An observational study in Phlebitis, Thrombophlebitis and Infiltration of Peripheral IV Therapy, sponsored by Sahlgrenska University Hospital. Not yet recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Sahlgrenska University Hospital · Observational
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:
The main questions it aims to answer are:
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:
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
15 studies on the registry are indexed under Thrombophlebitis; 2 are open to participants now.
Browse Thrombophlebitis studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
Compared within Thrombophlebitis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Phlebitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Sahlgrenska university hospital/Mölndal
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Exclusion Criteria:
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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
Care as usual with or without local changes
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.
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 encompasses nominal variables (0 or 1) and points are summarized with an optimal score of zero indicating high intravascular catheter care quality . Thrombophlebitis is classified using a severity grading scale from 0 to 4 grades, where higher grades indicate greater symptom severity. Staff knowledge test consist of 26 question from the National Board of Health and Welfare catheter best practices. Linear mixed models will be used for longitudinal analysis of the repeated measurements of intravascular catheter quality and staff knowledge test. With additional comparisons between intervention and control hospital.
Time frame: Monthly changes in quality of intravascular catheter care over time at the intervention and control hospital, over three years.
To translate and cross-culture adapt 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.
Time frame: 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 regarding feasibility, acceptability and fidelity.
The design integrates quantitative and qualitative process data, 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)
Time frame: From planning of the intervention to the end of post intervention measurement after three years.
To evaluate the cost-effectiveness of the intervention
Cost-effectiveness analysis will compare incremental costs from a health system perspective (implementation, intervention, and downstream) to the incremental health outcomes; the IVADs complications.
Time frame: From pre-planning to end of intervention period december 2028
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — Not ethical approved. Only data on group level.
Start is estimated for Jul 2026; primary completion for Dec 2028, 29 months later.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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