The Safe IVADs Project
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- To evaluate changes in intravascular catheter care quality and healthcare professionals' knowledge over time, at the intervention and control hospital.
研究概览
简要总结
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:
- translate and validate a tool for identifying patients with difficult vein access within the Swedish healthcare context,
- 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?
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Register nurses and anesthesiologist
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: The Safe IVADs project (Behavioral)
Control hospital
Care as usual with or without local changes
结局指标
主要结局
To evaluate changes in intravascular catheter care quality and healthcare professionals' knowledge over time, at the intervention and control hospital.
时间窗: Changes in quality of intravascular catheter care over time at the intervention and control hospital, over three years.
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
次要结局
- To perform a translation and cross-cultural adaptation of 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, that is its feasibility, acceptability, fidelity, and cost-effectiveness.(From planning of the intervention to the end of post intervention measurement after three years.)
研究者
Maria Frödin
Principal Investigator
Sahlgrenska University Hospital