Development and Evaluation of an Algorithm for Vascular Access Management - ALCOV Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 794
- 试验地点
- 1
- 主要终点
- 1. Number of venipunctures performed per patient after implementation of the algorithm
研究概览
简要总结
Two billion catheters are placed annually worldwide. Of all the people requiring vascular access, nearly a quarter have Difficult Intravenous access (DIVA), a source of multiple punctures. The increased risk of haematomas, haemorrhages, infection, pain and associated trauma is responsible for increased human costs and economic impact.
To limit the risks posed by the DIVA, practitioners have solutions such as the per-bone line, other types of lines, and placement of peripheral venous catheter with ultrasound or transluminescence. However, these solutions are not always applicable, depending on the care situation (non-substitutable venous access, fragile patient, etc.) or on the technical platform (available personnel and training, configuration of the premises, available equipment). Moreover, these actions are often taken after failures, in a non-anticipated and non-consensual manner.
In order to assess the risk of DIVA, F.Van Loon et al developed in 2016, and then modified in 2018, a DIVA Scale (the A-DIVA Scale) which allows a rapid scoring upstream of peripheral venous catheter placement to classify patients according to the risk of DIVA.
Composed of five items (non-palpable and non-visible vein, diameter < 3mm, history of DIVA, operator experience) worth one point each, the score allows three categories to be established: "low risk", "moderate risk", "high risk". The study showed that the proportion of first puncture failures increased with the risk of the patients (defined according to the categorized score).
The use of a tool such as the A-DIVA Scale is of interest if it allows the definition of actions to be taken in relation to the risk it identifies. In view of this, it appears essential to optimize the management of peripheral venous catheters, particularly for patients with DIVAs. The aim of this study is to develop a graduate and specific response to the issue of multiple punctures. Our project is to create and evaluate a specific algorithm, consisting of a risk assessment (the A-DIVA Scale) and a co-construct decision-making tree (the A-DIVA Tool). Built on the basis of objective clinical data collection and adapted to the possibilities and competencies, this new tool would bring real benefits to the patient in terms of safety (reduction of risks) and comfort (reduction of pain and duration of management), as well as a medico-economic benefit for the institutions. To date, such an algorithm does not exist and its beneficial effects have not been evaluated.
详细描述
This is a mixed (quantitative and qualitative), multicentre, non-randomised, quasi-experimental, before-and-after, open, cross-sectional study, with control and experimental groups and comprising three phases. This division into three data collection phases allows detailed analysis of the targeted care procedure and avoids errors of assessment of the impact of the different tools introduced in the interventional phase (the A-DIVA Scale in phase 2, then the algorithm [composed of the A-DIVA Scale and the new decision-making tree (A-DIVA Tool] in phase 3).
Phase 1 (observational: 4 months): Description of the inclusion centers and collection of pre-intervention data.
This phase will provide information on the actual practices and organization in the inclusion centers. The main objective of this phase is to provide a detailed description of existing practices for peripheral venous catheter placement in the inclusion centers.
It consists of individual semi-directive explanatory interviews with healthcare professionals in the inclusion centers, and a collection of judgment criteria (excluding the feelings of patients and caregivers concerning the implementation of the DIVA score and the catheter placement algorithm). Collection of socio-demographic and clinical characteristics of patients and description of the care strategy implemented.
Phase 2 (interventional: 4 months - implementation of the A-DIVA Scale alone): Collection of data related to the isolated implementation of a systematic scoring of the A-DIVA score.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient inclusion criteria: adult patients, initially requiring at least one peripheral venous catheter (PVC), having given their consent for the study.
- •Inclusion criteria for healthcare professionals: Nurses, specialized nurses (IADE) and physicians attached to the department.
排除标准
- •Patient exclusion criteria :
- •Minor patients
- •Patients under curators or guardianship
- •Patients who are non-communicative or unable to give consent
- •Patients not requiring a peripheral venous catheter, polytrauma patients and patients in shock (septic, hemorrhagic, cardiogenic, spinal, specific to certain centers and equipped upstream)
- •Patients who already have catheters on arrival.
- •Exclusion criteria for healthcare professionals: any professional not attached to the department and other professional categories.
研究组 & 干预措施
The control group
The control group will consist of patients included in phase 1. These are the patients from the "before" phase, i.e. before the implementation of the Difficult Intravenous Access Scale.
干预措施: Implementation of the A-DIVA Scale (Other)
The experimental group
The experimental group will consist of the patients included in phase 3. These are the patients from the "after" phases i.e after the implementation of the algorithm.
干预措施: Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) in the centers (Other)
结局指标
主要结局
1. Number of venipunctures performed per patient after implementation of the algorithm
时间窗: 20 months
Number of punctures performed per patient after implementation of the algorithm (collection according to a data grid filled in by the operator after the care).
次要结局
- Patient pain score measured immediately after vascular puncture (phase of potential acute pain during catheter insertion) using a self-assessment tool (numerical scale ranging from 0: no pain; 10: maximum pain)(8 months and 16 months)
- Insertion technique used for catheter placement(8 months ans 16 months)
- Number of operators required for catheter insertion(8 months ans 16 months)
- Frequency of second-line referral to another practitioner(8 months ans 16 months)
- Puncture result: success/failure(8 months ans 16 months)
- Care strategies implemented in the event of difficulties encountered when inserting peripheral venous lines collected by the operator at the end of care.(8 months ans 16 months)
- 2. Number of participants who approve the co-constructed algorithm.(8 months)
- 3. Acceptability and feasibility of using the VAD score in isolation and the score in conjunction with the catheter placement algorithm(4 months)
- 5. Number of venipunctures performed per patient after implementation of the venous access difficulty score(8 months)
研究者
SLOSSE Come
Principal Investigateur
Central Hospital, Nancy, France