................................................................................................. 3 
Design and Method .................................................................................................................... 4 
Setting, intervention and participants .................................................................................... 5 
Theories and strategies ........................................................................................................... 5 
Implementation object ....................................................................................................... 5 
Intervention delivery .......................................................................................................... 6 
Ethics...................................................................................................................................... 7 
Data management plan ........................................................................................................... 7 
Clinical implications of the SIVAD study ............................................................................. 7 
Research team ................................................................ Fel! Bokmärket är inte definierat. 
Study 1. Aim to evaluate changes in the quality of IVADs care quality, healthcare 
professionals’ knowledge and thrombophlebitis ....................................................................... 7 
Method ................................................................................................................................... 7 
Sample/ Data collection ..................................................................................................... 7 
Statistical analysis .............................................................................................................. 8 
Study 2. Aim, to perform a translation and cross-cultural adaptation of an adult difficult vein 
access scale (A-DIVA) to Swedish context, resulting in the A-DIVA-Swe .............................. 9 
Method ................................................................................................................................... 9 
Participants ......................................................................................................................... 9 
Statistical analysis .............................................................................................................. 9 
Psychometric properties evaluation ................................................................................... 9 
Study 3. Aim to evaluate the implementation process ............................................................... 9 
Method ................................................................................................................................... 9 
Data collection ................................................................................................................... 9 
Data analysis .................................................................................................................... 10 
Study 4. Aim to evaluate the cost-effectiveness of the intervention ........................................ 10 
Method ................................................................................................................................. 10 
Data collection ................................................................................................................. 10 
Statistical analysis ............................................................................................................ 10 

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References ................................................................................................................................ 11 
 
 
 

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Background 
Patients in the hospital rely on the safe and timely insertion of Intravascular Access Devices 
(IVADs) to obtain access to the bloodstream for the administration of medications, blood 
sampling, dialysis, interventional procedures, and continuous monitoring. The most used 
IVAD are peripheral intravenous catheters (PIVC). More than 70% of patients have at least 
one PIVCs during hospital stay. Other commonly used catheters are central vein catheters 
(CVC), midline and arterial catheters. Although IVADs are essential for patient care, they are 
associated with various complications, such as dislodgment, infiltration/extravasation, 
thrombophlebitis (vascular inflammation and/or thrombosis), bacteremia, and sepsis (1-5). 
These complications can delay or interrupt treatment, increase patient suffering, morbidity, 
mortality, length of hospital stay and costs. However, a systematic registration of these 
complications is lacking, so the extent of the problems remains unknown (6, 7).  
The recommendations to prevent these complications include for example: education, 
indication, hand disinfection and aseptic techniques for insertion and management, prompt 
removal and skill assessment (6, 8, 9). Findings from one of our previous study at the 
intervention-hospital (I-hospital), showed low and varied adherence to hand disinfection before 
IVADs insertion (21-64%) and frequent failure in aseptic techniques (44-88%) (10). Pre-
monitoring of the quality of IVADs showed high incidence of thrombophlebitis, dislocated 
catheters, infiltration and extravasation, contaminated dressings, unnecessary PIVCs, and 
inadequate documentation This non–evidence-based practice is of significant concern, as it can 
increase the risk of skin pathogens, such as Staphylococcus aureus, entering the bloodstream 
via the catheter or insertion site (11). In particular, sepsis is associated with increased mortality 
(11) and substantially higher healthcare costs (12). However, sepsis is a relatively rare event 
compared with thrombophlebitis and infiltration or extravasation of medications (2, 3).  
IVADs insertion, management and removal are carried out by both anesthesiologists and 
nurses, although the management and removal are primarily part of the nurse’s caregiving 
responsibilities. Insertion failures are a major concern for PIVCs, with approximately 35-50% 
failing on the first try (2, 13). PIVC insertion failures can be patient-related when veins are not 
visual, palpable or small, and/or staff related, i.e. limited clinical skills, insufficient use of 
appropriate technical equipment, and a lack of evidence-based knowledge. Ultrasound-guided 
insertion and prediction tools for difficult vein access can facilitate a successful first attempt 
(13-15). Specialized IVADs teams can also aid when first attempts failure is expected and the 
team can provide training, standardization of practices and offer expert consultation (13, 16, 
17). However, robust evidence to support their widespread use remains limited and Sweden 
lacks a validated difficult vein access tool. Despite the existence of guidelines for IVADs best 
practices, for insertion, management and removal, the implementation remains inconsistent 
across healthcare settings (2, 18-21). This compromise patient safety and undermines efforts 
to deliver sustainable, high-quality hospital care. The WHO identifies safe, effective, and 
affordable healthcare as central to Sustainable Development Goal (SDG) 3, yet this 

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sustainability perspective is largely absent in IVAD research, with few nursing studies 
addressing SDGs (22). Most studies focus on dwell time or complications without linking these 
outcomes to resource use, environmental impact, or equitable access. Applying a sustainability 
lens shows that each preventable IVAD-related complication not only harms patients but also 
consumes unnecessary financial and material resources, weakening cost-effectiveness and 
long-term healthcare sustainability. 
Our research group has recently conducted a theory-driven implementation of evidence-
based practices to prevent urinary tract infections and bladder distension (23). The result was 
an associated significant reduction in the incidence of these adverse events in patients with hip 
fractures, 19%-4% and 41%-9%, respectively (24, 25), and found to be cost-effective (26). 
Building on these findings, we aim to further test our implementation methods and strategies 
inspired by theories on organizational culture and leadership and dialogue (27, 28), on the 
prevention of IVADs complications. We aim to promote changes in staff (nurses and 
anesthesiologist) specific cultures related to IVADs best practices, using an integrated 
knowledge translation approach (29). The collaboration is grounded in the expertise of 
researchers, healthcare professionals, clinical experiences, and scientific evidence to improve 
safe IVAD practices. The implementation process is guided by the new medical research 
council (MRC) guidance for process evaluation of complex intervention (30). The intervention 
will be conducted at a smaller hospital located at a different site within the university hospital 
organization, while the control hospital is a county hospital. 
Aims 
This larger research project aims to evaluate the effectiveness of implementing a co-designed, 
standardized care bundle on IVADs quality and staff knowledge (nurses and anesthesiologists) 
before and after the intervention at the I-hospital, compared with the C-hospital. Additional 
aims are to: (a) translate and validate a tool for identifying patients with difficult vein access 
within the Swedish healthcare context; and (b) to evaluate the implementation related to its 
feasibility, acceptability, fidelity, and cost-effectiveness.  
Research questions 
• Does the implementation of standardized, evidence-based practices improve the quality of 
IVADs care and increase nurses’ and anesthesiologists´ knowledge, including reductions in 
complications such as thrombophlebitis? 
• Does the intervention bridge barriers to successful implementation and support routinization 
of evidence-based IVADs practices?  
• Which factors influence the implementation in terms of feasibility, acceptability, cost-
effectiveness and compatibility with professionals’ existing values and clinical workflows? 
 
 

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Table 1. 
PICOT framework for the study 
Population/Setting/Problem 
 
Population and Settings: The I-hospital is part of a university 
hospital, and the C-hospital is a county hospital. The 
implementation program targets all nurses and anesthesiologists 
working at the I-hospital involved in IVADs practices. Local 
champions (defined as clinically active staff members with specific 
training and responsibility for supporting practice change) will be 
selected in each unit to function as experts, to monitor the 
intravascular catheter quality and to ensure maintenance of the 
intervention. 
Problem: Patients with intravascular access devices (IVADs) 
experience preventable complications due to suboptimal adherence 
to evidence-based practices among healthcare professionals. 
Intervention 
 
I-hospital: The implementation program will be led by six 
facilitators. The implementation objects are co-designed 
standardized best practices (care bundles) to prevent IVADs-related 
complications.  
Comparison 
Compared with care as usual at the C-hospital. 
Outcomes 
 
Primary outcome: changes in quality of IVAD care and nurses’ and 
anesthesiologists’ knowledge of IVADs best practices. before and 
after the intervention at the I-hospital, compared with the C-
hospital. 
Secondary outcomes: (a) translate and validate a tool for 
identifying patients with difficult vein access within the Swedish 
healthcare context; and (b) to evaluate the implementation related 
to its feasibility, acceptability, fidelity, cost-effectiveness and 
compatibility with existing values.  
Type of study and time 
 
A longitudinal implementation study design with an embedded 
process evaluation conducted over three years, integrating mixed 
methods. 
Abbreviation: C-hospital=control hospital, I-hospital=intervention hospital, IVAD= Intravascular 
Access Device. 
Design and Method 
The study adopts a longitudinal implementation design with an embedded process evaluation, 
guided by Medical Research Council guidance (MRC) framework: developing, feasibility, 
refinement, implementation and evaluation (30). The design integrates mixed methods to assess 
the effectiveness, implementation process, and contextual factors influencing the prevention of 

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IVAD-related complications across an intervention and a control hospital. A logic model of the 
intervention assumption will be developed (30, 31). The standards for reporting 
implementation studies checklists for reporting evaluation will be used (32). The study will be 
registered in clinical trials, ClinicalTrials.gov. A series of companion publications will be 
reported, see below. All statistical analysis plans will involve statisticians. 
Setting, intervention and participants 
The I-hospital is part of a university hospital with approximately 13,500 hospital stays per year, 
employing ~650 registered nurses and ~50 anesthesiologists of which all will participate in the 
intervention. The units involved are; emergency department and related emergency medical 
service, three operating room departments, one intensive care unit, three post-anesthesia care 
units, three medical wards, two ortho-geriatric wards, four orthopedic wards, one 
ophthalmology ward and one rheumatology ward,  The C-hospital is a county hospital and will 
function as control for S. aureus-bacteremia, and a selection of similar units will function as 
controls units.    
The intervention will be led by six main facilitators with experience of participating in 
change projects. They are researchers, quality and safety coordinators, development leaders, 
one anesthesiologist, and one physician specialist within infection prevention and control. They 
will ensure commitment to intervention, bridge barriers, establish effective communications 
channels, encouraging reflections about attitudes, assumptions to become receptive to change, 
and how current ways of working affect the gap. They will also facilitate safe places for 
learning and re-learning. 
A specially educated IVAD team will be selected including four to five nurse anesthetists 
and one anesthesiologist. Each unit manager will select one or two nurses to be specially 
educated local champions. They will monitor the quality of IVADs care described below. The 
IVADs team and the local champions will co-design new innovations, see below. Timeline is 
presented in Table 2. 
Theories and strategies 
To enable the specific culture change, theories on organizational culture and leadership and 
dialogue will be used (27, 28). In line with our previous intervention (23) a multifaced 
implementation strategies will be used, i.e. collaboration and partnership between researchers 
and interest-holders, co-design of innovations, flexible facilitation, local champions, education 
and feedback on the quality of the IVADs. 
Implementation object 
The evidence-based recommendations consist of education, skill assessment, aseptic 
practices, chlorhexidine 5% cleansing before insertion and management, correct indications 
and removal plan, patients’ information (indication and when to alert if the catheter causes 
pain, is red, swollen or leaking), use of ultrasound guidance for selected IVADs. 

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Intervention delivery 
Step 1. Development - i) engaging interest-holders (managers, first and middle-liner leaders, 
controllers, development leaders, quality and safety coordinators, anesthesiologists and 
nurses), in collaboration with the main facilitators, ii) establishing the IVAD team, iii) 
validating a difficult vein access tool: iv) iterative co-design of innovations: a) standard 
practices for IVADs (peripheral, midline, central catheters and arterial catheter), b) co-design 
IVADs e-learning activities. 
Step 2. Feasibility - testing the innovations in selected units. 
Step 3. Refinement - in line with the findings from the feasibility test. 
Step 4. Implementation - standard practices (care bundles) for the specific IVADs, education 
and learning activities including skill performance and assessment. 
Step 5. Evaluation, if successful, adoption and routinization of the new practices. The process 
findings will be reported to all interest-holders including its cost-effectiveness, mechanism of 
impact and contextual factors affecting the intervention.  
C-hospital, care as usual, which may or may not include local initiatives related to IVADs 
during the study period. The monitoring of the quality of IVADs care may or may not change 
behavior related to IVADs practices. 
Table 2.  
Timeline, activities and data collection  
Time/ 
Activities 
Year 1 
2025 
Year  
2026 
Year 3 
2027 
Year 4 
2028 
Pre-planning 
I-H. engaging interest-holders – creating a 
shared sense of urgency 
x 
x 
(x) 
 
I-H. Implementation process - key 
uncertainties, barriers and enablers to change 
x 
x 
x 
x 
I-H Co-design, learning activities, IVAD team 
and local champions.  
Translating and validating a difficult vein 
access tool. 
 
x 
x 
 
I-H. Feasibility, refinement and 
Implementation   
 
x 
x 
 
Both sites Survey - knowledge test++ 
 
x 
x 
x 
I-H Implementing the IVAD e-learning 
activity (12 months)  
 
x 
x 
 
I-H. Feedback to interest-holders on the IVAD 
quality monitoring (monthly)+  
 
 
x 
x 
x 
C-H. Feedback to hospital management on 
bacteriemia (yearly) and IVAD quality 
monitoring (monthly). 
 
x 
x 
x 
Both sites. Collection of process data and 
costs. 
x 
x 
x 
x 
Both sites. Monitoring quality of IVADs and 
thrombophlebitis+ 
 (pre-tests) 
x 
x 
x 
I-H. Feedback on process outcomes –
Ownership of new practices. If successful 
adoption of the innovations at C-H 
 
 
 
x 
+ The quality monitoring protocol (33) 
++ Electronical knowledge test in line with The Handbook for Healthcare knowledge test (8)  
Abbreviations: I-H= intervention hospital, C-H=control hospital, IVAD=Intravascular access devices. 

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Ethics 
The project will be performed after approval from the Swedish Ethical Review Authority, in 
line with Helsinki declaration (34), carefully considering how the benefits, risks, and burdens 
related to the project are distributed for involved participants at both study sites. The project is 
approved by hospital manager and the chief medical officer at both study sites. 
Data management plan 
We will develop a data management plan following the Swedish national data service checklist, 
ensuring compliance with Swedish regulations, FAIR principles, and Horizon Europe 
guidelines throughout data collection, storage, sharing, and preservation. 
Clinical implications of the SIVAD study 
The intervention targets key factors that can improve clinical practice and prevent 
complications related to IVADs. The study will generate new knowledge on IVADs related 
complications, previously not monitored in Sweden. If successful, both the tool to monitor 
IVAD complications and the e-learning activities can be used in a wider healthcare context, as 
regular measures of the quality of IVAD care and as continuous learning activities to promote 
safe care. The findings may also inform decision-makers and policymakers about barriers and 
enablers to change when bridging the gap between evidence and practice for safe IVADs care. 
Given the research group’s expertise and the I-hospital’s prior experience in routinizing new 
ways of working, the SIVAD study has strong potential to facilitate sustained, longitudinal 
changes in clinical practice. 
Study 1. Aim to evaluate changes in the quality of IVADs 
care quality, healthcare professionals’ knowledge and 
thrombophlebitis 
Method 
Data on IVAD care quality and healthcare professionals’ knowledge will be collected 
longitudinally at both the intervention hospital (I-hospital) and the control hospital (C-hospital) 
over a three-year period. Multiple data sources will be used, including repeated bedside audits 
of IVADs and electronic knowledge questionnaires, to capture changes over time and between 
study sites. 
Sample/ Data collection 
In the present project, data collection will include Quality of IVADs care: All patients ≥18 
years present at the wards at the time of monitoring with an IVAD in situ on the observation 
day. Patients without IVADs will be counted. Data will be collected once per month. From 
March 2026 to December 2028. Exclusion criteria: critical ill patients for example persons 
receiving end-of-life care. Power calculation: A conservative sample size calculation was 

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based on a simple before–after comparison of independent PIVCs (PIVC-miniQ, SD = 1.55), 
assuming 80% power, a two-sided α = 0.05, and a detectable mean difference of 0.5 points, 
which requires approximately 150 PIVCs before and 150 after (≈300 total), inflated by 10–
30% to account for clustering. Although the study includes all types of IVADs, this calculation 
provides a conservative estimate of the required sample size. In practice, PIVC-miniQ will be 
measured monthly over three years and analyzed using linear mixed-effects models that 
explicitly account for clustering and repeated measures over time, which is expected to yield 
at least comparable, and likely higher, statistical power. 
Audit tool: Data on IVAD care quality will be collected by trained nurses, using a modified 
and validated audit tool (IVAD-miniQ) (33). The tool has been piloted at both sites and adapted 
to fit all IVAD commonly used at the study sites, IVAD-miniQ-Sweden. The final version is 
in electronic format. The instrument for monitoring IVADs, IVAD-miniQ-Sweden, is 
presented in additional file 1. The IVAD-miniQ-Sweden tool includes one part with 
information about age (years), sex (male/female), information brochure (yes/no) and unit. 
Other domains are type of intravenous device, insertion location, condition of dressing and 
equipment, documentation, and indication for use. Points are summarized, with an optimal 
score of zero indicating high quality in IVAD management, a summative score of ≤ 1, is 
assessed as high quality (4). Further assessment (6), thrombophlebitis, will be defined as 
redness, tenderness, swelling, pain, and a palpable cord along the affected vein, and classified 
using a severity grading scale from 0 to 4 grades, where higher grades indicate greater symptom 
severity (8, 35). The observer will notify nurses in charge if observing dislodgment, 
infiltration/extravasation or thrombophlebitis in line with hospital policy at the study sites. 
Knowledge assessment: Registered nurses and anesthesiologists involved in IVADs 
management at the study sites. Electronic knowledge questionnaire distributed before, during 
and after the care bundle implementation (mid-2026, mid-2027 and mid-2028). Based on the 
Swedish Handbook for Healthcare IVAD best-practice recommendations (8), see Additional 
file 2. 
Statistical analysis 
Descriptive statistics for patients with IVADs, healthcare staff, and IVAD characteristics. 
Linear mixed models will be used for longitudinal analysis of the repeated measurements of 
IVAD care quality and staff knowledge. With additional comparisons between the I-hospital 
and C-hospital. Different models will be used, the explanatory variables will be, nurses’ and 
anesthesiologists’ knowledge, care quality of IVAD and the hospital setting. Statistical 
significance set at p < 0.05; analyses conducted using standard statistical software packaging. 

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Study 2. Aim, to perform a translation and cross-cultural 
adaptation of an adult difficult vein access scale (A-
DIVA) to Swedish context, resulting in the A-DIVA-Swe 
Method 
Translation and cross-cultural adaptation (36): The adult difficult vein access scale, Adult-
DIVA scale (15) will be translated into Swedish and culturally adapted following 
internationally recommended guidelines. The process will include forward–backward 
translation, expert panel review, and cognitive debriefing with healthcare professionals to 
ensure conceptual, semantic, and operational equivalence. 
Participants 
To assess the validity and reliability among the Swedish registered nurse and anesthesiologists 
involved in difficult vein access management, a convenience sample (n=30) of general native 
Swedish speaking healthcare workers will be recruited from both I-hospital and C-hospital. 
After completing the cross-cultural adaptation, reliability and validity will be assessed within 
a larger sample (n=100) of healthcare workers involved with A-DIVA management. 
Statistical analysis 
Characteristics of the study participants are described using frequencies, percentages, mean 
and standard deviation. 
Psychometric properties evaluation 
Face validity (performed by the expert committee members through qualitative analysis of the 
participant’s comments), reliability (test-retest intra class correlation coefficient, one week 
interval), construct validity (exploratory factor analysis (EFA)) will be performed. Factors will 
be extracted using the maximum likelihood method (MLE). 
Study 3. Aim to evaluate the implementation process 
Method 
The implementation intervention will be guided by MRC framework (30). The design 
integrates quantitative and qualitative data to evaluate the implementation process, and 
contextual factors influencing the prevention of IVAD-related complications across an 
intervention and a control hospital. 
Data collection  
Quantitative process data: Attendance rate in meetings, completed IVAD certificates and staff 
turnover. Qualitative process data: Implementation logbook (notebook on processes, meetings, 
and reflections). Semi-structured interviews, with a strategic selection of participants on micro- 
and meso-level within the organization (variation from the involved units, type of profession, 
age, working years, and gender). The interviews will be performed by a researcher who is not 
involved in the intervention. 

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The questions will investigate the participants’ experiences of: 
-participating in the intervention, what worked? How and why? 
-how the intervention interacted with different contextual features? 
-how the intervention affected other care giving activities? 
-how competing priorities affected the intervention and its activities? 
-how different goals and prioritization such as limited resources in healthcare, affected the 
intervention? 
Data analysis 
The process data will be analyzed using a thematic analysis. 
Quantitative data: Descriptive statistics. 
Qualitative data: Thematic analysis according to Braun and Clarke (37, 38). Qualitative data 
will be analyzed thematically following Braun and Clarke’s six-phase framework, which 
includes: (1) familiarization with the data, (2) generating initial codes, (3) searching for 
themes, (4) reviewing themes, (5) defining and naming themes, and (6) producing the final 
report. 
Study 4. Aim to evaluate the cost-effectiveness of the intervention 
Method 
A cost-effectiveness of the intervention will be performed using  a before and after design 
(30). 
Data collection 
Implementation and intervention costs will be collected from logbooks and cost templates 
including mean salaries for different professions, including 50% social insurance and overhead 
costs. It includes activity-based costing methods based on time used and participants involved 
in different activities. Downstream costs will be estimated from administrative cost data 
provided by the hospital. Health outcomes will be patients with IVADs complications, i.e. 
thrombophlebitis and extravasation of intravenous medications, at baseline compared to post-
intervention, using hospital data related to these complications. The implementation costs will 
be discounted at an annual rate of 3%, to account for the time value of money over a four-year 
period. The design and reporting of the cost-effectiveness evaluation follow the Consolidated 
Health Economic Evaluation Reporting Standards (CHEERS) (39). 
Statistical analysis 
Cost-effectiveness analysis will be used to compare incremental costs from a health system 
perspective (implementation, intervention, and downstream) to the incremental health 
outcomes; the IVADs complications. The economic evaluation will include scenario analyses 
and sensitivity analyses according to state of the art, to account for uncertainty of parameters 
and underlying model uncertainty. 

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