Center Hospital Nancy
Vandœuvre-lès-Nancy, 54 500, France
Location status: Recruiting
Location contact
Amandine OSTERMANN
CONTACT
Côme SLOSSE
CONTACT
Côme SLOSSE
PRINCIPAL_INVESTIGATOR
Jean-Claude ORTH
SUB_INVESTIGATOR
NCT Number: NCT05935228
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.
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All sexes
Interventional
Not applicable
Vandœuvre-lès-Nancy, 54 500, France
Location status: Recruiting
Amandine OSTERMANN
CONTACT
Côme SLOSSE
CONTACT
Côme SLOSSE
PRINCIPAL_INVESTIGATOR
Jean-Claude ORTH
SUB_INVESTIGATOR
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.
Phase 2 aims to evaluate the impact of the implementation of the A-DIVA Scale (classification score for DIVA) on practitioners' approaches to the peripheral venous catheter placement. It consists of a systematic collection of peripheral venous catheter placement practices for quantitative data and a questionnaire on the opinions of professionals on the use of the A-DIVA Scale for qualitative data. The main objective of this phase is to recognize the potential appearance of changes in practices through the implementation of a score for evaluating DIVA (compared with the initial practices clarified in phase 1).
Compared to phase 1: addition of systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and assessment of overall comfort.
Interphase: (8 months) Co-construction of the decision-making tree (the A-DIVA Tool).The interphase will allow to analyze the data collected in phase 1 and phase 2 and to develop the algorithm (composed by the A-DIVA Scale and the new A-DIVA Tool).
Phase 3 (interventional: 4 months - use of the algorithm composed of the A-DIVA Scale and the Co-constructed decision-making tree [The A-DIVA Tool]): Implementation and evaluation of the algorithm in the centers. The main objective of this phase is to evaluate the impact of the algorithm on the quality of peripheral venous catheter placement.
Post processing - valorization (10 months): Data analysis and scientific production:
The post-processing will allow the analysis of all the data (phase 3 versus phase 1 in particular), the production of reports and scientific articles and the writing of the final report of the ALCOV study.
Representativeness of the sample:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patient exclusion criteria :
Exclusion criteria
for healthcare professionals: any professional not attached to the department and other professional categories.
Phase 2 aims to evaluate the impact of the implementation of the A-DIVA Scale (classification score for difficult intravenous access) on practitioners' approaches to the peripheral venous catheter placement. It consists of a systematic collection of peripheral venous catheter placement practices for quantitative data and a questionnaire of professionals' opinions on the use of the A-DIVA scale for qualitative data. The main objective of this phase is to recognize the potential appearance of changes in practices through the implementation of a tool for evaluating vascular access difficulties
The main objective of this phase is to evaluate the impact of the algorithm on the quality of peripheral venous catheter placement.
Time frame: 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).
Time frame: 8 months
Co-construct a catheter placement algorithm based on the venous access difficulty score
Time frame: 4 months
To meet this objective, caregivers' appreciation, use and feelings regarding the vascular access difficulties score and algorithm will be measured using a 23-item questionnaire scored on a 4-point Likert scale ("strongly disagree", "disagree", "agree", "strongly agree"). This questionnaire will also measure the effect of the vascular access difficulties score and the algorithm on practices.
Time frame: 8 months and 16 months
Describe how patients feel in terms of pain during care and overall comfort before and after the implementation of a catheter placement algorithm
Time frame: 8 months
Evaluate the effect of implementing the venous access difficulty score on the average number of venipunctures per patient
Time frame: 8 months ans 16 months
Assessing operators' professional practices
Time frame: 8 months ans 16 months
Assessing operators' professional practices
Time frame: 8 months ans 16 months
Assessing operators' professional practices
Time frame: 8 months ans 16 months
Assessing operators' professional practices
Time frame: 8 months ans 16 months
Strategies implemented in the event of difficulties will be measured using a multi-modality question (several answers possible): Call another practitioner, use an alternative insertion technique, choose another type of venous line, give up
Contact information is provided by the study sponsor or research team.
Central Hospital, Nancy, France
Other
Development and Evaluation of an Algorithm for Vascular Access Management - ALCOV Pilot Study
Acronym: ALCOV
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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