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.

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSahlgrenska University Hospital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Register nurses and anesthesiologist

Disqualifiers

None

Trial population

Sahlgrenska university hospital/Mölndal

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • The Safe IVADs project

    Behavioral

    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.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Intervention1 intervention
Group B: Control hospital0 interventions

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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

Other outcomes

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