Development and Evaluation of an Algorithm for Vascular Access Management (ALCOV)

December 20, 2023 updated by: SLOSSE Come, Central Hospital, Nancy, France

Development and Evaluation of an Algorithm for Vascular Access Management - ALCOV Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

  1. Organization of a working group (including the investigator and volunteer caregivers): The data acquired in phase 1 and 2 will be described and presented to the professionals of each center in order to provide a basis for co-constructing the decision-making tree during the work groups.
  2. Validation of the algorithm according to the A-DIVA Scale based on literature data, research hypotheses and working group data. Presentation of the model to the care teams, validation of its acceptability and feasibility.

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.

  • Systematic collection of judgment criteria and socio-demographic and clinical characteristics of patients. Description of the care strategy implemented (algorithm). Systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and evaluation of overall comfort.
  • In relation to phase 2: implementation of the algorithm and collection of data to evaluate the implementation of the algorithm (e.g., frequency of use, optimal implementation (yes/no))

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.

  • Analysis of the satisfaction questionnaire (proposed to caregivers at the end of the study) to complete the evaluation of the implementation of the algorithm.
  • Description of the data (global and phase-by-phase) and analysis of the data to answer the formulated objectives, coding of the data from the interviews and satisfaction questionnaires, production of reports and scientific articles.

Representativeness of the sample:

- Throughout the collection process (phase 1,2 and 3) the representativeness of the sample will be assessed. The data collected for this purpose will be, for each patient who has received a peripheral venous line and who meets the inclusion criteria: Included: yes/no, if no: reason.

Study Type

Interventional

Enrollment (Estimated)

794

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Vandœuvre-lès-Nancy, France, 54 500
        • Recruiting
        • Center Hospital Nancy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Côme SLOSSE
        • Sub-Investigator:
          • Jean-Claude ORTH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Implementation of the A-DIVA Scale
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
Experimental: 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.
Other: Implementation of the algorithm composed of the A-DIVA Scale and the new decision-making tree (the A-DIVA Tool) 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.

• Systematic collection of judgment criteria and socio-demographic and clinical characteristics of patients. Description of the care strategy implemented. Systematic collection of the A-DIVA Scale with identification of the patient's risk group, systematic rating of pain and evaluation of overall comfort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1. Number of venipunctures performed per patient after implementation of the algorithm
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).
20 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2. Number of participants who approve the co-constructed algorithm.
Time Frame: 8 months
Co-construct a catheter placement algorithm based on the venous access difficulty score
8 months
3. Acceptability and feasibility of using the VAD score in isolation and the score in conjunction with the catheter placement algorithm
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.
4 months
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)
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
8 months and 16 months
5. Number of venipunctures performed per patient after implementation of the venous access difficulty score
Time Frame: 8 months
Evaluate the effect of implementing the venous access difficulty score on the average number of venipunctures per patient
8 months
Insertion technique used for catheter placement
Time Frame: 8 months ans 16 months
Assessing operators' professional practices
8 months ans 16 months
Number of operators required for catheter insertion
Time Frame: 8 months ans 16 months
Assessing operators' professional practices
8 months ans 16 months
Frequency of second-line referral to another practitioner
Time Frame: 8 months ans 16 months
Assessing operators' professional practices
8 months ans 16 months
Puncture result: success/failure
Time Frame: 8 months ans 16 months
Assessing operators' professional practices
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.
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
8 months ans 16 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Côme SLOSSE, Center Hospital Nancy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

August 9, 2025

Study Completion (Estimated)

June 9, 2026

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

July 3, 2023

First Posted (Actual)

July 7, 2023

Study Record Updates

Last Update Posted (Actual)

December 26, 2023

Last Update Submitted That Met QC Criteria

December 20, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-A00223-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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