Implementing an Evidence-based, Standardized Care Bundle Targeting Register Nurses and Anaesthesiologists, to Enhance Patient Safety and Quality of Intravascular Access Devices Care Management - The Safe-IVADs Project. A Longitudinell Implementation Intervention With an Embedded Process Evaluation.

The Safe IVADs Project

The goal of this observational study spanning over three years is to evaluate the effectiveness of implementing a co-designed, care bundle on intravascular access device (IVAD) quality and nurses and anaesthesiologist knowledge of IVADs best practices, at an intervention hospital compare to care as usual the a control hospital. Additional aims are to:

1. translate and validate a tool for identifying patients with difficult vein access within the Swedish healthcare context,
2. to evaluate the implementation related to its feasibility, acceptability, fidelity, and cost-effectiveness.

The main questions it aims to answer are:

• Does the implementation of evidence-based practices improve the quality of IVADs care, e.g. thrombophlebitis/phlebitis, extravasation, infiltration, dislodgement and increase register nurses and anaesthesiologists' knowledge of IVADs best practices?
• Does the intervention bridge barriers to successful implementation and support routinization of evidence-based practices.
• Which factors influence the implementation in terms of feasibility, acceptability, cost-effectiveness and compatibility with professionals' existing values and clinical workflows?

Study Overview

• Status: Not yet recruiting
• Conditions: Extravasation Injury; Phlebitis; Thrombophlebitis; Infiltration of Peripheral IV Therapy; Infections Symtoms
• Intervention / Treatment: Behavioral: The Safe IVADs project

Detailed Description

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. The design integrates mixed methods to assess the effectiveness, implementation process, and contextual factors influencing the prevention of IVAD-related complications across an intervention and a control hospital.

Data on IVAD care quality and healthcare professionals' knowledge will be collected at both sites once a month 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.

Quality of IVADs, power calculation: A conservative sample size calculation was 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.

Data will be 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). 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.

Knowledge assessment: Registered nurses and anaesthesiologists involved in IVADs management at the study sites. Electronic knowledge questionnaire distributed before, during and after the care bundle implementation, based on the Swedish Handbook for Healthcare IVAD best-practice recommendations.

Translation and cross-cultural adaptation of an adult difficult vein access scale (A-DIVA) to Swedish context - 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)

Process evaluation 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.

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.

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.

Data management plan A data management plan will be developed 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

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Linda Ahlstrom, Associate professor; Phone Number: +46 070-5784636; Email: linda.ahlstrom@gu.se
• Study Contact Backup: Name: Maria Frödin Frödin, Dr; Phone Number: +46 0731 802487; Email: maria.frodin@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska Academy, Sahlgrenska University hospital/Mölndal
    • Contact: Linda Ahlstrom, Associate professor; Phone Number: +46 070-5784636; Email: linda.ahlstrom@gu.se
    • Contact: Maria Frödin Frödin, Dr; Phone Number: +46 0731 802487; Email: maria.frodin@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Sahlgrenska university hospital/Mölndal

Description

Inclusion Criteria:

• Register nurses and anesthesiologist

Exclusion Criteria:

-

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intervention; The implementation program is co-design with interest holders at the intervention hospital. The implementation object that is the co-design learning activities targets registered nurses and anesthesiologist at the intervention hospital.	Behavioral: The Safe IVADs project; The implementation intervention is based on classic theories on organisational culture and leadership and dialogue, to change nurses and anaesthesiologist way of thinking and acting to improve the quality of intravascular catheters. The implementation will be leas by six facilitators. Approximately 650 register nurses and 50 anaesthesiologist will participate in the implementation program. The implementation objects are co-designed learning activities that will be implemented over one year.
Control hospital; Care as usual with or without local changes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate changes in intravascular catheter care quality and healthcare professionals' knowledge over time, at the intervention and control hospital.	The protocol monitor intravascular catheters quality, such as, thrombophlebitis/phlebitis, extravasation, infiltration and dislodgment. Points are summarized with an optimal score of zero indicating high quality in intravascular catheter management. A summative score of ≤ 1, is assessed as high quality. Thrombophlebitis, 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. The knowledge test of catheter best practices is based on the test in the Swedish Handbook for Healthcare catheter best-practice recommendations	Changes in quality of intravascular catheter care over time at the intervention and control hospital, over three years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To perform a translation and cross-cultural adaptation of an adult difficult vein access scale (A-DIVA) to Swedish context,	The adult difficult vein access scale, Adult-DIVA scale 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. 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 intervention and control 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.	From enrollment to end of completion of the validation process within one year.
Process evaluation of the Safe IVADs implementation intervention, using Medical Research Council (MRC) guidance, that is its feasibility, acceptability, fidelity, and cost-effectiveness.	The design integrates quantitative and qualitative process data, including costs, to evaluate the implementation process, and contextual factors influencing the prevention of IVAD-related complications across an intervention and a control hospital. 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) Costs: Cost-effectiveness analysis will compare incremental costs from a health system perspective (implementation, intervention, and downstream) to the incremental health outcomes; the IVADs complications.	From planning of the intervention to the end of post intervention measurement after three years.

Collaborators and Investigators

• Sponsor: Sahlgrenska University Hospital
• Investigators: Principal Investigator: Maria Frödin, Dr, Göteborg University

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: April 5, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 5, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Implementation intervention; Quality of intravascular catheters; Quality of peripheral vein cathters; Point prevalence measure of quality of intravascular catheter
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Peripheral Vascular Diseases; Vasculitis; Venous Thrombosis; Thrombosis; Phlebitis; Thrombophlebitis
• Other Study ID Numbers: 2026-00217-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not ethical approved. Only data on group level.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No