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.

NCT07524608 | Not Yet Recruiting

• 1 other identifier: 2026-00217-01
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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?

Conditions

Phlebitis; Thrombophlebitis; Infiltration of Peripheral IV Therapy; Extravasation Injury; Infections Symtoms

Keywords

Quality of intravascular catheters; Quality of peripheral vein cathters; Point prevalence measure of quality of intravascular catheter; Implementation intervention

Outcome Measures

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.

  Monthly changes in quality of intravascular catheter care over time at the intervention and control hospital, over three years.

Secondary Outcomes (3)

• To translate and cross-culture adapt an adult difficult vein access scale (A-DIVA) to Swedish context.

  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.

  From planning of the intervention to the end of post intervention measurement after three years.

• To evaluate the cost-effectiveness of the intervention

  From pre-planning to end of intervention period december 2028

Study Arms (2)

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

Control hospital

Care as usual with or without local changes

Interventions

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sahlgrenska university hospital/Mölndal

You may qualify if:

• Register nurses and anesthesiologist

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska Academy, Sahlgrenska University hospital/Mölndal

Gothenburg, Sweden

Location

MeSH Terms

Conditions

Phlebitis; Thrombophlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Study Officials

• Maria Frödin, Dr

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Frödin Frödin, Dr

CONTACT

+46 0731 802487; maria.frodin@gu.se

Linda Ahlstrom, Associate professor

CONTACT

+46 070-5784636; linda.ahlstrom@gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 13, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)